Validation: A Family-Centered Communication Skill.

PubMed

Harvey, Pat; Ahmann, Elizabeth

2016-01-01

Family-centered care can seem challenging when family member behavior, choices, attitudes, or emotions are "difficult" or "challenging" to deal with. Yet nurses can develop skills to effectively interact with families in a wide variety of circumstances and then become able to practice family-centered care in any situation that might arise. One particularly useful skill is "validation," which means accepting what the family member says or does as a valid expression of thoughts and feelings in that particular circumstance at that particular time. Validation does not mean there is agreement or acceptance of unsafe behaviors, only that the nurse acknowledges that the family member's concerns and feelings are important and should be listened to and taken seriously, even in the presence of disagreement. Validation, which should be individualized, can take many forms, ranging from providing complete attention to reflection of statements, identification of possible unexpressed emotions, normalization, and finally, a full and genuine sense of connection. Understanding and practicing validation can empower nurses and family members, as well as support effectivefamily-centered communication and problem solving even in challenging circumstances.

Validation: a family-centered communication skill.

PubMed

Harvey, Pat; Ahmann, Elizabeth

2014-01-01

Family-centered care can seem challenging when family member behavior, choices, attitudes, or emotions are "difficult" or "challenging" to deal with. Yet nurses can develop skills to effectively interact with families in a wide variety of circumstances and then become able to practice family-centered care in any situation that might arise. One particularly useful skill is "validation," which means accepting what the family member says or does as a valid expression of thoughts and feelings in that particular circumstance at that particular time. Validation does not mean there is agreement or acceptance of unsafe behaviors, only that the nurse acknowledges that the family member's concerns and feelings are important and should be listened to and taken seriously, even in the presence of disagreement. Validation, which should be individualized, can take many forms, ranging from providing complete attention to reflection of statements, identification of possible unexpressed emotions, normalization, and finally, a full and genuine sense of connection. Understanding and practicing validation can empower nurses and family members, as well as support effective family-centered communication and problem solving, even in challenging circumstances.

Validation of the shake test for detecting freeze damage to adsorbed vaccines.

PubMed

Kartoglu, Umit; Ozgüler, Nejat Kenan; Wolfson, Lara J; Kurzatkowski, Wiesław

2010-08-01

To determine the validity of the shake test for detecting freeze damage in aluminium-based, adsorbed, freeze-sensitive vaccines. A double-blind crossover design was used to compare the performance of the shake test conducted by trained health-care workers (HCWs) with that of phase contrast microscopy as a "gold standard". A total of 475 vials of 8 different types of World Health Organization prequalified freeze-sensitive vaccines from 10 different manufacturers were used. Vaccines were kept at 5 degrees C. Selected numbers of vials from each type were then exposed to -25 degrees C and -2 degrees C for 24-hour periods. There was complete concordance between HCWs and phase-contrast microscopy in identifying freeze-damaged vials and non-frozen samples. Non-frozen samples showed a fine-grain structure under phase contrast microscopy, but freeze-damaged samples showed large conglomerates of massed precipitates with amorphous, crystalline, solid and needle-like structures. Particles in the non-frozen samples measured from 1 microm (vaccines against diphtheria-tetanus-pertussis; Haemophilus influenzae type b; hepatitis B; diphtheria-tetanus-pertussis-hepatitis B) to 20 microm (diphtheria and tetanus vaccines, alone or in combination). By contrast, aggregates in the freeze-damaged samples measured up to 700 microm (diphtheria-tetanus-pertussis) and 350 microm on average. The shake test had 100% sensitivity, 100% specificity and 100% positive predictive value in this study, which confirms its validity for detecting freeze damage to aluminium-based freeze-sensitive vaccines.

Validation of a scale to measure parental psychological empowerment in the vaccination decision.

PubMed

Marta, Fadda; Elisa, Galimberti; Luisa, Romanò; Marino, Faccini; Sabrina, Senatore; Alessandro, Zanetti; Peter J, Schulz

2017-09-21

Parents' empowerment is advocated to promote and preserve an informed and autonomous decision regarding their children' immunization. The scope of this study is to develop and evaluate the psychometric properties of an instrument to measure parents' psychological empowerment in their children's vaccination decision and propose a context-specific definition of this construct. Grounding in previous qualitative data, we generated an initial pool of items which was later content and face validated by a panel of experts. A pretest allowed us to reduce the initial pool to 9 items. Convergent and discriminant validity measures included the General Self-Efficacy Scale, a Psychological Empowerment Scale, and the Control Preference Scale. Vaccination-related outcomes such as attitude and intention were also included. Principal Component Analysis revealed a 2-factor structure, with each factor composed of 2 items. The first factor concerns the perceived influence of one's personal and family experience with vaccination, while the second factor represents the desire not to ask other parents about their experience with vaccination and their lack of interest in other parents' vaccination opinion. In light of its association with positive immunization-related outcomes, public health efforts should be directed to reinforce parents' empowerment.

Prevalence and factors associated with 2009 to 2011 influenza vaccinations at a university medical center.

PubMed

Crowley, Kathleen A; Myers, Ronnie; Magda, Lori A; Morse, Stephen S; Brandt-Rauf, Paul; Gershon, Robyn R M

2013-09-01

Information on the rates and factors associated with influenza vaccinations, although limited, is important because it can inform the development of effective vaccination campaigns in a university medical center setting. A study was conducted in 2011 to identify individual and organizational level barriers and facilitators to influenza vaccination among clinical and nonclinical personnel (N = 428) from a major university medical center. Seventy-one percent of clinical personnel (n = 170) reported pandemic H1N1 vaccination compared with 27% of nonclinical personnel (n = 258), even though vaccine was made widely available to all personnel at no cost. Similarly, disparate rates between clinical and nonclinical personnel were noted for the 2009/2010 seasonal influenza vaccine (82% vs 42%, respectively) and 2010/2011 combination (pandemic plus seasonal) influenza vaccine (73% vs 28%, respectively). Factors associated with pandemic vaccination in nonclinical personnel included the following: high level of influenza-related knowledge, concern regarding influenza contagion, history of previous influenza vaccinations or influenza illness, participation in vaccine-related training, and awareness of the institution's written pandemic plan. For clinicians, past history of seasonal influenza vaccination was associated with pandemic vaccination. For all participants, taking any 1 or more of the 3 influenza vaccines available in 2009 to 2011 was associated with intent to take a hypothetical future novel pandemic vaccine (odds ratio, 6.7; 95% confidence interval: 4.32-10.44; P < .001). Most of the risk factors associated with lack of vaccination uptake are amenable to organizational strategies. Copyright © 2013 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

PSI-Center Simulations of Validation Platform Experiments

NASA Astrophysics Data System (ADS)

Nelson, B. A.; Akcay, C.; Glasser, A. H.; Hansen, C. J.; Jarboe, T. R.; Marklin, G. J.; Milroy, R. D.; Morgan, K. D.; Norgaard, P. C.; Shumlak, U.; Victor, B. S.; Sovinec, C. R.; O'Bryan, J. B.; Held, E. D.; Ji, J.-Y.; Lukin, V. S.

2013-10-01

The Plasma Science and Innovation Center (PSI-Center - http://www.psicenter.org) supports collaborating validation platform experiments with extended MHD simulations. Collaborators include the Bellan Plasma Group (Caltech), CTH (Auburn U), FRX-L (Los Alamos National Laboratory), HIT-SI (U Wash - UW), LTX (PPPL), MAST (Culham), Pegasus (U Wisc-Madison), PHD/ELF (UW/MSNW), SSX (Swarthmore College), TCSU (UW), and ZaP/ZaP-HD (UW). Modifications have been made to the NIMROD, HiFi, and PSI-Tet codes to specifically model these experiments, including mesh generation/refinement, non-local closures, appropriate boundary conditions (external fields, insulating BCs, etc.), and kinetic and neutral particle interactions. The PSI-Center is exploring application of validation metrics between experimental data and simulations results. Biorthogonal decomposition is proving to be a powerful method to compare global temporal and spatial structures for validation. Results from these simulation and validation studies, as well as an overview of the PSI-Center status will be presented.

Optimization and Validation of ELISA for Pre-Clinical Trials of Influenza Vaccine.

PubMed

Mitic, K; Muhandes, L; Minic, R; Petrusic, V; Zivkovic, I

2016-01-01

Testing of every new vaccine involves investigation of its immunogenicity, which is based on monitoring its ability to induce specific antibodies in animals. The fastest and most sensitive method used for this purpose is enzyme-linked immunosorbent assay (ELISA). However, commercial ELISA kits with whole influenza virus antigens are not available on the market, and it is therefore essential to establish an adequate assay for testing influenza virusspecific antibodies. We developed ELISA with whole influenza virus strains for the season 2011/2012 as antigens and validated it by checking its specificity, accuracy, linearity, range, precision, and sensitivity. The results show that we developed high-quality ELISA that can be used to test immunogenicity of newly produced seasonal or pandemic vaccines in mice. The pre-existence of validated ELISA enables shortening the time from the process of vaccine production to its use in patients, which is particularly important in the case of a pandemic.

Evaluation of novel oral vaccine candidates and validation of a caprine model of Johne's disease

PubMed Central

Hines, Murray E.; Turnquist, Sue E.; Ilha, Marcia R. S.; Rajeev, Sreekumari; Jones, Arthur L.; Whittington, Lisa; Bannantine, John P.; Barletta, Raúl G.; Gröhn, Yrjö T.; Katani, Robab; Talaat, Adel M.; Li, Lingling; Kapur, Vivek

2014-01-01

Johne's disease (JD) caused by Mycobacterium avium subspecies paratuberculosis (MAP) is a major threat to the dairy industry and possibly some cases of Crohn's disease in humans. A MAP vaccine that reduced of clinical disease and/or reduced fecal shedding would aid in the control of JD. The objectives of this study were (1) to evaluate the efficacy of 5 attenuated strains of MAP as vaccine candidates compared to a commercial control vaccine using the protocol proposed by the Johne's Disease Integrated Program (JDIP) Animal Model Standardization Committee (AMSC), and (2) to validate the AMSC Johne's disease goat challenge model. Eighty goat kids were vaccinated orally twice at 8 and 10 weeks of age with an experimental vaccine or once subcutaneously at 8 weeks with Silirum® (Zoetis), or a sham control oral vaccine at 8 and 10 weeks. Kids were challenged orally with a total of approximately 1.44 × 109 CFU divided in two consecutive daily doses using MAP ATCC-700535 (K10-like bovine isolate). All kids were necropsied at 13 months post-challenge. Results indicated that the AMSC goat challenge model is a highly efficient and valid model for JD challenge studies. None of the experimental or control vaccines evaluated prevented MAP infection or eliminated fecal shedding, although the 329 vaccine lowered the incidence of infection, fecal shedding, tissue colonization and reduced lesion scores, but less than the control vaccine. Based on our results the relative performance ranking of the experimental live-attenuated vaccines evaluated, the 329 vaccine was the best performer, followed by the 318 vaccine, then 316 vaccine, 315 vaccine and finally the 319 vaccine was the worst performer. The subcutaneously injected control vaccine outperformed the orally-delivered mutant vaccine candidates. Two vaccines (329 and 318) do reduce presence of JD gross and microscopic lesions, slow progression of disease, and one vaccine (329) reduced fecal shedding and tissue colonization. PMID

User-Centered Design for Developing Interventions to Improve Clinician Recommendation of Human Papillomavirus Vaccination

PubMed Central

Henninger, Michelle L; McMullen, Carmit K; Firemark, Alison J; Naleway, Allison L; Henrikson, Nora B; Turcotte, Joseph A

2017-01-01

Introduction Human papillomavirus (HPV) is the most common sexually transmitted infection in the US and is associated with multiple types of cancer. Although effective HPV vaccines have been available since 2006, coverage rates in the US remain much lower than with other adolescent vaccinations. Prior research has shown that a strong recommendation from a clinician is a critical determinant in HPV vaccine uptake and coverage. However, few published studies to date have specifically addressed the issue of helping clinicians communicate more effectively with their patients about the HPV vaccine. Objective To develop one or more novel interventions for helping clinicians make strong and effective recommendations for HPV vaccination. Methods Using principles of user-centered design, we conducted qualitative interviews, interviews with persons from analogous industries, and a data synthesis workshop with multiple stakeholders. Results Five potential intervention strategies targeted at health care clinicians, youth, and their parents were developed. The two most popular choices to pursue were a values-based communication strategy and a puberty education workbook. Conclusion User-centered design is a useful strategy for developing potential interventions to improve the rate and success of clinicians recommending the HPV vaccine. Further research is needed to test the effectiveness and acceptability of these interventions in clinical settings. PMID:28898195

User-Centered Design for Developing Interventions to Improve Clinician Recommendation of Human Papillomavirus Vaccination.

PubMed

Henninger, Michelle L; Mcmullen, Carmit K; Firemark, Alison J; Naleway, Allison L; Henrikson, Nora B; Turcotte, Joseph A

2017-01-01

Human papillomavirus (HPV) is the most common sexually transmitted infection in the US and is associated with multiple types of cancer. Although effective HPV vaccines have been available since 2006, coverage rates in the US remain much lower than with other adolescent vaccinations. Prior research has shown that a strong recommendation from a clinician is a critical determinant in HPV vaccine uptake and coverage. However, few published studies to date have specifically addressed the issue of helping clinicians communicate more effectively with their patients about the HPV vaccine. To develop one or more novel interventions for helping clinicians make strong and effective recommendations for HPV vaccination. Using principles of user-centered design, we conducted qualitative interviews, interviews with persons from analogous industries, and a data synthesis workshop with multiple stakeholders. Five potential intervention strategies targeted at health care clinicians, youth, and their parents were developed. The two most popular choices to pursue were a values-based communication strategy and a puberty education workbook. User-centered design is a useful strategy for developing potential interventions to improve the rate and success of clinicians recommending the HPV vaccine. Further research is needed to test the effectiveness and acceptability of these interventions in clinical settings.

[Adverse effects of seasonal flu vaccine and new influenza A (H1N1) vaccine in health care workers].

PubMed

Torruella, Joan Inglés; Soto, Rosa Gil; Valls, Rosa Carreras; Lozano, Judit Valverde; Carreras, Dolors Benito; Cunillera, Arnau Besora

2013-01-01

To assess and compare adverse effects of Seasonal Influenza Vaccine (SIV) and new Influenza A(H1N1) Vaccine (AIV) in health care workers. Multicenter cross-sectional study in health care workers from acute care hospitals, primary health care centers, social centers, mental health centers and a geriatric hospital participating in the 2009 vaccination campaign. Self-administered questionnaires were sent to all workers vaccinated with SIV and/or AIV. 527 valid questionnaires were collected out of 1123 sent to SIV vaccinated workers (46.9%), and 241 out of 461 sent to AIV vaccinated workers (52.%%). Participant workers include 527 vaccinated only with SIV, 117 first vaccinated with SIV and later with AIV (SIV+AIV), and 125 vaccinated only with AIV. Overall, 18.4% (95%CI 15.1-21.7) of workers vaccinated only with SIV reported adverse effects, as compared to 45.3% (95I 36.3-54.3) reporting adverse effects to AIV in the SIV+AIV group and 46.4% (95%CI 37.7-55.1) of workers vaccinated only with AIV. In all participants the most common adverseeffect was a local reaction. Women wre more reactive to both SIV and AIV than men. In all age groups SIV vaccination alone caused fewer reactions that either AIV only or the combination of SIV+AIV, with the exception of workers below 29 years of age. AIV was associated with more reactions than SIV, with no differences observed in relation to administration sequence. There were differences by sex and age, but reactions always occurred more commonly with AIV. Copyright belongs to the Societat Catalana de Seguretat i Medicina del Treball.

Development and psychometric validation of a self-administered questionnaire assessing the acceptance of influenza vaccination: the Vaccinees' Perception of Injection (VAPI©) questionnaire

PubMed Central

Chevat, Catherine; Viala-Danten, Muriel; Dias-Barbosa, Carla; Nguyen, Van Hung

2009-01-01

Background Influenza is among the most common infectious diseases. The main protection against influenza is vaccination. A self-administered questionnaire was developed and validated for use in clinical trials to assess subjects' perception and acceptance of influenza vaccination and its subsequent injection site reactions (ISR). Methods The VAPI questionnaire was developed based on interviews with vaccinees. The initial version was administered to subjects in international clinical trials comparing intradermal with intramuscular influenza vaccination. Item reduction and scale construction were carried out using principal component and multitrait analyses (n = 549). Psychometric validation of the final version was conducted per country (n = 5,543) and included construct and clinical validity and internal consistency reliability. All subjects gave their written informed consent before being interviewed or included in the clinical studies. Results The final questionnaire comprised 4 dimensions ("bother from ISR"; "arm movement"; "sleep"; "acceptability") grouping 16 items, and 5 individual items (anxiety before vaccination; bother from pain during vaccination; satisfaction with injection system; willingness to be vaccinated next year; anxiety about vaccination next year). Construct validity was confirmed for all scales in most of the countries. Internal consistency reliability was good for all versions (Cronbach's alpha ranging from 0.68 to 0.94), as was clinical validity: scores were positively correlated with the severity of ISR and pain. Conclusion The VAPI questionnaire is a valid and reliable tool, assessing the acceptance of vaccine injection and reactions following vaccination. Trial registration NCT00258934, NCT00383526, NCT00383539. PMID:19261173

Tetanus vaccination status and its associated factors among women attending a primary healthcare center in Cairo governorate, Egypt.

PubMed

Hassan, Azza M; Shoman, Ahmed E; Abo-Elezz, Nahla F; Amer, Marwa M

2016-09-01

Maintaining maternal and neonatal tetanus (MNT) elimination status in Egypt requires continued strengthening of routine tetanus toxoid (TT) immunization services for pregnant women. To measure the frequency rate of TT vaccination among women attending the well-baby clinic at the El-Darb El-Ahmar primary healthcare center in Cairo governorate and to identify different associated factors. This was a cross sectional study that targeted 277 mothers who attended the well-baby clinic at the El-Darb El-Ahmar primary healthcare center. Mothers were interviewed by a questionnaire inquiring about their sociodemographic characteristics, obstetric history, details of the last pregnancy, TT vaccination status and knowledge of the TT vaccine, and MNT disease. The results showed that 60.6% had taken all required doses of TT vaccine and 42.6% of the mothers studied were fully protected against MNT in their last birth. The rate of vaccination was found to be affected by mothers' socioeconomic level, education level, place of receiving antenatal care, health education about importance of TT vaccine, knowledge of mothers about NT disease and TT vaccine and the source of this knowledge.

[Vaccine cold chain interruption in a primary care center and economic evaluation].

PubMed

Larena Fernández, Israel; Vara Callau, Marta; Peña Blasco, Guillermo; Atance Melendo, Esther; Gay Gasanz, Blanca; Pérez-Aramendía, María Jesús Blasco

Cold chain control is one of the most important facts to ensure the effectiveness of vaccines links, which requires specific material and human resources for management. The principal objective is to evaluate the interruptions in cold chain of the last 6 years and the possible cost savings that would result in further improvements. A retrospective and descriptive study based on a review of all cold chain interruptions during the last 6 years, at Valdefierro Primary Health Center. We had 5 interruptions, the maximum temperature reached was 23.1±3.4°C and the longest interruption lasted 25.2±20.7hours. 1611 vaccines were affected and 165 discarded. Total economic loss was 2.098,10 € and 33.611,64 € were savings. The electrical failure was the disruption cause in 5 cases. Equipment and staff are essential. The center did some corrective actions, such as minimizing refrigerator time control, minimum stock control, considering population changes, and the center has requested a electrical supply system. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

Quality of travel health advice in a French travel medicine and vaccine center: a prospective observational study.

PubMed

Bouldouyre, Marie-Anne; De Verdière, Nathalie Colin; Pavie, Juliette; De Castro, Nathalie; Ponscarme, Diane; Hamane, Samia; Rachline, Anne; Ferret, Samuel; Molina, Jean-Michel

2012-01-01

The number of international trips undertaken by French citizens is rising and we wished to assess the appropriateness of advices given to travelers in a vaccine and travel medicine center in France. We conducted a 3-month prospective study in one center in Paris where prescriptions and advice to travelers are given by trained physicians in travel medicine who have access to a computerized decision support system (Edisan). A questionnaire was used to record trip characteristics, patients' demographics, and prescriptions. Main outcome measure was the adequacy of prescriptions for malaria prophylaxis, yellow fever, and hepatitis A vaccines to French guidelines. A total of 730 subjects were enrolled in this study, with a median age of 28 years. Travel destinations were sub-Saharan Africa (58%), Asia (21%), and South America (18%). Among the 608 patients (83%) traveling to malaria-endemic areas, malaria prophylaxis was in accordance with guidelines in 578/608 patients (95.1%, 95% CI: 93-96.5), and doxycycline was the regimen of choice (48%). Inappropriate malaria prophylaxis was given to eight patients, one of whom developed plasmodium falciparum malaria. All 413 patients (100%, 95% CI: 99-100) traveling to yellow fever-endemic areas who needed vaccination were correctly vaccinated. However, three patients received yellow fever vaccination without indication. Also, 442 of 454 patients (97.4%, 95% CI: 95.4-98.5) eligible to receive hepatitis A vaccination were immunized. Appropriate advice for malaria prophylaxis, yellow fever, and hepatitis A vaccinations was provided in a travel medicine and vaccine center where trained physicians used a computerized decision support system. Even in this setting, however, errors can occur and professional practices should be regularly assessed to improve health care. © 2012 International Society of Travel Medicine.

Educating parents about the vaccination status of their children: A user-centered mobile application.

PubMed

Seeber, Lea; Conrad, Tim; Hoppe, Christian; Obermeier, Patrick; Chen, Xi; Karsch, Katharina; Muehlhans, Susann; Tief, Franziska; Boettcher, Sindy; Diedrich, Sabine; Schweiger, Brunhilde; Rath, Barbara

2017-03-01

Parents are often uncertain about the vaccination status of their children. In times of vaccine hesitancy, vaccination programs could benefit from active patient participation. The Vaccination App ( VAccApp ) was developed by the Vienna Vaccine Safety Initiative, enabling parents to learn about the vaccination status of their children, including 25 different routine, special indication and travel vaccines listed in the WHO Immunization Certificate of Vaccination (WHO-ICV). Between 2012 and 2014, the VAccApp was validated in a hospital-based quality management program in Berlin, Germany, in collaboration with the Robert Koch Institute. Parents of 178 children were asked to transfer the immunization data of their children from the WHO-ICV into the VAccApp . The respective WHO-ICV was photocopied for independent, professional data entry (gold standard). Demonstrating the status quo in vaccine information reporting, a Recall Group of 278 parents underwent structured interviews for verbal immunization histories, without the respective WHO-ICV. Only 9% of the Recall Group were able to provide a complete vaccination status; on average 39% of the questions were answered correctly. Using the WHO-ICV with the help of the VAccApp resulted in 62% of parents providing a complete vaccination status; on average 95% of the questions were answered correctly. After using the VAccApp , parents were more likely to remember key aspects of the vaccination history. User-friendly mobile applications empower parents to take a closer look at the vaccination record, thereby taking an active role in providing accurate vaccination histories. Parents may become motivated to ask informed questions and to keep vaccinations up-to-date.

Bridging the Gap Between Validation and Implementation of Non-Animal Veterinary Vaccine Potency Testing Methods

PubMed Central

Dozier, Samantha; Brown, Jeffrey; Currie, Alistair

2011-01-01

Simple Summary Many vaccines are tested for quality in experiments that require the use of large numbers of animals in procedures that often cause significant pain and distress. Newer technologies have fostered the development of vaccine quality control tests that reduce or eliminate the use of animals, but the availability of these newer methods has not guaranteed their acceptance by regulators or use by manufacturers. We discuss a strategic approach that has been used to assess and ultimately increase the use of non-animal vaccine quality tests in the U.S. and U.K. Abstract In recent years, technologically advanced high-throughput techniques have been developed that replace, reduce or refine animal use in vaccine quality control tests. Following validation, these tests are slowly being accepted for use by international regulatory authorities. Because regulatory acceptance itself has not guaranteed that approved humane methods are adopted by manufacturers, various organizations have sought to foster the preferential use of validated non-animal methods by interfacing with industry and regulatory authorities. After noticing this gap between regulation and uptake by industry, we began developing a paradigm that seeks to narrow the gap and quicken implementation of new replacement, refinement or reduction guidance. A systematic analysis of our experience in promoting the transparent implementation of validated non-animal vaccine potency assays has led to the refinement of our paradigmatic process, presented here, by which interested parties can assess the local regulatory acceptance of methods that reduce animal use and integrate them into quality control testing protocols, or ensure the elimination of peripheral barriers to their use, particularly for potency and other tests carried out on production batches. PMID:26486625

Evaluation of travel medicine practice by yellow fever vaccination centers in England, Wales, and Northern Ireland.

PubMed

Boddington, Nicola L; Simons, Hilary; Launders, Naomi; Gawthrop, Mary; Stillwell, Alexandra; Wong, Claire; Mathewson, John; Hill, David R

2012-01-01

The National Travel Health Network and Centre (NaTHNaC) introduced a program of registration, training, standards, and audit for yellow fever vaccination centers (YFVCs) in England, Wales, and Northern Ireland (EWNI) in 2005. Prior to rolling out the program, NaTHNaC surveyed YFVCs in England. To reassess the practice of YFVCs in 2009, 4 years after the institution of the NaTHNaC program, to identify areas for ongoing support, and to assess the impact of the program. In 2009, all YFVCs in EWNI were asked to complete a questionnaire on type of practice, administration of travel vaccines, staff training, vaccine storage and patient record keeping, use of travel health information, evaluation of NaTHNaC yellow fever (YF) training, and resource and training needs. Data were analyzed using Microsoft Excel® and STATA 9®. The questionnaire was completed by 1,438 YFVCs (41.5% of 3,465 YFVCs). Most YFVCs were based in General Practice (87.4%). In nearly all YFVCs (97.0%), nurses advised travelers and administered YF vaccine. An annual median of 50 doses of YF vaccine was given by each YFVC. A total of 96.7% of nurses had received training in travel medicine, often through study days run by vaccine manufacturers. The internet was frequently used for information during travel consultations (84.8%) and NaTHNaC's on-line and telephone advice resources were highly rated. Following YF training, 95.8% of attendees expressed improved confidence regarding YF vaccination issues. There was excellent adherence to vaccination standards: ≥ 94% correctly stored vaccines, recorded refrigerator temperatures, and maintained YF vaccination records. In the 4 years since institution of the NaTHNaC program for YFVCs, there has been improved adherence to basic standards of immunization practice and increased confidence of health professionals in YF vaccination. The NaTHNaC program could be a model for other national public health bodies, as they establish a program for YF centers. © 2012

Vaccines 2.0 | Center for Cancer Research

Cancer.gov

In 1974, Jay A. Berzofsky, M.D., Ph.D., now Chief of CCR’s Vaccine Branch, came to NIH to study protein folding. His curious mind and collaborative spirit quickly led him into the intertwined fields of immunology and vaccine development. With close to 500 publications to his name, Berzofsky has pioneered the characterization of B- and T-cell epitopes and their modification to make vaccines directed against cancer and chronic infectious diseases. He has also characterized and taken advantage of the cellular and molecular regulators of immune responses in order to enhance tumor immunity and vaccine efficacy. In the last several years, he has translated many of these strategies into promising clinical trials. From the microcosm of his laboratory, he brings the same spirit of cross-fertilizing, bench-to-bedside research to leading the Vaccine Branch as a whole.

Achieving the national health objective for influenza immunization: success of an institution-wide vaccination program.

PubMed

Nichol, K L; Korn, J E; Margolis, K L; Poland, G A; Petzel, R A; Lofgren, R P

1990-08-01

To enhance influenza vaccination rates for high-risk outpatients at the Department of Veterans Affairs Medical Center (VAMC) in Minneapolis, Minnesota, an institution-wide immunization program was implemented during 1987. The program consisted of: (1) a hospital policy allowing nurses to vaccinate without a signed physician's order; (2) stamped reminders on all clinic progress notes; (3) a 2-week walk-in flu shot clinic; (4) influenza vaccination "stations" in the busiest clinic areas; and (5) a mailing to all outpatients. Risk characteristics and vaccination rates for patients were estimated from a validated self-administered postcard questionnaire mailed to 500 randomly selected outpatients. For comparison, 500 patients were surveyed from each of three other Midwestern VAMCs without similar programs. Overall, 70.6% of Minneapolis patients were high-risk and 58.3% of them were vaccinated. In contrast, 69.9% of patients at the comparison medical centers were high-risk, but only 29.9% of them were vaccinated. The Minneapolis VAMC influenza vaccination program was highly successful and may serve as a useful model for achieving the national health objective for influenza immunization.

Validating a Technology Enhanced Student-Centered Learning Model

ERIC Educational Resources Information Center

Kang, Myunghee; Hahn, Jungsun; Chung, Warren

2015-01-01

The Technology Enhanced Student Centered Learning (TESCL) Model in this study presents the core factors that ensure the quality of learning in a technology-supported environment. Although the model was conceptually constructed using a student-centered learning framework and drawing upon previous studies, it should be validated through real-world…

Bridging the Gap Between Validation and Implementation of Non-Animal Veterinary Vaccine Potency Testing Methods.

PubMed

Dozier, Samantha; Brown, Jeffrey; Currie, Alistair

2011-11-29

In recent years, technologically advanced high-throughput techniques have been developed that replace, reduce or refine animal use in vaccine quality control tests. Following validation, these tests are slowly being accepted for use by international regulatory authorities. Because regulatory acceptance itself has not guaranteed that approved humane methods are adopted by manufacturers, various organizations have sought to foster the preferential use of validated non-animal methods by interfacing with industry and regulatory authorities. After noticing this gap between regulation and uptake by industry, we began developing a paradigm that seeks to narrow the gap and quicken implementation of new replacement, refinement or reduction guidance. A systematic analysis of our experience in promoting the transparent implementation of validated non-animal vaccine potency assays has led to the refinement of our paradigmatic process, presented here, by which interested parties can assess the local regulatory acceptance of methods that reduce animal use and integrate them into quality control testing protocols, or ensure the elimination of peripheral barriers to their use, particularly for potency and other tests carried out on production batches.

IN² Program Validates Data Center Cooling Solution | News | NREL

Science.gov Websites

IN2 Program Validates Data Center Cooling Solution February 21, 2018 IN2 Program Validates Data Center Cooling Solution NREL researchers and LiquidCool Solutions representatives stand along-side centers on average consuming an estimated 70 billion kWh per year, a disruptive energy-saving solution is

Ecological validity of cost-effectiveness models of universal HPV vaccination: a protocol for a systematic review.

PubMed

Favato, Giampiero; Noikokyris, Emmanouil; Vecchiato, Riccardo

2017-01-25

Sexually transmitted infection with high-risk, oncogenic strains of human papillomavirus (HPV) still induces a relevant burden of diseases on both men and women. Although vaccines appear to be highly efficacious in preventing the infection of the most common high-risk strains (HPV 6, 11, 16, 18), important questions regarding the appropriate target population for prophylactic vaccination are still debated. Models in the extant literature seem to converge on the cost-effectiveness of high coverage (>80%) of a single cohort of 12-year-old girls. This vaccination strategy should provide an adequate level of indirect protection (herd immunity) to the unvaccinated boys. This argument presupposes the ecological validity of the cost-effectiveness models; the implicit condition that the characteristics of the individuals and the sexual behaviours observed in the models is generalisable to the natural behaviours of the population. The primary aim of this review is to test the ecological validity of the cost-effectiveness models of universal HPV vaccination available in the literature. The ecological validity of each model will be defined by the number of representative characteristics and behaviours taken into consideration. Nine bibliographic databases will be searched: MEDLINE (via PubMed); Scopus; Science Direct; EMBASE via OVID SP, Web of Science, DARE, NHIR EED and HTA (via NHIR CRD); and CINHAL Plus. An additional search for grey literature will be conducted on Google Scholar and Open Grey. A search strategy will be developed for each of the databases. Data will be extracted following a pre-determined spreadsheet and then clustered and prioritised: the main outcomes will report the inputs to the demographic and epidemiological model, while additional outcomes will refer to basic inputs to the cost-effectiveness valuation. Each study included in the review will be scored by the number of representative characteristics and behaviours taken into consideration (yes or no

Factors that influence vaccination decision-making by parents who visit an anthroposophical child welfare center: a focus group study.

PubMed

Harmsen, Irene A; Ruiter, Robert A C; Paulussen, Theo G W; Mollema, Liesbeth; Kok, Gerjo; de Melker, Hester E

2012-01-01

In recent years, parents have become more disparaging towards childhood vaccination. One group that is critical about the National Immunization Program (NIP) and participates less comprises parents with an anthroposophical worldview. Despite the fact that various studies have identified anthroposophists as critical parents with lower vaccination coverage, no research has been done to explore the beliefs underlying their childhood vaccination decision-making. We conducted a qualitative study using three focus groups (n = 16) of parents who visit an anthroposophical child welfare center. Our findings show that participants did not refuse all vaccinations within the Dutch NIP, but mostly refused the Mumps, Measles, and Rubella (MMR) vaccination. Vaccination decisions are influenced by participants' lifestyle, perception of health, beliefs about childhood diseases, perceptions about the risks of diseases, perceptions about vaccine effectiveness and vaccine components, and trust in institutions. Parents indicated that they felt a need for more information. Sufficient references should be provided to sources containing more information about childhood vaccination, especially about the effectiveness of vaccines and vaccine components and the risks, such as possible side effects and benefits of vaccination. This may satisfy parents' information needs and enable them to make a sufficiently informed choice whether or not to vaccinate their child.

Progress in Vaccine-Preventable and Respiratory Infectious Diseases-First 10 Years of the CDC National Center for Immunization and Respiratory Diseases, 2006-2015.

PubMed

Schuchat, Anne; Anderson, Larry J; Rodewald, Lance E; Cox, Nancy J; Hajjeh, Rana; Pallansch, Mark A; Messonnier, Nancy E; Jernigan, Daniel B; Wharton, Melinda

2018-07-01

The need for closer linkages between scientific and programmatic areas focused on addressing vaccine-preventable and acute respiratory infections led to establishment of the National Center for Immunization and Respiratory Diseases (NCIRD) at the Centers for Disease Control and Prevention. During its first 10 years (2006-2015), NCIRD worked with partners to improve preparedness and response to pandemic influenza and other emergent respiratory infections, provide an evidence base for addition of 7 newly recommended vaccines, and modernize vaccine distribution. Clinical tools were developed for improved conversations with parents, which helped sustain childhood immunization as a social norm. Coverage increased for vaccines to protect adolescents against pertussis, meningococcal meningitis, and human papillomavirus-associated cancers. NCIRD programs supported outbreak response for new respiratory pathogens and oversaw response of the Centers for Disease Control and Prevention to the 2009 influenza A(H1N1) pandemic. Other national public health institutes might also find closer linkages between epidemiology, laboratory, and immunization programs useful.

Validity of the estimates of oral cholera vaccine effectiveness derived from the test-negative design.

PubMed

Ali, Mohammad; You, Young Ae; Sur, Dipika; Kanungo, Suman; Kim, Deok Ryun; Deen, Jacqueline; Lopez, Anna Lena; Wierzba, Thomas F; Bhattacharya, Sujit K; Clemens, John D

2016-01-20

The test-negative design (TND) has emerged as a simple method for evaluating vaccine effectiveness (VE). Its utility for evaluating oral cholera vaccine (OCV) effectiveness is unknown. We examined this method's validity in assessing OCV effectiveness by comparing the results of TND analyses with those of conventional cohort analyses. Randomized controlled trials of OCV were conducted in Matlab (Bangladesh) and Kolkata (India), and an observational cohort design was used in Zanzibar (Tanzania). For all three studies, VE using the TND was estimated from the odds ratio (OR) relating vaccination status to fecal test status (Vibrio cholerae O1 positive or negative) among diarrheal patients enrolled during surveillance (VE= (1-OR)×100%). In cohort analyses of these studies, we employed the Cox proportional hazard model for estimating VE (=1-hazard ratio)×100%). OCV effectiveness estimates obtained using the TND (Matlab: 51%, 95% CI:37-62%; Kolkata: 67%, 95% CI:57-75%) were similar to the cohort analyses of these RCTs (Matlab: 52%, 95% CI:43-60% and Kolkata: 66%, 95% CI:55-74%). The TND VE estimate for the Zanzibar data was 94% (95% CI:84-98%) compared with 82% (95% CI:58-93%) in the cohort analysis. After adjusting for residual confounding in the cohort analysis of the Zanzibar study, using a bias indicator condition, we observed almost no difference in the two estimates. Our findings suggest that the TND is a valid approach for evaluating OCV effectiveness in routine vaccination programs. Copyright © 2015 Elsevier Ltd. All rights reserved.

USDA regulatory guidelines and practices for veterinary Leptospira vaccine potency testing.

PubMed

Srinivas, G B; Walker, A; Rippke, B

2013-09-01

Batch-release potency testing of leptospiral vaccines licensed by the United States Department of Agriculture (USDA) historically was conducted through animal vaccination-challenge models. The hamster vaccination-challenge assay was Codified in 1974 for bacterins containing Leptospira pomona, Leptospira icterohaemorrhagiae, and Leptospira canicola, and in 1975 for bacterins containing Leptospira grippotyphosa. In brief, 10 hamsters are vaccinated with a specified dilution of bacterin. After a holding period, the vaccinated hamsters, as well as nonvaccinated controls, are challenged with virulent Leptospira and observed for mortality. Eighty percent of vaccinated hamsters must survive in the face of a valid challenge. The high cost of the Codified tests, in terms of monetary expense and animal welfare, prompted the Center for Veterinary Biologics (CVB) to develop ELISA alternatives for them. Potency tests for other serogroups, such as Leptospira hardjo-bovis, that do not have Codified requirements for potency testing continue to be examined on a case-by-case basis. Published by Elsevier Ltd.

Validation of current procedural terminology codes for rotavirus vaccination among infants in two commercially insured US populations.

PubMed

Hoffman, Veena; Everage, Nicholas J; Quinlan, Scott C; Skerry, Kathleen; Esposito, Daina; Praet, Nicolas; Rosillon, Dominique; Holick, Crystal N; Dore, David D

2016-12-01

We validated procedure codes used in health insurance claims for reimbursement of rotavirus vaccination by comparing claims for monovalent live-attenuated human rotavirus vaccine (RV1) and live, oral pentavalent rotavirus vaccine (RV5) to medical records. Using administrative data from two commercially insured United States populations, we randomly sampled vaccination claims for RV1 and RV5 from a cohort of infants aged less than 1 year from an ongoing post-licensure safety study of rotavirus vaccines. The codes for RV1 and RV5 found in claims were confirmed through medical record review. The positive predictive value (PPV) of the Current Procedural Terminology codes for RV1 and RV5 was calculated as the number of medical record-confirmed vaccinations divided by the number of medical records obtained. Medical record review confirmed 92 of 104 RV1 vaccination claims (PPV: 88.5%; 95% CI: 80.7-93.9%) and 98 of 113 RV5 vaccination claims (PPV: 86.7%; 95% CI: 79.1-92.4%). Among the 217 medical records abstracted, only three (1.4%) of vaccinations were misclassified in claims-all were RV5 misclassified as RV1. The medical records corresponding to 9 RV1 and 15 RV5 claims contained insufficient information to classify the type of rotavirus vaccine. Misclassification of rotavirus vaccines is infrequent within claims. The PPVs reported here are conservative estimates as those with insufficient information in the medical records were assumed to be incorrectly coded in the claims. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Motivation for HPV Vaccination Among Young Adult Men: Validation of TTM Decisional Balance and Self-Efficacy Constructs.

PubMed

Fernandez, Anne C; Amoyal, Nicole R; Paiva, Andrea L; Prochaska, James O

2016-01-01

In the United States, 36% of human papillomavirus (HPV)-related cancers occur among men. HPV vaccination can substantially reduce the risk of HPV infection; however, the vast majority of men are unvaccinated. This study developed and validated transtheoretical model-based measures for HPV vaccination in young adult men. Cross-sectional measurement development. Online survey of young adult men. Three hundred twenty-nine mostly college-attending men, ages 18 to 26. Stage of change, decisional balance (pros/cons), and self-efficacy. The sample was randomly split into halves for exploratory principal components analysis (PCA), followed by confirmatory factor analyses (CFA) to test measurement models. Multivariate analyses examined relationships between scales. For decisional balance, PCA revealed two uncorrelated five-item factors (pros α = .78; cons α = .83). For the self-efficacy scale, PCA revealed a single-factor solution (α = .83). CFA confirmed that the two-factor uncorrelated model for decisional balance and a single-factor model for self-efficacy. Follow-up analyses of variance supported the theoretically predicted relationships between stage of change, pros, and self-efficacy. This study resulted in reliable and valid measures of pros and self-efficacy for HPV vaccination that can be used in future clinical research.

A qualitatively validated mathematical-computational model of the immune response to the yellow fever vaccine.

PubMed

Bonin, Carla R B; Fernandes, Guilherme C; Dos Santos, Rodrigo W; Lobosco, Marcelo

2018-05-25

Although a safe and effective yellow fever vaccine was developed more than 80 years ago, several issues regarding its use remain unclear. For example, what is the minimum dose that can provide immunity against the disease? A useful tool that can help researchers answer this and other related questions is a computational simulator that implements a mathematical model describing the human immune response to vaccination against yellow fever. This work uses a system of ten ordinary differential equations to represent a few important populations in the response process generated by the body after vaccination. The main populations include viruses, APCs, CD8+ T cells, short-lived and long-lived plasma cells, B cells and antibodies. In order to qualitatively validate our model, four experiments were carried out, and their computational results were compared to experimental data obtained from the literature. The four experiments were: a) simulation of a scenario in which an individual was vaccinated against yellow fever for the first time; b) simulation of a booster dose ten years after the first dose; c) simulation of the immune response to the yellow fever vaccine in individuals with different levels of naïve CD8+ T cells; and d) simulation of the immune response to distinct doses of the yellow fever vaccine. This work shows that the simulator was able to qualitatively reproduce some of the experimental results reported in the literature, such as the amount of antibodies and viremia throughout time, as well as to reproduce other behaviors of the immune response reported in the literature, such as those that occur after a booster dose of the vaccine.

Nucleoside-modified mRNA vaccines induce potent T follicular helper and germinal center B cell responses.

PubMed

Pardi, Norbert; Hogan, Michael J; Naradikian, Martin S; Parkhouse, Kaela; Cain, Derek W; Jones, Letitia; Moody, M Anthony; Verkerke, Hans P; Myles, Arpita; Willis, Elinor; LaBranche, Celia C; Montefiori, David C; Lobby, Jenna L; Saunders, Kevin O; Liao, Hua-Xin; Korber, Bette T; Sutherland, Laura L; Scearce, Richard M; Hraber, Peter T; Tombácz, István; Muramatsu, Hiromi; Ni, Houping; Balikov, Daniel A; Li, Charles; Mui, Barbara L; Tam, Ying K; Krammer, Florian; Karikó, Katalin; Polacino, Patricia; Eisenlohr, Laurence C; Madden, Thomas D; Hope, Michael J; Lewis, Mark G; Lee, Kelly K; Hu, Shiu-Lok; Hensley, Scott E; Cancro, Michael P; Haynes, Barton F; Weissman, Drew

2018-06-04

T follicular helper (Tfh) cells are required to develop germinal center (GC) responses and drive immunoglobulin class switch, affinity maturation, and long-term B cell memory. In this study, we characterize a recently developed vaccine platform, nucleoside-modified, purified mRNA encapsulated in lipid nanoparticles (mRNA-LNPs), that induces high levels of Tfh and GC B cells. Intradermal vaccination with nucleoside-modified mRNA-LNPs encoding various viral surface antigens elicited polyfunctional, antigen-specific, CD4 + T cell responses and potent neutralizing antibody responses in mice and nonhuman primates. Importantly, the strong antigen-specific Tfh cell response and high numbers of GC B cells and plasma cells were associated with long-lived and high-affinity neutralizing antibodies and durable protection. Comparative studies demonstrated that nucleoside-modified mRNA-LNP vaccines outperformed adjuvanted protein and inactivated virus vaccines and pathogen infection. The incorporation of noninflammatory, modified nucleosides in the mRNA is required for the production of large amounts of antigen and for robust immune responses. © 2018 Pardi et al.

Validation of decisional balance and self-efficacy measures for HPV vaccination in college women.

PubMed

Lipschitz, Jessica M; Fernandez, Anne C; Larson, H Elsa; Blaney, Cerissa L; Meier, Kathy S; Redding, Colleen A; Prochaska, James O; Paiva, Andrea L

2013-01-01

Women younger than 25 years are at greatest risk for human papillomavirus (HPV) infection, including high-risk strains associated with 70% of cervical cancers. Effective model-based measures that can lead to intervention development to increase HPV vaccination rates are necessary. This study validated Transtheoretical Model measures of Decisional Balance and Self-Efficacy for seeking the HPV vaccine in a sample of female college students. Cross-sectional measurement development. Setting. Online survey of undergraduate college students. A total of 340 female students ages 18 to 26 years. Stage of Change, Decisional Balance, and Self-Efficacy. The sample was randomly split into halves for exploratory principal components analyses (PCAs), followed by confirmatory factor analyses (CFAs) to test measurement models. Multivariate analyses examined relationships between constructs. For Decisional Balance, PCA indicated two 4-item factors (Pros -α = .90; and Cons -α = .66). CFA supported a two-factor correlated model, χ(2)(19) = 39.33; p < .01; comparative fit index (CFI) = .97; and average absolute standardized residual statistic (AASR) = .03; with Pros α = .90 and Cons α = .67. For Self-Efficacy, PCA indicated one 6-item factor (α = .84). CFA supported this structure, χ(2)(9) = 50.87; p < .05; CFI = .94; AASR = .03; and α = .90. Multivariate analyses indicated significant cross-stage differences on Pros, Cons, and Self-Efficacy in expected directions. Findings support the internal and external validity of these measures and their use in Transtheoretical Model-tailored interventions. Stage-construct relationships suggest that reducing the Cons of vaccination may be more important for HPV than for behaviors with a true Maintenance stage.

Vaccines 2.0 | Center for Cancer Research

Cancer.gov

In 1974, Jay A. Berzofsky, M.D., Ph.D., now Chief of CCR’s Vaccine Branch, came to NIH to study protein folding. His curious mind and collaborative spirit quickly led him into the intertwined fields of immunology and vaccine development. With close to 500 publications to his name, Berzofsky has pioneered the characterization of B- and T-cell epitopes and their modification to

Vaccine-preventable diseases, vaccines and Guillain-Barre' syndrome.

PubMed

Principi, Nicola; Esposito, Susanna

2018-06-04

Guillain-Barré syndrome (GBS) is an acute, immune-mediated polyradiculoneuropathy. Infections and vaccines have been hypothesized to play a role in triggering GBS development. These beliefs can play a role in reducing vaccination coverage. In this report, data concerning this hypothesis are discussed. It is shown that an association between vaccine administration and GBS has never been proven for most of debated vaccines, although it cannot be definitively excluded. The only exception is the influenza vaccine, at least for the preparation used in 1976. For some vaccines, such as measles/mumps/rubella, human papillomavirus, tetravalent conjugated meningococcal vaccine, and influenza, the debate between supporters and opponents of vaccination remains robust and perception of vaccines' low safety remains a barrier to achieving adequate vaccination coverage. Less than 1 case of GBS per million immunized persons might occur for these vaccines. However, in some casesimmunization actually reduces the risk of GBS development. In addition, the benefits of vaccination are clearly demonstrated by the eradication or enormous decline in the incidence of many vaccine-preventable diseases. These data highlight that the hypothesized risks of adverse events, such as GBS, cannot be considered a valid reason to avoid the administration of currently recommended vaccines. Copyright © 2018 Elsevier Ltd. All rights reserved.

Vaccine Safety Datalink

Cancer.gov

The Vaccine Safety Datalink is part of the National Immunization Program within the Centers for Disease Control and Prevention and was started in recognition of gaps in the scientific knowledge of rare vaccine side effects.

A novel, disruptive vaccination technology: self-adjuvanted RNActive(®) vaccines.

PubMed

Kallen, Karl-Josef; Heidenreich, Regina; Schnee, Margit; Petsch, Benjamin; Schlake, Thomas; Thess, Andreas; Baumhof, Patrick; Scheel, Birgit; Koch, Sven D; Fotin-Mleczek, Mariola

2013-10-01

Nucleotide based vaccines represent an enticing, novel approach to vaccination. We have developed a novel immunization technology, RNActive(®) vaccines, that have two important characteristics: mRNA molecules are used whose protein expression capacity has been enhanced by 4 to 5 orders of magnitude by modifications of the nucleotide sequence with the naturally occurring nucleotides A (adenosine), G (guanosine), C (cytosine), U (uridine) that do not affect the primary amino acid sequence. Second, they are complexed with protamine and thus activate the immune system by involvement of toll-like receptor (TLR) 7. Essentially, this bestows self-adjuvant activity on RNActive(®) vaccines. RNActive(®) vaccines induce strong, balanced immune responses comprising humoral and cellular responses, effector and memory responses as well as activation of important subpopulations of immune cells, such as Th1 and Th2 cells. Pre-germinal center and germinal center B cells were detected in human patients upon vaccination. RNActive(®) vaccines successfully protect against lethal challenges with a variety of different influenza strains in preclinical models. Anti-tumor activity was observed preclinically under therapeutic as well as prophylactic conditions. Initial clinical experiences suggest that the preclinical immunogenicity of RNActive(®) could be successfully translated to humans.

Conserved Elements Vaccine for HIV | NCI Technology Transfer Center | TTC

Cancer.gov

Researchers at the National Cancer Institute (NCI) developed a DNA vaccine using conserved elements of HIV-1 Gag, administered in a prime-boost vaccination protocol. Two of the HIV Gag CE DNA vectors have been tested in a rhesus macaque model. Priming with the Gag CE vaccine and boosting with full length Gag DNA showed increased immune responses when compared to vaccination with Gag alone. Researchers seek licensing and/or co-development research collaborations for development this DNA vaccine.

Assessing the Importance of Domestic Vaccine Manufacturing Centers: An Overview of Immunization Programs, Vaccine Manufacture, and Distribution.

PubMed

Rey-Jurado, Emma; Tapia, Felipe; Muñoz-Durango, Natalia; Lay, Margarita K; Carreño, Leandro J; Riedel, Claudia A; Bueno, Susan M; Genzel, Yvonne; Kalergis, Alexis M

2018-01-01

Vaccines have significantly reduced the detrimental effects of numerous human infectious diseases worldwide, helped to reduce drastically child mortality rates and even achieved eradication of major pathogens, such as smallpox. These achievements have been possible due to a dedicated effort for vaccine research and development, as well as an effective transfer of these vaccines to public health care systems globally. Either public or private institutions have committed to developing and manufacturing vaccines for local or international population supply. However, current vaccine manufacturers worldwide might not be able to guarantee sufficient vaccine supplies for all nations when epidemics or pandemics events could take place. Currently, different countries produce their own vaccine supplies under Good Manufacturing Practices, which include the USA, Canada, China, India, some nations in Europe and South America, such as Germany, the Netherlands, Italy, France, Argentina, and Brazil, respectively. Here, we discuss some of the vaccine programs and manufacturing capacities, comparing the current models of vaccine management between industrialized and developing countries. Because local vaccine production undoubtedly provides significant benefits for the respective population, the manufacture capacity of these prophylactic products should be included in every country as a matter of national safety.

Assessing the Importance of Domestic Vaccine Manufacturing Centers: An Overview of Immunization Programs, Vaccine Manufacture, and Distribution

PubMed Central

Rey-Jurado, Emma; Tapia, Felipe; Muñoz-Durango, Natalia; Lay, Margarita K.; Carreño, Leandro J.; Riedel, Claudia A.; Bueno, Susan M.; Genzel, Yvonne; Kalergis, Alexis M.

2018-01-01

Vaccines have significantly reduced the detrimental effects of numerous human infectious diseases worldwide, helped to reduce drastically child mortality rates and even achieved eradication of major pathogens, such as smallpox. These achievements have been possible due to a dedicated effort for vaccine research and development, as well as an effective transfer of these vaccines to public health care systems globally. Either public or private institutions have committed to developing and manufacturing vaccines for local or international population supply. However, current vaccine manufacturers worldwide might not be able to guarantee sufficient vaccine supplies for all nations when epidemics or pandemics events could take place. Currently, different countries produce their own vaccine supplies under Good Manufacturing Practices, which include the USA, Canada, China, India, some nations in Europe and South America, such as Germany, the Netherlands, Italy, France, Argentina, and Brazil, respectively. Here, we discuss some of the vaccine programs and manufacturing capacities, comparing the current models of vaccine management between industrialized and developing countries. Because local vaccine production undoubtedly provides significant benefits for the respective population, the manufacture capacity of these prophylactic products should be included in every country as a matter of national safety. PMID:29403503

Primary Care Provider Practices and Perceptions Regarding HPV Vaccination and Anal Cancer Screening at a Boston Community Health Center.

PubMed

Apaydin, Kaan Z; Fontenot, Holly B; Shtasel, Derri L; Mayer, Kenneth H; Keuroghlian, Alex S

2018-02-26

Human papillomavirus (HPV) vaccination and anal cancer screening are valuable, yet underutilized, tools in prevention of HPV-related cancers among sexual and gender minority (SGM) populations. The aim of this study was to characterize primary care providers' (PCPs) practices and perceptions pertaining to HPV vaccination and anal cancer screening. A survey assessing self-reported practice characteristics related to HPV vaccination and anal cancer screening, as well as perceived barriers to vaccination and anal cancer screening at the patient-, provider-, and system-level was distributed to PCPs at a Federally-Qualified Health Center that specializes in care for SGM populations in the greater Boston area. A total of 33 PCPs completed the survey. All PCPs strongly recommended HPV vaccination to their patients by emphasizing that the vaccine is extremely important or very important. Most PCPs told their patients that the HPV vaccine prevents cervical cancer (96.9%), anal cancer (96.9%), oropharyngeal cancer (72.7%), penile cancer (57.5%), and genital warts (63.6%). There is substantial variability among providers regarding recommendations for anal cancer screening and follow-up. Most PCPs perceived that patient-level factors such as poverty, mental illness, and substance use disorders were barriers to HPV vaccination and anal cancer screening. Systems-level barriers such as lack of clinical time with each patient and lack of staffing were also described as barriers to vaccination and screening. Patient-, provider- and systems-level improvements are important to increase HPV vaccination and anal cancer screening rates.

Three-year duration of immunity in cats vaccinated with a canarypox-vectored recombinant rabies virus vaccine.

PubMed

Jas, D; Coupier, C; Toulemonde, C Edlund; Guigal, P-M; Poulet, H

2012-11-19

Despite the availability of efficacious vaccines for animals and humans, rabies is still a major zoonosis. Prevention of rabies in dogs and cats is key for reducing the risk of transmission of this deadly disease to humans. Most veterinary vaccines are adjuvanted inactivated vaccines and have been shown to provide one to four-year duration of immunity. In response to debates about the safety of adjuvanted vaccines in cats, a non-adjuvanted feline rabies vaccine with one-year duration of immunity claim was specifically developed using the canarypoxvirus vector technology. The objective of this study was to validate a vaccination program based on primary vaccination, revaccination one year later and boosters every three years. Seronegative cats were vaccinated at 12 weeks of age and received a booster vaccination one year later. This vaccination regimen induced a strong and sustained antibody response, and all vaccinated animals were protected against virulent rabies challenge carried out 3 years after vaccination. These results validated 3-year duration of immunity after a complete basic vaccination program consisting in primary vaccination from 12 weeks of age followed by revaccination one year later with a non-adjuvanted canarypox-vectored vaccine. Copyright © 2012 Elsevier Ltd. All rights reserved.

Asking about human papillomavirus vaccination and the usefulness of registry validation: a study of young women recruited using Facebook.

PubMed

Gunasekaran, Bharathy; Jayasinghe, Yasmin; Brotherton, Julia M L; Fenner, Yeshe; Moore, Elya E; Wark, John D; Fletcher, Ashley; Tabrizi, Sepehr N; Garland, Suzanne M

2015-02-04

Australia was the first country to implement a government-funded National Human Papillomavirus (HPV) Vaccination Programme. We assessed HPV vaccine uptake comparing self-reported and Register validated estimates, and the knowledge and attitudes of young women with regards to HPV vaccination post-implementation of the programme. Females, aged 16-25 years living in Victoria, Australia, were recruited using targeted advertising on Facebook from May to September 2010, to complete a web-based questionnaire. Geographic distribution, Indigenous and socio-economic status of the 278 participants were representative of the target population. Overall, 210/278 (76%) had heard of HPV vaccines, with 162/278 (58%) reporting receipt of at least one dose of vaccine, and 54 (19%) unsure. Verification of HPV vaccination status of 142 consenting participants (51%) showed 71% had received at least one dose. Main reasons for vaccination were for protection against HPV infection and cervical cancer (96%) and because it was free (87%), whereas unvaccinated women were uncertain of their eligibility (50%), concerned about adverse reactions (32%), or perceived that vaccination was not needed if they were monogamous (32%). The potential utility of a vaccination register in the context of a national programme is apparent from the large proportion of young women who were unsure of their vaccine status. HPV vaccine knowledge among participants was relatively high suggesting the national programme has successfully communicated to the majority of eligible women, the purpose and limitations of the vaccine. Vigilance is needed to ensure that young women follow through with Pap testing in vaccine eligible cohorts. The ongoing vaccination programme for pre-adolescent girls and boys should communicate to parents that those with one sexual partner can still acquire HPV and that the safety of the vaccine is now well demonstrated. Copyright © 2014 Elsevier Ltd. All rights reserved.

Anthrax vaccination in the Millennium Cohort: validation and measures of health.

PubMed

Smith, Besa; Leard, Cynthia A; Smith, Tyler C; Reed, Robert J; Ryan, Margaret A K

2007-04-01

In 1998, the United States Department of Defense initiated the Anthrax Vaccine Immunization Program. Concerns about vaccine-related adverse health effects followed, prompting several studies. Although some studies used self-reported vaccination data, the reliability of such data has not been established. The purpose of this study was to compare self-reported anthrax vaccination to electronic vaccine records among a large military cohort and to evaluate the relationship between vaccine history and health outcome data. Between September 2005 and February 2006 self-reported anthrax vaccination was compared to electronic records for 67,018 participants enrolled in the Millennium Cohort Study between 2001 and 2003 using kappa statistics. Multivariable modeling investigated vaccination concordance as it pertains to subjective health (functional status) and objective health (hospitalization) metrics. Greater than substantial agreement (kappa=0.80) was found between self-report and electronic recording of anthrax vaccination. Of all participants with electronic documentation of anthrax vaccination, 98% self-reported being vaccinated; and of all participants with no electronic record of vaccination, 90% self-reported not receiving a vaccination. There were no differences between vaccinated and unvaccinated participants in overall measures of health. Only the subset of participants who self-reported anthrax vaccination, but had no electronic confirmation, differed from others in the cohort, with consistently lower measures of health as indicated by Medical Outcomes Study 36-Item Short Form Health Survey for Veterans (SF-36V) scores. These results indicate that military members accurately recall their anthrax vaccinations. Results also suggest that anthrax vaccination among Millennium Cohort participants is not associated with self-reported health problems or broad measures of health problems severe enough to require hospitalization. Service members who self

Egg-Independent Influenza Vaccines and Vaccine Candidates

PubMed Central

Manini, Ilaria; Pozzi, Teresa; Rossi, Stefania; Montomoli, Emanuele

2017-01-01

Vaccination remains the principal way to control seasonal infections and is the most effective method of reducing influenza-associated morbidity and mortality. Since the 1940s, the main method of producing influenza vaccines has been an egg-based production process. However, in the event of a pandemic, this method has a significant limitation, as the time lag from strain isolation to final dose formulation and validation is six months. Indeed, production in eggs is a relatively slow process and production yields are both unpredictable and highly variable from strain to strain. In particular, if the next influenza pandemic were to arise from an avian influenza virus, and thus reduce the egg-laying hen population, there would be a shortage of embryonated eggs available for vaccine manufacturing. Although the production of egg-derived vaccines will continue, new technological developments have generated a cell-culture-based influenza vaccine and other more recent platforms, such as synthetic influenza vaccines. PMID:28718786

An Electronic Medical Record Alert Intervention to Improve HPV Vaccination Among Eligible Male College Students at a University Student Health Center.

PubMed

Martin, Suzanne; Warner, Echo L; Kirchhoff, Anne C; Mooney, Ryan; Martel, Laura; Kepka, Deanna

2018-02-16

This pilot study aims to improve HPV vaccination for college aged males at a student health center. The first part of the study consisted of a focus group that assessed the barriers and facilitators of HPV vaccination among healthcare providers and clinic staff (N = 16). Providers reported missed opportunities for HPV vaccination. For the second part of the study, providers and staff reviewed medical records of patients ages 18-26 with student health insurance and with < 3 doses of the HPV vaccine at baseline (12/1/2014 to 7/31/2015) and follow-up (12/1/2015 to 7/31/2016). A computer-automated EMR alert was generated in the medical record of eligible male patients (N = 386). Z-scores were estimated for two-sample proportions to measure change in HPV vaccine rates at baseline and follow-up for males and females. HPV vaccine initiation rates increased among males (baseline: 5.2% follow-up: 25.1%, p < 0.001). This study shows that EMR alerts improved HPV vaccine initiation rates among insured college-aged males.

Development, validation and field evaluation of a quantitative real-time PCR able to differentiate between field Mycoplasma synoviae and the MS-H-live vaccine strain.

PubMed

Dijkman, R; Feberwee, A; Landman, W J M

2017-08-01

A quantitative PCR (qPCR) able to differentiate between field Mycoplasma synoviae and MS-H vaccine strain was developed, validated and evaluated. It was developed using nucleotide differences in the obg gene. Analytical specificity and sensitivity assessed using DNA from 194 M. synoviae field samples, three different batches of MS-H vaccine and from 43 samples representing four other avian Mycoplasma species proved to be 100%. The detection limit for field M. synoviae and MS-H vaccine strain was 10 2-3 and 10 2 colony-forming units PCR equivalents/g trachea mucus, respectively. The qPCR was able to detect both, field M. synoviae and MS-H vaccine strain in ratios of 1:100 determined both using spiked and field samples. One hundred and twenty samples from M. synoviae-infected non-vaccinated birds, 110 samples from M. synoviae-vaccinated birds from a bird experiment and 224 samples from M. synoviae negative (serology and PCR) birds were used to determine the relative sensitivity and specificity using a previously described M. synoviae PCR as reference. The relative sensitivity and specificity for field M. synoviae were 95.0% and 99.6%, respectively, and 94.6% and 100% for the MS-H-live vaccine, respectively. Field validation and confirmation by multi locus sequence typing revealed that the qPCR correctly distinguished between MS-H and field M. synoviae. Evaluation of the differentiating M. synoviae qPCR in three commercial flocks suggested transmission of MS-H-live vaccine from vaccinated to non-vaccinated flocks at the same farm. Furthermore, it showed evidence for the colonization with field M. synoviae in MS-H-vaccinated flocks.

Ecological validity of cost-effectiveness models of universal HPV vaccination: A systematic literature review.

PubMed

Favato, Giampiero; Easton, Tania; Vecchiato, Riccardo; Noikokyris, Emmanouil

2017-05-09

The protective (herd) effect of the selective vaccination of pubertal girls against human papillomavirus (HPV) implies a high probability that one of the two partners involved in intercourse is immunised, hence preventing the other from this sexually transmitted infection. The dynamic transmission models used to inform immunisation policy should include consideration of sexual behaviours and population mixing in order to demonstrate an ecological validity, whereby the scenarios modelled remain faithful to the real-life social and cultural context. The primary aim of this review is to test the ecological validity of the universal HPV vaccination cost-effectiveness modelling available in the published literature. The research protocol related to this systematic review has been registered in the International Prospective Register of Systematic Reviews (PROSPERO: CRD42016034145). Eight published economic evaluations were reviewed. None of the studies showed due consideration of the complexities of human sexual behaviour and the impact this may have on the transmission of HPV. Our findings indicate that all the included models might be affected by a different degree of ecological bias, which implies an inability to reflect the natural demographic and behavioural trends in their outcomes and, consequently, to accurately inform public healthcare policy. In particular, ecological bias have the effect to over-estimate the preference-based outcomes of selective immunisation. A relatively small (15-20%) over-estimation of quality-adjusted life years (QALYs) gained with selective immunisation programmes could induce a significant error in the estimate of cost-effectiveness of universal immunisation, by inflating its incremental cost effectiveness ratio (ICER) beyond the acceptability threshold. The results modelled here demonstrate the limitations of the cost-effectiveness studies for HPV vaccination, and highlight the concern that public healthcare policy might have been

Co-administration of a meningococcal glycoconjugate ACWY vaccine with travel vaccines: a randomized, open-label, multi-center study.

PubMed

Alberer, Martin; Burchard, Gerd; Jelinek, Tomas; Reisinger, Emil; Beran, Jiri; Meyer, Seetha; Forleo-Neto, Eduardo; Gniel, Dieter; Dagnew, Alemnew F; Arora, Ashwani Kumar

2014-01-01

Potential interactions between vaccines may compromise the immunogenicity and/or safety of individual vaccines so must be assessed before concomitant administration is recommended. In this study, the immunogenicity and safety of travel vaccines against Japanese encephalitis (JEV) and rabies (PCECV) administered together with or without a quadrivalent meningococcal glycoconjugate ACWY-CRM vaccine were evaluated (NCT01466387). Healthy adults aged 18 to ≤60 years were randomized to one of four vaccine regimens: JEV + PCECV + MenACWY-CRM, JEV + PCECV, PCECV or MenACWY-CRM. Immunogenicity at baseline and 28 days post-complete vaccination was assessed by serum bactericidal assay using human complement or neutralization tests. Adverse events (AEs) were collected throughout the study period. JEV + PCECV + MenACWY-CRM was non-inferior to JEV + PCECV. Post-vaccination seroprotective neutralizing titers or concentrations were achieved in 98-99% (JE) and 100% (rabies) of subjects across the vaccine groups. Antibody responses to vaccine meningococcal serogroups were in the same range for MenACWY-CRM and JEV + PCECV + MenACWY-CRM. Rates of reporting of AEs were similar for JEV + PCECV and JEV + PCECV + MenACWY-CRM. MenACWY-CRM was administered with an inactivated adjuvanted JE and a purified chick embryo cell-culture rabies vaccine without compromising immunogenicity or safety of the individual vaccines. These data provide evidence that MenACWY-CRM could be effectively incorporated into travel vaccination programs. NCT01466387. Copyright © 2014 Elsevier Ltd. All rights reserved.

A successful strategy for increasing the influenza vaccination rate of healthcare workers without a mandatory policy outside of the United States: a multifaceted intervention in a Japanese tertiary care center.

PubMed

Honda, Hitoshi; Sato, Yumiko; Yamazaki, Akinori; Padival, Simi; Kumagai, Akira; Babcock, Hilary

2013-11-01

Although mandatory vaccination programs have been effective in improving the vaccination rate among healthcare workers, implementing this type of program can be challenging because of varied reasons for vaccine refusal. The purpose of our study is to measure improvement in the influenza vaccination rate from a multifaceted intervention at a Japanese tertiary care center where implementing a mandatory vaccination program is difficult. Before-and-after trial. Healthcare workers at a 550-bed, tertiary care, academic medical center in Sapporo, Japan. We performed a multifaceted intervention including (1) use of a declination form, (2) free vaccination, (3) hospital-wide announcements during the vaccination period, (4) prospective audit and real-time telephone interview for healthcare workers who did not receive the vaccine, (5) medical interview with the hospital executive for noncompliant (no vaccine, no declination form) healthcare workers during the vaccination period, and (6) mandatory submission of a vaccination document if vaccinated outside of the study institution. With the new multifaceted intervention, the vaccination rate in the 2012-2013 season increased substantially, up to 97%. This rate is similar to that reported in studies with a mandatory vaccination program. Improved vaccination acceptance, particularly among physicians, likely contributed to the overall increase in the vaccination rate reported in the study. Implementation of comprehensive strategies with strong leadership can lead to substantial improvements in vaccine uptake among healthcare workers even without a mandatory vaccination policy. The concept is especially important for institutions where implementing mandatory vaccination programs is challenging.

Vaccination against influenza at a European pediatric cancer center: immunization rates and attitudes among staff, patients, and their families.

PubMed

Pettke, Aleksandra; Jocham, Sophie; Wiener, Andreas; Löcken, Andreas; Groenefeld, Judith; Ahlmann, Martina; Groll, Andreas H

2017-12-01

Influenza is an important cause of infectious morbidity in pediatric cancer patients. We conducted a single-center survey to explore adherence and attitudes towards the recommended annual influenza vaccination. Self-administered, standardized questionnaires were distributed to 143 staff members and 264 families. Items analyzed included demographic data, knowledge about influenza, history of prior influenza infections and vaccinations, routes of information and education, and attitudes towards the recommended influenza. Variables associated with vaccination were explored by univariate and multivariate analyses. One hundred six staff members with patient contact and 139 primary caretakers completed the questionnaire. Fifty-nine percent of staff members and 60% of the caretakers provided correct answers to all four knowledge questions; 32 and 54% reported a history of prior influenza, and 61 and 47% had received at least one influenza vaccination in the past. Vaccination rates for the previous season were 47, 34, 30, 25, and 29% in staff members, primary caretakers, their partners, diseased children, and their siblings, respectively. Main motivations (>75% in ≥ 1 cohort) for vaccination were prevention of influenza disease and concerns to transmit it to others (77-100%) and reasons for not being immunized concerns of adverse effects and use of alternative protection (33-83%). Variables significantly associated with vaccination by multivariate analysis included receipt of influenza vaccinations in the past (OR 2.2-20.5), recommendations by health care providers (OR 4.8-45.5), a lower level of education (caretakers; OR 2.2), and younger age (children; OR 0.9). The results of this survey indicate insufficient vaccination rates and provide potential approaches for improved vaccination strategies in the setting of pediatric cancer care.

Understanding the Dimensions of Anti-Vaccination Attitudes: the Vaccination Attitudes Examination (VAX) Scale.

PubMed

Martin, Leslie R; Petrie, Keith J

2017-10-01

Anti-vaccination attitudes are important predictors of vaccination behavior. Existing measures of vaccination attitudes focus on specific age groups and/or particular vaccines; a more comprehensive measure would facilitate comparisons across studies. The aim of this study was to develop a short measure of general vaccination attitudes and establish its reliability and validity. Two studies were conducted using the VAX scale. For Study 1, participants were 409 individuals (53% female), with a mean age of 34.5 years. For Study 2, participants were 92 individuals (67% female) with a mean age of 28.6. Participants answered paper-and-pencil questions about their attitudes toward vaccines, prior and expected-future vaccination behaviors, perceived sensitivity to medicines, online behavior, and basic demographic information. Exploratory and confirmatory factor analyses were conducted with correlations and t tests then used to assess the scale's reliability and validity. Four distinct but correlated vaccine attitudes were identified: (1) mistrust of vaccine benefit, (2) worries about unforeseen future effects, (3) concerns about commercial profiteering, and (4) preference for natural immunity. These factors were significantly related to prior vaccination behavior, future intentions to obtain recommended vaccinations, perceived sensitivity to medicines, and the tendency to obtain health information online. The VAX scale provides an efficient method for identifying those with vaccination resistance, and the four subscales enable a more nuanced understanding of the nature of those views. It should be noted, however, that the strong correlations amongst the four subscales suggest that interventions should target all four attitude areas, and it remains to be seen whether differential emphasis across the four areas is warranted.

Vaccination Confidence and Parental Refusal/Delay of Early Childhood Vaccines.

PubMed

Gilkey, Melissa B; McRee, Annie-Laurie; Magnus, Brooke E; Reiter, Paul L; Dempsey, Amanda F; Brewer, Noel T

2016-01-01

To support efforts to address parental hesitancy towards early childhood vaccination, we sought to validate the Vaccination Confidence Scale using data from a large, population-based sample of U.S. parents. We used weighted data from 9,354 parents who completed the 2011 National Immunization Survey. Parents reported on the immunization history of a 19- to 35-month-old child in their households. Healthcare providers then verified children's vaccination status for vaccines including measles, mumps, and rubella (MMR), varicella, and seasonal flu. We used separate multivariable logistic regression models to assess associations between parents' mean scores on the 8-item Vaccination Confidence Scale and vaccine refusal, vaccine delay, and vaccination status. A substantial minority of parents reported a history of vaccine refusal (15%) or delay (27%). Vaccination confidence was negatively associated with refusal of any vaccine (odds ratio [OR] = 0.58, 95% confidence interval [CI], 0.54-0.63) as well as refusal of MMR, varicella, and flu vaccines specifically. Negative associations between vaccination confidence and measures of vaccine delay were more moderate, including delay of any vaccine (OR = 0.81, 95% CI, 0.76-0.86). Vaccination confidence was positively associated with having received vaccines, including MMR (OR = 1.53, 95% CI, 1.40-1.68), varicella (OR = 1.54, 95% CI, 1.42-1.66), and flu vaccines (OR = 1.32, 95% CI, 1.23-1.42). Vaccination confidence was consistently associated with early childhood vaccination behavior across multiple vaccine types. Our findings support expanding the application of the Vaccination Confidence Scale to measure vaccination beliefs among parents of young children.

Validation of Caregiver-Centered Delirium Detection Tools: A Systematic Review.

PubMed

Rosgen, Brianna; Krewulak, Karla; Demiantschuk, Danielle; Ely, E Wesley; Davidson, Judy E; Stelfox, Henry T; Fiest, Kirsten M

2018-04-18

To summarize the validity of caregiver-centered delirium detection tools in hospitalized adults and assess associated patient and caregiver outcomes. Systematic review. We searched MEDLINE, EMBASE, PsycINFO, CINAHL, and Scopus from inception to May 15, 2017. Hospitalized adults. Caregiver-centered delirium detection tools. We drafted a protocol from the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Two reviewers independently completed abstract and full-text review, data extraction, and quality assessment. We summarized findings using descriptive statistics including mean, median, standard deviation, range, frequencies (percentages), and Cohen's kappa. Studies that reported on the validity of caregiver-centered delirium detection tools or associated patient and caregiver outcomes and were cohort or cross-sectional in design were included. We reviewed 6,056 titles and abstracts, included 6 articles, and identified 6 caregiver-centered tools. All tools were designed to be administered in several minutes or less and had 11 items or fewer. Three tools were caregiver administered (completed independently by caregivers): Family Confusion Assessment Method (FAM-CAM), Informant Assessment of Geriatric Delirium (I-AGeD), and Sour Seven. Three tools were caregiver informed (administered by a healthcare professional using caregiver input): Single Question in Delirium (SQiD), Single Screening Question Delirium (SSQ-Delirium), and Stressful Caregiving Response to Experiences of Dying. Caregiver-administered tools had better psychometric properties (FAM-CAM sensitivity 75%, 95% confidence interval (CI)=35-95%, specificity 91%, 95% CI=74-97%; Sour Seven positive predictive value 89.5%, negative predictive value 90%) than caregiver-informed tools (SQiD: sensitivity 80%, 95% CI=28.4-99.5%; specificity 71%, 95% CI=41.9-91.6%; SSQ-Delirium sensitivity 79.6%, specificity 56.1%). Delirium detection is essential for appropriate delirium management

The HPV Vaccination Crisis

Cancer.gov

Following the release of a consensus statement from the NCI-Designated Cancer Centers urging HPV vaccination in the United States, Dr. Noel Brewer discusses the country’s low vaccination rates and how clinicians can help to improve them.

Vaccines and Immunization Practice.

PubMed

Hogue, Michael D; Meador, Anna E

2016-03-01

Vaccines are among most cost-effective public health strategies. Despite effective vaccines for many bacterial and viral illnesses, tens of thousands of adults and hundreds of children die each year in the United States from vaccine-preventable diseases. Underutilization of vaccines requires rethinking the approach to incorporating vaccines into practice. Arguably, immunizations could be a part all health care encounters. Shared responsibility is paramount if deaths are to be reduced. This article reviews the available vaccines in the US market, as well as practice recommendations of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices. Copyright © 2016 Elsevier Inc. All rights reserved.

Monitoring adherence to cold chain storage of vaccines in 2014 in the Małopolska province

PubMed

Wiercińska, Ewa; Orzeł-Nowak, Anita; Mrozowska, Barbara; Foremny, Jarosław

2017-01-01

The principles of „cold chain” have been developed for the safe transport and storage of vaccines because of their sensitivity to temperature and are guidelines for use in all countries. Available information on adherence to the principles of the “cold chain” by healthcare providers in Poland is insufficient. The aim of the study was to assess compliance with these rules in storing vaccines by vaccination centers implementing an immunization program in 2014 in the Malopolska province The study was conducted in 111 vaccination centers in 19 districts of Malopolska, which represents 12% of all vaccination centers in the Malopolska province in 2014. The selection of vaccination centers for the study was not random. During a routine inspection of vaccination centers, an employee of the District Sanitary-Epidemiological Station conducted a study using a specially-prepared questionnaire. Inspections in vaccination centers which qualified for the study were conducted from March to September 2015. Among the analyzed vaccinations centers 90% had a refrigerator or refrigerator-freezer, and 10% a pharmaceutical refrigerator. 3.6% of refrigerators were produced before 2000. A 24-hour recording of the temperature was conducted in 67.6% vaccination centers. 40.5% of vaccination centers had a 24-hour system of recording and notification when temperature parameters had been exceeded in refrigeration devices. 22.5% of vaccination centers had emergency power supply. 13.5% of vaccination centers a power failure occurred in refrigerators, including 40% of the vaccination centers which had a text message notification system.. Total cost of destroyed vaccines amounted to over 20 thousand zl. Correct storage conditions are needed for vaccines to maintain their full effectiveness, which is why it is necessary to intensify efforts to ensure compliance with the principles of the cold chain in the storage of vaccines by healthcare providers.

Estimating effectiveness of HPV vaccination against HPV infection from post-vaccination data in the absence of baseline data.

PubMed

Vänskä, Simopekka; Söderlund-Strand, Anna; Uhnoo, Ingrid; Lehtinen, Matti; Dillner, Joakim

2018-04-28

HPV vaccination programs have been introduced in large parts of the world, but monitoring of effectiveness is not routinely performed. Many countries introduced vaccination programs without establishing the baseline of HPV prevalences. We developed and validated methods to estimate protective effectiveness (PE) of vaccination from the post-vaccination data alone using references, which are invariant under HPV vaccination. Type-specific HPV prevalence data for 15-39 year-old women were collected from the pre- and post-vaccination era in a region in southern Sweden. In a region in middle Sweden, where no baseline data had been collected, only post-vaccination data was collected. The age-specific baseline prevalence of vaccine HPV types (vtHPV, HPV 6, 11, 16, 18) were reconstructed as Beta distributions from post-vaccination data by applying the reference odds ratios between the target HPV type and non-vaccine-type HPV (nvtHPV) prevalences. Older non-vaccinated age cohorts and the southern Sweden region were used as the references. The methods for baseline reconstructions were validated by computing the Bhattacharyya coefficient (BC), a measure for divergence, between reconstructed and actual observed prevalences for vaccine HPV types in Southern Sweden, and in addition, for non-vaccine types in both regions. The PE estimates among 18-21 year-old women were validated by comparing the PE estimates that were based on the reconstructed baseline prevalences against the PE estimates based on the actual baseline prevalences. In Southern Sweden the PEs against vtHPV were 52.2% (95% CI: 44.9-58.5) using the reconstructed baseline and 49.6% (43.2-55.5) using the actual baseline, with high BC 82.7% between the reconstructed and actual baseline. In the middle Sweden region where baseline data was missing, the PE was estimated at 40.5% (31.6-48.5). Protective effectiveness of HPV vaccination can be estimated from post-vaccination data alone via reconstructing the baseline

Vaccination Confidence and Parental Refusal/Delay of Early Childhood Vaccines

PubMed Central

Gilkey, Melissa B.; McRee, Annie-Laurie; Magnus, Brooke E.; Reiter, Paul L.; Dempsey, Amanda F.; Brewer, Noel T.

2016-01-01

Objective To support efforts to address parental hesitancy towards early childhood vaccination, we sought to validate the Vaccination Confidence Scale using data from a large, population-based sample of U.S. parents. Methods We used weighted data from 9,354 parents who completed the 2011 National Immunization Survey. Parents reported on the immunization history of a 19- to 35-month-old child in their households. Healthcare providers then verified children’s vaccination status for vaccines including measles, mumps, and rubella (MMR), varicella, and seasonal flu. We used separate multivariable logistic regression models to assess associations between parents’ mean scores on the 8-item Vaccination Confidence Scale and vaccine refusal, vaccine delay, and vaccination status. Results A substantial minority of parents reported a history of vaccine refusal (15%) or delay (27%). Vaccination confidence was negatively associated with refusal of any vaccine (odds ratio [OR] = 0.58, 95% confidence interval [CI], 0.54–0.63) as well as refusal of MMR, varicella, and flu vaccines specifically. Negative associations between vaccination confidence and measures of vaccine delay were more moderate, including delay of any vaccine (OR = 0.81, 95% CI, 0.76–0.86). Vaccination confidence was positively associated with having received vaccines, including MMR (OR = 1.53, 95% CI, 1.40–1.68), varicella (OR = 1.54, 95% CI, 1.42–1.66), and flu vaccines (OR = 1.32, 95% CI, 1.23–1.42). Conclusions Vaccination confidence was consistently associated with early childhood vaccination behavior across multiple vaccine types. Our findings support expanding the application of the Vaccination Confidence Scale to measure vaccination beliefs among parents of young children. PMID:27391098

DoD Influenza Surveillance and Vaccine Effectiveness

DTIC Science & Technology

2014-02-28

controls – No analyses by flu subtype (over 90% of flu samples were H1N1) 21 • Adjusted Estimates of Vaccine Effectiveness – Population: Service...DoD Influenza Surveillance and Vaccine Effectiveness Armed Forces Health Surveillance Center (AFHSC) Naval Health Research Center (NHRC) United... Vaccine Effectiveness 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e. TASK NUMBER 5f. WORK

Tuberculosis vaccines in clinical trials

PubMed Central

Rowland, Rosalind; McShane, Helen

2011-01-01

Effective prophylactic and/or therapeutic vaccination is a key strategy for controlling the global TB epidemic. The partial effectiveness of the existing TB vaccine, bacille Calmette–Guérin (BCG), suggests effective vaccination is possible and highlights the need for an improved vaccination strategy. Clinical trials are evaluating both modifications to the existing BCG immunization methods and also novel TB vaccines, designed to replace or boost BCG. Candidate vaccines in clinical development include live mycobacterial vaccines designed to replace BCG, subunit vaccines designed to boost BCG and therapeutic vaccines designed as an adjunct to chemotherapy. There is a great need for validated animal models, identification of immunological biomarkers of protection and field sites with the capacity for large-scale efficacy testing in order to develop and license a novel TB vaccine or regimen. PMID:21604985

Guillain-Barré Syndrome, Influenza Vaccination, and Antecedent Respiratory and Gastrointestinal Infections: A Case-Centered Analysis in the Vaccine Safety Datalink, 2009–2011

PubMed Central

Greene, Sharon K.; Rett, Melisa D.; Vellozzi, Claudia; Li, Lingling; Kulldorff, Martin; Marcy, S. Michael; Daley, Matthew F.; Belongia, Edward A.; Baxter, Roger; Fireman, Bruce H.; Jackson, Michael L.; Omer, Saad B.; Nordin, James D.; Jin, Robert; Weintraub, Eric S.; Vijayadeva, Vinutha; Lee, Grace M.

2013-01-01

Background Guillain-Barré Syndrome (GBS) can be triggered by gastrointestinal or respiratory infections, including influenza. During the 2009 influenza A (H1N1) pandemic in the United States, monovalent inactivated influenza vaccine (MIV) availability coincided with high rates of wildtype influenza infections. Several prior studies suggested an elevated GBS risk following MIV, but adjustment for antecedent infection was limited. Methods We identified patients enrolled in health plans participating in the Vaccine Safety Datalink and diagnosed with GBS from July 2009 through June 2011. Medical records of GBS cases with 2009–10 MIV, 2010–11 trivalent inactivated influenza vaccine (TIV), and/or a medically-attended respiratory or gastrointestinal infection in the 1 through 141 days prior to GBS diagnosis were reviewed and classified according to Brighton Collaboration criteria for diagnostic certainty. Using a case-centered design, logistic regression models adjusted for patient-level time-varying sources of confounding, including seasonal vaccinations and infections in GBS cases and population-level controls. Results Eighteen confirmed GBS cases received vaccination in the 6 weeks preceding onset, among 1.27 million 2009–10 MIV recipients and 2.80 million 2010–11 TIV recipients. Forty-four confirmed GBS cases had infection in the 6 weeks preceding onset, among 3.77 million patients diagnosed with medically-attended infection. The observed-versus-expected odds that 2009–10 MIV/2010–11 TIV was received in the 6 weeks preceding GBS onset was odds ratio = 1.54, 95% confidence interval (CI), 0.59–3.99; risk difference = 0.93 per million doses, 95% CI, −0.71–5.16. The association between GBS and medically-attended infection was: odds ratio = 7.73, 95% CI, 3.60–16.61; risk difference = 11.62 per million infected patients, 95% CI, 4.49–26.94. These findings were consistent in sensitivity analyses using alternative infection definitions

Validation sampling can reduce bias in healthcare database studies: an illustration using influenza vaccination effectiveness

PubMed Central

Nelson, Jennifer C.; Marsh, Tracey; Lumley, Thomas; Larson, Eric B.; Jackson, Lisa A.; Jackson, Michael

2014-01-01

Objective Estimates of treatment effectiveness in epidemiologic studies using large observational health care databases may be biased due to inaccurate or incomplete information on important confounders. Study methods that collect and incorporate more comprehensive confounder data on a validation cohort may reduce confounding bias. Study Design and Setting We applied two such methods, imputation and reweighting, to Group Health administrative data (full sample) supplemented by more detailed confounder data from the Adult Changes in Thought study (validation sample). We used influenza vaccination effectiveness (with an unexposed comparator group) as an example and evaluated each method’s ability to reduce bias using the control time period prior to influenza circulation. Results Both methods reduced, but did not completely eliminate, the bias compared with traditional effectiveness estimates that do not utilize the validation sample confounders. Conclusion Although these results support the use of validation sampling methods to improve the accuracy of comparative effectiveness findings from healthcare database studies, they also illustrate that the success of such methods depends on many factors, including the ability to measure important confounders in a representative and large enough validation sample, the comparability of the full sample and validation sample, and the accuracy with which data can be imputed or reweighted using the additional validation sample information. PMID:23849144

Validation of the safety of MDCK cells as a substrate for the production of a cell-derived influenza vaccine.

PubMed

Onions, David; Egan, William; Jarrett, Ruth; Novicki, Deborah; Gregersen, Jens-Peter

2010-09-01

Cell culture-based production methods may assist in meeting increasing demand for seasonal influenza vaccines and developing production flexibility required for addressing influenza pandemics. MDCK-33016PF cells are used in propagation of a cell-based seasonal influenza vaccine (Optaflu); but, like most continuous cell lines, can grow in immunocompromised mice to produce tumors. It is, therefore, essential that no residual cells remain within the vaccine, that cell lysates or DNA are not oncogenic, and that the cell substrate does not contain oncogenic viruses or oncogenic DNA. Multiple, redundant processes ensure the safety of influenza vaccines produced in MDCK-33016PF cells. The probability of a residual cell being present in a dose of vaccine is approximately 1 in 10(34). Residual MDCK-DNA is < or =10 ng per dose and the ss-propiolactone used to inactivate influenza virus results in reduction of detectable DNA to less than 200 base pairs (bp). Degenerate PCR and specific PCR confirm exclusion of oncogenic viruses. The manufacturing process has been validated for its capacity to remove and inactivate viruses. We conclude that the theoretical risks arising from manufacturing seasonal influenza vaccine using MDCK-33016PF cells are reduced to levels that are effectively zero by the multiple, orthogonal processes used during production. Copyright 2010 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.

Rabies preexposure vaccination among veterinarians and at-risk staff.

PubMed

Trevejo, R T

2000-12-01

To measure rabies preexposure vaccination rate and identify factors potentially associated with lack of vaccination among veterinarians and at-risk staff. Cross-sectional survey. At-risk veterinary medical association (VMA) members, their staff members, and animal shelter and wildlife rehabilitation center personnel located in a California county. A questionnaire was mailed to VMA members and managers of animal shelters and wildlife rehabilitation centers. Respondents were requested to provide data on vaccination history and potential factors associated with vaccination status for themselves and their at-risk staff members. Vaccinated and unvaccinated individuals were compared by use of univariate and logistic regression analyses to identify factors associated with vaccination status. Fifty-eight percent (79/137) of persons who received questionnaires responded; 74 were eligible for the study. Respondents provided data for 47.6% (219/460) of their staff members. The vaccination rate was greater among respondents (85.1 %) than among their staff members (17.5%). Among staff members, age and duration of employment were significantly associated with vaccination status. A large proportion of at-risk staff members working in veterinary clinics, animal shelters, and wildlife rehabilitation centers in the study area did not receive rabies preexposure vaccination per the Centers for Disease Control and Prevention's published recommendations of the Advisory Committee on Immunization Practices (ACIP). The cost of the preexposure vaccine series may be a barrier, particularly for young employees who are commonly short-term, part-time, or volunteer workers. Efforts are needed to increase awareness of the ACIP recommendations and to increase access to vaccination through agencies such as public health clinics.

Haemophilus influenzae activity in a single medical center in Israel in the post-vaccine era.

PubMed

Megged, Orli; Bar-Meir, Maskit; Schlesinger, Yechiel

2012-07-01

The incidence of invasive disease due to Haemophilus influenzae has decreased since the implementation of vaccination against serotype B. To describe the epidemiological, clinical and microbiological characteristics of patients with H. influenzae meningitis or bacteremia in the vaccine era in Israel. We reviewed the medical records of all patients admitted to Shaare Zedek Medical Center between 1997 and 2010 who had blood or cerebrospinal fluid culture positive for H. influenzae. The study group comprised 104 patients - 57 children and 47 adults. Overall, 21 (20%) of the infections were due to serotype b. The children had shorter hospitalizations (6vs. 12 days, P = 0.005) and lower mortality rate (5% vs. 28%, P = 0.003) as compared to the adults. Bacteremic pneumonia was the most common diagnosis in adults (45% vs. 28% in children, P = 0.08) while meningitis was more common in children (17% vs. 3.5%, P = 0.09). There was a seasonal pattern, with infections being more common during the winter and spring. Invasive H. influenzae disease is uncommon but still exists in both children and adults. The disease course tends to be more severe in adults. Even in the global vaccination era, serotype b constitutes a significant portion of invasive disease.

Strategies and actions of multi-purpose health communication on vaccine preventable infectious diseases in order to increase vaccination coverage in the population: The ESCULAPIO project

PubMed Central

Bonanni, Paolo; Lauri, Sara; Tiscione, Emilia; Levi, Miriam; Prato, Rosa; Fortunato, Francesca; Martinelli, Domenico; Gasparini, Roberto; Panatto, Donatella; Amicizia, Daniela; Coppola, Rosa Cristina; Vitale, Francesco; Iannazzo, Stefania

2017-01-01

ABSTRACT The ESCULAPIO Project aims at increasing awareness on vaccine preventable infectious diseases (VPID) and vaccinations in different target populations and to spread the culture of prevention. Information/training interventions on VPID have been developed and health promotion activities for the general population, students and their parents, teachers and health care workers (HCWs) were set up. In Tuscany, educational courses on VPID in high schools were organized and students were stimulated to prepare informative materials on VPID for lower grade school pupils. In Liguria, an educational card game (named ‘Vaccine at the Fair’) was presented to children of primary schools. Stands in shopping centers were used in Palermo to distribute the regional vaccination schedule and gadgets, also providing indications on reliable websites where to find correct information on vaccinations. A music video played by health care workers (HCWs) was created and used in the University Hospital of Cagliari to promote the anti-flu vaccination campaign in HCWs. In Apulia, meetings with the general population were organized to collect controversial issues about vaccinations and a national call center was launched to create a direct line from the general population to experts in vaccines and vaccination strategies. In Veneto, meetings in the birth centers and home visits for subjects refusing vaccination have been organized. All activities are useful and effective tools to increase knowledge about VPID and confidence in vaccination, which are crucial aspects in order to increase vaccine uptake. The project was funded by the Italian Ministry of Health, Center for Disease Prevention and Control (CCM) in 2013. PMID:28215120

Strategies and actions of multi-purpose health communication on vaccine preventable infectious diseases in order to increase vaccination coverage in the population: The ESCULAPIO project.

PubMed

Bechini, Angela; Bonanni, Paolo; Lauri, Sara; Tiscione, Emilia; Levi, Miriam; Prato, Rosa; Fortunato, Francesca; Martinelli, Domenico; Gasparini, Roberto; Panatto, Donatella; Amicizia, Daniela; Coppola, Rosa Cristina; Pellizzari, Barbara; Tabacchi, Garden; Costantino, Claudio; Vitale, Francesco; Iannazzo, Stefania; Boccalini, Sara

2017-02-01

The ESCULAPIO Project aims at increasing awareness on vaccine preventable infectious diseases (VPID) and vaccinations in different target populations and to spread the culture of prevention. Information/training interventions on VPID have been developed and health promotion activities for the general population, students and their parents, teachers and health care workers (HCWs) were set up. In Tuscany, educational courses on VPID in high schools were organized and students were stimulated to prepare informative materials on VPID for lower grade school pupils. In Liguria, an educational card game (named 'Vaccine at the Fair') was presented to children of primary schools. Stands in shopping centers were used in Palermo to distribute the regional vaccination schedule and gadgets, also providing indications on reliable websites where to find correct information on vaccinations. A music video played by health care workers (HCWs) was created and used in the University Hospital of Cagliari to promote the anti-flu vaccination campaign in HCWs. In Apulia, meetings with the general population were organized to collect controversial issues about vaccinations and a national call center was launched to create a direct line from the general population to experts in vaccines and vaccination strategies. In Veneto, meetings in the birth centers and home visits for subjects refusing vaccination have been organized. All activities are useful and effective tools to increase knowledge about VPID and confidence in vaccination, which are crucial aspects in order to increase vaccine uptake. The project was funded by the Italian Ministry of Health, Center for Disease Prevention and Control (CCM) in 2013.

Validation of HAV biomarker 2A for differential diagnostic of hepatitis A infected and vaccinated individuals using multiplex serology.

PubMed

Bohm, Katrin; Filomena, Angela; Schneiderhan-Marra, Nicole; Krause, Gérard; Sievers, Claudia

2017-10-13

Worldwide about 1.5 million clinical cases of hepatitis A virus (HAV) infections occur every year and increasingly countries are introducing HAV vaccination into the childhood immunization schedule with a single dose instead of the originally licenced two dose regimen. Diagnosis of acute HAV infection is determined serologically by anti-HAV-IgM detection using ELISA. Additionally anti-HAV-IgG can become positive during the early phase of symptoms, but remains detectable after infection and also after vaccination against HAV. Currently no serological marker allows the differentiation of HAV vaccinated individuals and those with a past infection with HAV. Such differentiation would greatly improve evaluation of vaccination campaigns and risk assessment of HAV outbreaks. Here we tested the HAV non-structural protein 2A, important for the capsid assembly, as a biomarker for the differentiation of the immune status in previously infected and vaccinated individuals. HAV antigens were recombinantly expressed as glutathione-S-transferase (GST) fusion proteins. Using glutathione tagged, magnetic fluorescent beads (Luminex®), the proteins were affinity purified and used in a multiplex serological assay. The multiplex HAV assay was validated using 381 reference sera in which the immune status HAV negative, vaccinated or infected was established using the Abbott ARCHITECT® HAVAb-IgM or IgG, the commercial HAV ELISA from Abnova and documentation in vaccination cards. HAV multiplex serology showed a sensitivity of 99% and specificity of 95% to detect anti-HAV IgG/IgM positive individuals. HAV biomarker 2A allowed the differentiation between previously infected and vaccinated individuals. HAV vaccinated individuals and previously infected individuals could be identified with 92% accuracy. HAV biomarker 2A can be used to differentiate between previously HAV-vaccinated and naturally infected individuals. Within a multiplex serological approach this assay can provide valuable

Influenza Vaccine Effectiveness Among US Military Basic Trainees, 2005-06 Season

DTIC Science & Technology

2007-04-01

receive mandatory influenza vaccination , either the trivalent inactivated influenza vaccine by injection (FluZone, Sanofi Pasteur, Lyon, France) or...Naval Health Research Center Influenza Vaccine Effectiveness Among US Military Basic Trainees, 2005–06 Season J. K. Strickler A. W...Naval Health Research Center 140 Sylvester Road San Diego, California 92106 Influenza Vaccine Effectiveness among US Military Basic Trainees, 2005

Validating the Center for Epidemiological Studies Depression Scale for Children in Rwanda

ERIC Educational Resources Information Center

Betancourt, Theresa; Scorza, Pamela; Meyers-Ohki, Sarah; Mushashi, Christina; Kayiteshonga, Yvonne; Binagwaho, Agnes; Stulac, Sara; Beardslee, William R.

2012-01-01

Objective: We assessed the validity of the Center for Epidemiological Studies Depression Scale for Children (CES-DC) as a screen for depression in Rwandan children and adolescents. Although the CES-DC is widely used for depression screening in high-income countries, its validity in low-income and culturally diverse settings, including sub-Saharan…

The HPV Vaccine | Center for Cancer Research

Cancer.gov

Two researchers leveraged CCR’s unique environment of investigator-driven inquiry to pursue studies of two cancer-causing genes that eventually led to the development of a vaccine against two forms of human papillomavirus.

Vaccination of rhesus macaques with the live-attenuated HSV-1 vaccine VC2 stimulates the proliferation of mucosal T cells and germinal center responses resulting in sustained production of highly neutralizing antibodies.

PubMed

Stanfield, Brent A; Pahar, Bapi; Chouljenko, Vladimir N; Veazey, Ronald; Kousoulas, Konstantin G

2017-01-23

We have shown that the live-attenuated HSV-1 VC2 vaccine strain with mutations in glycoprotein K (gK) and the membrane protein UL20 is unable to establish latency in vaccinated animals and produces a robust immune response capable of completely protecting mice against lethal vaginal HSV-1 or HSV-2 infections. To better understand the immune response generated by vaccination with VC2, we tested its ability to elicit immune responses in rhesus macaques. Vaccinated animals showed no signs of disease and developed increasing HSV-1 and HSV-2 reactive IgG 1 after two booster vaccinations, while IgG subtypes IgG 2 and IgG 3 remained at low to undetectable levels. All vaccinated animals produced high levels of cross protective neutralizing antibodies. Flow cytometry analysis of cells isolated from draining lymph nodes showed that VC2 vaccination stimulated significant increases in plasmablast (CD27 high CD38 high ) and mature memory (CD21 - IgM - ) B cells. T cell analysis on cells isolated from draining lymph node biopsies demonstrated a statistically significant increase in proliferating (Ki67 + ) follicular T helper cells and regulatory CXCR5 + CD8 + cytotoxic T cells. Analysis of plasma isolated two weeks post vaccination showed significant increases in circulating CXCL13 indicating increased germinal center activity. Cells isolated from vaginal biopsy samples collected over the course of the study exhibited vaccination-dependent increases in proliferating (Ki67 + ) CD4 + and CD8 + T cell populations. These results suggest that intramuscular vaccination with the live-attenuated HSV-1 VC2 vaccine strain can stimulate robust IgG 1 antibody responses that persist for >250days post vaccination. In addition, vaccination lead to the maturation of B cells into plasmablast and mature memory B cells, the expansion of follicular T helper cells, and affects in the mucosal immune responses. These data suggest that the HSV VC2 vaccine induces potent immune responses that could help

Stennis Space Center Verification & Validation Capabilities

NASA Technical Reports Server (NTRS)

Pagnutti, Mary; Ryan, Robert E.; Holekamp, Kara; ONeal, Duane; Knowlton, Kelly; Ross, Kenton; Blonski, Slawomir

2005-01-01

Scientists within NASA s Applied Sciences Directorate have developed a well-characterized remote sensing Verification & Validation (V&V) site at the John C. Stennis Space Center (SSC). This site enables the in-flight characterization of satellite and airborne high spatial and moderate resolution remote sensing systems and their products. The smaller scale of the newer high resolution remote sensing systems allows scientists to characterize geometric, spatial, and radiometric data properties using a single V&V site. The targets and techniques used to characterize data from these newer systems can differ significantly from the techniques used to characterize data from the earlier, coarser spatial resolution systems. Scientists are also using the SSC V&V site to characterize thermal infrared systems and active lidar systems. SSC employs geodetic targets, edge targets, radiometric tarps, atmospheric monitoring equipment, and thermal calibration ponds to characterize remote sensing data products. The SSC Instrument Validation Lab is a key component of the V&V capability and is used to calibrate field instrumentation and to provide National Institute of Standards and Technology traceability. This poster presents a description of the SSC characterization capabilities and examples of calibration data.

Relationship between vaccine vial monitors and cold chain infrastructure in a rural district of India.

PubMed

Samant, Y; Lanjewar, H; Parker, L; Block, D; Stein, B; Tomar, G

2007-01-01

The potency of oral polio vaccine (OPV), a heat-labile vaccine, is preserved by the cold chain. The Vaccine Vial Monitor, a heat-sensitive label, is critical to the monitoring and maintenance of the cold chain. This study was conducted to evaluate the relationship between the adequacy of cold chain infrastructure and the proper use of Vaccine Vial Monitor in a rural district of India. Forty-six health centers in a rural district were included in our evaluation of the cold chain equipment and the Vaccine Vial Monitors. Cold chain equipment and vaccine vials within each health center were evaluated for adherence to WHO cold chain maintenance protocols and the Vaccine Vial Monitor stage, respectively. Among the 46 health centers, Vaccine Vial Monitor stage I was found at 58% of the health centers, 33% of the health centers reported stage II and 9% reported a stage III, indicating weaknesses in the cold chain mechanism Cold chain for the OPV was not adequately maintained at primary and sub-health centers in this rural district. Well maintained ice packs and vaccine carriers will help ensure delivery and availability of a safe and potent vaccine to children in rural areas of India.

Private-sector vaccine purchase costs and insurer payments: a disincentive for using combination vaccines?

PubMed

Clark, Sarah J; Cowan, Anne E; Freed, Gary L

2011-04-01

Combination vaccines have been endorsed as a means to decrease the number of injections needed to complete the childhood immunization schedule, yet anecdotal reports suggest that private providers lose money on combination vaccines. The objective of this study was to determine whether practices purchasing combination vaccines had significantly different vaccine costs and reimbursement compared to practices that were not purchasing combination vaccines. Using cross-sectional purchase and insurer payment data collected from a targeted sample of private practices in five US states, we calculated the average total vaccine cost and reimbursement across the childhood immunization schedule. The average vaccine purchase cost across the childhood schedule was significantly higher for practices using a combined vaccine with diphtheria, tetanus, acellular pertussis vaccine, inactivated polio vaccine, and Hepatitis B vaccine (DTaP-IPV-HepB) than for practices using either separate vaccine products or a combined vaccine with Haemophilus influenzae, type b vaccine and Hepatitis B vaccine (Hib-HepB). The average insurer payment for vaccine administration across the childhood schedule was significantly lower for practices using DTaP-IPV-HepB combination vaccine than for practices using separate vaccine products. This study appears to validate anecdotal reports that vaccine purchase costs and insurer payment for combination vaccines can have a negative financial impact for practices that purchase childhood vaccines.

Neurologic complications of vaccinations.

PubMed

Miravalle, Augusto A; Schreiner, Teri

2014-01-01

This chapter reviews the most common neurologic disorders associated with common vaccines, evaluates the data linking the disorder with the vaccine, and discusses the potential mechanism of disease. A literature search was conducted in PubMed using a combination of the following terms: vaccines, vaccination, immunization, and neurologic complications. Data were also gathered from publications of the American Academy of Pediatrics Committee on Infectious Diseases, the World Health Organization, the US Centers for Disease Control and Prevention, and the Vaccine Adverse Event Reporting System. Neurologic complications of vaccination are rare. Many associations have been asserted without objective data to support a causal relationship. Rarely, patients with a neurologic complication will have a poor outcome. However, most patients recover fully from the neurologic complication. Vaccinations have altered the landscape of infectious disease. However, perception of risk associated with vaccinations has limited the success of disease eradication measures. Neurologic complications can be severe, and can provoke fear in potential vaccines. Evaluating whether there is causal link between neurologic disorders and vaccinations, not just temporal association, is critical to addressing public misperception of risk of vaccination. Among the vaccines available today, the cost-benefit analysis of vaccinations and complications strongly argues in favor of vaccination. © 2014 Elsevier B.V. All rights reserved.

VaxView: Vaccination Coverage [data] in the U.S.

MedlinePlus

... TeenVaxView AdultVaxView FluVaxView Related Links Vaccines & Immunizations Vaccine Safety Immunization Action Coalition AIM Vaccine Education Center Recommend on Facebook Tweet Share Compartir << Back ...

Validation sampling can reduce bias in health care database studies: an illustration using influenza vaccination effectiveness.

PubMed

Nelson, Jennifer Clark; Marsh, Tracey; Lumley, Thomas; Larson, Eric B; Jackson, Lisa A; Jackson, Michael L

2013-08-01

Estimates of treatment effectiveness in epidemiologic studies using large observational health care databases may be biased owing to inaccurate or incomplete information on important confounders. Study methods that collect and incorporate more comprehensive confounder data on a validation cohort may reduce confounding bias. We applied two such methods, namely imputation and reweighting, to Group Health administrative data (full sample) supplemented by more detailed confounder data from the Adult Changes in Thought study (validation sample). We used influenza vaccination effectiveness (with an unexposed comparator group) as an example and evaluated each method's ability to reduce bias using the control time period before influenza circulation. Both methods reduced, but did not completely eliminate, the bias compared with traditional effectiveness estimates that do not use the validation sample confounders. Although these results support the use of validation sampling methods to improve the accuracy of comparative effectiveness findings from health care database studies, they also illustrate that the success of such methods depends on many factors, including the ability to measure important confounders in a representative and large enough validation sample, the comparability of the full sample and validation sample, and the accuracy with which the data can be imputed or reweighted using the additional validation sample information. Copyright © 2013 Elsevier Inc. All rights reserved.

Center of pressure based segment inertial parameters validation

PubMed Central

Rezzoug, Nasser; Gorce, Philippe; Isableu, Brice; Venture, Gentiane

2017-01-01

By proposing efficient methods for estimating Body Segment Inertial Parameters’ (BSIP) estimation and validating them with a force plate, it is possible to improve the inverse dynamic computations that are necessary in multiple research areas. Until today a variety of studies have been conducted to improve BSIP estimation but to our knowledge a real validation has never been completely successful. In this paper, we propose a validation method using both kinematic and kinetic parameters (contact forces) gathered from optical motion capture system and a force plate respectively. To compare BSIPs, we used the measured contact forces (Force plate) as the ground truth, and reconstructed the displacements of the Center of Pressure (COP) using inverse dynamics from two different estimation techniques. Only minor differences were seen when comparing the estimated segment masses. Their influence on the COP computation however is large and the results show very distinguishable patterns of the COP movements. Improving BSIP techniques is crucial and deviation from the estimations can actually result in large errors. This method could be used as a tool to validate BSIP estimation techniques. An advantage of this approach is that it facilitates the comparison between BSIP estimation methods and more specifically it shows the accuracy of those parameters. PMID:28662090

Parental perspectives on influenza vaccination of children with chronic medical conditions.

PubMed Central

Lin, Chyongchiou J.; Zimmerman, Richard K.; Nowalk, Mary Patricia; Ko, Feng-Shou; Raymund, Mahlon; Hoberman, Alejandro; Kearney, Diana H.; Block, Bruce

2006-01-01

BACKGROUND: Minorities and those living in the inner city have a higher respiratory disease burden than other groups. Yet, influenza vaccination rates among all children with chronic medical conditions remain low. METHODS: Parents of 2-13-year-old children with high-risk medical conditions from health centers in low-income urban neighborhoods completed a mailed survey. Immunization status from medical records was used to calculate validity measures. Survey data are presented for those whose vaccination status was concordant between parental report and the medical record (n=183). RESULTS: Parent-reported influenza vaccination versus medical record review showed 84.9% sensitivity, 68.7% specificity, 49.1% positive predictive value and 92.7% negative predictive value, with a kappa of 0.43. Vaccination rate was 30.6%. Medical record-verified influenza vaccination was associated with parental beliefs that the doctor recommends a flu shot (OR, 40.9; 95% Cl, 9.0-184.9) and that relatives recommend a flu shot (OR, 4.3; 95% Cl, 1.7-10.5), and was less likely if the parent believed that the child will get the flu if a household member is infected (OR, 0.2; 95% Cl, 0.1-0.6). CONCLUSIONS: The message that influenza vaccination is important to protect children with chronic medical conditions may be relayed through physician recommendation or a relative's suggestion and may be more effective if it addresses vaccine efficacy issues. PMID:16708499

Development and validation of an anti-N3 indirect immunofluorescent antibody test to be used as a companion diagnostic test in the framework of a "DIVA" vaccination strategy for avian influenza infections in poultry.

PubMed

Cattoli, Giovanni; Milani, Adelaide; Bettini, Francesca; Serena Beato, Maria; Mancin, Marzia; Terregino, Calogero; Capua, Ilaria

2006-04-01

Avian influenza (AI) infections have become of growing importance both for animal and human health. Vaccination has become a recommended tool to support eradication efforts and limit the economic losses caused by this disease. The "DIVA" system, using a vaccine containing a heterologous neuraminidase to the field virus, has been shown to be an effective tool in increasing the resistance of birds to field challenge, preventing clinical signs and reducing viral shedding in the environment. The companion diagnostic test to the vaccine, however, has been only partially validated in the field against one subtype of neuraminidase (N1). The present paper presents the results of a full laboratory and field validation of the diagnostic test developed to detect antibodies to the N3 subtype of AI in vaccinated and unvaccinated chickens and turkeys. Antibody kinetic studies conducted in the laboratory have shown that antibodies to the N protein may be detected earlier than antibodies to the haemagglutinin. The data derived from this extensive validation trial indicate the excellent capability of this assay in detecting the presence of active AI infection at an early stage in both unvaccinated and vaccinated birds and the lack of interference with vaccine-induced antibodies.

Using an Inpatient Quality Improvement Curriculum for Internal Medicine Residents to Improve Pneumococcal Conjugate Vaccine Administration Rates.

PubMed

Jolin, Jonathan; van Aalst, Robertus; Volpp, Bryan; Taylor, Thomas; Cohen, Emily

2018-06-01

Pneumococcal infections are an important source of morbidity and mortality in older adults and persons with compromised immune systems. New recommendations from the Advisory Committee on Immunization Practices (ACIP) became available September 2014, which included recommendations for the use of the 13-valent pneumococcal conjugate vaccine (PCV13). A study was conducted to increase the PCV13 vaccination rates of hospitalized patients at the White River Junction Veterans Affairs Medical Center (White River Junction, Vermont) through the use of a resident-driven quality improvement (QI) project. From December 2014 through April 2016, 16 internal medicine inpatient residents addressed inpatient PCV13 vaccination rates by participating in the facility's QI curriculum. Eight Plan-Do-Study-Act cycles were used, including discharge template editing, electronic reminders, and the discovery of a vaccination administration documentation error in the record through data validation. The measure was the monthly percentage of patients who received PCV13 vaccination (vaccination completion rate) of those discharged from the hospital medicine service who were due for PCV13 vaccination. The percentage of veterans discharged with an up-to-date PCV13 vaccination on discharge increased from approximately 30% to 87% and was sustained. Despite being driven by many different residents, this project demonstrates that continuous improvement can be achieved through a structured and iterative process while providing active learning of core QI concepts to residents. It also displays a method in which new guidelines can be incorporated into practice in an effective manner. Finally, this project is an example of how resident-driven data validation can lead to further improvement. Published by Elsevier Inc.

Pre-vaccination inflammation and B-cell signalling predict age-related hyporesponse to hepatitis B vaccination

PubMed Central

Fourati, Slim; Cristescu, Razvan; Loboda, Andrey; Talla, Aarthi; Filali, Ali; Railkar, Radha; Schaeffer, Andrea K.; Favre, David; Gagnon, Dominic; Peretz, Yoav; Wang, I-Ming; Beals, Chan R.; Casimiro, Danilo R.; Carayannopoulos, Leonidas N.; Sékaly, Rafick-Pierre

2016-01-01

Aging is associated with hyporesponse to vaccination, whose mechanisms remain unclear. In this study hepatitis B virus (HBV)-naive older adults received three vaccines, including one against HBV. Here we show, using transcriptional and cytometric profiling of whole blood collected before vaccination, that heightened expression of genes that augment B-cell responses and higher memory B-cell frequencies correlate with stronger responses to HBV vaccine. In contrast, higher levels of inflammatory response transcripts and increased frequencies of pro-inflammatory innate cells correlate with weaker responses to this vaccine. Increased numbers of erythrocytes and the haem-induced response also correlate with poor response to the HBV vaccine. A transcriptomics-based pre-vaccination predictor of response to HBV vaccine is built and validated in distinct sets of older adults. This moderately accurate (area under the curve≈65%) but robust signature is supported by flow cytometry and cytokine profiling. This study is the first that identifies baseline predictors and mechanisms of response to the HBV vaccine. PMID:26742691

Stennis Space Center Verification & Validation Capabilities

NASA Technical Reports Server (NTRS)

Pagnutti, Mary; Ryan, Robert E.; Holekamp, Kara; O'Neal, Duane; Knowlton, Kelly; Ross, Kenton; Blonski, Slawomir

2007-01-01

Scientists within NASA#s Applied Research & Technology Project Office (formerly the Applied Sciences Directorate) have developed a well-characterized remote sensing Verification & Validation (V&V) site at the John C. Stennis Space Center (SSC). This site enables the in-flight characterization of satellite and airborne high spatial resolution remote sensing systems and their products. The smaller scale of the newer high resolution remote sensing systems allows scientists to characterize geometric, spatial, and radiometric data properties using a single V&V site. The targets and techniques used to characterize data from these newer systems can differ significantly from the techniques used to characterize data from the earlier, coarser spatial resolution systems. Scientists have used the SSC V&V site to characterize thermal infrared systems. Enhancements are being considered to characterize active lidar systems. SSC employs geodetic targets, edge targets, radiometric tarps, atmospheric monitoring equipment, and thermal calibration ponds to characterize remote sensing data products. Similar techniques are used to characterize moderate spatial resolution sensing systems at selected nearby locations. The SSC Instrument Validation Lab is a key component of the V&V capability and is used to calibrate field instrumentation and to provide National Institute of Standards and Technology traceability. This poster presents a description of the SSC characterization capabilities and examples of calibration data.

Informing vaccine decision-making: A strategic multi-attribute ranking tool for vaccines-SMART Vaccines 2.0.

PubMed

Knobler, Stacey; Bok, Karin; Gellin, Bruce

2017-01-20

SMART Vaccines 2.0 software is being developed to support decision-making among multiple stakeholders in the process of prioritizing investments to optimize the outcomes of vaccine development and deployment. Vaccines and associated vaccination programs are one of the most successful and effective public health interventions to prevent communicable diseases and vaccine researchers are continually working towards expanding targets for communicable and non-communicable diseases through preventive and therapeutic modes. A growing body of evidence on emerging vaccine technologies, trends in disease burden, costs associated with vaccine development and deployment, and benefits derived from disease prevention through vaccination and a range of other factors can inform decision-making and investment in new and improved vaccines and targeted utilization of already existing vaccines. Recognizing that an array of inputs influences these decisions, the strategic multi-attribute ranking method for vaccines (SMART Vaccines 2.0) is in development as a web-based tool-modified from a U.S. Institute of Medicine Committee effort (IOM, 2015)-to highlight data needs and create transparency to facilitate dialogue and information-sharing among decision-makers and to optimize the investment of resources leading to improved health outcomes. Current development efforts of the SMART Vaccines 2.0 framework seek to generate a weighted recommendation on vaccine development or vaccination priorities based on population, disease, economic, and vaccine-specific data in combination with individual preference and weights of user-selected attributes incorporating valuations of health, economics, demographics, public concern, scientific and business, programmatic, and political considerations. Further development of the design and utility of the tool is being carried out by the National Vaccine Program Office of the Department of Health and Human Services and the Fogarty International Center of the

Brazilian Center for the Validation of Alternative Methods (BraCVAM) and the process of validation in Brazil.

PubMed

Presgrave, Octavio; Moura, Wlamir; Caldeira, Cristiane; Pereira, Elisabete; Bôas, Maria H Villas; Eskes, Chantra

2016-03-01

The need for the creation of a Brazilian centre for the validation of alternative methods was recognised in 2008, and members of academia, industry and existing international validation centres immediately engaged with the idea. In 2012, co-operation between the Oswaldo Cruz Foundation (FIOCRUZ) and the Brazilian Health Surveillance Agency (ANVISA) instigated the establishment of the Brazilian Center for the Validation of Alternative Methods (BraCVAM), which was officially launched in 2013. The Brazilian validation process follows OECD Guidance Document No. 34, where BraCVAM functions as the focal point to identify and/or receive requests from parties interested in submitting tests for validation. BraCVAM then informs the Brazilian National Network on Alternative Methods (RENaMA) of promising assays, which helps with prioritisation and contributes to the validation studies of selected assays. A Validation Management Group supervises the validation study, and the results obtained are peer-reviewed by an ad hoc Scientific Review Committee, organised under the auspices of BraCVAM. Based on the peer-review outcome, BraCVAM will prepare recommendations on the validated test method, which will be sent to the National Council for the Control of Animal Experimentation (CONCEA). CONCEA is in charge of the regulatory adoption of all validated test methods in Brazil, following an open public consultation. 2016 FRAME.

Retrospective multicenter matched case-control study on the risk factors for narcolepsy with special focus on vaccinations (including pandemic influenza vaccination) and infections in Germany.

PubMed

Oberle, Doris; Pavel, Jutta; Mayer, Geert; Geisler, Peter; Keller-Stanislawski, Brigitte

2017-06-01

Studies associate pandemic influenza vaccination with narcolepsy. In Germany, a retrospective, multicenter, matched case-control study was performed to identify risk factors for narcolepsy, particularly regarding vaccinations (seasonal and pandemic influenza vaccination) and infections (seasonal and pandemic influenza) and to quantify the detected risks. Patients with excessive daytime sleepiness who had been referred to a sleep center between April 2009 and December 2012 for multiple sleep latency test (MSLT) were eligible. Case report forms were validated according to the criteria for narcolepsy defined by the Brighton Collaboration (BC). Confirmed cases of narcolepsy (BC level of diagnostic certainty 1-4a) were matched with population-based controls by year of birth, gender, and place of residence. A second control group was established including patients in whom narcolepsy was definitely excluded (test-negative controls). A total of 103 validated cases of narcolepsy were matched with 264 population-based controls. The second control group included 29 test-negative controls. A significantly increased odd ratio (OR) to develop narcolepsy (crude OR [cOR] = 3.9, 95% confidence interval [CI] = 1.8-8.5; adjusted OR [aOR] = 4.5, 95% CI = 2.0-9.9) was detected in individuals immunized with pandemic influenza A/H1N1/v vaccine prior to symptoms onset as compared to nonvaccinated individuals. Using test-negative controls, in individuals immunized with pandemic influenza A/H1N1/v vaccine prior to symptoms onset, a nonsignificantly increased OR of narcolepsy was detected when compared to nonvaccinated individuals (whole study population, BC levels 1-4a: cOR = 1.9, 95% CI = 0.5-6.9; aOR = 1.8, 95% CI = 0.3-10.1). The findings of this study support an increased risk for narcolepsy after immunization with pandemic influenza A/H1N1/v vaccine. Copyright © 2017 Elsevier B.V. All rights reserved.

Identification of Mutations in a Candidate Dengue 4 Vaccine Strain 341750 PDK20 and Construction of a Full-Length eDNA Clone of the PDK20 Vaccine Candidate

DTIC Science & Technology

2010-01-01

comply with a collection of information if it does not display a currently valid OMB control number . 1. REPORT DATE OCT 2009 2. REPORT TYPE 3. DATES...construction of a full-length eDNA clone of the PDK20 vaccine candidate 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d...PROJECT NUMBER 5e. TASK NUMBER 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) Naval Medical Research Center,Infectious

Novel Method Of Preparing Vaccines | NCI Technology Transfer Center | TTC

Cancer.gov

This invention from the NCI Cancer and Inflammation Program describes methods to prepare vaccines for the treatment of human immunodeficiency virus (HIV) infections. The National Cancer Institute's Cancer and Inflammation Program seeks parties interested in licensing or collaborative research to further develop, evaluate, or commercialize novel methods of preparing vaccines.

Designing pediatric vaccine formularies and pricing pediatric combination vaccines using operations research models and algorithms.

PubMed

Jacobson, Sheldon H; Sewell, Edward C; Allwine, Daniel A; Medina, Enrique A; Weniger, Bruce G

2003-02-01

The National Immunization Program, housed within the Centers for Disease Control and Prevention in the USA, has identified several challenges that must be faced in childhood immunization programs to deliver and procure vaccines that immunize children from the plethora of childhood diseases. The biomedical issues cited include how drug manufacturers can combine and formulate vaccines, how such vaccines are scheduled and administered and how economically sound vaccine procurement can be achieved. This review discusses how operations research models can be used to address the economics of pediatric vaccine formulary design and pricing, as well as how such models can be used to address a new set of pediatric formulary problems that will surface with the introduction of pediatric combination vaccines into the US pediatric immunization market.

Progress towards development of an HIV vaccine: report of the AIDS Vaccine 2009 Conference.

PubMed

Ross, Anna Laura; Bråve, Andreas; Scarlatti, Gabriella; Manrique, Amapola; Buonaguro, Luigi

2010-05-01

The search for an HIV/AIDS vaccine is steadily moving ahead, generating and validating new concepts in terms of novel vectors for antigen delivery and presentation, new vaccine and adjuvant strategies, alternative approaches to design HIV-1 antigens for eliciting protective cross-neutralising antibodies, and identification of key mechanisms in HIV infection and modulation of the immune system. All these different perspectives are contributing to the unprecedented challenge of developing a protective HIV-1 vaccine. The high scientific value of this massive effort is its great impact on vaccinology as a whole, providing invaluable scientific information for the current and future development of new preventive vaccine as well as therapeutic knowledge-based infectious-disease and cancer vaccines. Copyright 2010 Elsevier Ltd. All rights reserved.

[Design and Validation of a Questionnaire on Vaccination in Students of Health Sciences, Spain].

PubMed

Fernández-Prada, María; Ramos-Martín, Pedro; Madroñal-Menéndez, Jaime; Martínez-Ortega, Carmen; González-Cabrera, Joaquín

2016-11-07

Immunization rates among medicine and nursing students -and among health professional in general- during hospital training are low. It is necessary to investigate the causes for these low immunization rates. The objective of this study was to design and validate a questionnaire for exploring the attitudes and behaviours of medicine and nursing students toward immunization of vaccine-preventable diseases. An instrument validation study. The sample included 646 nursing and medicine students at University of Oviedo, Spain. It was a non-ramdom sampling. After the content validation process, a 24-item questionnaire was designed to assess attitudes and behaviours/behavioural intentions. Reliability (ordinal alpha), internal validity (exploratory factor analysis by parellel analysis), ANOVA and mediational model tests were performed. Exploratory factor analysis yielded two factors which accounted for 48.8% of total variance. Ordinal alpha for the total score was 0.92. Differences were observed across academic years in the dimensions of attitudes (F5.447=3.728) and knowledge (F5.448=65.59), but not in behaviours/behavioural intentions (F5.461=1.680). Attitudes demonstrated to be a moderating variable of knowledge and attitudes/behavioural attitudes (Indirect effect B=0.15; SD=0.3; 95% CI:0.09-0.19). We developed a questionnaie based on sufficient evidence of reliability and internal validity. Scores on attitudes and knowledge increase with the academic year. Attitudes act as a moderating variable between knowledge and behaviours/behavioural intentions.

Replication of Rubella Vaccine Population Genetic Studies: Validation of HLA Genotype and Humoral Response Associations

PubMed Central

Ovsyannikova, Inna G.; Jacobson, Robert M.; Vierkant, Robert A.; O’Byrne, Megan M.; Poland, Gregory A.

2009-01-01

Purported genetic associations found in population studies require validation for confirmation. We previously reported rubella vaccine-induced immune responses and HLA associations in 346 adolescents, age 12–18 years (1st cohort), following two doses of a rubella-containing vaccine. We sought to replicate the associations discovered in that work by verifying these associations in a new cohort of 396 subjects, age 11–19 years (2nd cohort), all having had two doses of a rubella-containing vaccine. We found that B*2705 (median 1st cohort 20.9 IU/ml, p=0.028; 2nd cohort 20.5 IU/ml, p=0.001) and DPA1*0201 (median 1st cohort 32.5 IU/ml, p=0.048; 2nd cohort 25.8 IU/ml, p=0.025) alleles were consistently associated with lower rubella-induced antibodies. Further, DPB1*0401 (median 1st cohort 43.5 IU/ml, p=0.021; 2nd cohort 36.2 IU/ml, p=0.002) alleles were associated with higher antibody levels in both populations. The association of DRB1*04-DQB1*03-DPB1*03 (mean 1st cohort 25.2 IU/ml, p=0.011; 2nd cohort 21.4 IU/ml, p=0.032) and DRB1*15/16-DQB1*06-DPB1*03 (1st cohort 16.3 IU/ml, p=0.043; 2nd cohort 19.1 IU/ml, p=0.023) haplotypes with lower rubella-specific antibodies were observed in both studies. This study provides confirmatory evidence for an association between specific class I and II HLA markers and haplotypes with rubella vaccine-induced humoral responses and lends further weight to their influence on rubella immune responses. PMID:19761839

Status of vaccine research and development of vaccines for tuberculosis.

PubMed

Evans, Thomas G; Schrager, Lew; Thole, Jelle

2016-06-03

TB is now the single pathogen that causes the greatest mortality in the world, at over 1.6 million deaths each year. The widely used the 90 year old BCG vaccine appears to have minimal impact on the worldwide incidence despite some efficacy in infants. Novel vaccine development has accelerated in the past 15 years, with 15 candidates entering human trials; two vaccines are now in large-scale efficacy studies. Modeling by three groups has consistently shown that mass vaccination that includes activity in the latently infected population, especially adolescents and young adults, will likely have the largest impact on new disease transmission. At present the field requires better validated animal models, better understanding of a correlate of immunity, new cost-effective approaches to Proof of Concept trials, and increased appreciation by the public health and scientific community for the size of the problem and the need for a vaccine. Such a vaccine is likely to also play a role in the era of increasing antibiotic resistance. Ongoing efforts and studies are working to implement these needs over the next 5 years, which will lead to an understanding that will increase the likelihood of a successful TB vaccine. Copyright © 2016 World Health Organization. Published by Elsevier Ltd.. All rights reserved.

Childhood immunization rates in rural Intibucá, Honduras: an analysis of a local database tool and community health center records for assessing and improving vaccine coverage.

PubMed

He, Yuan; Zarychta, Alan; Ranz, Joseph B; Carroll, Mary; Singleton, Lori M; Wilson, Paria M; Schlaudecker, Elizabeth P

2012-12-07

Vaccines are highly effective at preventing infectious diseases in children, and prevention is especially important in resource-limited countries where treatment is difficult to access. In Honduras, the World Health Organization (WHO) reports very high immunization rates in children. To determine whether or not these estimates accurately depict the immunization coverage in non-urban regions of the country, we compared the WHO data to immunization rates obtained from a local database tool and community health center records in rural Intibucá, Honduras. We used data from two sources to comprehensively evaluate immunization rates in the area: 1) census data from a local database and 2) immunization data collected at health centers. We compared these rates using logistic regression, and we compared them to publicly available WHO-reported estimates using confidence interval inclusion. We found that mean immunization rates for each vaccine were high (range 84.4 to 98.8 percent), but rates recorded at the health centers were significantly higher than those reported from the census data (p ≤ 0.001). Combining the results from both databases, the mean rates of four out of five vaccines were less than WHO-reported rates (p <0.05). Overall immunization rates were significantly different between townships (p=0.03). The rates by individual vaccine were similar across townships (p >0.05), except for diphtheria/tetanus/pertussis vaccine (p=0.02) and oral polio vaccine (p <0.01). Immunization rates in Honduras were high across data sources, though most of the rates recorded in rural Honduras were less than WHO-reported rates. Despite geographical difficulties and barriers to access, the local database and Honduran community health workers have developed a thorough system for ensuring that children receive their immunizations on time. The successful integration of community health workers and a database within the Honduran decentralized health system may serve as a model for

Childhood immunization rates in rural Intibucá, Honduras: an analysis of a local database tool and community health center records for assessing and improving vaccine coverage

PubMed Central

2012-01-01

Background Vaccines are highly effective at preventing infectious diseases in children, and prevention is especially important in resource-limited countries where treatment is difficult to access. In Honduras, the World Health Organization (WHO) reports very high immunization rates in children. To determine whether or not these estimates accurately depict the immunization coverage in non-urban regions of the country, we compared the WHO data to immunization rates obtained from a local database tool and community health center records in rural Intibucá, Honduras. Methods We used data from two sources to comprehensively evaluate immunization rates in the area: 1) census data from a local database and 2) immunization data collected at health centers. We compared these rates using logistic regression, and we compared them to publicly available WHO-reported estimates using confidence interval inclusion. Results We found that mean immunization rates for each vaccine were high (range 84.4 to 98.8 percent), but rates recorded at the health centers were significantly higher than those reported from the census data (p≤0.001). Combining the results from both databases, the mean rates of four out of five vaccines were less than WHO-reported rates (p <0.05). Overall immunization rates were significantly different between townships (p=0.03). The rates by individual vaccine were similar across townships (p >0.05), except for diphtheria/tetanus/pertussis vaccine (p=0.02) and oral polio vaccine (p <0.01). Conclusions Immunization rates in Honduras were high across data sources, though most of the rates recorded in rural Honduras were less than WHO-reported rates. Despite geographical difficulties and barriers to access, the local database and Honduran community health workers have developed a thorough system for ensuring that children receive their immunizations on time. The successful integration of community health workers and a database within the Honduran decentralized

Germinal Center B Cell and T Follicular Helper Cell Responses to Viral Vector and Protein-in-Adjuvant Vaccines

PubMed Central

Wang, Chuan; Hart, Matthew; Chui, Cecilia; Ajuogu, Augustine; Brian, Iona J.; de Cassan, Simone C.; Borrow, Persephone; Draper, Simon J.

2016-01-01

There is great interest in the development of Ab-inducing subunit vaccines targeting infections, including HIV, malaria, and Ebola. We previously reported that adenovirus vectored vaccines are potent in priming Ab responses, but uncertainty remains regarding the optimal approach for induction of humoral immune responses. In this study, using OVA as a model Ag, we assessed the magnitude of the primary and anamnestic Ag–specific IgG responses of mice to four clinically relevant vaccine formulations: replication-deficient adenovirus; modified vaccinia Ankara (a poxvirus); protein with alum; and protein in the squalene oil-in-water adjuvant Addavax. We then used flow cytometric assays capable of measuring total and Ag-specific germinal center (GC) B cell and follicular Th cell responses to compare the induction of these responses by the different formulations. We report that adenovirus vectored vaccines induce Ag insert–specific GC B cell and Ab responses of a magnitude comparable to those induced by a potent protein/squalene oil-in-water formulation whereas—despite a robust overall GC response—the insert-specific GC B cell and Ab responses induced by modified vaccinia Ankara were extremely weak. Ag-specific follicular Th cell responses to adenovirus vectored vaccines exceeded those induced by other platforms at day 7 after immunization. We found little evidence that innate immune activation by adenovirus may act as an adjuvant in such a manner that the humoral response to a recombinant protein may be enhanced by coadministering with an adenovirus lacking a transgene of interest. Overall, these studies provide further support for the use of replication-deficient adenoviruses to induce humoral responses. PMID:27412417

Enhancing Malaria Vaccine Development by the Naval Medical Research Center

DTIC Science & Technology

2003-03-01

optimized in Milestone 1 of this Phase II project. Reduction in particle size of the biopolymeric carrier was sufficient for intramuscular administration of...glycolide) (PLGA) with incorporated DNA plasmid were developed for systemic administration of DNA plasmids for use as a malaria vaccine. Objectives in...with incorporated DNA plasmid were developed for systemic administration of DNA plasmids for use as a malaria vaccine. Objectives in Milestone 1

Successful Control of Winter Pyrexias Caused by Equine Herpesvirus Type 1 in Japanese Training Centers by Achieving High Vaccination Coverage

PubMed Central

Mae, Naomi; Ode, Hirotaka; Nemoto, Manabu; Tsujimura, Koji; Yamanaka, Takashi; Kondo, Takashi; Matsumura, Tomio

2014-01-01

Equine herpesvirus type 1 (EHV-1) is a major cause of winter pyrexia in racehorses in two training centers (Ritto and Miho) in Japan. Until the epizootic period of 2008-2009, a vaccination program using a killed EHV-1 vaccine targeted only susceptible 3-year-old horses with low antibody levels to EHV-1 antigens. However, because the protective effect was not satisfactory, in 2009-2010 the vaccination program was altered to target all 3-year-old horses. To evaluate the vaccine's efficacy, we investigated the number of horses with pyrexia due to EHV-1 or equine herpesvirus type 4 (EHV-4) infection or both and examined the vaccination coverage in the 3-year-old population and in the whole population before and after changes in the program. The mean (± standard deviation [SD]) estimated numbers of horses infected with EHV-1 or EHV-4 or both, among pyretic horses from 1999-2000 to 2008-2009 were 105 ± 47 at Ritto and 66 ± 44 at Miho. Although the estimated number of infected horses did not change greatly in the first period of the current program, it decreased from the second period, with means (±SD) of 21 ± 12 at Ritto and 14 ± 15 at Miho from 2010-2011 to 2012-2013. Vaccination coverage in the 3-year-old population was 99.4% at Ritto and 99.8% at Miho in the first period, and similar values were maintained thereafter. Coverage in the whole population increased more gradually than that in the 3-year-old population. The results suggest that EHV-1 epizootics can be suppressed by maintaining high vaccination coverage, not only in the 3-year-old population but also in the whole population. PMID:24872513

Vaccine Hesitancy Among Caregivers and Association with Childhood Vaccination Timeliness in Addis Ababa, Ethiopia.

PubMed

Masters, Nina B; Tefera, Yemesrach A; Wagner, Abram L; Boulton, Matthew L

2018-05-24

Vaccines are vital to reducing childhood mortality, and prevent an estimated 2 to 3 million deaths annually which disproportionately occur in the developing world. Overall vaccine coverage is typically used as a metric to evaluate the adequacy of vaccine program performance, though it does not account for untimely administration, which may unnecessarily prolong children's susceptibility to disease. This study explored a hypothesized positive association between increasing vaccine hesitancy and untimeliness of immunizations administered under the Expanded Program on Immunization (EPI) in Addis Ababa, Ethiopia. This cross-sectional survey employed a multistage sampling design, randomly selecting one health center within five sub-cities of Addis Ababa. Caregivers of 3 to 12-month-old infants completed a questionnaire on vaccine hesitancy, and their infants' vaccination cards were examined to assess timeliness of received vaccinations. The sample comprised 350 caregivers. Overall, 82.3% of the surveyed children received all recommended vaccines, although only 55.9% of these vaccinations were timely. Few caregivers (3.4%) reported ever hesitating and 3.7% reported ever refusing a vaccine for their child. Vaccine hesitancy significantly increased the odds of untimely vaccination (AOR 1.94, 95% CI: 1.02, 3.71) in the adjusted analysis. This study found high vaccine coverage among a sample of 350 young children in Addis Ababa, though only half received all recommended vaccines on time. High vaccine hesitancy was strongly associated with infants' untimely vaccination, indicating that increased efforts to educate community members and providers about vaccines may have a beneficial impact on vaccine timeliness in Addis Ababa.

Vaccine Safety Resources for Nurses

PubMed Central

Shimabukuro, Tom T.; Hibbs, Beth F.; Moro, Pedro L.; Broder, Karen R.; Vellozzi, Claudia

2015-01-01

Overview Nurses are on the front lines of health care delivery, and many of them routinely administer immunizations. The authors describe the Centers for Disease Control and Prevention’s (CDC) vaccine safety monitoring systems, explaining how nurses can access inquiry channels and other immunization information resources. Examples of recent vaccine safety inquiries are also provided. PMID:26222474

Field validation of experimental challenge models for IPN vaccines.

PubMed

Ramstad, A; Romstad, A B; Knappskog, D H; Midtlyng, P J

2007-12-01

Atlantic salmon S1/2 pre-smolts from the VESO Vikan hatchery were assigned to study groups, i.p. immunized with commercially available, multivalent oil-adjuvanted vaccines with (Norvax Compact 6 - NC-6) or without (Norvax Compact 4 - NC-4) recombinant infectious pancreatic necrosis virus (IPNV) antigen. A control group received saline solution. When ready for sea, the fish were transported to the VESO Vikan experimental laboratory, where two identical tanks were stocked with 75 fish per group before being transferred to 10 degrees C sea water and exposed by bath to first passage IPNV grown in CHSE-214 cells. The third tank containing 40 fish from each group was challenged by the introduction of 116 fish that had received an i.p injection of IPNV-challenge material. The remaining vaccinated fish were transported to the VESO Vikan marine field trial site and placed in two identical pens, each containing approximately 53 000 fish from the NC-6 group and 9000 fish from the NC-4 group. In the experimental bath challenge trial, the cumulative mortality was 75% and 78% in the control groups, and the relative percentage survival (RPS) of the NC-6-immunized fish vs. the reference vaccine groups was 60% and 82%, respectively. In the cohabitation challenge, the control mortality reached 74% and the IPNV-specific vaccine RPS was 72%. In both models, the reference vaccine lacking IPNV antigen gave a moderate but statistically significant non-specific protection. In the field, a natural outbreak of infectious pancreatic necrosis (IPN) occurred after 7 weeks lasting for approximately 3.5 months before problems due to winter ulcers became dominating. During this outbreak, mortality in the NC-4 groups were 33.5% and 31.6%, respectively, whereas mortality in the NC-6 groups were 6.9% and 5.3%, respectively, amounting to 81% IPNV-specific protection. In conclusion, the IPN protection estimates obtained by experimental challenges were consistent between tanks, and were confirmed by

New Meningococcal Vaccine Recommendations under Consideration

ERIC Educational Resources Information Center

Turner, James C.

2004-01-01

The Advisory Committee on Immunization Practices (ACIP) at the Center for Disease Control and Prevention (CDC) will be considering a new vaccination recommendation for the prevention of invasive "N. meningitidis" infection when meningococcal conjugate vaccines are licensed in the United States. The CDC has also updated the Working Group…

Nuclear Energy Knowledge and Validation Center (NEKVaC) Needs Workshop Summary Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gougar, Hans

2015-02-01

The Department of Energy (DOE) has made significant progress developing simulation tools to predict the behavior of nuclear systems with greater accuracy and of increasing our capability to predict the behavior of these systems outside of the standard range of applications. These analytical tools require a more complex array of validation tests to accurately simulate the physics and multiple length and time scales. Results from modern simulations will allow experiment designers to narrow the range of conditions needed to bound system behavior and to optimize the deployment of instrumentation to limit the breadth and cost of the campaign. Modern validation,more » verification and uncertainty quantification (VVUQ) techniques enable analysts to extract information from experiments in a systematic manner and provide the users with a quantified uncertainty estimate. Unfortunately, the capability to perform experiments that would enable taking full advantage of the formalisms of these modern codes has progressed relatively little (with some notable exceptions in fuels and thermal-hydraulics); the majority of the experimental data available today is the "historic" data accumulated over the last decades of nuclear systems R&D. A validated code-model is a tool for users. An unvalidated code-model is useful for code developers to gain understanding, publish research results, attract funding, etc. As nuclear analysis codes have become more sophisticated, so have the measurement and validation methods and the challenges that confront them. A successful yet cost-effective validation effort requires expertise possessed only by a few, resources possessed only by the well-capitalized (or a willing collective), and a clear, well-defined objective (validating a code that is developed to satisfy the need(s) of an actual user). To that end, the Idaho National Laboratory established the Nuclear Energy Knowledge and Validation Center to address the challenges of modern code validation

Vaccination of day-care center attendees reduces carriage of Streptococcus pneumoniae among their younger siblings.

PubMed

Givon-Lavi, Noga; Fraser, Drora; Dagan, Ron

2003-06-01

We conducted a study to determine whether administration of a pneumococcal conjugate vaccine to toddlers attending day-care centers (DCCs) could prevent acquisition of Streptococcus pneumoniae of the vaccine serotypes (VT) by their younger siblings. In a double blind study, 262 DCC attendees ages 12 to 35 months were randomized to receive a 9-valent pneumococcal conjugate vaccine (PnCRM9; n = 132), or a control vaccine (meningococcus C vaccine; n = 130). It was planned to follow the groups for 2 years with monthly nasopharyngeal pneumococcal cultures during the first follow-up year and every 2 months during the second year. Forty-six younger siblings of the above described children, age <18 months (23 siblings of the PnCRM9 recipients and 23 of the controls), were also enrolled, and nasopharyngeal cultures were obtained monthly until the children reached the age of 18 months or started to attend DCC, if before the age of 18 months. Pneumococcal isolates were serotyped and tested for antibiotic susceptibility. Of the 3748 cultures obtained from the DCC attendees, 2450 (65%) were positive for S. pneumoniae. Of 306 cultures obtained from the younger siblings, 151 (49%) were positive. Among the PnCRM9 recipients, cultures were significantly less frequently positive for the VT S. pneumoniae than among the controls (13% vs. 21%, respectively; P < 0.001). The same pattern was seen in the younger siblings of PnCRM9 recipients vs. the siblings of controls (21% vs. 34%, respectively; P = 0.017). The reverse trend was seen for non-VT strains in both the DCC attendees (44% vs. 34%, respectively; P < 0.001) and their younger siblings (19% vs. 13%, respectively; P = 0.15). There was a significant decrease in the carriage rate of antibiotic-resistant S. pneumoniae in both the PnCRM9 recipients and their younger siblings. The relative risks (and 95% confidence intervals) to carry S. pneumoniae penicillin-nonsusceptible, resistant to > or =1, > or =2 and > or =3 antibiotic

Monitoring vaccine and non-vaccine HPV type prevalence in the post-vaccination era in women living in the Basilicata region, Italy.

PubMed

Carozzi, Francesca; Puliti, Donella; Ocello, Cristina; Anastasio, Pasquale Silvio; Moliterni, Espedito Antonio; Perinetti, Emilia; Serradell, Laurence; Burroni, Elena; Confortini, Massimo; Mantellini, Paola; Zappa, Marco; Dominiak-Felden, Géraldine

2018-01-15

A large free-of-charge quadrivalent HPV (qHPV) vaccination program, covering four cohorts annually (women 11, 14, 17 and 24 years), has been implemented in Basilicata since 2007. This study evaluated vaccine and non-vaccine HPV prevalence 5-7 years post-vaccination program implementation in vaccinated and unvaccinated women. This population-based, cross-sectional study was conducted in the public screening centers of the Local Health Unit in Matera between 2012 and 2014. Cervical samples were obtained for Pap and HPV testing (HC2, LiPA Extra® assay) and participants completed a sociodemographic and behavioral questionnaire. Detailed HPV vaccination status was retrieved from the official HPV vaccine registry. HPV prevalence was described overall, by type and vaccination status. The association between HPV type-detection and risk/protective factors was studied. Direct vaccine protection (qHPV vaccine effectiveness [VE]), cross-protection, and type-replacement were evaluated in cohorts eligible for vaccination, by analyzing HPV prevalence of vaccine and non-vaccine types according to vaccination status. Overall, 2793 women (18-50 years) were included, 1314 of them having been in birth cohorts eligible for the HPV vaccination program (18- to 30-year-old women at enrolment). Among the latter, qHPV vaccine uptake was 59% (at least one dose), with 94% completing the schedule; standardized qHPV type prevalence was 0.6% in vaccinated versus 5.5% in unvaccinated women (P <0.001); adjusted VE against vaccine type infections was 90% (95% CI: 73%-96%) for all fully vaccinated women and 100% (95% CI not calculable) in women vaccinated before sexual debut. No statistically significant difference in overall high-risk HPV, high-risk non-vaccine HPV, or any single non-vaccine type prevalence was observed between vaccinated and unvaccinated women. These results, conducted in a post-vaccine era, suggest a high qHPV VE and that a well-implemented catch-up vaccination program may be

Influenza vaccinations and chemosensory function.

PubMed

Doty, Richard L; Berman, Austin H; Izhar, Mohammad; Hamilton, Hugh B; Villano, Danylko; Vazquez, Britney E; Warrum, Maja N; Mahbob, Mariam

2014-01-01

Although influenza vaccines have saved millions of lives, some have been associated with extremely rare adverse effects such as Guillain-Barré syndrome, Bell's palsy, and optic neuritis. Despite the fact that olfactory loss after an influenza vaccination is noted in one case report, no quantitative olfactory testing was performed. Hence, it is unclear whether, in fact, olfactory dysfunction can be associated with such vaccinations. This study was designed to (1) identify patients from the University of Pennsylvania Smell and Taste Center who attributed their empirically determined chemosensory disturbances to influenza vaccinations and (2) determine whether influenza vaccinations add to the degree of olfactory or gustatory dysfunction due to other causes. A retrospective analysis of self-reported etiologies of 4554 consecutive patients presenting to the University of Pennsylvania Smell and Taste Center with complaints of chemosensory dysfunction was performed. Those who reported dysfunction secondary to influenza vaccinations were identified. Additionally, in a subset of 925 patients for whom detailed inoculation histories were available, it was determined whether the number of lifetime inoculations added to the deficits due to other causes. Nine of the 4554 patients (0.19%) attributed olfactory disturbances to an influenza vaccination. None complained of taste dysfunction. All nine had abnormally low scores on the University of Pennsylvania Smell Identification Test (p < 0.001), with three being anosmic and six microsmic. Seven had elevated phenyl ethyl alcohol detection thresholds (p < 0.05). Two cases exhibited mild-to-moderate loss of whole mouth taste function. Of the 925 patients, no association was evident between the number of lifetime vaccinations and the chemosensory test scores. In accord with previous studies, age and sex were significantly related to the test scores. A very small percentage of the 4554 patients evaluated (0.19%) attributed their

Occurrence of early adverse events after vaccination against influenza at a Brazilian reference center.

PubMed

Lopes, Marta Heloísa; Mascheretti, Melissa; Franco, Marilia Miranda; Vasconcelos, Ricardo; Gutierrez, Eliana Battaggia

2008-02-01

Since 1999, the Ministry of Health in Brazil has conducted campaigns of vaccination against influenza targeted towards the elderly, chronically-diseased people and health care workers. The vaccine against influenza is associated with adverse events of minor importance. To investigate the early adverse events related to the vaccine against influenza. CASUISTICS AND METHODS: One hundred and ninety seven elderly individuals and health care workers vaccinated against influenza were included. An inquiry regarding adverse events related to the vaccine was applied seven days after the vaccination. Local adverse events were reported by 32.5% and systemic effects by 26.4% of the vaccinated subjects. Pain in the region of the injection, headache, myalgia, malaise, and coryza were more frequent in the workers than in the elderly (p<0.05). There was no statistically significant difference in the occurrence of fever. The belief of part of the population that credits frequent and uncomfortable adverse events to the vaccine was not confirmed. The subjective adverse events were more frequent in the health care workers, which can influence, in a negative way, the disclosure of the benefits of this vaccine due to their role as opinion makers.

Vaccinating my way--use of alternative vaccination schedules in New York State.

PubMed

Nadeau, Jessica A; Bednarczyk, Robert A; Masawi, Munyaradzi R; Meldrum, Megan D; Santilli, Loretta; Zansky, Shelley M; Blog, Debra S; Birkhead, Guthrie S; McNutt, Louise-Anne

2015-01-01

To identify children vaccinated following an alternative vaccine schedule using immunization information system data and determine the impact of alternative schedule use on vaccine coverage. Children born in New York State, outside New York City, between January 1, 2009 and August 14, 2011 were assessed for vaccination patterns consistent with use of an alternative schedule. Children who by 9 months of age had at least 3 vaccination visits recorded in the statewide mandatory immunization information system after 41 days of age were classified as either attempting to conform to the Centers for Disease Control and Prevention published recommended vaccination schedule or an alternative schedule. The number of vaccination visits and up-to-date status at age 9 months were compared between groups. Of the 222 628 children studied, the proportion of children following an alternative schedule was 25%. These children were significantly less likely to be up-to-date at age 9 months (15%) compared with those conforming to the routine schedule (90%, P < .05). Children following an alternative schedule on average had about 2 extra vaccine visits compared with children following a routine schedule (P < .05). Almost 1 in 4 children in this study appear to be intentionally deviating from the routine schedule. Intentional deviation leads to poor vaccination coverage leaving children vulnerable to infection and increasing the potential for vaccine-preventable disease outbreaks. Copyright © 2015 Elsevier Inc. All rights reserved.

Measles, mumps, and rubella vaccines.

PubMed

Wharton, M; Cochi, S L; Williams, W W

1990-03-01

With widespread use of the live virus vaccines for measles, mumps, and rubella, there has been a dramatic decrease in the incidence of all three diseases. At the same time, an increasing proportion of the remaining cases are occurring in adolescents and adults. Thus, vaccinations for these three diseases of childhood must be included in a comprehensive program for adult immunization. The vaccines have a proven history of safety and efficacy and are usually administered together as combined measles-mumps-rubella (MMR) vaccine. Vaccination for measles, mumps, and rubella is particularly important for susceptible adults likely to come in contact with infected children. Adults at particularly high risk for exposure may include daycare center workers, teachers and other school employees, college students, medical personnel, and those planning to travel outside the United States.

Pneumococcal Vaccination in Low-Income Latinos: An Unexpected Trend in Oregon Community Health Centers.

PubMed

Heintzman, John; Bailey, Steffani R; Cowburn, Stuart; Dexter, Eve; Carroll, Joseph; Marino, Miguel

2016-01-01

In cross-sectional studies, Latino and Spanish-speaking U.S. residents age 65 and over are less likely to receive pneumococcal vaccination than non-Hispanic Whites. We performed a time-to-event, cohort analysis, in 23 Oregon community health centers of low-income patients who turned 65 in the study period (2009-2013; n = 1,248). The outcome measure was receipt of PPSV-23 in the study period by race / ethnicity, preferred language, and insurance status. Insured Latino patients were more likely to receive PPSV-23 than insured non-Hispanic Whites (HR = 2.05, p < .001). Uninsured Latino seniors showed no difference from insured non-Hispanic Whites in PPSV-23 receipt (HR = 1.26, p = .381) unless they averaged fewer than one clinic visit yearly (HR = 1.80, p = .001). Low-income Latino seniors in Oregon community health centers were immunized against pneumococcus more frequently than insured non-Hispanic Whites, although this finding was mitigated in Latinos without insurance. This finding needs further research in order to reduce adult immunization disparities in the society at large.

Traveling Abroad: Latest Yellow Fever Vaccine Update | Poster

Cancer.gov

Earlier this month, the U.S. Centers for Disease Control and Prevention (CDC) released its list of clinics that are administering the yellow fever vaccine Stamaril, which has been made available to address the total depletion of the United States’ primary yellow fever vaccine, YF-VAX. These clinics will provide the vaccine to individuals preparing for international travel,

Predictors of completed childhood vaccination in Bolivia.

PubMed

Osetinsky, Brianna; Gaydos, Laura M; Leon, Juan S

This project examines how access issues, ethnicity, and geographic region affect vaccination of children by two years of age in Bolivia. Bolivia's rich variation in culture and geography results in unequal healthcare utilization even for basic interventions such as childhood vaccination. This study utilizes secondary data from the 2008 Demographic and Health Survey for Bolivia to examine predictors of vaccination completion in children by two years of age. Using logistic regression methods, we control for health system variables (difficulty getting to a health center and type of health center as well as demographic and socio-economic covariates). The results indicated that children whose parents reported distance as a problem in obtaining health care were less likely to have completed all vaccinations. Ethnicity was not independently statistically significant, however, in a sub-analysis, people from the Quechua ethnic group were more likely to report 'distance as a problem in obtaining healthcare.' Surprisingly, living in a rural environment has a protective effect on completed vaccinations. However, geographic region did predict significant differences in the probability that children would be fully vaccinated; children in the region with the lowest vaccination completion coverage were 80% less likely to have completed vaccination compared to children in the best performing region, which may indicate unequal access and utilization of health services nationally. Further study of regional differences, urbanicity, and distance as a healthcare access problem will help refine implications for the Bolivian health system.

Predictors of completed childhood vaccination in Bolivia

PubMed Central

Osetinsky, Brianna; Gaydos, Laura M; Leon, Juan S

2015-01-01

This project examines how access issues, ethnicity, and geographic region affect vaccination of children by two years of age in Bolivia. Bolivia’s rich variation in culture and geography results in unequal healthcare utilization even for basic interventions such as childhood vaccination. This study utilizes secondary data from the 2008 Demographic and Health Survey for Bolivia to examine predictors of vaccination completion in children by two years of age. Using logistic regression methods, we control for health system variables (difficulty getting to a health center and type of health center as well as demographic and socio-economic covariates). The results indicated that children whose parents reported distance as a problem in obtaining health care were less likely to have completed all vaccinations. Ethnicity was not independently statistically significant, however, in a sub-analysis, people from the Quechua ethnic group were more likely to report ‘distance as a problem in obtaining healthcare.’ Surprisingly, living in a rural environment has a protective effect on completed vaccinations. However, geographic region did predict significant differences in the probability that children would be fully vaccinated; children in the region with the lowest vaccination completion coverage were 80% less likely to have completed vaccination compared to children in the best performing region, which may indicate unequal access and utilization of health services nationally. Further study of regional differences, urbanicity, and distance as a healthcare access problem will help refine implications for the Bolivian health system. PMID:26609338

Semantic network analysis of vaccine sentiment in online social media.

PubMed

Kang, Gloria J; Ewing-Nelson, Sinclair R; Mackey, Lauren; Schlitt, James T; Marathe, Achla; Abbas, Kaja M; Swarup, Samarth

2017-06-22

To examine current vaccine sentiment on social media by constructing and analyzing semantic networks of vaccine information from highly shared websites of Twitter users in the United States; and to assist public health communication of vaccines. Vaccine hesitancy continues to contribute to suboptimal vaccination coverage in the United States, posing significant risk of disease outbreaks, yet remains poorly understood. We constructed semantic networks of vaccine information from internet articles shared by Twitter users in the United States. We analyzed resulting network topology, compared semantic differences, and identified the most salient concepts within networks expressing positive, negative, and neutral vaccine sentiment. The semantic network of positive vaccine sentiment demonstrated greater cohesiveness in discourse compared to the larger, less-connected network of negative vaccine sentiment. The positive sentiment network centered around parents and focused on communicating health risks and benefits, highlighting medical concepts such as measles, autism, HPV vaccine, vaccine-autism link, meningococcal disease, and MMR vaccine. In contrast, the negative network centered around children and focused on organizational bodies such as CDC, vaccine industry, doctors, mainstream media, pharmaceutical companies, and United States. The prevalence of negative vaccine sentiment was demonstrated through diverse messaging, framed around skepticism and distrust of government organizations that communicate scientific evidence supporting positive vaccine benefits. Semantic network analysis of vaccine sentiment in online social media can enhance understanding of the scope and variability of current attitudes and beliefs toward vaccines. Our study synthesizes quantitative and qualitative evidence from an interdisciplinary approach to better understand complex drivers of vaccine hesitancy for public health communication, to improve vaccine confidence and vaccination coverage

Whooping crane titers to eastern equine encephalitis vaccinations

USGS Publications Warehouse

Olsen, Glenn H.; Kolski, E.; Hatfield, J.S.; Docherty, D.E.; Chavez-Ramirez, Felipe

2005-01-01

In 1984 an epizootic of eastern equine encephalitis (EEE) virus killed 7 of 39 (18%) whooping cranes in captivity at the Patuxent Wildlife Research Center in Laurel, Maryland, USA. Since that time whooping cranes have been vaccinated with a human EEE vaccine. This vaccine was unavailable for several years, necessitating use of an equine vaccine in the cranes. This study compared the antibody titers measured for three years using the human vaccine with those measured for two years using the equine form. Whooping cranes developed similarly elevated titers in one year using the human vaccine and both years using the equine vaccine. However, in two years where the human vaccine was used, the whooping cranes developed significantly lower titers compared to other years.

Design and Implementation Content Validity Study: Development of an instrument for measuring Patient-Centered Communication

PubMed Central

Zamanzadeh, Vahid; Ghahramanian, Akram; Rassouli, Maryam; Abbaszadeh, Abbas; Alavi-Majd, Hamid; Nikanfar, Ali-Reza

2015-01-01

Introduction: The importance of content validity in the instrument psychometric and its relevance with reliability, have made it an essential step in the instrument development. This article attempts to give an overview of the content validity process and to explain the complexity of this process by introducing an example. Methods: We carried out a methodological study conducted to examine the content validity of the patient-centered communication instrument through a two-step process (development and judgment). At the first step, domain determination, sampling (item generation) and instrument formation and at the second step, content validity ratio, content validity index and modified kappa statistic was performed. Suggestions of expert panel and item impact scores are used to examine the instrument face validity. Results: From a set of 188 items, content validity process identified seven dimensions includes trust building (eight items), informational support (seven items), emotional support (five items), problem solving (seven items), patient activation (10 items), intimacy/friendship (six items) and spirituality strengthening (14 items). Content validity study revealed that this instrument enjoys an appropriate level of content validity. The overall content validity index of the instrument using universal agreement approach was low; however, it can be advocated with respect to the high number of content experts that makes consensus difficult and high value of the S-CVI with the average approach, which was equal to 0.93. Conclusion: This article illustrates acceptable quantities indices for content validity a new instrument and outlines them during design and psychometrics of patient-centered communication measuring instrument. PMID:26161370

Remote Sensing Product Verification and Validation at the NASA Stennis Space Center

NASA Technical Reports Server (NTRS)

Stanley, Thomas M.

2005-01-01

Remote sensing data product verification and validation (V&V) is critical to successful science research and applications development. People who use remote sensing products to make policy, economic, or scientific decisions require confidence in and an understanding of the products' characteristics to make informed decisions about the products' use. NASA data products of coarse to moderate spatial resolution are validated by NASA science teams. NASA's Stennis Space Center (SSC) serves as the science validation team lead for validating commercial data products of moderate to high spatial resolution. At SSC, the Applications Research Toolbox simulates sensors and targets, and the Instrument Validation Laboratory validates critical sensors. The SSC V&V Site consists of radiometric tarps, a network of ground control points, a water surface temperature sensor, an atmospheric measurement system, painted concrete radial target and edge targets, and other instrumentation. NASA's Applied Sciences Directorate participates in the Joint Agency Commercial Imagery Evaluation (JACIE) team formed by NASA, the U.S. Geological Survey, and the National Geospatial-Intelligence Agency to characterize commercial systems and imagery.

Human Papillomavirus Vaccine Increases High-Risk Sexual Behaviors: A Myth or Valid Concern

ERIC Educational Resources Information Center

Ratanasiripong, Nop T.

2014-01-01

In 2006, the first human pappilomavirus (HPV) vaccine was approved for females aged 9 to 26. However, the national HPV vaccination rate among young women has been low. Public concerns were raised in regard to the fact that HPV vaccination might encourage unsafe sex. This cross-sectional study examined the differences in sexual practices between…

Traveling Abroad: Latest Yellow Fever Vaccine Update | Poster

Cancer.gov

Earlier this month, the U.S. Centers for Disease Control and Prevention (CDC) released its list of clinics that are administering the yellow fever vaccine Stamaril, which has been made available to address the total depletion of the United States’ primary yellow fever vaccine, YF-VAX. These clinics will provide the vaccine to individuals preparing for international travel, including NCI at Frederick staff and scientists.

Engineering Enhanced Vaccine Cell Lines To Eradicate Vaccine-Preventable Diseases: the Polio End Game

PubMed Central

van der Sanden, Sabine M. G.; Wu, Weilin; Dybdahl-Sissoko, Naomi; Weldon, William C.; Brooks, Paula; O'Donnell, Jason; Jones, Les P.; Brown, Cedric; Tompkins, S. Mark; Karpilow, Jon; Tripp, Ralph A.

2015-01-01

ABSTRACT Vaccine manufacturing costs prevent a significant portion of the world's population from accessing protection from vaccine-preventable diseases. To enhance vaccine production at reduced costs, a genome-wide RNA interference (RNAi) screen was performed to identify gene knockdown events that enhanced poliovirus replication. Primary screen hits were validated in a Vero vaccine manufacturing cell line using attenuated and wild-type poliovirus strains. Multiple single and dual gene silencing events increased poliovirus titers >20-fold and >50-fold, respectively. Host gene knockdown events did not affect virus antigenicity, and clustered regularly interspaced short palindromic repeat (CRISPR)-Cas9-mediated knockout of the top candidates dramatically improved viral vaccine strain production. Interestingly, silencing of several genes that enhanced poliovirus replication also enhanced replication of enterovirus 71, a clinically relevant virus to which vaccines are being targeted. The discovery that host gene modulation can markedly increase virus vaccine production dramatically alters mammalian cell-based vaccine manufacturing possibilities and should facilitate polio eradication using the inactivated poliovirus vaccine. IMPORTANCE Using a genome-wide RNAi screen, a collection of host virus resistance genes was identified that, upon silencing, increased poliovirus and enterovirus 71 production by from 10-fold to >50-fold in a Vero vaccine manufacturing cell line. This report provides novel insights into enterovirus-host interactions and describes an approach to developing the next generation of vaccine manufacturing through engineered vaccine cell lines. The results show that specific gene silencing and knockout events can enhance viral titers of both attenuated (Sabin strain) and wild-type polioviruses, a finding that should greatly facilitate global implementation of inactivated polio vaccine as well as further reduce costs for live-attenuated oral polio vaccines

Engineering Enhanced Vaccine Cell Lines To Eradicate Vaccine-Preventable Diseases: the Polio End Game.

PubMed

van der Sanden, Sabine M G; Wu, Weilin; Dybdahl-Sissoko, Naomi; Weldon, William C; Brooks, Paula; O'Donnell, Jason; Jones, Les P; Brown, Cedric; Tompkins, S Mark; Oberste, M Steven; Karpilow, Jon; Tripp, Ralph A

2016-02-15

Vaccine manufacturing costs prevent a significant portion of the world's population from accessing protection from vaccine-preventable diseases. To enhance vaccine production at reduced costs, a genome-wide RNA interference (RNAi) screen was performed to identify gene knockdown events that enhanced poliovirus replication. Primary screen hits were validated in a Vero vaccine manufacturing cell line using attenuated and wild-type poliovirus strains. Multiple single and dual gene silencing events increased poliovirus titers >20-fold and >50-fold, respectively. Host gene knockdown events did not affect virus antigenicity, and clustered regularly interspaced short palindromic repeat (CRISPR)-Cas9-mediated knockout of the top candidates dramatically improved viral vaccine strain production. Interestingly, silencing of several genes that enhanced poliovirus replication also enhanced replication of enterovirus 71, a clinically relevant virus to which vaccines are being targeted. The discovery that host gene modulation can markedly increase virus vaccine production dramatically alters mammalian cell-based vaccine manufacturing possibilities and should facilitate polio eradication using the inactivated poliovirus vaccine. Using a genome-wide RNAi screen, a collection of host virus resistance genes was identified that, upon silencing, increased poliovirus and enterovirus 71 production by from 10-fold to >50-fold in a Vero vaccine manufacturing cell line. This report provides novel insights into enterovirus-host interactions and describes an approach to developing the next generation of vaccine manufacturing through engineered vaccine cell lines. The results show that specific gene silencing and knockout events can enhance viral titers of both attenuated (Sabin strain) and wild-type polioviruses, a finding that should greatly facilitate global implementation of inactivated polio vaccine as well as further reduce costs for live-attenuated oral polio vaccines. This work

Cost Effectiveness of Influenza Vaccine for U.S. Children: Live Attenuated and Inactivated Influenza Vaccine.

PubMed

Shim, Eunha; Brown, Shawn T; DePasse, Jay; Nowalk, Mary Patricia; Raviotta, Jonathan M; Smith, Kenneth J; Zimmerman, Richard K

2016-09-01

Prior studies showed that live attenuated influenza vaccine (LAIV) is more effective than inactivated influenza vaccine (IIV) in children aged 2-8 years, supporting the Centers for Disease Control and Prevention (CDC) recommendations in 2014 for preferential LAIV use in this age group. However, 2014-2015 U.S. effectiveness data indicated relatively poor effectiveness of both vaccines, leading CDC in 2015 to no longer prefer LAIV. An age-structured model of influenza transmission and vaccination was developed, which incorporated both direct and indirect protection induced by vaccination. Based on this model, the cost effectiveness of influenza vaccination strategies in children aged 2-8 years in the U.S. was estimated. The base case assumed a mixed vaccination strategy where 33.3% and 66.7% of vaccinated children aged 2-8 years receive LAIV and IIV, respectively. Analyses were performed in 2014-2015. Using published meta-analysis vaccine effectiveness data (83% LAIV and 64% IIV), exclusive LAIV use would be a cost-effective strategy when vaccinating children aged 2-8 years, whereas IIV would not be preferred. However, when 2014-2015 U.S. effectiveness data (0% LAIV and 15% IIV) were used, IIV was likely to be preferred. The cost effectiveness of influenza vaccination in children aged 2-8 years is highly dependent on vaccine effectiveness; the vaccine type with higher effectiveness is preferred. In general, exclusive IIV use is preferred over LAIV use, as long as vaccine effectiveness is higher for IIV than for LAIV. Copyright © 2016 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Spanish validation of the Person-centered Care Assessment Tool (P-CAT).

PubMed

Martínez, Teresa; Suárez-Álvarez, Javier; Yanguas, Javier; Muñiz, José

2016-01-01

Person-centered Care (PCC) is an innovative approach which seeks to improve the quality of care services given to the care-dependent elderly. At present there are no Spanish language instruments for the evaluation of PCC delivered by elderly care services. The aim of this work is the adaptation and validation of the Person-centered Care Assessment Tool (P-CAT) for a Spanish population. The P-CAT was translated and adapted into Spanish, then given to a sample of 1339 front-line care professionals from 56 residential elderly care homes. The reliability and validity of the P-CAT were analyzed, within the frameworks of Classical Test Theory and Item Response Theory models. The Spanish P-CAT demonstrated good reliability, with an alpha coefficient of .88 and a test-retest reliability coefficient of .79. The P-CAT information function indicates that the test measures with good precision for the majority of levels of the measured variables (θ values between -2 and +1). The factorial structure of the test is essentially one-dimensional and the item discrimination indices are high, with values between .26 and .61. In terms of predictive validity, the correlations which stand out are between the P-CAT and organizational climate (r = .689), and the burnout factors; personal accomplishment (r = .382), and emotional exhaustion (r = - .510). The Spanish version of the P-CAT demonstrates good psychometric properties for its use in the evaluation of elderly care homes both professionally and in research.

Development and Validation of Quality Criteria for Providing Patient- and Family-centered Injury Care.

PubMed

Boyd, Jamie M; Burton, Rachael; Butler, Barb L; Dyer, Dianne; Evans, David C; Felteau, Melissa; Gruen, Russell L; Jaffe, Kenneth M; Kortbeek, John; Lang, Eddy; Lougheed, Val; Moore, Lynne; Narciso, Michelle; Oxland, Peter; Rivara, Frederick P; Roberts, Derek; Sarakbi, Diana; Vine, Karen; Stelfox, Henry T

2017-08-01

The aim of this study was to develop and evaluate the content validity of quality criteria for providing patient- and family-centered injury care. Quality criteria have been developed for clinical injury care, but not patient- and family-centered injury care. Using a modified Research AND Development Corporation (RAND)/University of California, Los Angeles (UCLA) Appropriateness Methodology, a panel of 16 patients, family members, injury and quality of care experts serially rated and revised criteria for patient- and family-centered injury care identified from patient and family focus groups. The criteria were then sent to 384 verified trauma centers in the United States, Canada, Australia, and New Zealand for evaluation. A total of 46 criteria were rated and revised by the panel over 4 rounds of review producing 14 criteria related to clinical care (n = 4; transitions of care, pain management, patient safety, provider competence), communication (n = 3; information for patients/families; communication of discharge plans to patients/families, communication between hospital and community providers), holistic care (n = 4; patient hygiene, kindness and respect, family access to patient, social and spiritual support) and end-of-life care (n = 3; decision making, end-of-life care, family follow-up). Medical directors, managers, or coordinators representing 254 trauma centers (66% response rate) rated 12 criteria to be important (95% of responses) for patient- and family-centered injury care. Fewer centers rated family access to the patient (80%) and family follow-up after patient death (65%) to be important criteria. Fourteen-candidate quality criteria for patient- and family-centered injury care were developed and shown to have content validity. These may be used to guide quality improvement practices.

Seasonal influenza vaccination rates and reasons for non-vaccination in children with gastrointestinal disorders.

PubMed

Peleg, Noam; Zevit, Noam; Shamir, Raanan; Chodick, Gabriel; Levy, Itzhak

2015-01-01

Despite advances in the treatment and prevention of influenza, it is still considered an important cause of morbidity and mortality worldwide. Annual vaccination is the safest and most effective mean of prevention. Our study aims were to explore the uptake of influenza vaccination among children with gastrointestinal disorders, and to characterize non-adherent patients. The present cross-sectional study included parents of pediatric patients attending the Gastroenterology Institute at Schneider Children's Medical Center of Israel between September and October 2011. Parents were asked to complete a questionnaire concerning demographic and clinical parameters, influenza vaccination of the child, and reasons for not vaccinating the child, when appropriate. The study population included 273 patients (50% female), with a median age of 10 years (range, 2-18 years). Overall, the rate of seasonal influenza vaccination was 30.8%. Higher rates were found among immunosuppressed patients (46.1%), and in patients with inflammatory bowel disease (50%). There was no significant effect of patient age, gender, ethnic origin or parental level of education on the vaccination rate. Vaccination rates were significantly associated with parents' information and knowledge of, as well as their personal beliefs regarding the vaccine (P<0.001). Influenza vaccination rates are relatively low in the pediatric population attending gastroenterology clinics, in both high- and low-risk groups. The importance of parental knowledge in compliance with influenza vaccination of children should prompt general pediatricians and gastroenterologists to discuss and address the common misconceptions regarding the vaccine. Copyright © 2014 Elsevier Ltd. All rights reserved.

Vaccination coverage survey in Dhaka District.

PubMed

Khan, M N A; Rahman, M L; Awal Miah, A; Islam, M S; Musa, S A J M; Tofail, F

2005-08-01

A survey was conducted in Dhaka District to measure the level of routine immunization coverage of children (12-23 months), to assess the tetanus toxoid (TT) immunization coverage among mothers of children (12-23 month), to evaluate EPI program continuity (dropout rates) and quality (percent of Invalid doses, vaccination card availability etc.) For this purpose, a thirty cluster cross-sectional survey was conducted in October 2002 to assess the immunization coverage in Dhaka. In this survey 30 clusters were randomly selected from a list of villages in 63 Unions of Dhaka following probability proportion to size (PPS) sampling procedure. A total of 210 children was studied using pre-tested structured questionnaire. Descriptive statistics was employed using software SPSS package for data analysis. The study showed that the routine immunization coverage in Dhaka among children by 12 months of age by card + history was 97% for BCG, 97% for Diphtheria, Pertussis Tetanus (DPT 1) and Oral Polio Vaccine (OPV 1), 75% for DPT3 and OPV3 and 67% for measles. Sixty six percent of all children surveyed had received valid doses of all vaccines by 12 months (fully immunized child). Programme access as measured by crude DPT1 coverage was better in Keranigonj (97%). Vaccination cards retention rate for children was 84%. Invalid DPT (1,2 or 3) doses were given to 25% of vaccinated children; 18% of measles doses were invalid. Surprisingly, major cause for invalid doses were not due to early immunizations or due to card lost but for giving tick in the card, instead of writing a valid date. DPT1 and DPT3 and DPT1- Measles drop out rates were 5% and 13% respectively. Major reason parents gave for never vaccinating their children (zero dose children) was (43%), major reasons for incomplete vaccination was lack of knowledge regarding subsequent doses (46%). TT surveys were also conducted for mothers of the children surveyed for vaccination coverage (mothers between 15-49 year old). Valid TT

[Preventive vaccinations in dentistry].

PubMed

Rostetter, Claudio; Lübbers, Heinz-Theo; Kruse, Astrid L; Metzler, Philipp

2015-01-01

The purpose of this current paper is to give a simple update and overview about vaccinations for dental health care workers considering the new guidelines published in February 2014 by the Swiss Federal Office of Public Health. It is recommended to have at least a valid protection against hepatitis B, measles, mumps, rubella, influenza, varicella, diphtheria, tetanus, poliomyelitis and pertussis. Dental health care workers are highly exposed and high risk carriers for inoculable diseases, therefore regular refreshment of vaccinations is necessary for public health and their own health.

Description, Evaluation, and Validation of a Pilot Developmental Assessment Center in a Military-Educational Environment.

ERIC Educational Resources Information Center

Butler, Richard P.; And Others

The purpose of this report is to describe, evaluate, and validate a pilot assessment center (AC) established in the Center for Leadership and Personal Development at the U.S. Military Academy to develop cadets on job skills needed by newly commissioned officers in the U.S. Army. The AC programs employ a leadership evaluation development method…

Application of Droplet Digital PCR to Validate Rift Valley Fever Vaccines.

PubMed

Ly, Hoai J; Lokugamage, Nandadeva; Ikegami, Tetsuro

2016-01-01

Droplet Digital™ polymerase chain reaction (ddPCR™) is a promising technique that quantitates the absolute concentration of nucleic acids in a given sample. This technique utilizes water-in-oil emulsion technology, a system developed by Bio-Rad Laboratories that partitions a single sample into thousands of nanoliter-sized droplets and counts nucleic acid molecules encapsulated in each individual particle as one PCR reaction. This chapter discusses the applications and methodologies of ddPCR for development of Rift Valley fever (RVF) vaccine, using an example that measures RNA copy numbers of a live-attenuated MP-12 vaccine from virus stocks, infected cells, or animal blood. We also discuss how ddPCR detects a reversion mutant of MP-12 from virus stocks accurately. The use of ddPCR improves the quality control of live-attenuated vaccines in the seed lot systems.

Food and Drug Administration regulation and evaluation of vaccines.

PubMed

Marshall, Valerie; Baylor, Norman W

2011-05-01

The vaccine-approval process in the United States is regulated by the Center for Biologics Evaluation and Research of the US Food and Drug Administration. Throughout the life cycle of development, from preclinical studies to after licensure, vaccines are subject to rigorous testing and oversight. Manufacturers must adhere to good manufacturing practices and control procedures to ensure the quality of vaccines. As mandated by Title 21 of the Code of Regulations, licensed vaccines must meet stringent criteria for safety, efficacy, and potency.

Multivariate analysis of the immune response to a vaccine as an alternative to the repetition of animal challenge studies for vaccines with demonstrated efficacy.

PubMed

Chapat, Ludivine; Hilaire, Florence; Bouvet, Jérome; Pialot, Daniel; Philippe-Reversat, Corinne; Guiot, Anne-Laure; Remolue, Lydie; Lechenet, Jacques; Andreoni, Christine; Poulet, Hervé; Day, Michael J; De Luca, Karelle; Cariou, Carine; Cupillard, Lionel

2017-07-01

The assessment of vaccine combinations, or the evaluation of the impact of minor modifications of one component in well-established vaccines, requires animal challenges in the absence of previously validated correlates of protection. As an alternative, we propose conducting a multivariate analysis of the specific immune response to the vaccine. This approach is consistent with the principles of the 3Rs (Refinement, Reduction and Replacement) and avoids repeating efficacy studies based on infectious challenges in vivo. To validate this approach, a set of nine immunological parameters was selected in order to characterize B and T lymphocyte responses against canine rabies virus and to evaluate the compatibility between two canine vaccines, an inactivated rabies vaccine (RABISIN ® ) and a combined vaccine (EURICAN ® DAPPi-Lmulti) injected at two different sites in the same animals. The analysis was focused on the magnitude and quality of the immune response. The multi-dimensional picture given by this 'immune fingerprint' was used to assess the impact of the concomitant injection of the combined vaccine on the immunogenicity of the rabies vaccine. A principal component analysis fully discriminated the control group from the groups vaccinated with RABISIN ® alone or RABISIN ® +EURICAN ® DAPPi-Lmulti and confirmed the compatibility between the rabies vaccines. This study suggests that determining the immune fingerprint, combined with a multivariate statistical analysis, is a promising approach to characterizing the immunogenicity of a vaccine with an established record of efficacy. It may also avoid the need to repeat efficacy studies involving challenge infection in case of minor modifications of the vaccine or for compatibility studies. Copyright © 2017 Elsevier B.V. All rights reserved.

Factors associated with poor adherence to MMR vaccination in parents who follow vaccination schedule

PubMed Central

Restivo, Vincenzo; Napoli, Giuseppe; Marsala, Maria Grazia Laura; Bonanno, Valentina; Sciuto, Valentina; Amodio, Emanuele; Calamusa, Giuseppe; Vitale, Francesco; Firenze, Alberto

2014-01-01

Due to median vaccination coverage far from elimination level, Italy is still an European country with high number of measles cases per million of people. In this study we explored potential socioeconomic, medical and demographic factors which could influence the propensity of family members for measles vaccination schedule. A cross-sectional study was performed through a questionnaire administered to the parents of children who received the first dose of MMR vaccine in two different vaccination centers in the Palermo area from November 2012 to May 2013. Overall, the role played by internet (OR 19.8 P = 0.001) and the large number of children in a family (OR 7.3 P ≤ 0.001) were the factors more associated to be unvaccinated, whereas the birth order of the child (OR 0.3 P = < 0.05 for the oldest children vs. the closer young one) and reporting a lack of MMR vaccination as a “personal decision” (OR 0.19 P ≤ 0.01) inversely correlated with the risk of quitting vaccination. These findings can be useful for a better knowledge of disaffection to vaccination practice in local settings and could contribute to improve and maintain timely uptake, suggesting approaches to optimize the uptake of MMR tailored to the needs of local populations. PMID:25483527

Factors associated with poor adherence to MMR vaccination in parents who follow vaccination schedule.

PubMed

Restivo, Vincenzo; Napoli, Giuseppe; Marsala, Maria Grazia Laura; Bonanno, Valentina; Sciuto, Valentina; Amodio, Emanuele; Calamusa, Giuseppe; Vitale, Francesco; Firenze, Alberto

2015-01-01

Due to median vaccination coverage far from elimination level, Italy is still an European country with high number of measles cases per million of people. In this study we explored potential socioeconomic, medical and demographic factors which could influence the propensity of family members for measles vaccination schedule. A cross-sectional study was performed through a questionnaire administered to the parents of children who received the first dose of MMR vaccine in two different vaccination centers in the Palermo area from November 2012 to May 2013. Overall, the role played by internet (OR 19.8 P = 0.001) and the large number of children in a family (OR 7.3 P ≤ 0.001) were the factors more associated to be unvaccinated, whereas the birth order of the child (OR 0.3 P = < 0.05 for the oldest children vs. the closer young one) and reporting a lack of MMR vaccination as a "personal decision" (OR 0.19 P ≤ 0.01) inversely correlated with the risk of quitting vaccination. These findings can be useful for a better knowledge of disaffection to vaccination practice in local settings and could contribute to improve and maintain timely uptake, suggesting approaches to optimize the uptake of MMR tailored to the needs of local populations.

Cost-effectiveness analysis of catch-up hepatitis A vaccination among unvaccinated/partially-vaccinated children

PubMed Central

Hankin-Wei, Abigail; Rein, David B.; Hernandez-Romieu, Alfonso; Kennedy, Mallory J.; Bulkow, Lisa; Rosenberg, Eli; Trigg, Monica; Nelson, Noele P.

2017-01-01

Background Since 2006, the US Centers for Disease Control and Prevention has recommended hepatitis A (HepA) vaccination routinely for children aged 12–23 months to prevent hepatitis A virus (HAV) infection. However, a substantial proportion of US children are unvaccinated and susceptible to infection. We present results of economic modeling to assess whether a one-time catch-up HepA vaccination recommendation would be cost-effective. Methods We developed a Markov model of HAV infection that followed a single cohort from birth through death (birth to age 95 years). The model compared the health and economic outcomes from catch-up vaccination interventions for children at target ages from two through 17 years vs. outcomes resulting from maintaining the current recommendation of routine vaccination at age one year with no catch-up intervention. Results Over the lifetime of the cohort, catch-up vaccination would reduce the total number of infections relative to the baseline by 741 while increasing doses of vaccine by 556,989. Catch-up vaccination would increase net costs by $10.2 million, or $2.38 per person. The incremental cost of HepA vaccine catch-up intervention at age 10 years, the midpoint of the ages modeled, was $452,239 per QALY gained. Across age-cohorts, the cost-effectiveness of catch-up vaccination is most favorable at age 12 years, resulting in an Incremental Cost-Effectiveness Ratio of $189,000 per QALY gained. Conclusions Given the low baseline of HAV disease incidence achieved by current vaccination recommendations, our economic model suggests that a catch-up vaccination recommendation would be less cost-effective than many other vaccine interventions, and that HepA catch-up vaccination would become cost effective at a threshold of $50,000 per QALY only when incidence of HAV rises about 5.0 cases per 100,000 population. PMID:27317459

Cost-effectiveness analysis of catch-up hepatitis A vaccination among unvaccinated/partially-vaccinated children.

PubMed

Hankin-Wei, Abigail; Rein, David B; Hernandez-Romieu, Alfonso; Kennedy, Mallory J; Bulkow, Lisa; Rosenberg, Eli; Trigg, Monica; Nelson, Noele P

2016-07-29

Since 2006, the US Centers for Disease Control and Prevention has recommended hepatitis A (HepA) vaccination routinely for children aged 12-23months to prevent hepatitis A virus (HAV) infection. However, a substantial proportion of US children are unvaccinated and susceptible to infection. We present results of economic modeling to assess whether a one-time catch-up HepA vaccination recommendation would be cost-effective. We developed a Markov model of HAV infection that followed a single cohort from birth through death (birth to age 95years). The model compared the health and economic outcomes from catch-up vaccination interventions for children at target ages from two through 17years vs. outcomes resulting from maintaining the current recommendation of routine vaccination at age one year with no catch-up intervention. Over the lifetime of the cohort, catch-up vaccination would reduce the total number of infections relative to the baseline by 741 while increasing doses of vaccine by 556,989. Catch-up vaccination would increase net costs by $10.2million, or $2.38 per person. The incremental cost of HepA vaccine catch-up intervention at age 10years, the midpoint of the ages modeled, was $452,239 per QALY gained. Across age-cohorts, the cost-effectiveness of catch-up vaccination is most favorable at age 12years, resulting in an Incremental Cost-Effectiveness Ratio of $189,000 per QALY gained. Given the low baseline of HAV disease incidence achieved by current vaccination recommendations, our economic model suggests that a catch-up vaccination recommendation would be less cost-effective than many other vaccine interventions, and that HepA catch-up vaccination would become cost effective at a threshold of $50,000 per QALY only when incidence of HAV rises about 5.0 cases per 100,000 population. Copyright © 2016 Elsevier Ltd. All rights reserved.

Lessons Learned from Emergency Response Vaccination Efforts for Cholera, Typhoid, Yellow Fever, and Ebola

PubMed Central

Date, Kashmira A.; Sreenivasan, Nandini; Harris, Jennifer B.; Hyde, Terri B.

2017-01-01

Countries must be prepared to respond to public health threats associated with emergencies, such as natural disasters, sociopolitical conflicts, or uncontrolled disease outbreaks. Rapid vaccination of populations vulnerable to epidemic-prone vaccine-preventable diseases is a major component of emergency response. Emergency vaccination planning presents challenges, including how to predict resource needs, expand vaccine availability during global shortages, and address regulatory barriers to deliver new products. The US Centers for Disease Control and Prevention supports countries to plan, implement, and evaluate emergency vaccination response. We describe work of the Centers for Disease Control and Prevention in collaboration with global partners to support emergency vaccination against cholera, typhoid, yellow fever, and Ebola, diseases for which a new vaccine or vaccine formulation has played a major role in response. Lessons learned will help countries prepare for future emergencies. Integration of vaccination with emergency response augments global health security through reducing disease burden, saving lives, and preventing spread across international borders. PMID:29155670

Validation of a new ELISA method for in vitro potency testing of hepatitis A vaccines.

PubMed

Morgeaux, S; Variot, P; Daas, A; Costanzo, A

2013-01-01

The goal of the project was to standardise a new in vitro method in replacement of the existing standard method for the determination of hepatitis A virus antigen content in hepatitis A vaccines (HAV) marketed in Europe. This became necessary due to issues with the method used previously, requiring the use of commercial test kits. The selected candidate method, not based on commercial kits, had already been used for many years by an Official Medicines Control Laboratory (OMCL) for routine testing and batch release of HAV. After a pre-qualification phase (Phase 1) that showed the suitability of the commercially available critical ELISA reagents for the determination of antigen content in marketed HAV present on the European market, an international collaborative study (Phase 2) was carried out in order to fully validate the method. Eleven laboratories took part in the collaborative study. They performed assays with the candidate standard method and, in parallel, for comparison purposes, with their own in-house validated methods where these were available. The study demonstrated that the new assay provides a more reliable and reproducible method when compared to the existing standard method. A good correlation of the candidate standard method with the in vivo immunogenicity assay in mice was shown previously for both potent and sub-potent (stressed) vaccines. Thus, the new standard method validated during the collaborative study may be implemented readily by manufacturers and OMCLs for routine batch release but also for in-process control or consistency testing. The new method was approved in October 2012 by Group of Experts 15 of the European Pharmacopoeia (Ph. Eur.) as the standard method for in vitro potency testing of HAV. The relevant texts will be revised accordingly. Critical reagents such as coating reagent and detection antibodies have been adopted by the Ph. Eur. Commission and are available from the EDQM as Ph. Eur. Biological Reference Reagents (BRRs).

Casting off vaccine supply charity -- the pace quickens. CVI goal: quality vaccines for all children.

PubMed

1995-10-01

Several proposals are offered for production of high-quality vaccines within developing countries. The World Health Organization's Vaccine Supply and Quality (VSQ) team from the Global Program for Vaccines and Immunization (GPV) visited 10 countries (Bangladesh, Brazil, Egypt, India, Indonesia, Iran, Mexico, Pakistan, Philippines, and South Africa) out of 14 priority countries (China, Russia, Thailand, and Vietnam were not visited) producing vaccines and found only two with a quality control system that was acceptable. Vaccine-producing countries are urged to consider the full costs of production that include necessary infrastructure, an independent national control authority and laboratory, manufacturers with managerial autonomy, and manufacturers with good management, a qualified staff, and adequate technology. UNICEF has urged both private and public sectors to combine forces in bringing down the price of new vaccines for distribution to a very large market. Some imaginative proposals were made by some manufacturers for vaccine production and supply for a range of less traditional vaccines. The Director of the Massachusetts Public Health Biologic Laboratories proposed the formation of a consortium of vaccine manufacturers who would support public health priorities for market-affordable, simple vaccines against the major childhood diseases. The aim would be international validation of high-quality local vaccine production in developing countries, ease of research collaboration, improvement in information exchange between countries, and structured assistance. Lack of political commitment has been blamed for poor quality local production. A small cooperative effort among some Latin American countries, the Pan American Association's Regional Vaccine System for Latin America (SIREVA), is backed by the Children's Vaccine Initiative. SIREVA is a consortium of manufacturers in Brazil, Chile, and Mexico that plans joint development of some vaccines. Donor assistance is

Data Validation in the Kepler Science Operations Center Pipeline

NASA Technical Reports Server (NTRS)

Wu, Hayley; Twicken, Joseph D.; Tenenbaum, Peter; Clarke, Bruce D.; Li, Jie; Quintana, Elisa V.; Allen, Christopher; Chandrasekaran, Hema; Jenkins, Jon M.; Caldwell, Douglas A.;

Immunizing Cancer Patients: Which Patients? Which Vaccines? When to Give?

PubMed

Shah, Monika K; Kamboj, Mini

2018-05-15

Patients receiving treatment for cancer should be considered for age- and indication-appropriate vaccinations, and the responsibility for administration of these vaccines is shared between the oncologist and the primary care provider. Certain vaccine-preventable diseases have higher incidence rates among cancer patients and are associated with worse clinical outcomes. The Centers for Disease Control and Prevention and the Advisory Committee on Immunization Practices recommend certain vaccines for routine use in adults, including those with cancer. This article provides guidance to oncology clinicians on vaccine recommendations and safety of use in their patients.

Public Health and Economic Consequences of Vaccine Hesitancy for Measles in the United States.

PubMed

Lo, Nathan C; Hotez, Peter J

2017-09-01

Routine childhood vaccination is declining in some regions of the United States due to vaccine hesitancy, which risks the resurgence of many infectious diseases with public health and economic consequences. There are ongoing policy debates on the state and national level, including legislation around nonmedical (personal-belief) exemptions for childhood vaccination and possibly a special government commission on vaccine safety, which may affect vaccine coverage. To estimate the number of measles cases in US children and the associated economic costs under scenarios of different levels of vaccine hesitancy, using the case example of measles, mumps, and rubella (MMR) vaccination and measles. Publicly available data from the US Centers for Disease Control and Prevention were used to simulate county-level MMR vaccination coverage in children (age 2-11 years) in the United States. A stochastic mathematical model was adapted for infectious disease transmission that estimated a distribution for outbreak size as it relates to vaccine coverage. Economic costs per measles case were obtained from the literature. The predicted effects of increasing the prevalence of vaccine hesitancy as well as the removal of nonmedical exemptions were estimated. The model was calibrated to annual measles cases in US children over recent years, and the model prediction was validated using an independent data set from England and Wales. Annual measles cases in the United States and the associated public sector costs. A 5% decline in MMR vaccine coverage in the United States would result in an estimated 3-fold increase in measles cases for children aged 2 to 11 years nationally every year, with an additional $2.1 million in public sector costs. The numbers would be substantially higher if unvaccinated infants, adolescents, and adult populations were also considered. There was variation around these estimates due to the stochastic elements of measles importation and sensitivity of some model

Increasing influenza vaccination rates via low cost messaging interventions.

PubMed

Baskin, Ernest

2018-01-01

This article tests low cost interventions to increase influenza vaccination rates. By changing an email announcement sent out to employees in 2014 (n > 30,000), the following interventions are tested: incentives, attention to the negative impacts of not get vaccinated, and showing a map to the vaccination centers at the end of the email announcement. Only the map condition helped increase influenza vaccination rates. The use of low-cost interventions can improve influenza vaccination rates though not all interventions work as well as others in the field. In particular, while including maps helped increase vaccination rates, other factors such as negative impact reminders and incentives, which previous studies have found to be successful in the laboratory, did not.

MMR (measles, mumps, and rubella) vaccine - what you need to know

MedlinePlus

Centers for Disease Control and Prevention website. MMR (measles, mumps, and rubella) vaccine. www.cdc.gov/vaccines/hcp/vis/vis-statements/mmr.html . Updated February 12, 2018. Accessed February 14, 2018.

Communicating with parents about vaccination: a framework for health professionals.

PubMed

Leask, Julie; Kinnersley, Paul; Jackson, Cath; Cheater, Francine; Bedford, Helen; Rowles, Greg

2012-09-21

A critical factor shaping parental attitudes to vaccination is the parent's interactions with health professionals. An effective interaction can address the concerns of vaccine supportive parents and motivate a hesitant parent towards vaccine acceptance. Poor communication can contribute to rejection of vaccinations or dissatisfaction with care. We sought to provide a framework for health professionals when communicating with parents about vaccination. Literature review to identify a spectrum of parent attitudes or 'positions' on childhood vaccination with estimates of the proportion of each group based on population studies. Development of a framework related to each parental position with determination of key indicators, goals and strategies based on communication science, motivational interviewing and valid consent principles. Five distinct parental groups were identified: the 'unquestioning acceptor' (30-40%), the 'cautious acceptor' (25-35%); the 'hesitant' (20-30%); the 'late or selective vaccinator' (2-27%); and the 'refuser' of all vaccines (<2%). The goals of the encounter with each group will vary, depending on the parents' readiness to vaccinate. In all encounters, health professionals should build rapport, accept questions and concerns, and facilitate valid consent. For the hesitant, late or selective vaccinators, or refusers, strategies should include use of a guiding style and eliciting the parent's own motivations to vaccinate while, avoiding excessive persuasion and adversarial debates. It may be necessary to book another appointment or offer attendance at a specialised adverse events clinic. Good information resources should also be used. Health professionals have a central role in maintaining public trust in vaccination, including addressing parents' concerns. These recommendations are tailored to specific parental positions on vaccination and provide a structured approach to assist professionals. They advocate respectful interactions that aim to

Human Papillomavirus Vaccine as an Anti-cancer Vaccine: Collaborative Efforts to Promote HPV Vaccine in the National Comprehensive Cancer Control Program

PubMed Central

Townsend, Julie S.; Steele, C. Brooke; Hayes, Nikki; Bhatt, Achal; Moore, Angela R.

2018-01-01

Background Widespread use of the HPV vaccine has the potential to reduce incidence from HPV-associated cancers. However, vaccine uptake among adolescents remains well below the Healthy People 2020 targets. The Centers for Disease Control and Prevention (CDC)’s National Comprehensive Cancer Control Program awardees (NCCCP) are well positioned to work with immunization programs to increase vaccine uptake. Methods CDC’s chronic disease management information system was queried for objectives and activities associated with HPV vaccine that were reported by NCCCP awardees from 2013 – 2016 as part of program reporting requirements. A content analysis was conducted on the query results to categorize interventions according to strategies outlined in The Guide to Community Preventive Services and the 2014 President’s Cancer Panel report. Results Sixty-two percent of NCCCP awardees had planned or implemented at least one activity since 2013 to address low HPV vaccination coverage in their jurisdictions. Most NCCCP awardees (86%) reported community education activities, while 65% reported activities associated with provider education. Systems-based strategies such as client reminders or provider assessment and feedback were each reported by less than 25% of NCCCP awardees. Conclusion Many NCCCP awardees report planning or implementing activities to address low HPV vaccination coverage, often in conjunction with state immunization programs. NCCCP awardees can play a role in increasing HPV vaccination coverage through their cancer prevention and control expertise and access to partners in the health care community. PMID:28263672

The case for vaccinating boys against human papillomavirus.

PubMed

Hull, Sarah C; Caplan, Arthur L

2009-01-01

Vaccination policy in the case of human papillomavirus (HPV) has remained a constant source of controversy ever since Gardasil, Merck's vaccine against HPV, received US Food and Drug Administration approval in the summer of 2006. This controversy has centered on the risks and benefits of vaccinating girls and women in rich and poor nations alike. However, despite all of the attention created by this important policy question, relatively little has been focused on another key public health question: should boys be vaccinated against HPV as well? If herd immunity against the most carcinogenic strains of HPV could be more rapidly and efficiently achieved by vaccinating everyone at risk for being a carrier, it logically follows that vaccine policy should expand to include boys and men. Copyright 2009 S. Karger AG, Basel.

Factors effecting influenza vaccination uptake among health care workers: a multi-center cross-sectional study.

PubMed

Asma, Süheyl; Akan, Hülya; Uysal, Yücel; Poçan, A Gürhan; Sucaklı, Mustafa Haki; Yengil, Erhan; Gereklioğlu, Çiğdem; Korur, Aslı; Başhan, İbrahim; Erdogan, A Ferit; Özşahin, A Kürşat; Kut, Altuğ

2016-05-04

The present study aimed to identify factors affecting vaccination against influenza among health professionals. We used a multi-centre cross-sectional design to conduct an online self-administered questionnaire with physicians and nurses at state and foundation university hospitals in the south-east of Turkey, between 1 January 2015 and 1 February 2015. The five participating hospitals provided staff email address lists filtered for physicians and nurses. The questionnaire comprised multiple choice questions covering demographic data, knowledge sources, and Likert-type items on factors affecting vaccination against influenza. The target response rate was 20 %. In total, 642 (22 %) of 2870 health professionals (1220 physicians and 1650 nurses) responded to the questionnaire. Participants' mean age was 29.6 ± 9.2 years (range 17-62 years); 177 (28.2 %) were physicians and 448 (71.3 %) were nurses. The rate of regular vaccination was 9.2 % (15.2 % for physicians and 8.2 % for nurses). Increasing age, longer work duration in health services, being male, being a physician, working in an internal medicine department, having a chronic disease, and living with a person over 65 years old significantly increased vaccination compliance (p < 0.05). We found differences between vaccine compliant and non-compliant groups for expected benefit from vaccination, social influences, and personal efficacy (p < 0.05). Univariate analysis showed differences between the groups in perceptions of personal risks, side effects, and efficacy of the vaccine (p < 0.05). Multivariate analysis found that important factors influencing vaccination behavior were work place, colleagues' opinions, having a chronic disease, belief that vaccination was effective, and belief that flu can be prevented by natural ways. Numerous factors influence health professionals' decisions about influenza vaccination. Strategies to increase the ratio of vaccination among physicians and nurses

Vaccine cold chain: Part 2. Training personnel and program management.

PubMed

Rogers, Bonnie; Dennison, Kim; Adepoju, Nikki; Dowd, Shelia; Uedoi, Kenneth

2010-09-01

The Centers for Disease Control and Prevention reports that professionals in clinic settings may not be adequately storing and handling vaccine, leading to insufficient immunity of vaccinated individuals. Part 2 of this article provides information about the importance of adequate personnel training and program management policies and procedures needed to implement and maintain an effective vaccine cold chain program. Copyright 2010, SLACK Incorporated.

Computational identification, characterization and validation of potential antigenic peptide vaccines from hrHPVs E6 proteins using immunoinformatics and computational systems biology approaches

PubMed Central

Junaid, Muhammad; Kaushik, Aman Chandra; Ali, Arif; Ali, Syed Shujait; Mehmood, Aamir; Wei, Dong-Qing

2018-01-01

High-risk human papillomaviruses (hrHPVs) are the most prevalent viruses in human diseases including cervical cancers. Expression of E6 protein has already been reported in cervical cancer cases, excluding normal tissues. Continuous expression of E6 protein is making it ideal to develop therapeutic vaccines against hrHPVs infection and cervical cancer. Therefore, we carried out a meta-analysis of multiple hrHPVs to predict the most potential prophylactic peptide vaccines. In this study, immunoinformatics approach was employed to predict antigenic epitopes of hrHPVs E6 proteins restricted to 12 Human HLAs to aid the development of peptide vaccines against hrHPVs. Conformational B-cell and CTL epitopes were predicted for hrHPVs E6 proteins using ElliPro and NetCTL. The potential of the predicted peptides were tested and validated by using systems biology approach considering experimental concentration. We also investigated the binding interactions of the antigenic CTL epitopes by using docking. The stability of the resulting peptide-MHC I complexes was further studied by molecular dynamics simulations. The simulation results highlighted the regions from 46–62 and 65–76 that could be the first choice for the development of prophylactic peptide vaccines against hrHPVs. To overcome the worldwide distribution, the predicted epitopes restricted to different HLAs could cover most of the vaccination and would help to explore the possibility of these epitopes for adaptive immunotherapy against HPVs infections. PMID:29715318

Updated postlicensure surveillance of the meningococcal C conjugate vaccine in England and Wales: effectiveness, validation of serological correlates of protection, and modeling predictions of the duration of herd immunity.

PubMed

Campbell, Helen; Andrews, Nick; Borrow, Ray; Trotter, Caroline; Miller, Elizabeth

2010-05-01

Meningococcal serogroup C conjugate (MCC) vaccines were licensed in the United Kingdom more than 10 years ago based on correlates of protection that had previously been established for serogroup C-containing polysaccharide vaccines by using the serum bactericidal antibody (SBA) assay. These correlates of protection were subsequently validated against postlicensure estimates of observed vaccine effectiveness up to 7 to 9 months after the administration of the MCC vaccine. Vaccine effectiveness was, however, shown to fall significantly more than 1 year after the administration of a 3-dose course in infancy. Despite this finding, the marked impact on serogroup C disease has been sustained, with the lowest recorded incidence (0.02 case per 100,000 population) in the 2008-2009 epidemiological year, mainly due to the indirect herd immunity effect of the vaccine in reducing carriage. Updated estimates of vaccine effectiveness through 30 June 2009 confirmed high short-term protection after vaccination in infancy, at 97% (95% confidence interval [CI], 91% to 99%), falling to 68% (95% CI, -63% to 90%) more than a year after vaccination. The observed vaccine effectiveness more than 12 months postvaccination was consistent with measured declining SBA levels, but confidence intervals were imprecise; vaccine effectiveness estimates were consistent with SBA titers of 1:4 or 1:8 as correlates of long-term protection after a primary course in infants. Modeling suggested that protection against carriage persists for at least 3 years and predicted the stabilization of serogroup C disease at low levels (fewer than 50 cases per year) up to 2015-2016.

78 FR 60884 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-02

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Immunoregulation, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics...

76 FR 44016 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-22

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research...

Evaluation of pneumococcal vaccination rates after vaccine protocol changes and nurse education in a tertiary care teaching hospital.

PubMed

Smith, Jennifer G; Metzger, Nicole L

2011-11-01

Pneumococcal vaccination in eligible patients is recommended by the Infectious Disease Society of America and the Centers for Disease Control (CDC) Advisory Committee on Immunization Practices. Because hospitalization provides an opportunity to vaccinate patients at high risk for developing serious pneumonia complications, eligibility screening and administration of the pneumococcal vaccine prior to discharge in qualified patients are evaluated by the Joint Commission and the Centers for Medicare Medicaid Services (CMS) as part of pneumococcal vaccination core quality measures. Among patients with an inpatient diagnosis of pneumonia in 2008, 56% in our 580-bed tertiary care teaching hospital, compared with 84% nationwide, received pneumococcal vaccination. To improve pneumococcal vaccination rates for all patients in the study facility and not just those with pneumonia, a multifaceted intervention including a revised nurse screening tool, rescheduling of the vaccine order, storage of the vaccine in automated dispensing cabinets on the nursing unit, and creation of a vaccine tracking system was developed and implemented between August 2009 and October 2009. To determine the impact of a multifaceted intervention on pneumococcal vaccine screening and administration rates in eligible patients according to the CDC recommendations who were admitted to an internal medicine unit of a tertiary care teaching hospital. All patients aged 18 years or older from 2 internal medicine units were identified during 4-month time intervals before (pre-intervention, April through July 2009) and after (post-intervention, November 2009 through February 2010) implementation of the multifaceted pneumococcal vaccine protocol. Of these, 150 patients from each 4-month period were randomly selected for electronic medical record review. Eligibility for pneumococcal vaccination was derived from the CDC recommendations and consensus of the vaccine steering committee at the study institution; the

Improving accountability in vaccine decision-making.

PubMed

Timmis, James Kenneth; Black, Steven; Rappuoli, Rino

2017-11-01

Healthcare decisions, in particular those affecting entire populations, should be evidence-based and taken by decision-makers sharing broad alignment with affected stakeholders. However, criteria, priorities and procedures for decision-making are sometimes non-transparent, frequently vary considerably across equivalent decision-bodies, do not always consider the broader benefits of new health-measures, and therefore do not necessarily adequately represent the relevant stakeholder-spectrum. Areas covered: To address these issues in the context of the evaluation of new vaccines, we have proposed a first baseline set of core evaluation criteria, primarily selected by members of the vaccine research community, and suggested their implementation in vaccine evaluation procedures. In this communication, we review the consequences and utility of stakeholder-centered core considerations to increase transparency in and accountability of decision-making procedures, in general, and of the benefits gained by their inclusion in Multi-Criteria-Decision-Analysis tools, exemplified by SMART Vaccines, specifically. Expert commentary: To increase effectiveness and comparability of health decision outcomes, decision procedures should be properly standardized across equivalent (national) decision bodies. To this end, including stakeholder-centered criteria in decision procedures would significantly increase their transparency and accountability, support international capacity building to improve health, and reduce societal costs and inequity resulting from suboptimal health decision-making.

BCG vaccination in patients with severe combined immunodeficiency: complications, risks, and vaccination policies.

PubMed

Marciano, Beatriz E; Huang, Chiung-Yu; Joshi, Gyan; Rezaei, Nima; Carvalho, Beatriz Costa; Allwood, Zoe; Ikinciogullari, Aydan; Reda, Shereen M; Gennery, Andrew; Thon, Vojtech; Espinosa-Rosales, Francisco; Al-Herz, Waleed; Porras, Oscar; Shcherbina, Anna; Szaflarska, Anna; Kiliç, Şebnem; Franco, Jose L; Gómez Raccio, Andrea C; Roxo, Persio; Esteves, Isabel; Galal, Nermeen; Grumach, Anete Sevciovic; Al-Tamemi, Salem; Yildiran, Alisan; Orellana, Julio C; Yamada, Masafumi; Morio, Tomohiro; Liberatore, Diana; Ohtsuka, Yoshitoshi; Lau, Yu-Lung; Nishikomori, Ryuta; Torres-Lozano, Carlos; Mazzucchelli, Juliana T L; Vilela, Maria M S; Tavares, Fabiola S; Cunha, Luciana; Pinto, Jorge A; Espinosa-Padilla, Sara E; Hernandez-Nieto, Leticia; Elfeky, Reem A; Ariga, Tadashi; Toshio, Heike; Dogu, Figen; Cipe, Funda; Formankova, Renata; Nuñez-Nuñez, M Enriqueta; Bezrodnik, Liliana; Marques, Jose Gonçalo; Pereira, María I; Listello, Viviana; Slatter, Mary A; Nademi, Zohreh; Kowalczyk, Danuta; Fleisher, Thomas A; Davies, Graham; Neven, Bénédicte; Rosenzweig, Sergio D

2014-04-01

Severe combined immunodeficiency (SCID) is a syndrome characterized by profound T-cell deficiency. BCG vaccine is contraindicated in patients with SCID. Because most countries encourage BCG vaccination at birth, a high percentage of patients with SCID are vaccinated before their immune defect is detected. We sought to describe the complications and risks associated with BCG vaccination in patients with SCID. An extensive standardized questionnaire evaluating complications, therapeutics, and outcomes regarding BCG vaccination in patients given a diagnosis of SCID was widely distributed. Summary statistics and association analysis was performed. Data on 349 BCG-vaccinated patients with SCID from 28 centers in 17 countries were analyzed. Fifty-one percent of the patients had BCG-associated complications, 34% disseminated and 17% localized (a 33,000- and 400-fold increase, respectively, over the general population). Patients receiving early vaccination (≤1 month) showed an increased prevalence of complications (P = .006) and death caused by BCG-associated complications (P < .0001). The odds of experiencing complications among patients with T-cell numbers of 250/μL or less at diagnosis was 2.1 times higher (95% CI, 1.4-3.4 times higher; P = .001) than among those with T-cell numbers of greater than 250/μL. BCG-associated complications were reported in 2 of 78 patients who received antimycobacterial therapy while asymptomatic, and no deaths caused by BCG-associated complications occurred in this group. In contrast, 46 BCG-associated deaths were reported among 160 patients treated with antimycobacterial therapy for a symptomatic BCG infection (P < .0001). BCG vaccine has a very high rate of complications in patients with SCID, which increase morbidity and mortality rates. Until safer and more efficient antituberculosis vaccines become available, delay in BCG vaccination should be considered to protect highly vulnerable populations from preventable complications

Immunogenicity of a Psoralen-Inactivated Dengue Virus Type 1 Vaccine Candidate in Mice

DTIC Science & Technology

2010-02-01

United States Naval Medical Research Center Detachment, Lima, Peru , 1 and United States Naval Medical Research Center, Silver Spring, Maryland2 R...and 28. The mice in group B mice received 10-ng vaccine doses on study clays 0, 14, and 28. The mice in group C received 10-ng vaccine doses on

Accelerating the development of a safe and effective HIV vaccine: HIV vaccine case study for the Decade of Vaccines.

PubMed

Koff, Wayne C; Russell, Nina D; Walport, Mark; Feinberg, Mark B; Shiver, John W; Karim, Salim Abdool; Walker, Bruce D; McGlynn, Margaret G; Nweneka, Chidi Victor; Nabel, Gary J

2013-04-18

Human immunodeficiency virus (HIV), the etiologic agent that causes AIDS, is the fourth largest killer in the world today. Despite the remarkable achievements in development of anti-retroviral therapies against HIV, and the recent advances in new prevention technologies, the rate of new HIV infections continue to outpace efforts on HIV prevention and control. Thus, the development of a safe and effective vaccine for prevention and control of AIDS remains a global public health priority and the greatest opportunity to eventually end the AIDS pandemic. Currently, there is a renaissance in HIV vaccine development, due in large part to the first demonstration of vaccine induced protection, albeit modest, in human efficacy trials, a generation of improved vaccine candidates advancing in the clinical pipeline, and newly defined targets on HIV for broadly neutralizing antibodies. The main barriers to HIV vaccine development include the global variability of HIV, lack of a validated animal model, lack of correlates of protective immunity, lack of natural protective immune responses against HIV, and the reservoir of infected cells conferred by integration of HIV's genome into the host. Some of these barriers are not unique to HIV, but generic to other variable viral pathogens such as hepatitis C and pandemic influenza. Recommendations to overcome these barriers are presented in this document, including but not limited to expansion of efforts to design immunogens capable of eliciting broadly neutralizing antibodies against HIV, expansion of clinical research capabilities to assess multiple immunogens concurrently with comprehensive immune monitoring, increased support for translational vaccine research, and engaging industry as full partners in vaccine discovery and development. Copyright © 2012 Elsevier Ltd. All rights reserved.

Vaccination coverage among children in Germany estimated by analysis of health insurance claims data

PubMed Central

Rieck, Thorsten; Feig, Marcel; Eckmanns, Tim; Benzler, Justus; Siedler, Anette; Wichmann, Ole

2014-01-01

In Germany, the national routine childhood immunization schedule comprises 12 vaccinations. Primary immunizations should be completed by 24 mo of age. However, nationwide monitoring of vaccination coverage (VC) is performed only at school entry. We utilized health insurance claims data covering ~85% of the total population with the objectives to (1) assess VC of all recommended childhood vaccinations in birth-cohorts 2004–2009, (2) analyze cross-sectional (at 24 and 36 mo) and longitudinal trends, and (3) validate the method internally and externally. Counting vaccine doses in a retrospective cohort fashion, we assembled individual vaccination histories and summarized VC to nationwide figures. For most long-established vaccinations, VC at 24 mo was at moderate levels (~73–80%) and increased slightly across birth-cohorts. One dose measles VC was high (94%), but low (69%) for the second dose. VC with a full course of recently introduced varicella, pneumococcal, and meningococcal C vaccines increased across birth-cohorts from below 10% above 60%, 70%, and 80%, respectively. At 36 mo, VC had increased further by up to 15 percentage points depending on vaccination. Longitudinal analysis suggested a continued VC increase until school entry. Validation of VC figures with primary data showed an overall good agreement. In conclusion, analysis of health insurance claims data allows for the estimation of VC among children in Germany considering completeness and timeliness of vaccination series. This approach provides valid nationwide VC figures for all currently recommended pediatric vaccinations and fills the information gap between early infancy and late assessment at school entry. PMID:24192604

Development and Initial Validation of the Counseling Center Assessment of Psychological Symptoms-34

ERIC Educational Resources Information Center

Locke, Benjamin D.; McAleavey, Andrew A.; Zhao, Yu; Lei, Pui-Wa; Hayes, Jeffrey A.; Castonguay, Louis G.; Li, Hongli; Tate, Robin; Lin, Yu-Chu

2012-01-01

A short version of the Counseling Center Assessment of Psychological Symptoms-62 (CCAPS-62) was created via three studies. The final short version (CCAPS-34), which contains 34 items and 7 subscales, demonstrated good discrimination power, support for the proposed factor structure, strong initial convergent validity, and adequate test-retest…

Communicating with parents about vaccination: a framework for health professionals

PubMed Central

2012-01-01

Background A critical factor shaping parental attitudes to vaccination is the parent’s interactions with health professionals. An effective interaction can address the concerns of vaccine supportive parents and motivate a hesitant parent towards vaccine acceptance. Poor communication can contribute to rejection of vaccinations or dissatisfaction with care. We sought to provide a framework for health professionals when communicating with parents about vaccination. Methods Literature review to identify a spectrum of parent attitudes or ‘positions’ on childhood vaccination with estimates of the proportion of each group based on population studies. Development of a framework related to each parental position with determination of key indicators, goals and strategies based on communication science, motivational interviewing and valid consent principles. Results Five distinct parental groups were identified: the ‘unquestioning acceptor’ (30–40%), the ‘cautious acceptor’ (25–35%); the ‘hesitant’ (20–30%); the ‘late or selective vaccinator’ (2–27%); and the ‘refuser’ of all vaccines (<2%). The goals of the encounter with each group will vary, depending on the parents’ readiness to vaccinate. In all encounters, health professionals should build rapport, accept questions and concerns, and facilitate valid consent. For the hesitant, late or selective vaccinators, or refusers, strategies should include use of a guiding style and eliciting the parent’s own motivations to vaccinate while, avoiding excessive persuasion and adversarial debates. It may be necessary to book another appointment or offer attendance at a specialised adverse events clinic. Good information resources should also be used. Conclusions Health professionals have a central role in maintaining public trust in vaccination, including addressing parents’ concerns. These recommendations are tailored to specific parental positions on vaccination and provide a structured

77 FR 3780 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-25

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. The...

76 FR 55397 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-07

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Laboratory of Method Development, Division of Viral Products, Office of Vaccines Research and Review, Center...

78 FR 20663 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-05

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function..., Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. FDA intends to...

Genomics of immune response to typhoid and cholera vaccines

PubMed Central

Majumder, Partha P.

2015-01-01

Considerable variation in antibody response (AR) was observed among recipients of an injectable typhoid vaccine and an oral cholera vaccine. We sought to find whether polymorphisms in genes of the immune system, both innate and adaptive, were associated with the observed variation in response. For both vaccines, we were able to discover and validate several polymorphisms that were significantly associated with immune response. For the typhoid vaccines, these polymorphisms were on genes that belonged to pathways of polysaccharide recognition, signal transduction, inhibition of T-cell proliferation, pro-inflammatory signalling and eventual production of antimicrobial peptides. For the cholera vaccine, the pathways included epithelial barrier integrity, intestinal homeostasis and leucocyte recruitment. Even though traditional wisdom indicates that both vaccines should act as T-cell-independent antigens, our findings reveal that the vaccines induce AR using different pathways. PMID:25964454

Promoting influenza vaccination: Insights from a qualitative meta-analysis of 14 years of influenza-related communications research by U.S. Centers for Disease Control and Prevention (CDC)

PubMed Central

Nowak, Glen J.; Sheedy, Kristine; Bursey, Kelli; Smith, Teresa M.; Basket, Michelle

2018-01-01

Introduction A primary mission of the U.S. Centers for Disease Control and Prevention's (CDC) is promoting immunization against seasonal influenza. As with most education efforts, CDCs influenza-related communications are often informed by formative research. Methods A qualitative meta-analysis of 29 unpublished, primarily qualitative CDC-sponsored studies related to flu and flu vaccination knowledge, attitudes and beliefs (KABs). The studies, undertaken between 2000 and 2013, involved focus groups, in-depth interviews, message testing and surveys. Some involved health care professionals, while others involved members of the public, including sub-populations at risk for severe illness. Findings The themes that emerged suggested progress in terms of KABs related to influenza and influenza vaccination, but also the persistence of many barriers to vaccine acceptance. With respect to the public, recurring themes included limited understanding of influenza and immunization recommendations, indications of greater sub-group recognition of the value of flu vaccination, continued resistance to vaccination among many, and overestimation of the effectiveness of non-vaccine measures. Seven cognitive facilitators of vaccination were identified in the studies along with six cognitive barriers. For health care providers, the analysis suggests greater knowledge and more favorable beliefs, but many misperceptions persist and are similar to those held by the public. KABs often differed by type or category of health care provider. Conclusions The themes identified in this qualitative analysis illustrate the difficulty in changing KABs related to influenza and influenza vaccine, particularly on the scope and scale needed to greatly improve uptake. Even with an influenza pandemic and more vaccine options available, public and some health care provider perceptions and beliefs are difficult and slow to change. This meta-analysis does, however, provide important insights from previously

Estimation of Nationwide Vaccination Coverage and Comparison of Interview and Telephone Survey Methodology for Estimating Vaccination Status

PubMed Central

Park, Boyoung; Lee, Yeon-Kyeng; Cho, Lisa Y.; Go, Un Yeong; Yang, Jae Jeong; Ma, Seung Hyun; Choi, Bo-Youl; Lee, Moo-Sik; Lee, Jin-Seok; Choi, Eun Hwa; Lee, Hoan Jong

2011-01-01

This study compared interview and telephone surveys to select the better method for regularly estimating nationwide vaccination coverage rates in Korea. Interview surveys using multi-stage cluster sampling and telephone surveys using stratified random sampling were conducted. Nationwide coverage rates were estimated in subjects with vaccination cards in the interview survey. The interview survey relative to the telephone survey showed a higher response rate, lower missing rate, higher validity and a less difference in vaccination coverage rates between card owners and non-owners. Primary vaccination coverage rate was greater than 90% except for the fourth dose of DTaP (diphtheria/tetanus/pertussis), the third dose of polio, and the third dose of Japanese B encephalitis (JBE). The DTaP4: Polio3: MMR1 fully vaccination rate was 62.0% and BCG1:HepB3:DTaP4:Polio3:MMR1 was 59.5%. For age-appropriate vaccination, the coverage rate was 50%-80%. We concluded that the interview survey was better than the telephone survey. These results can be applied to countries with incomplete registry and decreasing rates of landline telephone coverage due to increased cell phone usage and countries. Among mandatory vaccines, efforts to increase vaccination rate for the fourth dose of DTaP, the third dose of polio, JBE and regular vaccinations at recommended periods should be conducted in Korea. PMID:21655054

The Nuclear Energy Knowledge and Validation Center – Summary of Activities Conducted in FY15

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gougar, Hans David; Hong, Bonnie Colleen

2016-05-01

The Nuclear Energy Knowledge and Validation Center (NEKVaC) is a new initiative by the Department of Energy and the Idaho National Laboratory to coordinate and focus the resources and expertise that exist with the DOE Complex toward solving issues in modern nuclear code validation. In time, code owners, users, and developers will view the Center as a partner and essential resource for acquiring the best practices and latest techniques for validating codes, for guidance in planning and executing experiments, for facilitating access to, and maximizing the usefulness of, existing data, and for preserving knowledge for continual use by nuclear professionalsmore » and organizations for their own validation needs. The scope of the center covers many inter-related activities which will need to be cultivated carefully in the near-term and managed properly once the Center is fully functional. Three areas comprise the principal mission: 1) identification and prioritization of projects that extend the field of validation science and its application to modern codes, 2) adapt or develop best practices and guidelines for high fidelity multiphysics/multiscale analysis code development and associated experiment design, and 3) define protocols for data acquisition and knowledge preservation and provide a portal for access to databases currently scattered among numerous organizations. These mission areas, while each having a unique focus, are inter-dependent and complementary. Likewise, all activities supported by the NEKVaC, both near-term and long-term), must possess elements supporting all three. This cross-cutting nature is essential to ensuring that activities and supporting personnel do not become ‘stove-piped’, i.e. focused so much on a specific function that the activity itself becomes the objective rather than the achieving the larger vision. Achieving the broader vision will require a healthy and accountable level of activity in each of the areas. This will take time

Federal and state public health authority and mandatory vaccination: is Jacobson v Massachusetts still valid?

PubMed

Marshall, Lewis W; Marshall, Brenda L; Valladares, Glenn

2010-01-01

Novel H1N1 influenza virus infected more than 43,000 people, killed 353 and spread to more than 122 countries within a few months. The World Health Organization declared a stage 6 worldwide pandemic. Healthcare workers and hospitals prepared for the worst. Federal and State regulations provided the legal framework to allow for the preparation and planning for a pandemic. One State had mandated both seasonal and Novel H1N1 vaccination of all healthcare workers in an effort to reduce transmission of influenza in healthcare facilities. The US Supreme Court decided in 1905 that the police power of the State permitted a State Department of Health the leeway to mandate vaccination in the face of a contagious disease. Law suits were filed, and a temporary injunction barring mandatory vaccination was entered by the court. While awaiting a court hearing, the mandatory vaccination regulation was rescinded because of the shortage of both seasonal and H1N1 vaccine. Based on the current state of the pandemic and the shortage of vaccination, it is possible that the US Supreme Court would uphold mandatory vaccination in a pandemic.

Vaccine candidate discovery for the next generation of malaria vaccines.

PubMed

Tuju, James; Kamuyu, Gathoni; Murungi, Linda M; Osier, Faith H A

2017-10-01

Although epidemiological observations, IgG passive transfer studies and experimental infections in humans all support the feasibility of developing highly effective malaria vaccines, the precise antigens that induce protective immunity remain uncertain. Here, we review the methodologies applied to vaccine candidate discovery for Plasmodium falciparum malaria from the pre- to post-genomic era. Probing of genomic and cDNA libraries with antibodies of defined specificities or functional activity predominated the former, whereas reverse vaccinology encompassing high throughput in silico analyses of genomic, transcriptomic or proteomic parasite data sets is the mainstay of the latter. Antibody-guided vaccine design spanned both eras but currently benefits from technological advances facilitating high-throughput screening and downstream applications. We make the case that although we have exponentially increased our ability to identify numerous potential vaccine candidates in a relatively short space of time, a significant bottleneck remains in their validation and prioritization for evaluation in clinical trials. Longitudinal cohort studies provide supportive evidence but results are often conflicting between studies. Demonstration of antigen-specific antibody function is valuable but the relative importance of one mechanism over another with regards to protection remains undetermined. Animal models offer useful insights but may not accurately reflect human disease. Challenge studies in humans are preferable but prohibitively expensive. In the absence of reliable correlates of protection, suitable animal models or a better understanding of the mechanisms underlying protective immunity in humans, vaccine candidate discovery per se may not be sufficient to provide the paradigm shift necessary to develop the next generation of highly effective subunit malaria vaccines. © 2017 The Authors. Immunology Published by John Wiley & Sons Ltd.

Sex and Vaccination

ERIC Educational Resources Information Center

Zavrel, Erik; Herreid, Clyde Freeman

2008-01-01

This case study is centered upon the recent debate concerning the decision by Texas Governor Rick Perry to mandate the compulsory vaccination of girls in the Texas public school system against the human papillomavirus (HPV) prior to entering the sixth grade. The interrupted case method is particularly appropriate for this subject with the case…

Establishing and maintaining the National Vaccination Register in Finland.

PubMed

Baum, Ulrike; Sundman, Jonas; Jääskeläinen, Susanna; Nohynek, Hanna; Puumalainen, Taneli; Jokinen, Jukka

2017-04-27

Computerised, population-based vaccination registers are valuable tools for assessing the vaccine uptake and impact in populations. However, reliable impact assessment is only possible if the data quality can be reviewed and monitored continuously. This report describes the establishment and maintenance of the National Vaccination Register (NVR) in Finland. Currently, the NVR covers nationwide records of vaccinations given within the frame of the National Vaccination Programme since 2009. All vaccinations registered in the NVR contain a record of the personal identity code, the administered vaccine, and the date of vaccination. The vaccine lot number is the key component for recording and identifying vaccinations, because of its broad availability across patient information systems and its importance in vaccine safety monitoring. Vaccination records are accumulated and updated daily into the NVR, and their completeness is monitored monthly to assess deficiencies in data entry and data collection. Additionally, an alert system reports unexpected changes in data accumulation prompting the validation of observed changes in vaccination coverage. The presented process documentation may serve as basis to improve the design and quality of other vaccination or healthcare registers and aims to inspire the set-up of vaccination registers in those countries which still do not have one. This article is copyright of The Authors, 2017.

Knowledge of HPV and HPV Vaccine among Women Ages 19 to 26.

PubMed

Unger, Zoe; Maitra, Abby; Kohn, Julia; Devaskar, Sangita; Stern, Lisa; Patel, Ashlesha

2015-01-01

To describe knowledge about human papillomavirus (HPV) and HPV vaccination among women ages 19 to 26 seeking a variety of services at reproductive health centers. A secondary objective was to identify common sources of HPV information. Ten reproductive health centers enrolled 365 women ages 19 to 26 in a randomized, controlled trial to determine the effect of automated reminder messages on HPV vaccine completion. Using responses from a 61-item self-administered baseline questionnaire completed before initiating the HPV vaccine, this subanalysis assessed participants' knowledge regarding HPV and the HPV vaccine. Knowledge of HPV prevention, transmission, and disease outcomes among the study population was highly variable. The mean HPV knowledge score was 11.0 of a possible 19 (SD = 3.8). Most participants (77%) had heard of the HPV vaccine before completing the questionnaire and indicated that their primary sources of information about the vaccine were television ads (61%), health care providers (52%), and friends (45%). Despite a relatively high awareness of the vaccine, specific knowledge regarding HPV and the HPV vaccine varied substantially and participant scores highlighted knowledge gaps among vaccine-eligible young women. Media, health care providers, and friends were identified by participants as sources of information and may influence their knowledge of HPV and the HPV vaccine. Copyright © 2015 Jacobs Institute of Women's Health. Published by Elsevier Inc. All rights reserved.

Vaccines are different: A systematic review of budget impact analyses of vaccines.

PubMed

Loze, Priscilla Magalhaes; Nasciben, Luciana Bertholim; Sartori, Ana Marli Christovam; Itria, Alexander; Novaes, Hillegonda Maria Dutilh; de Soárez, Patrícia Coelho

2017-05-15

Several countries require manufacturers to present a budget impact analysis (BIA), together with a cost-effectiveness analysis, to support national funding requests. However, guidelines for conducting BIA of vaccines are scarce. To analyze the methodological approaches used in published budget impact analysis (BIA) of vaccines, discussing specific methodological issues related to vaccines. This systematic review of the literature on BIA of vaccines was carried out in accordance with the Centre for Reviews and Dissemination - CRD guidelines. We searched multiple databases: MedLine, Embase, Biblioteca Virtual de Saúde (BVS), Cochrane Library, DARE Database, NHS Economic Evaluation Database (NHS EED), HTA Database (via Centre for Reviews and Dissemination - CRD), and grey literature. Two researchers, working independently, selected the studies and extracted the data. The methodology quality of individual studies was assessed using the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force. A qualitative narrative synthesis was conducted. Twenty-two studies were reviewed. The most frequently evaluated vaccines were pneumococcal (41%), influenza (23%) and rotavirus (18%). The target population was stated in 21 studies (95%) and the perspective was clear in 20 (91%). Only 36% reported the calculations used to complete the BIA, 27% informed the total and disaggregated costs for each time period, and 9% showed the change in resource use for each time period. More than half of the studies (55%, n=12) reported less than 50% of the items recommended in the checklist. The production of BIA of vaccines has increased from 2009. The report of the methodological steps was unsatisfactory, making it difficult to assess the validity of the results presented. Vaccines specific issues should be discussed in international guidelines for BIA of vaccines, to improve the quality of the studies. Copyright © 2017 Elsevier Ltd. All rights reserved.

Vaccine refrigeration

PubMed Central

McColloster, Patrick J; Martin-de-Nicolas, Andres

2014-01-01

This commentary reviews recent changes in Centers for Disease Control (CDC) vaccine storage guidelines that were developed in response to an investigative report by the Office of the Inspector General. The use of temperature data loggers with probes residing in glycol vials is advised along with storing vaccines in pharmaceutical refrigerators. These refrigerators provide good thermal distribution but can warm to 8 °C in less than one hour after the power is discontinued. Consequently, electric grid instability influences appropriate refrigerator selection and the need for power back-up. System Average Interruption Duration Index (SAIDI) values quantify this instability and can be used to formulate region-specific guidelines. A novel aftermarket refrigerator regulator with a battery back-up power supply and microprocessor control system is also described. PMID:24442209

Characterization of a whole, inactivated influenza (H5N1) vaccine.

PubMed

Tada, Yoshikazu

2008-11-01

Effective vaccines against the highly pathogenic influenza A/H5N1 virus are being developed worldwide. In Japan, two adjuvanted, inactivated, whole-virion influenza vaccines were recently developed and licensed as mock-up, pre-pandemic vaccine formulations by the Ministry of Health and Labor Welfare of Japan. During the vaccine design and development process, various obstacles were overcome and, in this report, we introduce the non clinical production, immunogenicity data in human and development process that was associated with egg-derived adjuvanted, inactivated, whole-virion influenza A (H5N1) vaccine. Pilot lots of H5N1 vaccine were produced using the avirulent H5N1 reference strain A/Vietnam/1194/2004 (H5N1) NIBRG-14 and administered following adsorption with aluminum hydroxide as an adjuvant. Quality control and formulation stability tests were performed before clinical trials were initiated (phase I-III). The research foundation for microbial diseases of Osaka University (BIKEN) carried out vaccine production, quality control, stability testing and the phase I clinical trial in addition to overseeing the licensing of this vaccine. Mitsubishi Chemical Safety Institute Ltd. carried out the non clinical pharmacological toxicity and safety studies and the Japanese medical association carried out the phase II/III trials. Phase I-III trials took place in 2006. The production processes were well controlled by established tests and validations. Vaccine quality was confirmed by quality control, stability and pre-clinical tests, and the vaccine was approved as a mock-up, pre-pandemic vaccine by the Ministry of Health and Labor Welfare of Japan. Numerous safety and efficacy procedures were carried out prior to the approval of the described vaccine formulation. Some of these procedures were of particular importance e.g., vaccine development, validation, and quality control tests that included strict monitoring of the hemagglutinin (HA) content of the vaccine

Updated Postlicensure Surveillance of the Meningococcal C Conjugate Vaccine in England and Wales: Effectiveness, Validation of Serological Correlates of Protection, and Modeling Predictions of the Duration of Herd Immunity ▿

PubMed Central

Campbell, Helen; Andrews, Nick; Borrow, Ray; Trotter, Caroline; Miller, Elizabeth

2010-01-01

Meningococcal serogroup C conjugate (MCC) vaccines were licensed in the United Kingdom more than 10 years ago based on correlates of protection that had previously been established for serogroup C-containing polysaccharide vaccines by using the serum bactericidal antibody (SBA) assay. These correlates of protection were subsequently validated against postlicensure estimates of observed vaccine effectiveness up to 7 to 9 months after the administration of the MCC vaccine. Vaccine effectiveness was, however, shown to fall significantly more than 1 year after the administration of a 3-dose course in infancy. Despite this finding, the marked impact on serogroup C disease has been sustained, with the lowest recorded incidence (0.02 case per 100,000 population) in the 2008-2009 epidemiological year, mainly due to the indirect herd immunity effect of the vaccine in reducing carriage. Updated estimates of vaccine effectiveness through 30 June 2009 confirmed high short-term protection after vaccination in infancy, at 97% (95% confidence interval [CI], 91% to 99%), falling to 68% (95% CI, −63% to 90%) more than a year after vaccination. The observed vaccine effectiveness more than 12 months postvaccination was consistent with measured declining SBA levels, but confidence intervals were imprecise; vaccine effectiveness estimates were consistent with SBA titers of 1:4 or 1:8 as correlates of long-term protection after a primary course in infants. Modeling suggested that protection against carriage persists for at least 3 years and predicted the stabilization of serogroup C disease at low levels (fewer than 50 cases per year) up to 2015-2016. PMID:20219881

Effectiveness of an influenza vaccine used in Poland in the 1998-1999 influenza season.

PubMed

Banzhoff, A; Kaniok, W; Muszer, A

2001-05-01

The aim of this study was to evaluate the effectiveness of the influenza vaccine used at the Proelmed Medical Center, Poland during the influenza season 1998-1999. The study randomised patients attending the Proelmed Medical Center, Poland to receive influenza vaccination or not. Volunteers were monitored for the following 6 months by interviews at which systemic and local symptoms were recorded. 193 volunteers were randomised to receive influenza vaccine and 206 to the control group. In the vaccinated group, 7 cases (3.7%) of influenza were recorded, compared to 59 cases (28.6%) in the unvaccinated group. Respiratory disease other than influenza occurred in 29.5% of the vaccinated group and 34.5% of the unvaccinated group. Vaccinated patients had a total of 62 days off sick due to influenza, compared to 467 days for the unvaccinated patients. No unexpected adverse events were reported. The influenza vaccine used is highly efficacious in protecting against influenza infection leading to absenteeism from work, and has a good safety profile.

Salmonella-based plague vaccines for bioterrorism.

PubMed

Calhoun, Leona Nicole; Kwon, Young-Min

2006-04-01

Yersinia pestis, the causative agent of plague, is an emerging threat as a means of bioterrorism. Accordingly, the Working Group on Civilian Biodefense, as well as the Centers for Disease Control and Prevention, has specified Y. pestis as a prime candidate for use in bioterrorism. As the threat of bioterrorism increases, so does the need for an effective vaccine against this potential agent. Experts agree that a stable, non-invasive vaccine would be necessary for the rapid large-scale immunization of a population following a bioterrorism attack. Thus far, live Salmonella-based oral vaccines show the most potential for this purpose. When delivered via a mucosal route, Salmonella-based plague vaccines show the ability to protect against the deadly pneumonic form of plague. Also, mass production, distribution, and administration are easier and less costly for attenuated Salmonella-based plague vaccines than for plague vaccines consisting of purified proteins. Most attenuated Salmonella-based plague vaccines have utilized a plasmid-based expression system to deliver plague antigen(s) to the mucosa. However, these systems are frequently associated with plasmid instability, an increased metabolic burden upon the vaccine strain, and highly undesirable antibiotic resistance genes. The future of Salmonella-based plague vaccines seems to lie in the use of chromosomally encoded plague antigens and the use of in vivo inducible promoters to drive their expression. This method of vaccine development has been proven to greatly increase the retention of foreign genes, and also eliminates the need for antibiotic resistance genes within Salmonella-based vaccines.

Antibody persistence 5 years after vaccination at 2 to 10 years of age with Quadrivalent MenACWY-CRM conjugate vaccine, and responses to a booster vaccination.

PubMed

Block, Stan L; Christensen, Shane; Verma, Bikash; Xie, Fang; Keshavan, Pavitra; Dull, Peter M; Smolenov, Igor

2015-04-27

In a multi-center extension study, children 2-10 years of age, initially vaccinated with one or two doses (2-5 year-olds) or one dose (6-10 year-olds) of quadrivalent meningococcal CRM197-conjugate vaccine (MenACWY-CRM), were assessed five years later for antibody persistence and booster response using serum bactericidal assay with human complement (hSBA). Children 7-10 and 11-15 years of age, who received MenACWY-CRM in the original study, and age-matched vaccine-naïve children, were enrolled in this extension study. After an initial blood draw, children received one dose of MenACWY-CRM as booster or primary dose, with a second blood draw 28 days later. hSBA titers decreased five years after primary vaccination, but were higher than in non-vaccinated controls against serogroups C, W and Y, with substantial proportions having titers ≥8: 7-22% for A, 32-57% for C, 74-83% for W, and 48-54% for Y. Previously-vaccinated children demonstrated booster responses to revaccination against all four serogroups. Responses to primary vaccination in vaccine-naïve controls were lower and similar to primary responses observed in the original study. All vaccinations were generally well tolerated, with no safety concern raised. Approximately half the children vaccinated as 2-10 year-olds maintained protective antibodies against serogroups C, W and Y five years later, but fewer did against serogroup A. Declining titers five years after vaccination and robust booster responses suggest that five years may be an appropriate interval to revaccinate children, subject to epidemiology and delivery considerations. Copyright © 2015 Elsevier Ltd. All rights reserved.

Factors Associated with HPV Vaccine Refusal among Young Adult Women after Ten Years of Vaccine Implementation.

PubMed

Restivo, Vincenzo; Costantino, Claudio; Fazio, Tiziana Francesca; Casuccio, Nicolò; D'Angelo, Claudio; Vitale, Francesco; Casuccio, Alessandra

2018-04-17

In Italy, the Human Papillomavirus (HPV) vaccination was implemented for twelve years old girls in 2007, but its coverage was lower than the recommended level. Sicily is one of the Italian administrative regions with lower vaccination coverage, with a value of 59% for those born in 1996 increasing to 62% coverage for those born in 1999. The aim of the study was to investigate factors associated with the refusal of HPV vaccination among young adult women of Palermo, Italy. The study was approved by the Ethics Committee of the Policlinico “Paolo Giaccone” Hospital (Palermo 1) and the questionnaire was validated in a convenience sample representing 10% of the young women. A cross-sectional study was conducted through the administration of a telephone questionnaire, consisting of 23 items on HPV infection and vaccination knowledge based on the Health Belief Model framework. The eligible population were young women (18–21 years old) who had at least a vaccination among all included in the Sicilian vaccination schedule, without starting or completing HPV vaccination. Overall, 141 young women were enrolled (response rate 22%). Among them, 84.4% were unvaccinated and 15.6% had at least one dose of the HPV vaccine. In multivariate analysis, the factors associated with the refusal of the HPV vaccination were a bachelor’s as the education level (OR = 10.2, p = 0.041), lower participation at school seminar on HPV (OR = 0.2, p = 0.047) and lower perception of HPV vaccine benefits (OR = 0.4, p = 0.048). Public health educational program focusing and tailored on benefits perception of HPV vaccine and HPV disease severity, carried out at school or during medical visits, can be useful to improve HPV vaccination uptake.

Multiplexing T- and B-Cell FLUOROSPOT Assays: Experimental Validation of the Multi-Color ImmunoSpot® Software Based on Center of Mass Distance Algorithm.

PubMed

Karulin, Alexey Y; Megyesi, Zoltán; Caspell, Richard; Hanson, Jodi; Lehmann, Paul V

2018-01-01

Over the past decade, ELISPOT has become a highly implemented mainstream assay in immunological research, immune monitoring, and vaccine development. Unique single cell resolution along with high throughput potential sets ELISPOT apart from flow cytometry, ELISA, microarray- and bead-based multiplex assays. The necessity to unambiguously identify individual T and B cells that do, or do not co-express certain analytes, including polyfunctional cytokine producing T cells has stimulated the development of multi-color ELISPOT assays. The success of these assays has also been driven by limited sample/cell availability and resource constraints with reagents and labor. There are few commercially available test kits and instruments available at present for multi-color FLUOROSPOT. Beyond commercial descriptions of competing systems, little is known about their accuracy in experimental settings detecting individual cells that secrete multiple analytes vs. random overlays of spots. Here, we present a theoretical and experimental validation study for three and four color T- and B-cell FLUOROSPOT data analysis. The ImmunoSpot ® Fluoro-X™ analysis system we used includes an automatic image acquisition unit that generates individual color images free of spectral overlaps and multi-color spot counting software based on the maximal allowed distance between centers of spots of different colors or Center of Mass Distance (COMD). Using four color B-cell FLUOROSPOT for IgM, IgA, IgG1, IgG3; and three/four color T-cell FLUOROSPOT for IL-2, IFN-γ, TNF-α, and GzB, in serial dilution experiments, we demonstrate the validity and accuracy of Fluoro-X™ multi-color spot counting algorithms. Statistical predictions based on the Poisson spatial distribution, coupled with scrambled image counting, permit objective correction of true multi-color spot counts to exclude randomly overlaid spots.

From Epidemic Meningitis Vaccines for Africa to the Meningitis Vaccine Project.

PubMed

Aguado, M Teresa; Jodar, Luis; Granoff, Dan; Rabinovich, Regina; Ceccarini, Costante; Perkin, Gordon W

2015-11-15

Polysaccharide vaccines had been used to control African meningitis epidemics for >30 years but with little or modest success, largely because of logistical problems in the implementation of reactive vaccination campaigns that are begun after epidemics are under way. After the major group A meningococcal meningitis epidemics in 1996-1997 (250,000 cases and 25,000 deaths), African ministers of health declared the prevention of meningitis a high priority and asked the World Health Organization (WHO) for help in developing better immunization strategies to eliminate meningitis epidemics in Africa. WHO accepted the challenge and created a project called Epidemic Meningitis Vaccines for Africa (EVA) that served as an organizational framework for external consultants, PATH, the US Centers for Disease Control and Prevention (CDC), and the Bill & Melinda Gates Foundation (BMGF). Consultations were initiated with major vaccine manufacturers. EVA commissioned a costing study/business plan for the development of new group A or A/C conjugate vaccines and explored the feasibility of developing these products as a public-private partnership. Representatives from African countries were consulted. They confirmed that the development of conjugate vaccines was a priority and provided information on preferred product characteristics. In parallel, a strategy for successful introduction was also anticipated and discussed. The expert consultations recommended that a group A meningococcal conjugate vaccine be developed and introduced into the African meningitis belt. The results of the costing study indicated that the "cost of goods" to develop a group A - containing conjugate vaccine in the United States would be in the range of US$0.35-$1.35 per dose, depending on composition (A vs A/C), number of doses/vials, and presentation. Following an invitation from BMGF, a proposal was submitted in the spring of 2001. In June 2001, BMGF awarded a grant of US$70 million to create the Meningitis

HPV and HPV vaccines: the knowledge levels, opinions, and behavior of parents.

PubMed

Grabiel, Marlee; Reutzel, Thomas J; Wang, Sheila; Rubin, Rochelle; Leung, Vinvia; Ordonez, Adrienne; Wong, Maggie; Jordan, Emily

2013-12-01

To measure parent knowledge levels and opinions related to the human papillomavirus (HPV) and the two vaccines used to prevent it. To measure parent behavior in terms of whether or not to have their children vaccinated. Between June 19, 2012, and August 24, 2012, questionnaires were distributed to parents while waiting for their child to see their pediatrician at a local group practice. The survey was reviewed for face validity by College of Pharmacy social science and clinical faculty members, and an earlier version of it had been used successfully in a published study of biomedical students' knowledge of and attitudes toward the HPV vaccine. 129 usable surveys were obtained. 48.1% of subjects said they learned about the HPV vaccines from the media, while 47.3% identified health care practitioner(s) as a source of knowledge. The mean score on a 20-item knowledge test regarding the infection and vaccines was 36% (range 0-80%). Opinions on the subject varied widely. For example, 22.4% of subjects agreed that schools should require that students be vaccinated before enrolling, while 3.2% agreed that vaccination causes patients to become sexually active. Subjects reported vaccination status for 253 children (mean age 13) as follows: 33% vaccinated; 28% not vaccinated but will be; 11% will never be vaccinated; and 28% not decided. These results are somewhat encouraging, because many parents are hearing about the vaccines from their providers. Although not an equally valid source, the media are also raising awareness. Based on the knowledge and opinion results of this study, there is a need for pharmacists and other providers to educate their patients about the vaccines and the virus and to converse with them regarding the moral and psychological implications of vaccination. Still, it is encouraging that these subjects had or plan to have over half (61%) of their children vaccinated.

Assessing providers' vaccination behaviors during routine immunization in India.

PubMed

Cohen, Megan A; Gargano, Lisa M; Thacker, Naveen; Choudhury, Panna; Weiss, Paul S; Arora, Manisha; Orenstein, Walter A; Omer, Saad B; Hughes, James M

2015-08-01

Progress has been made toward improving routine immunization coverage in India, but universal coverage has not been achieved. Little is known about how providers' vaccination behaviors affect coverage rates. The purpose of this study was to identify provider behaviors that served as barriers to vaccination that could lead to missed opportunities to vaccinate. We conducted a study of health-care providers' vaccination behaviors during clinic visits for children <3 years of age. Information on provider behaviors was collected through parent report and direct observation. Compared with illness visits, parents were eight times more likely to report vaccination status was verified (p < 0.001) and three times more likely to report receiving counseling on immunization (p = 0.022) during vaccination visits. Training of all vaccination practitioners should focus on behaviors such as the necessity of verifying vaccination status regardless of visit type, stressing the importance of counseling parents on immunization and emphasizing what is a valid contraindication to vaccination. © The Author [2015]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Developing and testing a decision model for predicting influenza vaccination compliance.

PubMed Central

Carter, W B; Beach, L R; Inui, T S; Kirscht, J P; Prodzinski, J C

1986-01-01

Influenza vaccination has long been recommended for elderly high-risk patients, yet national surveys indicate that vaccination compliance rates are remarkably low (20 percent). We conducted a study to model prospectively the flu shot decisions and subsequent behavior of an elderly and/or chronically diseased (at high risk for complications of influenza) ambulatory care population at the Seattle VA Medical Center. Prior to the 1980-81 flu shot season, a random (stratified by disease) sample of 63 patients, drawn from the total population of high-risk patients in the general medicine clinic, was interviewed to identify patient-defined concerns regarding flu shots. Six potential consequences of influenza and nine of vaccination were emphasized by patients and provided the content for a weighted hierarchical utility model questionnaire. The utility model provides an operational framework for (1) obtaining subjective value and relative importance judgments from patients; (2) combining these judgments to obtain a prediction of behavioral intention and behavior for each patient; and, if the model is valid (predictive of behavior), (3) identifying those factors which are most salient to patient's decisions and subsequent behavior. Prior to the 1981-82 flu season, the decision model questionnaire was administered to 350 other high-risk patients from the same general medicine clinic population. The decision model correctly predicted behavioral intention for 87 percent and vaccination behavior for 82 percent of this population and, more importantly, differentiated shot "takers" and "nontakers" along several attitudinal dimensions that suggest specific content areas for clinical compliance intervention strategies. PMID:3949541

US vaccine refrigeration guidelines: loose links in the cold chain.

PubMed

McColloster, Patrick J

2011-05-01

This commentary compares Centers for Disease Control (CDC) guidelines for vaccine storage with international cold chain standards. Problems related to the use of domestic refrigerators in clinical settings are discussed. Optimal vaccine refrigerator design characteristics are summarized. The adoption of World Health Organization storage recommendations is advised.

Opportunities and strategies to further reduce animal use for Leptospira vaccine potency testing.

PubMed

Walker, A; Srinivas, G B

2013-09-01

Hamsters are routinely infected with virulent Leptospira for two purposes in the regulation of biologics: the performance of Codified potency tests and maintenance of challenge culture for the Codified potency tests. Options for reducing animal use in these processes were explored in a plenary lecture at the "International Workshop on Alternative Methods for Leptospira Vaccine Potency Testing: State of the Science and the Way Forward" held at the Center for Veterinary Biologics in September 2012. The use of validated in vitro potency assays such as those developed by the U.S. Department of Agriculture for Leptospira (L.) canicola, Leptospira grippotyphosa, Leptospira pomona, and Leptospira icterohaemorrhagiae rather than the Codified hamster vaccination-challenge assay was encouraged. Alternatives such as reduced animal numbers in the hamster vaccination-challenge testing were considered for problematic situations. Specifically, the merits of sharing challenge controls, reducing group sizes, and eliminating animals for concurrent challenge dose titration were assessed. Options for maintaining virulent, stable cultures without serial passage through hamsters or with decreased hamster use were also discussed. The maintenance of virulent Leptospira without the use of live animals is especially difficult since a reliable means to maintain virulence after multiple in vitro passages has not yet been identified. Published by Elsevier Ltd.

Acellular pertussis vaccines--a question of efficacy.

PubMed

Olin, P

1995-06-01

Whole cell pertussis vaccine is considered to offer at least 80% protection against typical whooping cough. The quest for an equally effective but less reactogenic vaccine is now drawing to a close. During the forthcoming year a number of efficacy trials of acellular pertussis vaccines will be terminated. A variety of vaccines containing one, two, three or five purified pertussis antigens are being tested in Germany, Italy, Senegal and Sweden. About 30,000 infants have been enrolled in placebo-controlled studies and more than 100,000 in whole cell vaccine-controlled trials. The final plans for analysis of a Swedish placebo-controlled trial of whole cell and acellular vaccines is presented. Due to the unexpected high incidence of pertussis in Sweden during 1993-1994, relative risk comparisons between vaccines will be attempted in that trial, in addition to estimating absolute efficacy. A crucial issue is to what extent data may be compared between trials, given differences in design, vaccination schedules, and chosen endpoints. A primary case definition of laboratory-confirmed pertussis with at least 21 days of paroxysmal cough have been adopted in most trials. Pre-planned meta-analysis using this single endpoint will facilitate comparisons between vaccines. Serological correlates to protection in individuals will be sought in the ongoing placebo-controlled trials. The concept of a serological correlate valid for a vaccinated population but not necessarily for the vaccinated individual, as is the case with Hib vaccines, may turn out to be the only alternative to performing large efficacy trials in the future.

Suitability of differently formulated dry powder Newcastle disease vaccines for mass vaccination of poultry.

PubMed

Huyge, Katrien; Van Reeth, Kristien; De Beer, Thomas; Landman, Wil J M; van Eck, Jo H H; Remon, Jean Paul; Vervaet, Chris

2012-04-01

Dry powders containing a live-attenuated Newcastle disease vaccine (LZ58 strain) and intended for mass vaccination of poultry were prepared by spray drying using mannitol in combination with trehalose or inositol, polyvinylpyrrolidone (PVP) and/or bovine serum albumin (BSA) as stabilizers. These powders were evaluated for vaccine stabilizing capacity during production and storage (at 6 °C and 25 °C), moisture content, hygroscopicity and dry powder dispersibility. A mixture design, varying the ratio of mannitol, inositol and BSA, was used to select the stabilizer combination which resulted in the desired powder properties (i.e. good vaccine stability during production and storage, low moisture content and hygroscopicity and good dry dispersibility). Inositol-containing powders had the same vaccine stabilizing capacity as trehalose powders, but were less hygroscopic. Incorporation of BSA enhanced the vaccine stability in the powders compared to PVP-containing formulations. However, increasing the BSA concentration increased the hygroscopicity and reduced the dry dispersibility of the powder. No valid mathematical model could be calculated for vaccine stability during production or storage, but the individual experiments indicated that a formulation combining mannitol, inositol and BSA in a ratio of 73.3:13.3:13.3 (wt/wt) resulted in the lowest vaccine titre loss during production (1.6-2.0 log(10) 50% egg infectious dose (EID(50)) and storage at 6 °C (max. 0.8 log(10) EID(50) after 6 months) in combination with a low moisture content (1.1-1.4%), low hygroscopicity (1.9-2.1% water uptake at 60% relative humidity) and good dry dispersibility properties. Copyright © 2011 Elsevier B.V. All rights reserved.

Evaluation of Measles-Mumps-Rubella Vaccination Among Newly Arrived Refugees.

PubMed

Lee, Deborah; Weinberg, Michelle; Benoit, Stephen

2017-05-01

To assess US availability and use of measles-mumps-rubella (MMR) vaccination documentation for refugees vaccinated overseas. We selected 1500 refugee records from 14 states from March 2013 through July 2015 to determine whether overseas vaccination records were available at the US postarrival health assessment and integrated into the Advisory Committee on Immunization Practices schedule. We assessed number of doses, dosing interval, and contraindications. Twelve of 14 (85.7%) states provided data on 1118 (74.5%) refugees. Overseas records for 972 (86.9%) refugees were available, most from the Centers for Disease Control and Prevention's Electronic Disease Notification system (66.9%). Most refugees (829; 85.3%) were assessed appropriately for MMR vaccination; 37 (3.8%) should have received MMR vaccine but did not; 106 (10.9%) did not need the MMR vaccine but were vaccinated. Overseas documentation was available at most clinics, and MMR vaccinations typically were given when needed. Further collaboration between refugee health clinics and state immunization information systems would improve accessibility of vaccination documentation.

Military Health: DOD’s Vaccine Healthcare Centers Network

DTIC Science & Technology

2007-06-29

example, according to CDC’s Morbidity and Mortality Weekly Report of May 18, 2007, a child of a servicemember who received the smallpox vaccine...must be rated as “fully medically ready.” To meet this requirement, among other things, servicemembers must receive all immunizations that, depending...Diphtheria, hepatitis A, hepatitis B, influenza, measles , meningococcal disease, mumps, pertussis, poliovirus, rubella, tetanus, varicella, yellow

Statistical Physics of Vaccine Design

NASA Astrophysics Data System (ADS)

Deem, Michael

2009-03-01

I will define a new parameter to quantify the antigenic distance between two H3N2 influenza strains. I will use this parameter to measure antigenic distance between circulating H3N2 strains and the closest vaccine component of the influenza vaccine. For the data between 1971 and 2004, the measure of antigenic distance correlates better with efficacy in humans of the H3N2 influenza A annual vaccine than do current state of the art measures of antigenic distance such as phylogenetic sequence analysis or ferret antisera inhibition assays. I suggest that this measure of antigenic distance can be used to guide the design of the annual flu vaccine. I will describe combining this measure of antigenic distance with a multiple-strain avian influenza transmission model to study the threat of simultaneous introduction of multiple avian influenza strains. For H3N2 influenza, the model is validated against observed viral fixation rates and epidemic progression rates from the World Health Organization FluNet - Global Influenza Surveillance Network. I find that a multiple-component avian influenza vaccine is helpful to control a simultaneous multiple introduction of bird-flu strains. I introduce Population at Risk (PaR) to quantify the risk of a flu pandemic, and calculate by this metric the improvement that a multiple vaccine offers.

Vaccine manufacturing and technology: from biotechnological platforms to syntethic epitopes, current viepoint.

PubMed

Ignateva, G A

2016-01-01

The Purposes: the review take into account short history of vaccination practice and development of vaccine technology. In the review we include data from several monographs about manufacturing of vaccines published by authors from such companies as Merck & Co; Sanofi Pasteur; Dynavax Europe/Rhein Biotech GmbH; Latham Biopharm Group; Aridis Pharmaceuticals LLC; Genentech; Amgen; Shamir Biologics LLC; Biopharm Services US; Novartis Pharma AG, аnd several research centers: Laboratory of Bacterial Polysaccharides, Center for Biologics Evaluation and Research; Purdue University, West Lafayette, IN, US; Department of Pharmaceutical Chemistry, Univ. Of Kansas; Max Planck Institute for dynamics of Complex Technical Systems; Fraunhofer USA Center for Molecular Biotechnology; US Dep. of Agriculture Animal and Plant Health Inspection Service, etc. In historic literature there are data about inoculation practices in antique China, Persia, India, Byzantium, native Americans, some African population. In modern immunology since the end of XIX century the vaccines were produced at the in vivo platforms - in animals (rabbits, mice, cows). Since 1931 due to E. Goodpasture' elaboration most virus vaccines were and are produced at the in ovo platform. In 1949 J.F. Enders elaborated large-scale polio virus production in the primary culture of monkey kidney cells in vitro. Up to day primary culture of chiken embrio fibroblasts are used to large-scale production of vaccine viruses of measles, mumps, rabies. Since 2000-th in Western countries most part of virus vaccines were began to produced via a cultivation in continuous tumor cell lines. The last technology is the most low cost for large-scale production of vaccines. We review several new biotechnological platforms for the production of the recombinant protein or virus-like particles as subunit vaccines: plant system, algae, mushrooms, insect cells, etc. Beside of good purpose of vaccination - prophylactic of several infectious

[Vaccination schedule of the Spanish Association of Pediatrics: recommendations 2005].

PubMed

2005-02-01

The Advisory Committee on Vaccines of the Spanish Association of Pediatrics provides information and comments on the new developments in vaccines that have taken place in 2004 and recommends a few modifications to the Immunization Schedule for 2005. Concerning the meningococcal C vaccine, no change is made to the possibility of administering two doses for the first vaccination with one of the available formulations. The existence of immunization failure in children who have received a first vaccination with three vaccine doses before the age of 12 months is discussed, and the health authorities will probably include a booster dose in the second year of life throughout 2005. The recommendations of the European Medicines Evaluation Agency (EMEA) on hexavalent vaccines continue to be valid and consequently the use of these vaccines should not be stopped. This year the need for adolescents to receive a booster dose of the pertussis vaccine, with administration of an acellular, low antigenic load preparation together with the adult diphtheria and tetanus vaccine is stressed.

Promoting influenza vaccination: insights from a qualitative meta-analysis of 14 years of influenza-related communications research by U.S. Centers for Disease Control and Prevention (CDC).

PubMed

Nowak, Glen J; Sheedy, Kristine; Bursey, Kelli; Smith, Teresa M; Basket, Michelle

2015-06-04

A primary mission of the U.S. Centers for Disease Control and Prevention's (CDC) is promoting immunization against seasonal influenza. As with most education efforts, CDC's influenza-related communications are often informed by formative research. A qualitative meta-analysis of 29 unpublished, primarily qualitative CDC-sponsored studies related to flu and flu vaccination knowledge, attitudes and beliefs (KABs). The studies, undertaken between 2000 and 2013, involved focus groups, in-depth interviews, message testing and surveys. Some involved health care professionals, while others involved members of the public, including sub-populations at risk for severe illness. The themes that emerged suggested progress in terms of KABs related to influenza and influenza vaccination, but also the persistence of many barriers to vaccine acceptance. With respect to the public, recurring themes included limited understanding of influenza and immunization recommendations, indications of greater sub-group recognition of the value of flu vaccination, continued resistance to vaccination among many, and overestimation of the effectiveness of non-vaccine measures. Seven cognitive facilitators of vaccination were identified in the studies along with six cognitive barriers. For health care providers, the analysis suggests greater knowledge and more favorable beliefs, but many misperceptions persist and are similar to those held by the public. KABs often differed by type or category of health care provider. The themes identified in this qualitative analysis illustrate the difficulty in changing KABs related to influenza and influenza vaccine, particularly on the scope and scale needed to greatly improve uptake. Even with an influenza pandemic and more vaccine options available, public and some health care provider perceptions and beliefs are difficult and slow to change. This meta-analysis does, however, provide important insights from previously unpublished information that can help

Association of vaccination coverage with sociodemographic factors in workers of primary health care centers of Cordoba, Argentina.

PubMed

Acevedo, Gabriel; López, Laura; Willington, Ana; Burrone, Soledad; Farias, Alejandra; Sánchez, Julieta

2016-01-01

The activities performed by the health personnel have specific occupational risks making it more susceptible to get infectious diseases. Therefore, all healthcare workers must be properly immunized against vaccinepreventable diseases. Assessing the proportion of healthcare workers from the public subsector who are vaccinated and relating the sociodemographic factors with the proportion of the Meningitis vaccination condition of the workers from the primary care level of the city of Córdoba Methods: An observational analytical cross-sectional study was carried out with a sample of 157 workers of the municipal district of Cordoba. A self-administered survey was conducted and univariate and bivariate analyses were performed. For the evaluation of factors related with the vaccination a Chi-Square Test was implemented. The measures of immunization coverage found were: hepatitis B vaccine 67,5%, anti flu vaccine 66,25%, trabadouble bacterial vaccine 60,51% and triple or double viral vaccine 50,32%. The overall analysis showed higher levels of coverage among those workers with a higher level of education and less seniority. This was also evident among the youngest and the physicians. With important differences depending on the educational level for hepatitis B vaccine, for triple or double viral among the youngest workers and double bacterial for those with less seniority. The health personnel studied on this research has a vaccination status that is lower than that of the internationally recommended vaccination status. Although, this status is similar to the one reported in several countries it shows that the under-coverage of vaccination among these workers is an extended problem which must be prioritized by health authorities; given the implications for the health of workers and the population these workers assist.

Improving the cold chain for vaccines.

PubMed

Lloyd, J S

1977-01-01

The cold chain may be defined as a system for transporting and storing vaccines at very low temperataures, particularly in tropical countries. In Ghana, efforts are being made, with the assistance of the World Health Organization (WHO) to develop and test a new cold chain technology. Emphasis is on local production in order to meet the needs of the countrywide immunization program, and, if possible, of similar programs in other West African nations. Focus in this discussion is on the losses resulting from mishandling of vaccines during storage and in transit through various stages in the cold chain as well as the problems, requirements, and proposed solutions. In most countries with immunization programs, breakdowns in refrigeration during the transport and storage of vaccines in remote rural areas or at the regional and national central stores have led to great losses of vaccine. The losses are often caused by inappropriate management and technology. The most promising recent development in the area of storage is an enzyme-based time/temperature indicator contained in a paper tab which is attached to the vaccine packet. In order to reduce to a minimum the handling of vaccines at the national central store it is proposed that the ministry of health submit details of regional requirements in their requisition to the manufacturer. Then the manufacturer can make presealed packages which are dispatched by air to the national central store and from there to the regions, while they are still sealed. Insulated boxes for this purpose have been tested in Sweden and been shown to maintain deep-freezing temperatures for 5 days. Road communications to the regional centers are good in Ghana and the 5-day cold boxes give adequate safety margins. The plan for the immunization program in Ghana is to employ a combination of teams from both fixed and mobile centers. 3 contacts, 3 months apart, will be made by the fixed teams; mobile teams will make 2 contacts, 2 months apart. Mobile

Two Birds With One Stone: Estimating Population Vaccination Coverage From a Test-negative Vaccine Effectiveness Case-control Study.

PubMed

Doll, Margaret K; Morrison, Kathryn T; Buckeridge, David L; Quach, Caroline

2016-10-15

Vaccination program evaluation includes assessment of vaccine uptake and direct vaccine effectiveness (VE). Often examined separately, we propose a design to estimate rotavirus vaccination coverage using controls from a rotavirus VE test-negative case-control study and to examine coverage following implementation of the Quebec, Canada, rotavirus vaccination program. We present our assumptions for using these data as a proxy for coverage in the general population, explore effects of diagnostic accuracy on coverage estimates via simulations, and validate estimates with an external source. We found 79.0% (95% confidence interval, 74.3%, 83.0%) ≥2-dose rotavirus coverage among participants eligible for publicly funded vaccination. No differences were detected between study and external coverage estimates. Simulations revealed minimal bias in estimates with high diagnostic sensitivity and specificity. We conclude that controls from a VE case-control study may be a valuable resource of coverage information when reasonable assumptions can be made for estimate generalizability; high rotavirus coverage demonstrates success of the Quebec program. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

Low vaccine coverage among children born to HIV infected women in Niamey, Niger.

PubMed

Tchidjou, Hyppolite Kuekou; Vescio, Maria Fenicia; Sanou Sobze, Martin; Souleyman, Animata; Stefanelli, Paola; Mbabia, Adalbert; Moussa, Ide; Gentile, Bruno; Colizzi, Vittorio; Rezza, Giovanni

2016-01-01

The effect of mother's HIV-status on child vaccination is an important public health issue in countries with high HIV prevalence. We conducted a study in a primary healthcare center located in Niamey, the capital of Niger, which offers free of charge services to HIV positive and/or underprivileged mothers, with the aim of assessing: 1) vaccination coverage for children 0-36 months old, born to HIV-infected mothers, and 2) the impact of maternal HIV status on child vaccination. Mothers of children less than 36 months old attending the center were interviewed, to collect information on vaccines administered to their child, and family's socio-demographic characteristics. Overall, 502 children were investigated. Children of HIV-seropositive mothers were less likely to receive follow up vaccinations for Diphtheria-Tetanus-Pertussis (DTP) than those of HIV-seronegative mothers, with a prevalence ratio (PR) of 2.03 (95%CI: 1.58-2.61). Children born to HIV-seropositive mothers were less likely to miss vaccination for MMR than those born to HIV negative mothers, with a RR of 0.46 (95%CI: 0.30-0.72). Vaccine coverage among children born to HIV infected mothers was rather low. It is important to favor access to vaccination programs in this population.

Overview of cancer vaccines

PubMed Central

Kudrin, Alex

2012-01-01

Cancer immunotherapy has seen a tremendous number of failures and only few recent regulatory successes. This is a review dedicated to determine major regulatory and developmental issues around cancer immunotherapeutics. A three pillar approach should be used in setting a development path: discovery platforms and sufficient pool of validated tumor antigens, product development strategy enabling to bring the product closer to the patient and clinical development strategy accounting for competitive landscape, treatment paradigm, technical and commercial risks. Regulatory framework existing around cancer vaccines in the EU, US, Japan and some developing countries is outlined. In addition, the review covers some specific issues on the design and conduct of clinical trials with cancer vaccines. PMID:22894970

Effect of bivalent human papillomavirus vaccination on pregnancy outcomes: long term observational follow-up in the Costa Rica HPV Vaccine Trial.

PubMed

Panagiotou, Orestis A; Befano, Brian L; Gonzalez, Paula; Rodríguez, Ana Cecilia; Herrero, Rolando; Schiller, John T; Kreimer, Aimée R; Schiffman, Mark; Hildesheim, Allan; Wilcox, Allen J; Wacholder, Sholom

2015-09-07

To examine the effect of the bivalent human papillomavirus (HPV) vaccine on miscarriage. Observational long term follow-up of a randomized, double blinded trial combined with an independent unvaccinated population based cohort. Single center study in Costa Rica. 7466 women in the trial and 2836 women in the unvaccinated cohort enrolled at the end of the randomized trial and in parallel with the observational trial component. Women in the trial were assigned to receive three doses of bivalent HPV vaccine (n=3727) or the control hepatitis A vaccine (n=3739). Crossover bivalent HPV vaccination occurred in the hepatitis A vaccine arm at the end of the trial. Women in the unvaccinated cohort received (n=2836) no vaccination. Risk of miscarriage, defined by the US Centers for Disease Control and Prevention as fetal loss within 20 weeks of gestation, in pregnancies exposed to bivalent HPV vaccination in less than 90 days and any time from vaccination compared with pregnancies exposed to hepatitis A vaccine and pregnancies in the unvaccinated cohort. Of 3394 pregnancies conceived at any time since bivalent HPV vaccination, 381 pregnancies were conceived less than 90 days from vaccination. Unexposed pregnancies comprised 2507 pregnancies conceived after hepatitis A vaccination and 720 conceived in the unvaccinated cohort. Miscarriages occurred in 451 (13.3%) of all exposed pregnancies, in 50 (13.1%) of the pregnancies conceived less than 90 days from bivalent HPV vaccination, and in 414 (12.8%) of the unexposed pregnancies, of which 316 (12.6%) were in the hepatitis A vaccine group and 98 (13.6%) in the unvaccinated cohort. The relative risk of miscarriage for pregnancies conceived less than 90 days from vaccination compared with all unexposed pregnancies was 1.02 (95% confidence interval 0.78 to 1.34, one sided P=0.436) in unadjusted analyses. Results were similar after adjusting for age at vaccination (relative risk 1.15, one sided P=0.17), age at conception (1.03, P=0

Evaluating the Safety of New Vaccines: Summary of a Workshop

PubMed Central

Ellenberg, Susan S.; Foulkes, Mary A.; Midthun, Karen; Goldenthal, Karen L.

2005-01-01

Public concerns about the safety of vaccines arise on a regular basis. In November 2000, a workshop titled “Evaluation of New Vaccines: How Much Safety Data?” was convened by US Public Health Service agencies, including the Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Health Resources and Services Administration, to discuss appropriate methods for evaluating the safety of new vaccines. Workshop presentations addressed the current standards and approaches for new vaccine evaluation and postlicensure surveillance, as well as public views about vaccine safety and alternative approaches that could be considered. The advantages and disadvantages of conducting large controlled trials before licensure or widespread use of a new vaccine were discussed. We summarize these presentations and discussions. PMID:15855455

Updates in vaccination: Recommendations for adult inflammatory bowel disease patients

PubMed Central

Chaudrey, Khadija; Salvaggio, Michelle; Ahmed, Aftab; Mahmood, Sultan; Ali, Tauseef

2015-01-01

Treatment regimens for inflammatory bowel disease (IBD) incorporate the use of a variety of immunosuppressive agents that increase the risk of infections. Prevention of many of these infections can be achieved by the timely and judicious use of vaccinations. IBD patients tend to be under-immunized. Some of the contributing factors are lack of awareness regarding the significance of vaccinating IBD patients, misperception about safety of vaccinations in immunocompromised patients, ambiguity about the perceived role of the gastroenterologist in contrast to the primary care physician and unavailability of vaccination guidelines focused on IBD population. In general, immunocompetent IBD patients can be vaccinated using standard vaccination recommendations. However there are special considerations for IBD patients receiving immunosuppressive therapy, IBD travelers and pregnant women with IBD. This review discusses current vaccination recommendations with updates for adult IBD patients. Centers for Disease Control and Prevention 2013 vaccination guidelines with 2014 updates and the Advisory Committee on Immunization Practices recommendations have been highlighted as a primary source of recommendations. PMID:25805924

A Multiyear Model of Influenza Vaccination in the United States.

PubMed

Kamis, Arnold; Zhang, Yuji; Kamis, Tamara

2017-07-28

Vaccinating adults against influenza remains a challenge in the United States. Using data from the Centers for Disease Control and Prevention, we present a model for predicting who receives influenza vaccination in the United States between 2012 and 2014, inclusive. The logistic regression model contains nine predictors: age, pneumococcal vaccination, time since last checkup, highest education level attained, employment, health care coverage, number of personal doctors, smoker status, and annual household income. The model, which classifies correctly 67 percent of the data in 2013, is consistent with models tested on the 2012 and 2014 datasets. Thus, we have a multiyear model to explain and predict influenza vaccination in the United States. The results indicate room for improvement in vaccination rates. We discuss how cognitive biases may underlie reluctance to obtain vaccination. We argue that targeted communications addressing cognitive biases could be useful for effective framing of vaccination messages, thus increasing the vaccination rate. Finally, we discuss limitations of the current study and questions for future research.

Challenges and impact of conducting vaccine trials in Asia and Africa

PubMed Central

Kochhar, Sonali

2013-01-01

Immunization is one of the most beneficial and cost-effective disease prevention measures. There are global efforts to develop new vaccines for disease control. The vaccine clinical trials must be conducted in the countries where they will be used. This has led to vaccine trials being conducted across Asia and Africa where there is a high burden of infectious diseases. The setup and successful conduct of International standard GCP vaccine trials across trial centers located in resource constrained settings are challenging. The challenges, ethical considerations and impact of the implementation of clinical trials in low-resource settings are highlighted here to help vaccine development programs successfully conduct such trials. PMID:23321645

Transgenic mice as an alternative to monkeys for neurovirulence testing of live oral poliovirus vaccine: validation by a WHO collaborative study.

PubMed Central

Dragunsky, Eugenia; Nomura, Tatsuji; Karpinski, Kazimir; Furesz, John; Wood, David J.; Pervikov, Yuri; Abe, Shinobu; Kurata, Takeshi; Vanloocke, Olivier; Karganova, Galina; Taffs, Rolf; Heath, Alan; Ivshina, Anna; Levenbook, Inessa

2003-01-01

OBJECTIVE: Extensive WHO collaborative studies were performed to evaluate the suitability of transgenic mice susceptible to poliovirus (TgPVR mice, strain 21, bred and provided by the Central Institute for Experimental Animals, Japan) as an alternative to monkeys in the neurovirulence test (NVT) of oral poliovirus vaccine (OPV). METHODS: Nine laboratories participated in the collaborative study on testing neurovirulence of 94 preparations of OPV and vaccine derivatives of all three serotypes in TgPVR21 mice. FINDINGS: Statistical analysis of the data demonstrated that the TgPVR21 mouse NVT was of comparable sensitivity and reproducibility to the conventional WHO NVT in simians. A statistical model for acceptance/rejection of OPV lots in the mouse test was developed, validated, and shown to be suitable for all three vaccine types. The assessment of the transgenic mouse NVT is based on clinical evaluation of paralysed mice. Unlike the monkey NVT, histological examination of central nervous system tissue of each mouse offered no advantage over careful and detailed clinical observation. CONCLUSIONS: Based on data from the collaborative studies the WHO Expert Committee for Biological Standardization approved the mouse NVT as an alternative to the monkey test for all three OPV types and defined a standard implementation process for laboratories that wish to use the test. This represents the first successful introduction of transgenic animals into control of biologicals. PMID:12764491

77 FR 68783 - Prospective Grant of Exclusive License: Veterinary Vaccines for Rift Valley Fever Virus

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-16

... Grant of Exclusive License: Veterinary Vaccines for Rift Valley Fever Virus AGENCY: Centers for Disease... territories other than Africa, in the field of use of veterinary vaccines, to practice the inventions listed... precisely defined attenuated vaccine constructs that contain complete deletions of critical virulence...

Comprehensive hands-on training for influenza vaccine manufacturing: a WHO-BARDA-BTEC partnership for global workforce development.

PubMed

Ruiz, Jennifer; Gilleskie, Gary L; Brown, Patty; Burnett, Bruce; Carbonell, Ruben G

2014-01-01

The critical need for enhancing influenza pandemic preparedness in many developing nations has led the World Health Organization (WHO) and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), to develop an international influenza vaccine capacity-building program. Among the critical limitations faced by many of these nations is lack of access to training programs for staff supporting operations within vaccine production facilities. With support from BARDA, the Biomanufacturing Training and Education Center (BTEC) at North Carolina State University has addressed this need for training by developing and delivering a comprehensive training program, consisting of three courses: Fundamentals of cGMP Influenza Vaccine Manufacturing, Advanced Upstream Processes for Influenza Vaccine Manufacturing, and Advanced Downstream Processes for Influenza Vaccine Manufacturing. The courses cover process design, transfer, and execution at manufacturing scale, quality systems, and regulations covering both manufacturing and approval of pandemic vaccines. The Fundamentals course focuses on the concepts, equipment, applicable regulations, and procedures commonly used to produce influenza vaccine. The two Advanced courses focus on process design, scale up, validation, and new technologies likely to improve efficiency of vaccine production. All three courses rely on a combination of classroom instruction and hands-on training in BTEC's various laboratories. Each course stands alone, and participants may take one or more of the three courses. Overall participant satisfaction with the courses has been high, and follow-up surveys show that participants actively transferred the knowledge they gained to the workplace. Future plans call for BTEC to continue offering the three courses and to create an online version of several modules of the Fundamentals course. Copyright © 2014 Wiley Periodicals, Inc.

Roadmap to developing a recombinant coronavirus S protein receptor-binding domain vaccine for severe acute respiratory syndrome

PubMed Central

Jiang, Shibo; Bottazzi, Maria Elena; Du, Lanying; Lustigman, Sara; Tseng, Chien-Te Kent; Curti, Elena; Jones, Kathryn; Zhan, Bin; Hotez, Peter J

2013-01-01

A subunit vaccine, RBD-S, is under development to prevent severe acute respiratory syndrome (SARS) caused by SARS coronavirus (SARS-CoV), which is classified by the US NIH as a category C pathogen. This vaccine is comprised of a recombinant receptor-binding domain (RBD) of the SARS-CoV spike (S) protein and formulated on alum, together with a synthetic glucopyranosyl lipid A. The vaccine would induce neutralizing antibodies without causing Th2-type immunopathology. Vaccine development is being led by the nonprofit product development partnership; Sabin Vaccine Institute and Texas Children’s Hospital Center for Vaccine Development in collaboration with two academic partners (the New York Blood Center and University of Texas Medical Branch); an industrial partner (Immune Design Corporation); and Walter Reed Army Institute of Research. A roadmap for the product development of the RBD-S SARS vaccine is outlined with a goal to manufacture the vaccine for clinical testing within the next 5 years. PMID:23252385

Space Weather Model Testing And Validation At The Community Coordinated Modeling Center

NASA Astrophysics Data System (ADS)

Hesse, M.; Kuznetsova, M.; Rastaetter, L.; Falasca, A.; Keller, K.; Reitan, P.

The Community Coordinated Modeling Center (CCMC) is a multi-agency partner- ship aimed at the creation of next generation space weather models. The goal of the CCMC is to undertake the research and developmental work necessary to substantially increase the present-day modeling capability for space weather purposes, and to pro- vide models for transition to the rapid prototyping centers at the space weather forecast centers. This goal requires close collaborations with and substantial involvement of the research community. The physical regions to be addressed by CCMC-related activities range from the solar atmosphere to the Earth's upper atmosphere. The CCMC is an integral part of NASA's Living With aStar initiative, of the National Space Weather Program Implementation Plan, and of the Department of Defense Space Weather Tran- sition Plan. CCMC includes a facility at NASA Goddard Space Flight Center, as well as distributed computing facilities provided by the Air Force. CCMC also provides, to the research community, access to state-of-the-art space research models. In this paper we will provide updates on CCMC status, on current plans, research and devel- opment accomplishments and goals, and on the model testing and validation process undertaken as part of the CCMC mandate.

Nine μg intradermal influenza vaccine and 15 μg intramuscular influenza vaccine induce similar cellular and humoral immune responses in adults

PubMed Central

Nougarede, Nolwenn; Bisceglia, Hélène; Rozières, Aurore; Goujon, Catherine; Boudet, Florence; Laurent, Philippe; Vanbervliet, Beatrice; Rodet, Karen; Hennino, Ana; Nicolas, Jean-François

2014-01-01

Intanza® 9 μg (Sanofi Pasteur), a trivalent split-virion vaccine administered by intradermal (ID) injection, was approved in Europe in 2009 for the prevention of seasonal influenza in adults 18 to 59 years. Here, we examined the immune responses induced in adults by the ID 9 μg vaccine and the standard trivalent intramuscular (IM) vaccine (Vaxigrip® 15 μg, Sanofi Pasteur). This trial was a randomized, controlled, single-center, open-label study in healthy adults 18 to 40 years of age during the 2007/8 influenza season. Subjects received a single vaccination with the ID 9 μg (n = 38) or IM 15 μg (n = 42) vaccine. Serum, saliva, and peripheral blood mononuclear cells were collected up to 180 days post-vaccination. Geometric mean hemagglutination inhibition titers, seroprotection rates, seroconversion rates, and pre-vaccination-to-post-vaccination ratios of geometric mean hemagglutination inhibition titers did not differ between the two vaccines. Compared with pre-vaccination, the vaccines induced similar increases in vaccine-specific circulating B cells at day 7 but did not induce significant increases in vaccine-specific memory B cells at day 180. Cell-mediated immunity to all three vaccine strains, measured in peripheral blood mononuclear cells, was high at baseline and not increased by either vaccine. Neither vaccine induced a mucosal immune response. These results show that the humoral and cellular immune responses to the ID 9 μg vaccine are similar to those to the standard IM 15 μg vaccine. PMID:25483667

Nine μg intradermal influenza vaccine and 15 μg intramuscular influenza vaccine induce similar cellular and humoral immune responses in adults.

PubMed

Nougarede, Nolwenn; Bisceglia, Hélène; Rozières, Aurore; Goujon, Catherine; Boudet, Florence; Laurent, Philippe; Vanbervliet, Beatrice; Rodet, Karen; Hennino, Ana; Nicolas, Jean-François

2014-01-01

Intanza® 9 μg (Sanofi Pasteur), a trivalent split-virion vaccine administered by intradermal (ID) injection, was approved in Europe in 2009 for the prevention of seasonal influenza in adults 18 to 59 years. Here, we examined the immune responses induced in adults by the ID 9 μg vaccine and the standard trivalent intramuscular (IM) vaccine (Vaxigrip® 15 μg, Sanofi Pasteur). This trial was a randomized, controlled, single-center, open-label study in healthy adults 18 to 40 years of age during the 2007/8 influenza season. Subjects received a single vaccination with the ID 9 μg (n=38) or IM 15 μg (n=42) vaccine. Serum, saliva, and peripheral blood mononuclear cells were collected up to 180 days post-vaccination. Geometric mean hemagglutination inhibition titers, seroprotection rates, seroconversion rates, and pre-vaccination-to-post-vaccination ratios of geometric mean hemagglutination inhibition titers did not differ between the two vaccines. Compared with pre-vaccination, the vaccines induced similar increases in vaccine-specific circulating B cells at day 7 but did not induce significant increases in vaccine-specific memory B cells at day 180. Cell-mediated immunity to all three vaccine strains, measured in peripheral blood mononuclear cells, was high at baseline and not increased by either vaccine. Neither vaccine induced a mucosal immune response. These results show that the humoral and cellular immune responses to the ID 9 μg vaccine are similar to those to the standard IM 15 μg vaccine.

Mutual interference on the immune response to yellow fever vaccine and a combined vaccine against measles, mumps and rubella.

PubMed

Nascimento Silva, Juliana Romualdo; Camacho, Luiz Antonio B; Siqueira, Marilda M; Freire, Marcos de Silva; Castro, Yvone P; Maia, Maria de Lourdes S; Yamamura, Anna Maya Y; Martins, Reinaldo M; Leal, Maria de Luz F

2011-08-26

A randomized trial was conducted to assess the immunogenicity and reactogenicity of yellow fever vaccines (YFV) given either simultaneously in separate injections, or 30 days or more after a combined measles-mumps-rubella (MMR) vaccine. Volunteers were also randomized to YFV produced from 17DD and WHO-17D-213 substrains. The study group comprised 1769 healthy 12-month-old children brought to health care centers in Brasilia for routine vaccination. The reactogenicity was of the type and frequency expected for the vaccines and no severe adverse event was associated to either vaccine. Seroconversion and seropositivity 30 days or more after vaccination against yellow fever was similar across groups defined by YFV substrain. Subjects injected YFV and MMR simultaneously had lower seroconversion rates--90% for rubella, 70% for yellow fever and 61% for mumps--compared with those vaccinated 30 days apart--97% for rubella, 87% for yellow fever and 71% for mumps. Seroconversion rates for measles were higher than 98% in both comparison groups. Geometric mean titers for rubella and for yellow fever were approximately three times higher among those who got the vaccines 30 days apart. For measles and mumps antibodies GMTs were similar across groups. MMR's interference in immune response of YFV and YFV's interference in immune response of rubella and mumps components of MMR had never been reported before but are consistent with previous observations from other live vaccines. These results may affect the recommendations regarding primary vaccination with yellow fever vaccine and MMR. Copyright © 2011 Elsevier Ltd. All rights reserved.

[Serologic survey of rubella in the pre-vaccine era in child-care centers, schools and maternity units of Fortaleza

PubMed

Rey, L C; Barbosa, L M; Osterno, C L; Ramalho, I L; Vilar, D C; Memória, A M; Vieira, L C; Gonçalves, V F

1998-01-01

OBJECTIVES: To identify rubella prevalence in different ages and population groups and rubella susceptibility of pregnant and postpartum women according to age, number of children and spontaneous abortion. METHODS: Cross-sectional study of sero-survey type. Children and students were selected in day-care centers and schools distributed by health districts of Fortaleza. Pregnant and postpartum healthy women were recruited in two large maternity units and three antenatal clinics; individuals previously vaccinated and presenting chronic or acute diseases where excluded. Written consent was obtained from participants or their caretakers. Anti-rubella IgG qualitative detection was performed with an Elisa-sandwich assay. RESULTS: Mean age-specific sero-prevalence rates of 999 samples were: 2 to 5 years= 59% (136/231); 6 to 9 years= 47% (95/204); 10 to 19 years= 56% (243/432) and 20 to 39 years= 80% (106/132). The mean age of 187 pregnant and postpartum women was 23 years (10-39) with a sero-prevalence of 76% (142/187), where 62% sero-positives aged 15 to 19 and 83% aged 26 to 39 years. A higher sero-prevalence was related to womeńs age (p<0.001), history of spontaneous abortion (p= 0.03), and two or more children (p=0.01). CONCLUSIONS: The high sero-prevalence of rubella in preschool age children reflects the intense viral transmission in child-care centers. The high susceptibility in adolescents (45%), among whom pregnancy is common, emphasizes the need to introduce rubella vaccine early and keep high immunization coverages in youngsters in order to eradicate congenital rubella syndrome. Also, postpartum routine immunization against rubella in this age group is of particular benefit.

Cholera Vaccination in Urban Haiti

PubMed Central

Rouzier, Vanessa; Severe, Karine; Juste, Marc Antoine Jean; Peck, Mireille; Perodin, Christian; Severe, Patrice; Deschamps, Marie Marcelle; Verdier, Rose Irene; Prince, Sabine; Francois, Jeannot; Cadet, Jean Ronald; Guillaume, Florence D.; Wright, Peter F.; Pape, Jean W.

2013-01-01

Successful and sustained efforts have been made to curtail the major cholera epidemic that occurred in Haiti in 2010 with the promotion of hygiene and sanitation measures, training of health personnel and establishment of treatment centers nationwide. Oral cholera vaccine (OCV) was introduced by the Haitian Ministry of Health as a pilot project in urban and rural areas. This paper reports the successful OCV pilot project led by GHESKIO Centers in the urban slums of Port-au-Prince where 52,357 persons received dose 1 and 90.8% received dose 2; estimated coverage of the at-risk community was 75%. This pilot study demonstrated the effort, community mobilization, and organizational capacity necessary to achieve these results in a challenging setting. The OCV intervention paved the way for the recent launching of a national cholera vaccination program integrated in a long-term ambitious and comprehensive plan to address Haiti's critical need in water security and sanitation. PMID:24106194

Evaluation of vaccine cold chain in urban health centers of municipal corporation of surat city, Western India.

PubMed

Naik, Ashish K; Rupani, Mihir P; Bansal, R K

2013-12-01

The success of immunization depends highly on the level of cold chain maintenance. The aim of the study was to assess the condition of cold chain equipment, practices adopted for cold chain maintenance and knowledge of the vaccinators. It was a cross-sectional study conducted in 20 UHCs of Surat Municipal Corporation (SMC). Cold chain equipment were observed with regards to their condition, along with the practices adopted by vaccinators for cold chain maintenance. A pre-designed and pre-tested questionnaire was used to interview the vaccinators regarding their knowledge and awareness regarding cold chain practices, management and handling. Data were entered and analyzed using Epi Info v 3.5.1. Simple proportions were calculated. Absence of separate stabilizer for deep freezers and ILRs (85%), ill-maintained temperature-record register, lack of criss-cross pattern of ice packs in deep freezer (65%), presence of things other than ice packs in deep freezer (10%) and things other than vaccines in ILR (10%) indicate poor cold chain maintenance. In addition to this, expired vaccines in ILR (5%), vaccines in the "unusable" stages of VVM (15%), lack of emergency contact number nearby in case of cold chain failure (85%), lack of inverter (85%), lack of generator (85%) and failure to note time of reconstitution on the vaccine vial at the time of vaccination (25%) indicate poor cold chain practices. Lack of knowledge of defrosting of ILR and deep freezer (45%), lack of knowledge about Shake test (40%), lack of knowledge of temperature range to be maintained in deep freezer (70%) and in ILR (15%) indicate poor knowledge of vaccinators. Cold chain maintenance and practices need improvement. Knowledge of vaccinators was overall unsatisfactory.

Early Lessons Learned from Extramural School Programs That Offer HPV Vaccine

ERIC Educational Resources Information Center

Hayes, Kim A.; Entzel, Pamela; Berger, Wendy; Caskey, Rachel N.; Shlay, Judith C.; Stubbs, Brenda W.; Smith, Jennifer S.; Brewer, Noel T.

2013-01-01

Background: There has been little evaluation of school-located vaccination programs that offer human papillomavirus (HPV) vaccine in US schools without health centers (ie, extramural programs). This article summarizes lessons learned from such programs. Methods: In July to August 2010, 5 programs were identi?ed. Semistructured, in-depth telephone…

Accuracy of parent-reported measles-containing vaccination status of children with measles.

PubMed

Liu, G; Liao, Z; Xu, X; Liang, Y; Xiong, Y; Ni, J

2017-03-01

The validity of parent-reported measles-containing vaccination history in children with measles has not been assessed. This study evaluated the accuracy of parental recall of measles-containing vaccination histories in Shenzhen, China. A retrospective study was performed to compare the data from the electronic records with parental recall. The electronic records were regarded as accurate data about the children's measles-containing vaccination status. We collected data from the National Notifiable Diseases Surveillance System and the Immunization Program Information Management System in Shenzhen city, China. Between 2009 and 2014, there were 163 children with measles who had electronic vaccination records; the vaccination status of these cases was reported by the parents in the field epidemiological investigation. We validated parental recall with electronic records. The agreement between parental recall and electronic records was 78.7%. The kappa value was 0.57. The parent-reported measles-containing vaccination rate was higher than the electronic record (48.5% vs 41.7%, χ 2  = 53.64, P < 0.001). The true positive rate for parental recall was 82.4%, and the true negative rate was 75.8%. The positive predictive value was 70.9%, and the negative predictive value was 76.6%. In children with measles, parental recall slightly overestimated the measles vaccination rate, and the vaccination status recalled by parents was in moderate agreement with the electronic record. Copyright © 2016 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

Validation of Force Limited Vibration Testing at NASA Langley Research Center

NASA Technical Reports Server (NTRS)

Rice, Chad; Buehrle, Ralph D.

2003-01-01

Vibration tests were performed to develop and validate the forced limited vibration testing capability at the NASA Langley Research Center. The force limited vibration test technique has been utilized at the Jet Propulsion Laboratory and other NASA centers to provide more realistic vibration test environments for aerospace flight hardware. In standard random vibration tests, the payload is mounted to a rigid fixture and the interface acceleration is controlled to a specified level based on a conservative estimate of the expected flight environment. In force limited vibration tests, both the acceleration and force are controlled at the mounting interface to compensate for differences between the flexible flight mounting and rigid test fixture. This minimizes the over test at the payload natural frequencies and results in more realistic forces being transmitted at the mounting interface. Force and acceleration response data was provided by NASA Goddard Space Flight Center for a test article that was flown in 1998 on a Black Brant sounding rocket. The measured flight interface acceleration data was used as the reference acceleration spectrum. Using this acceleration spectrum, three analytical methods were used to estimate the force limits. Standard random and force limited vibration tests were performed and the results are compared with the flight data.

GOSAT validation out standing in the field: A case study of satellite validation using the SSEC Portable Atmospheric Research Center (SPARC)

NASA Astrophysics Data System (ADS)

Wagner, T. J.; Borg, L. A.; Feltz, M.; Gero, P. J.; Knuteson, R. O.; Olson, E.

2016-12-01

The Space Science and Engineering Center (SSEC) at the University of Wisconsin-Madison has developed the SSEC Portable Atmospheric Research Center (SPARC), a mobile 11 m trailer that houses numerous in situ and ground-based remote sensing instruments. Available instrumentation includes the Atmospheric Emitted Radiance Interferometer (AERI), a hyperspectral infrared radiometer from which trace gas concentrations and profiles of temperature and water vapor can be retrieved; the High Spectral Resolution Lidar (HSRL), a multichannel lidar capable of directly retrieving profiles of optical depth and backscatter depolarization; and a Doppler lidar wind profiler. The remote instrumentation suite is complemented by surface meteorology observations and a radiosonde ground station. Collectively, these instruments enable SPARC to participate in a wide variety of field studies, including meteorological field experiments and ground-based satellite calibration and validation studies. In August 2016, SPARC traveled to the Chequamegon National Forest in northern Wisconsin for a two week long deployment alongside the WLEF-TV tower. This 447 m tower houses long-term observations of thermodynamic and atmospheric composition at multiple heights, enabling studies of phenomena like atmospheric/land surface interactions and carbon uptake. During this deployment, SPARC launched radiosondes coincident with clear-sky overpasses of the Greenhouse gases Observing SATellite (GOSAT). Thermodynamic profiles from the radiosondes and AERI combined with the trace gas observations from the tower were used to validate the GOSAT observations of carbon dioxide and methane. The on-site presence of SPARC allowed for better characterization of the environment and greater observational certainty than was possible with the tower alone. Examples from this particular validation study as well as a discussion of how SPARC can contribute to other satellite calibration and validation investigations will be

[Legal Bases Of Vaccination In Ukraine].

PubMed

Terzi, Olena O

2018-01-01

Introduction: Despite the extraordinary progress made in the field of vaccination, a large number of children in the last decade, 24 million children, or nearly 20% of children born every year, do not receive a full plan for vaccination during their first year of life. The aim: The purpose of the article is to analyze the legal framework of vaccination in Ukraine, comparing the approach of the domestic legislator to the vaccination with foreign experience. Materials and methods: Methods of research are selected based on the goal of the study. In order to establish the objectivity and validity of scientific statements and conclusions, during the conducted research a complex of general scientific and special scientific methods was used, in particular such as: the formal legal method; comparative legal method; the method of forecasting and modeling; historical-legal method. Review: In countries with epidemics, a state of emergency can be established and quarantine measures and vaccination to exercise the right to collective health, which may limit the right to individual health by limiting the right to consent to vaccination. Conclusions: It is concluded that in world practice there is no single approach to the recognition of the right to vaccination, as a human right, or as a duty to preserve the epidemiological security of the state. It has been proved that infectious diseases evolve, change their form, the only effective means of preventing pandemics, which may question the existence of man as a biological species, is the vaccination system.

77 FR 68783 - Prospective Grant of Co-Exclusive License: Veterinary Vaccines for Rift Valley Fever Virus

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-16

... Grant of Co-Exclusive License: Veterinary Vaccines for Rift Valley Fever Virus AGENCY: Centers for... veterinary vaccines, to practice the inventions listed in the patent applications referred to below to... generation of precisely defined attenuated vaccine constructs that contain complete deletions of critical...

Rural School Employees' Status, Awareness, and Perceptions of Adult Vaccinations

ERIC Educational Resources Information Center

Luthy, Karlen E.; Thornton, Eli; Beckstrand, Renea L.; Macintosh, Janelle; Lakin, Richard G.

2013-01-01

As key members of the school environment, it is important for school employees to be vaccinated. Employees are in direct contact with children in close quarters for long periods of time and such an environment can easily serve as an outbreak center for vaccine-preventable communicable diseases such as measles. Despite the fact that most school…

Human papillomavirus vaccine awareness, acceptability, and decision-making factors among Chinese college students.

PubMed

Wang, Shao-Ming; Zhang, Shao-Kai; Pan, Xiong-Fei; Ren, Ze-Fang; Yang, Chun-Xia; Wang, Zeng-Zhen; Gao, Xiao-Hong; Li, Man; Zheng, Quan-Qing; Ma, Wei; Zhao, Fang-Hui; Qiao, You-Lin; Sivasubramaniam, Priya

2014-01-01

College students are recommended as the target groups for catch-up human papillomavirus (HPV) vaccination. Systematical exploration of awareness, acceptability, and decision-making factors of HPV vaccination among Chinese college students has been limited. A multi-center survey was conducted in mainland China between November 2011 and May 2012. College students aged 18-22 years were stratified by their grade, gender, and major for sampling. Socio-demographic and HPV-related information such as knowledge, perceptions, acceptability, and attitudes were collected through a questionnaire. A total of 3,497 undergraduates completed the questionnaire, among which 1,686 were males. The acceptability of the HPV vaccine was high (70.8%). Undergraduates from high-level universities, at lower grade, or with greater prior knowledge of HPV vaccines showed higher acceptability of HPV vaccination (ptrend <0.001). Additionally, undergraduates with vaccination experience outside the National Expanded Program on Immunization (OR=1.29; 95%CI: 1.10-1.51) or fear of HPV-related diseases (OR=2.79; 95%CI: 2.28-3.41) were more willing to accept HPV vaccination. General knowledge of HPV vaccine was low among undergraduates, and safety was a major concern (71.05%). The majority of students wished to pay less than 300RMB for HPV vaccine and chose the Chinese Center for Disease Control and Prevention as the most appropriate venue for vaccination. Although most undergraduates demonstrate positive attitudes towards HPV vaccination, challenges pertaining to introduction exist in China. Corresponding proactive education and governmental subsidy to do so are urgently needed by this age-group population. Suggestions and potential strategies indicated may help shape the future HPV vaccination program in China.

Priorities for CMV vaccine development

PubMed Central

Krause, Philip R.; Bialek, Stephanie R.; Boppana, Suresh B.; Griffiths, Paul D.; Laughlin, Catherine A.; Ljungman, Per; Mocarski, Edward S.; Pass, Robert F.; Read, Jennifer S.; Schleiss, Mark R.; Plotkin, Stanley A.

2015-01-01

A multidisciplinary meeting addressed priorities related to development of vaccines against cytomegalovirus (CMV), the cause of congenital CMV (cCMV) disease and of serious disease in the immunocompromised. Participants discussed optimal uses of a CMV vaccine, aspects of clinical study design, and the value of additional research. A universal childhood CMV vaccine could potentially rapidly reduce cCMV disease, as infected children are sources of viral transmission to seronegative and seropositive mothers. A vaccine administered to adolescents or adult women could also reduce cCMV disease by making them immune prior to pregnancy. Clinical trials of CMV vaccines in women should evaluate protection against cCMV infection, an essential precursor of cCMV disease, which is a more practical and acceptable endpoint for assessing vaccine effects on maternal-fetal transmission. Clinical trials of vaccines to evaluate prevention of CMV disease in stem cell transplant recipients could use CMV viremia at a level triggering preemptive antiviral therapy as an endpoint, because widespread use of preemptive and prophylactic antivirals has rendered CMV-induced disease too rare to be a practical endpoint for clinical trials. In solid organ transplant patients, CMV-associated disease is sufficiently common for use as a primary endpoint. Additional research to advance CMV vaccine development should include identifying factors that predict fetal loss due to CMV, determining age-specific incidence and transmission rates, defining the mechanism and relative contributions of maternal reactivation and re-infection to cCMV disease, developing assays that can distinguish between reactivation and re-infection in seropositive vaccinees, further defining predictors of sequelae from cCMV infection, and identifying clinically relevant immune response parameters to CMV (including developing validated assays that could assess CMV antibody avidity) that could lead to the establishment of immune

Fatal vaccine-induced canine distemper virus infection in black-footed ferrets

USGS Publications Warehouse

Carpenter, J.W.; Appel, M.J.G.; Erickson, R.C.; Novilla, M.N.

1976-01-01

Four black-footed ferrets that were live-trapped in South Dakota and transported to the Patuxent Wildlife Research Center died within 21 days after vaccination with modified live canine distemper virus. Immunofluorescence, European ferret inoculation, virus isolation attempts, and serum-neutralization tests indicated insufficient attenuation of the vaccine for this species.

Fatal vaccine-induced canine distemper virus infection in black-footed ferrets.

PubMed

Carpenter, J W; Appel, M J; Erickson, R C; Novilla, M N

1976-11-01

Four black-footed ferrets that were live-trapped in South Dakota and transported to the Patuxent Wildlife Research Center died within 21 days after vaccination with modified live canine distemper virus. Immunofluorescence, European ferret inoculation, virus isolation attempts, and serum-neutralization tests indicated insufficient attenuation of the vaccine for this species.

Missed opportunities for MMR vaccination among departing U.S. adult travelers receiving pretravel health consultations

PubMed Central

Hyle, Emily P.; Rao, Sowmya R.; Jentes, Emily S.; Fiebelkorn, Amy Parker; Hagmann, Stefan H.F.; Walker, Allison Taylor; Walensky, Rochelle P.; Ryan, Edward T.; LaRocque, Regina C.

2017-01-01

Background Measles outbreaks continue to occur in the United States and are mostly due to infections in returning travelers. Objective We described how providers assessed the measles immunity status of departing U.S. adult travelers seeking pretravel consultation and assessed reasons given for nonvaccination among those considered eligible to receive the measles-mumps-rubella (MMR) vaccine. Design Observational study in U.S. pretravel clinics. Setting 24 sites associated with Global TravEpiNet (GTEN), a Centers for Disease Control and Prevention-funded consortium. Patients Adults (born in or after 1957) attending pre-travel consultations at GTEN sites (2009-2014). Measurements Structured questionnaire completed by traveler and provider during pretravel consultation. Results We included 40,810 adult travelers; providers considered 6,612 (16%) to be eligible for MMR vaccine at the time of pretravel consultation. Of the MMR-eligible, 3,477 (53%) were not vaccinated at the visit; of these, 1,689 (48%) were not vaccinated due to traveler refusal, 966 (28%) due to provider decision, and 822 (24%) due to health systems barriers. Most MMR-eligible travelers who were not vaccinated were evaluated in the South (2,262 travelers, 65%) or at nonacademic centers (1,777 travelers, 51%). Nonvaccination due to traveler refusal was most frequent in the South (1,432 travelers, 63%) or at nonacademic centers (1,178 travelers, 66%). Limitations Our estimates could underrepresent the opportunities for MMR vaccination, as providers accepted verbal histories of disease and vaccination as evidence of immunity. Conclusions Sixteen percent of U.S. adult travelers who presented for pretravel consultation at GTEN sites met criteria for MMR vaccination according to the provider's assessment, but fewer than half of these travelers were vaccinated. An increase in MMR vaccination of eligible U.S. adult travelers could reduce the likelihood of measles importations and transmissions. PMID:28505632

HPV Knowledge and Vaccine Acceptability Among Hispanic Fathers

PubMed Central

Byrne, Margaret M.; Vanderpool, Robin; Shin, Sarah; Kobetz, Erin

2013-01-01

The purpose of this study was to examine human papillomavirus (HPV) knowledge and vaccine acceptability in a convenience sample of immigrant Hispanic men, many of whom are parents of adolescents. Data on 189 male callers were collected from the National Cancer Institute’s Cancer Information Service Spanish-language call center. Most participants were willing to vaccinate their adolescent son (87.5 %) or daughter (78.8 %) against HPV. However, among this sample, awareness of HPV was low and knowledge of key risk factors varied. These findings can help guide the development of culturally informed educational efforts aimed at increasing informed decision-making about HPV vaccination among Hispanic fathers. PMID:23377881

Low vaccine coverage among children born to HIV infected women in Niamey, Niger

PubMed Central

Tchidjou, Hyppolite Kuekou; Vescio, Maria Fenicia; Sanou Sobze, Martin; Souleyman, Animata; Stefanelli, Paola; Mbabia, Adalbert; Moussa, Ide; Gentile, Bruno; Colizzi, Vittorio; Rezza, Giovanni

2016-01-01

Background: The effect of mother’s HIV-status on child vaccination is an important public health issue in countries with high HIV prevalence. We conducted a study in a primary healthcare center located in Niamey, the capital of Niger, which offers free of charge services to HIV positive and/or underprivileged mothers, with the aim of assessing: 1) vaccination coverage for children 0–36 months old, born to HIV-infected mothers, and 2) the impact of maternal HIV status on child vaccination. Methods: Mothers of children less than 36 months old attending the center were interviewed, to collect information on vaccines administered to their child, and family’s socio-demographic characteristics. Results: Overall, 502 children were investigated. Children of HIV-seropositive mothers were less likely to receive follow up vaccinations for Diphtheria-Tetanus-Pertussis (DTP) than those of HIV-seronegative mothers, with a prevalence ratio (PR) of 2.03 (95%CI: 1.58–2.61). Children born to HIV-seropositive mothers were less likely to miss vaccination for MMR than those born to HIV negative mothers, with a RR of 0.46 (95%CI: 0.30–0.72). Conclusions: Vaccine coverage among children born to HIV infected mothers was rather low. It is important to favor access to vaccination programs in this population. PMID:26237156

Immunogenicity and safety of the inactivated Japanese encephalitis vaccine IXIARO® in elderly subjects: Open-label, uncontrolled, multi-center, phase 4 study.

PubMed

Cramer, Jakob P; Dubischar, Katrin; Eder, Susanne; Burchard, Gerd D; Jelinek, Tomas; Jilma, Bernd; Kollaritsch, Herwig; Reisinger, Emil; Westritschnig, Kerstin

2016-08-31

IXIARO® is a Vero cell-derived, inactivated Japanese encephalitis (JE) vaccine licensed mainly in western countries for children and adults traveling to JE endemic areas. Limited immunogenicity and safety data in elderly travelers have been available. To evaluate safety and immunogenicity of IXIARO in elderly subjects. Open-label, single arm, multi-centered study. Two-hundred subjects with good general health, including adequately controlled chronic conditions, received two doses of IXIARO®, 28days apart. Protective levels of antibodies were tested 42days after the second dose. Systemic and local adverse events (AEs) were solicited for 7days after each dose, unsolicited AEs were collected up to day 70 and in a phone call at month 7. Subjects were aged 64-83years (median 69.0years). Nineteen percent of subjects had serious or medically attended AEs up to Day 70 (primary endpoint), none of them causally linked to IXIARO. Solicited local AEs were reported by 33.5% (most common: local tenderness) and solicited systemic AEs by 27% (most common: headache) of subjects. The seroprotection rate was 65% with a geometric mean titre (GMT) of 37. Subjects with tick borne encephalitis (TBE) vaccinations in the past 5years (N=29) had a SCR of 90% and GMT of 65. IXIARO is generally well tolerated in the elderly, and the safety profile is largely comparable with younger adults. SCR and GMT are lower compared to younger adults, but SCR is in the range reported in elderly for other vaccines e.g. against TBE, hepatitis-A virus (HAV)/hepatitis-B virus (HBV), influenza. The differences in SCR and GMT from younger to elderly adults were in the range of other vaccines. Duration of protection is uncertain in older persons, therefore a booster dose (third dose) should be considered before any further exposure to JE virus. Copyright © 2016. Published by Elsevier Ltd.

Pathogenicity of West Nile virus and response to vaccination in sandhill cranes (Grus canadensis) using a killed vaccine.

PubMed

Olsen, Glenn H; Miller, Kimberli J; Docherty, Douglas E; Bochsler, Valerie S; Sileo, Louis

2009-06-01

West Nile virus was introduced into the United States in the vicinity of New York, New York, USA in 1999. The virus has since killed large numbers of birds nationwide, especially, but not limited to, crows (Corvus brachyrhinchos). One sandhill crane (Grus canadensis) at the Bridgeport Zoo (Bridgeport, Connecticut, USA) reportedly died from West Nile virus, so sandhill cranes and endangered whooping cranes (Grus americana), both in the wild and in captive breeding colonies at United States Geological Service (USGS) Patuxent Wildlife Research Center (Laurel, Maryland, USA) were considered at risk. A killed vaccine in sandhill cranes was evaluated by vaccinating and then challenging these cranes with live West Nile virus. No sandhill cranes inoculated with the killed vaccine developed significant titers when compared with unvaccinated controls. No sandhill cranes inoculated with the vaccine and challenged with the virus died from West Nile virus infection. In addition, no unvaccinated challenged sandhill cranes died. However, 2 days postchallenge, vaccinated cranes had significantly less viremia (P < 0.05) than unvaccinated cranes. Seven days postchallenge vaccinated cranes had significantly less cloacal shedding of the virus (P < 0.05) than unvaccinated cranes and significantly less weight loss (P < 0.05) as compared with unvaccinated cranes. Vaccinated sandhill cranes developed significantly higher titers 14 days postchallenge and were viremic for shorter periods of time after challenge than unvaccinated individuals. Unvaccinated challenged cranes had glial cell aggregates in both the brain and brain stem areas, and this was not observed in vaccinated challenged cranes or in vaccinated unchallenged cranes.

Pathogenicity of West Nile virus and response to vaccination in sandhill cranes (Grus canadensis) using a killed vaccine

USGS Publications Warehouse

Olsen, Glenn H.; Miller, Kimberli J.; Docherty, Douglas E.; Shearn-Bochsler, Valerie I.; Sileo, Louis

2009-01-01

West Nile virus was introduced into the United States in the vicinity of New York, New York, USA in 1999. The virus has since killed large numbers of birds nationwide, especially, but not limited to, crows (Corvus brachyrhinchos). One sandhill crane (Grus canadensis) at the Bridgeport Zoo (Bridgeport, Connecticut, USA) reportedly died from West Nile virus, so sandhill cranes and endangered whooping cranes (Grus americana), both in the wild and in captive breeding colonies at United States Geological Service (USGS) Patuxent Wildlife Research Center (Laurel, Maryland, USA) were considered at risk. A killed vaccine in sandhill cranes was evaluated by vaccinating and then challenging these cranes with live West Nile virus. No sandhill cranes inoculated with the killed vaccine developed significant titers when compared with unvaccinated controls. No sandhill cranes inoculated with the vaccine and challenged with the virus died from West Nile virus infection. In addition, no unvaccinated challenged sandhill cranes died. However, 2 days postchallenge, vaccinated cranes had significantly less viremia (P < 0.05) than unvaccinated cranes. Seven days postchallenge vaccinated cranes had significantly less cloacal shedding of the virus (P < 0.05) than unvaccinated cranes and significantly less weight loss (P < 0.05) as compared with unvaccinated cranes. Vaccinated sandhill cranes developed significantly higher titers 14 days postchallenge and were viremic for shorter periods of time after challenge than unvaccinated individuals. Unvaccinated challenged cranes had glial cell aggregates in both the brain and brain stem areas, and this was not observed in vaccinated challenged cranes or in vaccinated unchallenged cranes.

A Randomized Phase II Study of Concurrent Docetaxel Plus Vaccine Versus Vaccine Alone in Metastatic Androgen Independent Prostate Cancer

PubMed Central

Arlen, Philip M.; Gulley, James L.; Parker, Catherine; Skarupa, Lisa; Pazdur, Mary; Panicali, Dennis; Beetham, Patricia; Tsang, Kwong Y.; Grosenbach, Douglas W.; Feldman, Jarett; Steinberg, Seth M.; Jones, Elizabeth; Chen, Clara; Marte, Jennifer; Schlom, Jeffrey; Dahut, William

2006-01-01

Purpose: Docetaxel has activity against androgen insensitive prostate cancer (AIPC) and preclinical studies have demonstrated that taxane-based chemotherapy can enhance antitumor response of vaccines. The primary objective of this study was to determine if concurrent docetaxel (with dexamethasone) had any effect on generating an immune response to the vaccine. Secondary endpoints were whether vaccine could be given safely with docetaxel and the clinical outcome of the treatment regimen. Experimental Design: The vaccination regimen was composed of (1) recombinant vaccinia virus (rV) that expresses the prostate-specific antigen gene (rV-PSA) admixed with (2) rV that expresses the B7.1 costimulatory gene (rV-B7.1), and (3) sequential booster vaccinations with recombinant fowlpox virus (rF-) containing the PSA gene (rF- PSA). Patients received GM-CSF with each vaccination. Twenty-eight patients with metastatic AIPC were randomized to receive either vaccine and weekly docetaxel or vaccine alone. Patients on the vaccine alone arm were allowed to cross over to receive docetaxel alone at time of disease progression. The ELISPOT assay was used to monitor immune responses for PSA-specific T cells. Results: The median increase in these T-cell precursors to PSA was 3.33-fold in both arms following 3 months of therapy. In addition, immune responses to other prostate cancer associated tumor antigens were also detected post-vaccination. Eleven patients who progressed on vaccine alone crossed over to receive docetaxel at time of progression. Median PFS on docetaxel was 6.1 months after receiving vaccine compared with 3.7 months with the same regimen in a historical control. Conclusion: This is the first clinical trial to demonstrate that docetaxel can be administered safely with immunotherapy without inhibiting vaccine specific T-cell responses. Furthermore, patients previously vaccinated with an anticancer vaccine may respond longer to docetaxel compared with a historical control

Alternative vaccine administration by powder injection: Needle-free dermal delivery of the glycoconjugate meningococcal group Y vaccine

PubMed Central

Schiffter, Heiko A.; Carlisle, Robert C.; Rollier, Christine S.; Prud’homme, Robert K.; Pollard, Andrew J.

2017-01-01

Powder-injectors use gas propulsion to deposit lyophilised drug or vaccine particles in the epidermal and sub epidermal layers of the skin. We prepared dry-powder (Tg = 45.2 ± 0.5°C) microparticles (58.1 μm) of a MenY-CRM197 glyconjugate vaccine (0.5% wt.) for intradermal needle-free powder injection (NFPI). SFD used ultrasound atomisation of the liquid vaccine-containing excipient feed, followed by lyophilisation above the glass transition temperature (Tg’ = − 29.9 ± 0.3°C). This resulted in robust particles (density~ 0.53 ±0.09 g/cm3) with a narrow volume size distribution (mean diameter 58.1 μm, and span = 1.2), and an impact parameter (ρvr ~ 11.5 kg/m·s) sufficient to breach the Stratum corneum (sc). The trehalose, manitol, dextran (10 kDa), dextran (150 kDa) formulation, or TMDD (3:3:3:1), protected the MenY-CRM197 glyconjugate during SFD with minimal loss, no detectable chemical degradation or physical aggregation. In a capsular group Y Neisseria meningitidis serum bactericidal assay (SBA) with human serum complement, the needle free vaccine, which contained no alum adjuvant, induced functional protective antibody responses in vivo of similar magnitude to the conventional vaccine injected by hypodermic needle and syringe and containing alum adjuvant. These results demonstrate that needle-free vaccination is both technically and immunologically valid, and could be considered for vaccines in development. PMID:28837693

Effectiveness of Pentavalent Rotavirus Vaccine Under Conditions of Routine Use in Rwanda.

PubMed

Tate, Jacqueline E; Ngabo, Fidele; Donnen, Philippe; Gatera, Maurice; Uwimana, Jeannine; Rugambwa, Celse; Mwenda, Jason M; Parashar, Umesh D

2016-05-01

Rotavirus vaccine efficacy is lower in low-income countries than in high-income countries. Rwanda was one of the first low-income countries in sub-Saharan Africa to introduce rotavirus vaccine into its national immunization program. We sought to evaluate rotavirus vaccine effectiveness (VE) in this setting. VE was assessed using a case-control design. Cases and test-negative controls were children who presented with a diarrheal illness to 1 of 8 sentinel district hospitals and 10 associated health centers and had a stool specimen that tested positive (cases) or negative (controls) for rotavirus by enzyme immunoassay. Due to high vaccine coverage almost immediately after vaccine introduction, the analysis was restricted to children 7-18 weeks of age at time of rotavirus vaccine introduction. VE was calculated as (1 - odds ratio) × 100, where the odds ratio was the adjusted odds ratio for the rotavirus vaccination rate among case-patients compared with controls. Forty-eight rotavirus-positive and 152 rotavirus-negative children were enrolled. Rotavirus-positive children were significantly less likely to have received rotavirus vaccine (33/44 [73%] unvaccinated) compared with rotavirus-negative children (81/136 [59%] unvaccinated) (P= .002). A full 3-dose series was 75% (95% confidence interval [CI], 31%-91%) effective against rotavirus gastroenteritis requiring hospitalization or a health center visit and was 65% (95% CI, -80% to 93%) in children 6-11 months of age and 81% (95% CI, 25%-95%) in children ≥12 months of age. Rotavirus vaccine is effective in preventing rotavirus disease in Rwandan children who began their rotavirus vaccine series from 7 to 18 weeks of age. Protection from vaccination was sustained after the first year of life. Published by Oxford University Press for the Infectious Diseases Society of America 2016. This work is written by (a) US Government employee(s) and is in the public domain in the US.

A physician's reflection on the moral use of human papilloma virus vaccine.

PubMed

Burke, Greg F

2016-08-01

Controversies often surround the use of vaccines, particularly among the pediatric population. Often, the possible temporal relationship between vaccination and subsequent disease is at the center of the controversy. However, others have questioned the moral status of the human papilloma virus (HPV) vaccine because of some instances of state coercion and also the possibility that the vaccine may promote promiscuity. This article addresses the moral status of the HPV vaccine from the perspective of a primary care physician and father of four daughters. Lay Summary: Parents are often asked by pediatricians for permission to vaccinate their children under the age of consent against the sexually transmitted virus HPV. This article addresses the medical and moral concerns about vaccination with some guiding principles to assist in a final decision.

Receipt of Recommended Adolescent Vaccines Among Youth With Special Health Care Needs.

PubMed

McRee, Annie-Laurie; Maslow, Gary R; Reiter, Paul L

2017-05-01

We examined vaccination coverage among youth with special health care needs (YSHCN) using data from parents of adolescents (11-17 years) who responded to a statewide survey in 2010-2012 (n = 2156). Using a validated screening tool, we identified 29% of adolescents as YSHCN. Weighted multivariable logistic regression assessed associations between special health care needs and receipt of tetanus booster, meningococcal, and human papillomavirus (HPV) vaccines. Only 12% of youth had received all 3 vaccines, with greater coverage for individual vaccines (tetanus booster, 91%; meningococcal, 32%; HPV, 26%). YSHCN had greater odds of HPV vaccination than other youth (33% vs 23%, OR = 1.70, 95% CI = 1.16-2.50) but vaccination coverage was similar ( P ≥ .05) for other outcomes. In subgroup analyses, HPV vaccination also differed depending on the number and type of special health care needs identified. Findings highlight low levels of vaccination overall and missed opportunities to administer recommended vaccines among all youth, including YSHCN.

How advances in immunology provide insight into improving vaccine efficacy

PubMed Central

Slifka, Mark K.; Amanna, Ian

2014-01-01

Vaccines represent one of the most compelling examples of how biomedical research has improved society by saving lives and dramatically reducing the burden of infectious disease. Despite the importance of vaccinology, we are still in the early stages of understanding how the best vaccines work and how we can achieve better protective efficacy through improved vaccine design. Most successful vaccines have been developed empirically, but recent advances in immunology are beginning to shed new light on the mechanisms of vaccine-mediated protection and development of long-term immunity. Although natural infection will often elicit lifelong immunity, almost all current vaccines require booster vaccination in order to achieve durable protective humoral immune responses, regardless of whether the vaccine is based on infection with replicating live-attenuated vaccine strains of the specific pathogen or whether they are derived from immunization with inactivated, non-replicating vaccines or subunit vaccines. The form of the vaccine antigen (e.g., soluble or particulate/aggregate) appears to play an important role in determining immunogenicity and the interactions between dendritic cells, B cells and T cells in the germinal center are likely to dictate the magnitude and duration of protective immunity. By learning how to optimize these interactions, we may be able to elicit more effective and long-lived immunity with fewer vaccinations. PMID:24709587

Strategies to advance vaccine technologies for resource-poor settings.

PubMed

Kristensen, Debra; Chen, Dexiang

2013-04-18

New vaccine platform and delivery technologies that can have significant positive impacts on the effectiveness, acceptability, and safety of immunizations in developing countries are increasingly available. Although donor support for vaccine technology development is strong, the uptake of proven technologies by the vaccine industry and demand for them by purchasers continues to lag. This article explains the challenges and opportunities associated with accelerating the availability of innovative and beneficial vaccine technologies to meet critical needs in resource-poor settings over the next decade. Progress will require increased dialog between the public and private sectors around vaccine product attributes; establishment of specifications for vaccines that mirror programmatic needs; stronger encouragement of vaccine developers to consider novel technologies early in the product development process; broader facilitation of research and access to technologies through the formation of centers of excellence; the basing of vaccine purchase decisions on immunization systems costs rather than price per dose alone; possible subsidization of early technology adoption costs for vaccine producers that take on the risks of new technologies of importance to the public sector; and the provision of data to purchasers, better enabling them to make informed decisions that take into account the value of specific product attributes. Copyright © 2012 Elsevier Ltd. All rights reserved.

Immunogenicity and safety of a CRM-conjugated meningococcal ACWY vaccine administered concomitantly with routine vaccines starting at 2 months of age.

PubMed

Nolan, Terry M; Nissen, Michael D; Naz, Aftab; Shepard, Julie; Bedell, Lisa; Hohenboken, Matthew; Odrljin, Tatjana; Dull, Peter M

2014-01-01

Infants are at the highest risk for meningococcal disease and a broadly protective and safe vaccine is an unmet need in this youngest population. We evaluated the immunogenicity and safety of a 4-dose infant/toddler regimen of MenACWY-CRM given at 2, 4, 6, and 12 months of age concomitantly with pentavalent diphtheria-tetanus-acellular pertussis-Hemophilus influenzae type b-inactivated poliovirus-combination vaccine (DTaP-IPV/Hib), hepatitis B vaccine (HBV), 7- or 13-valent conjugate pneumococcal vaccine (PCV), and measles, mumps, and rubella vaccine (MMR). Four doses of MenACWY-CRM induced hSBA titers ≥8 in 89%, 95%, 97%, and 96% of participants against serogroups A, C, W-135, and Y, respectively. hSBA titers ≥8 were present in 76-98% of participants after the first 3 doses. A categorical linear analysis incorporating vaccine group and study center showed responses to routine vaccines administered with MenACWY-CRM were non-inferior to routine vaccines alone, except for seroresponse to the pertussis antigen fimbriae. The reactogenicity profile was not affected when MenACWY-CRM was administered concomitantly with routine vaccines. MenACWY-CRM administered with routine concomitant vaccinations in young infants was well tolerated and induced highly immunogenic responses against each of the serogroups without significant interference with the immune responses to routine infant vaccinations. Healthy 2 month old infants were randomized to receive MenACWY-CRM with routine vaccines (n = 258) or routine vaccines alone (n = 271). Immunogenicity was assessed by serum bactericidal assay using human complement (hSBA). Medically attended adverse events (AEs), serious AEs (SAEs) and AEs leading to study withdrawal were collected throughout the study period.

Understanding reduced rotavirus vaccine efficacy in low socio-economic settings.

PubMed

Lopman, Benjamin A; Pitzer, Virginia E; Sarkar, Rajiv; Gladstone, Beryl; Patel, Manish; Glasser, John; Gambhir, Manoj; Atchison, Christina; Grenfell, Bryan T; Edmunds, W John; Kang, Gagandeep; Parashar, Umesh D

2012-01-01

Rotavirus vaccine efficacy ranges from >90% in high socio-economic settings (SES) to 50% in low SES. With the imminent introduction of rotavirus vaccine in low SES countries, understanding reasons for reduced efficacy in these settings could identify strategies to improve vaccine performance. We developed a mathematical model to predict rotavirus vaccine efficacy in high, middle and low SES based on data specific for each setting on incidence, protection conferred by natural infection and immune response to vaccination. We then examined factors affecting efficacy. Vaccination was predicted to prevent 93%, 86% and 51% of severe rotavirus gastroenteritis in high, middle and low SES, respectively. Also predicted was that vaccines are most effective against severe disease and efficacy declines with age in low but not high SES. Reduced immunogenicity of vaccination and reduced protection conferred by natural infection are the main factors that compromise efficacy in low SES. The continued risk of severe disease in non-primary natural infections in low SES is a key factor underpinning reduced efficacy of rotavirus vaccines. Predicted efficacy was remarkably consistent with observed clinical trial results from different SES, validating the model. The phenomenon of reduced vaccine efficacy can be predicted by intrinsic immunological and epidemiological factors of low SES populations. Modifying aspects of the vaccine (e.g. improving immunogenicity in low SES) and vaccination program (e.g. additional doses) may bring improvements.

Implementing the Customer Contact Center: An Opportunity to Create a Valid Measurement System for Assessing and Improving a Library's Telephone Services

ERIC Educational Resources Information Center

Murphy, Sarah Anne; Cerqua, Judith

2012-01-01

A customer contact center offers academic libraries the ability to consistently improve their telephone, e-mail, and IM services. This paper discusses the establishment of a contact center and the benefits of implementing the contact center model at this institution. It then introduces a practical methodology for developing a valid measurement…

[The history of smallpox vaccination in the Imperial Moscow foster house].

PubMed

Sher, S A

2011-01-01

The article deals with the history of vaccination against natural smallpox which is directly connected to the Imperial Moscow foster house which became one of smallpox vaccination centers in Russia of XIX century. In 1801, when variolations were substituted by more safe cowpox vaccinations, in Russia the first vaccination using the method of Jenner was made exactly in in the Imperial Moscow foster house. From 1805, the smallpox vaccination received the status of force of law, the Imperial Moscow foster house began to produce and to distribute the smallpox vaccine all over the country and apply the smallpox vaccination not only to its foster children but to all turned to and, besides that, to train the smallpox vaccination. In 1857, the Imperial Moscow foster house became the first establishment in Russia where the revaccination was applied. In 1980, the WHO proclaimed that the implementation of the global program of smallpox irradiation resulted in the natural smallpox elimination on Earth. The smallpox became the first communicable disease defeated due to mass vaccination. One third of Earth population was vaccinated by the Soviet vaccine, which originated mainly because of the activities of physicians of the Imperial Moscow foster house.

Immunisation coverage of adults: a vaccination counselling campaign in the pharmacies in Switzerland.

PubMed

Valeri, Fabio; Hatz, Christoph; Jordan, Dominique; Leuthold, Claudine; Czock, Astrid; Lang, Phung

2014-01-01

To assess vaccination coverage for adults living in Switzerland. Through a media campaign, the general population was invited during 1 month to bring their vaccination certificates to the pharmacies to have their immunisation status evaluated with the software viavac©, and to complete a questionnaire. A total of 496 pharmacies in Switzerland participated in the campaign, of which 284 (57%) submitted valid vaccination information. From a total of 3,634 participants in the campaign, there were 3,291 valid cases (participants born ≤ 1992) and 1,011 questionnaires completed. Vaccination coverage for the participants was 45.9% and 34.6% for five and six doses of diphtheria, 56.4% and 44.0% for tetanus and 66.3% and 48.0% for polio, respectively. Coverage estimates for one and two doses of measles vaccine were 76.5% and 49.4%, respectively, for the birth cohort 1967-1992 and 4.0% and 0.8%, respectively, for the cohort ≤ 1966. There was a significant difference in coverage for most vaccinations between the two aforementioned birth cohorts. A plot of the measles vaccine coverage over time shows that the increase in coverage correlated with policy changes in the Swiss Immunisation Schedule. Despite selection bias and low participation, this study indicates that vaccination coverage for the basic recommended immunisations in the adult population in Switzerland is suboptimal. More efforts using various means and methods are needed to increase immunisation coverage in adolescents before they leave school. An established method to determine vaccination coverage for the general population could provide invaluable insights into the effects of changes in vaccination policies and disease outbreaks.

In silico design of Mycobacterium tuberculosis epitope ensemble vaccines.

PubMed

Shah, Preksha; Mistry, Jaymisha; Reche, Pedro A; Gatherer, Derek; Flower, Darren R

2018-05-01

Effective control of Mycobacterium tuberculosis is a global necessity. In 2015, tuberculosis (TB) caused more deaths than HIV. Considering the increasing prevalence of multi-drug resistant forms of M. tuberculosis, the need for effective TB vaccines becomes imperative. Currently, the only licensed TB vaccine is Bacillus Calmette-Guérin (BCG). Yet, BCG has many drawbacks limiting its efficacy and applicability. We applied advanced computational procedures to derive a universal TB vaccine and one targeting East Africa. Our approach selects an optimal set of highly conserved, experimentally validated epitopes, with high projected population coverage (PPC). Through rigorous data analysis, five different potential vaccine combinations were selected each with PPC above 80% for East Africa and above 90% for the World. Two potential vaccines only contained CD8+ epitopes, while the others included both CD4+ and CD8+ epitopes. Our prime vaccine candidate was a putative seven-epitope ensemble comprising: SRGWSLIKSVRLGNA, KPRIITLTMNPALDI, AAHKGLMNIALAISA, FPAGGSTGSL, MLLAVTVSL, QSSFYSDW and KMRCGAPRY, with a 97.4% global PPC and a 92.7% East African PPC. Copyright © 2018 Elsevier Ltd. All rights reserved.

Tetanus, Diphtheria, and Pertussis Vaccines - Multiple Languages

MedlinePlus

... Kreyol ayisyen) Hmong (Hmoob) Ilocano (ilokano) Indonesian (Bahasa Indonesia) Japanese (日本語) Karen (S’gaw Karen) Khmer (ភាសា ... Centers for Disease Control and Prevention Indonesian (Bahasa Indonesia) Expand Section Vaccine Information Statement (VIS) -- Tdap (Tetanus, ...

Predicting the impact of measles vaccination in England and Wales: model validation and analysis of policy options.

PubMed Central

Babad, H. R.; Nokes, D. J.; Gay, N. J.; Miller, E.; Morgan-Capner, P.; Anderson, R. M.

1995-01-01

Measles incidence in England and Wales has fallen to an all-time low. Attention is now focused on preventing local outbreaks, and, in the long run, on the elimination of indigenous measles. A realistic age-structured (RAS) mathematical model of measles transmission is used to reconstruct the impact of measles vaccination in England and Wales from 1968 to the present and to evaluate the merits of future policy options. In general, the predictions of the model show good agreement with long-term age stratified case reports and seroprevalence surveys. The model underestimates the proportion of cases that are notified in 0-2-year-old children. However, recent work suggests a high degree of misdiagnosis in this age group. Projections on the basis of the existing vaccination strategy in the UK suggest that the present level of measles vaccine coverage will be insufficient to eliminate small seasonal outbreaks of measles. This result is, however, sensitive to the assumed level of vaccine efficacy. Explorations of a variety of changes to current vaccination strategy favour a 2-dose schedule with the second dose administered at age 4 years irrespective of vaccination history. A vaccination campaign in school-age children, to reduce deficits in herd immunity, would accelerate progress towards measles elimination. PMID:7705494

Predicting the impact of measles vaccination in England and Wales: model validation and analysis of policy options.

PubMed

Babad, H R; Nokes, D J; Gay, N J; Miller, E; Morgan-Capner, P; Anderson, R M

1995-04-01

Measles incidence in England and Wales has fallen to an all-time low. Attention is now focused on preventing local outbreaks, and, in the long run, on the elimination of indigenous measles. A realistic age-structured (RAS) mathematical model of measles transmission is used to reconstruct the impact of measles vaccination in England and Wales from 1968 to the present and to evaluate the merits of future policy options. In general, the predictions of the model show good agreement with long-term age stratified case reports and seroprevalence surveys. The model underestimates the proportion of cases that are notified in 0-2-year-old children. However, recent work suggests a high degree of misdiagnosis in this age group. Projections on the basis of the existing vaccination strategy in the UK suggest that the present level of measles vaccine coverage will be insufficient to eliminate small seasonal outbreaks of measles. This result is, however, sensitive to the assumed level of vaccine efficacy. Explorations of a variety of changes to current vaccination strategy favour a 2-dose schedule with the second dose administered at age 4 years irrespective of vaccination history. A vaccination campaign in school-age children, to reduce deficits in herd immunity, would accelerate progress towards measles elimination.

Experimental program for real gas flow code validation at NASA Ames Research Center

NASA Technical Reports Server (NTRS)

Deiwert, George S.; Strawa, Anthony W.; Sharma, Surendra P.; Park, Chul

1989-01-01

The experimental program for validating real gas hypersonic flow codes at NASA Ames Rsearch Center is described. Ground-based test facilities used include ballistic ranges, shock tubes and shock tunnels, arc jet facilities and heated-air hypersonic wind tunnels. Also included are large-scale computer systems for kinetic theory simulations and benchmark code solutions. Flight tests consist of the Aeroassist Flight Experiment, the Space Shuttle, Project Fire 2, and planetary probes such as Galileo, Pioneer Venus, and PAET.

Local health department 2009 H1N1 influenza vaccination clinics-CDC staffing model comparison and other best practices.

PubMed

Porter, Dayna; Hall, Mark; Hartl, Brian; Raevsky, Cathy; Peacock, Roberta; Kraker, David; Walls, Sandra; Brink, Gail

2011-01-01

Mass vaccination clinic staffing models, such as the Centers for Disease Control and Prevention Large-Scale Vaccination Clinic Output and Staff Estimates: An Example, provide guidance on appropriate roles and number of staff for successful mass vaccination clinics within local and state health departments. The Kent County Health Department used this model as a starting point for mass vaccination clinics in response to 2009 H1N1 influenza. In addition to discussion of successful modification of the Centers for Disease Control and Prevention model to maximize local health department mass vaccination clinic efficiency, additional best practices including use of the Incident Command System and a reservation system are provided. Use of the provided modified staffing model and additional best practices will increase the success of health department mass vaccination clinics, and should be considered not only for future public health emergencies, but also for seasonal influenza vaccination campaigns.

Psychosocial Correlates of Intention to Receive an Influenza Vaccination among Rural Adolescents

ERIC Educational Resources Information Center

Painter, Julia E.; Sales, Jessica M.; Pazol, Karen; Wingood, Gina M.; Windle, Michael; Orenstein, Walter A.; Diclemente, Ralph J.

2010-01-01

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recently expanded annual influenza vaccination recommendations to include all children 6 months through 18 years of age. Adolescent attitudes toward influenza vaccination may play a key role in reaching this newly added age group. This study examined the…

[Vaccination schedule of the Spanish Association of Pediatrics: recommendations 2006].

PubMed

2006-01-01

Based on the evidence available, the Vaccines Advisory Committee (VAC) of the Spanish Association of Pediatrics reports and comments on the new developments in vaccines that have taken place in 2005 and recommends some modifications to the vaccination schedule for 2006. In agreement with changes in the product monographs for the meningococcal C vaccine, the VAC recommends two doses for the three commercially available preparations with a booster dose in the second year of life. The European Medicines Evaluation Agency (EMEA) has temporarily suspended the sale of the Hexavac vaccine due to doubts about its long-term protection against hepatitis B. The VAC continues to support the use of these combined vaccines. Currently only Infranrix Hexa is available in Spain. The recommendation of vaccinating adolescents with a booster dose of pertussis vaccine via the administration of an acellular preparation of low antigenic load together with the adult diphtheria and tetanus vaccine remains valid. Vaccination against chickenpox in susceptible children aged more than 12 months old continues to be recommended. There is wide coverage for the 7-valent pneumococcal conjugate vaccine in many areas of Spain. In view of the studies published, the VAC reiterates the need for universal immunization by introducing this vaccine in the official vaccination schedule. Finally, other vaccines not included in this schedule are discussed, with special mention of the advisability of influenza vaccination in children, according to the recommendations of the VAC available at the beginning of each season on the web site of the Spanish Association of Pediatrics www.aeped.es; www. vacunasaep.org.

Vaccines Cold Chain Monitoring: A Cross Sectional Study at Three District In Indonesia

NASA Astrophysics Data System (ADS)

Saraswati, L. D.; Ginandjar, P.; Budiyono; Martini; Udiyono, A.; Kairul

2018-02-01

Vaccine cold chain is a procedure that is used to keep vaccines at a certain temperature. The aim was to describe the vaccine cold chain management of basic immunization program in health centers district. The study design descriptive observational. The samples was Health Centers (HCs); 12 HCs in Sarolangun Jambi Province, 16 HCs in Brebes Central Java Province, and 24 HCs in Temanggung Central Java Provice. Basic immunization vaccines were BCG, DPT-HB-HIB, Polio, and Measles. The results showed proportion of officers graduated from college in Sorolangun, Brebes, and Temanggung were 66.7%, 81.3%, and 52.0% respectively. Proportion of HC that did not have thermometer and fridge freeze was mostly found in Temanggung (52%) and in Sorolangun (91.7%). The heat-sensitive vaccines arranged near the evaporator mostly found in Temanggung (88%), while freeze-sensitive vaccines prepared away of the evaporator mostly in Brebes (100%). Freezer temperature recording chart is not available mostly found in Sorolangun and Brebes (50%), In Sorolangun 41.7% of the officers monitoring 2 times a day and mostly (91.7%) the refrigerator thermostat tape was not isolated. The officers did not perform daily maintenance (50%), weekly (66.7%), and montly (33.3%) mostly found in Sorolangun. From this study we can conclude there is no vaccine immunization program management in Sarolangun, Brebes, and Temanggung that managed according to Ministry of Health Regulations number 42/2013 on the Implementation of immunization. Improvement oversight, control over management of vaccine and management personal, also managing the temperature of the vaccine were recommended.

Tuberculin reactivity in Bacillus Calmette-Guérin vaccinated subjects.

PubMed

Miret-Cuadras, P; Pina-Gutierrez, J M; Juncosa, S

1996-02-01

The Centre for Prevention and Control of Tuberculosis in Barcelona, Spain, where the staff appointed to Training Centers are examined. To check for tuberculin sensitivity due to Bacillus Calmette-Guérin (BCG) vaccine and ascertain its duration. We compared the results of a tuberculin test (TT) on vaccinated and non-vaccinated subjects. The induration diameter and the time elapsed between BCG vaccination and the TT were determined. Of the 2424 vaccinated subjects, 1489 (61.4%) reacted to TT (> or = 5 mm) and of the 3135 non-vaccinated, 905 (28.9%) reacted, a significant difference. Of 1978 subjects vaccinated between 6 and 14 years of age, 63.3% were TT reactors, compared to 23.9% of the 1948 non-vaccinated. Induration diameters > or = 15 mm amounted to 11% for vaccinated subjects and 8% for those not vaccinated, a significant difference. The time from vaccination to TT was 13-25 years. Of the 446 subjects vaccinated at birth, 237 were reactors (53.1%); of the 887 non-vaccinated subjects of the same age, 154 (17.4%) reacted. Reactors > or = 15 mm amounted to 40 (9%) for vaccinated subjects and 46 for non-vaccinated (5.2%), a significant difference. The time elapsed between vaccination and TT was 20-25 years. For 124 vaccinated subjects with a previous negative TT, a second test was positive for 87 (70.2%), and for 257 non-vaccinated it was positive for 64 (24.9%). The difference is due to a booster effect. BCG vaccination at birth and for school age children causes a reactivity to tuberculin which persists for 20 to 25 years. An induration diameter of > or = 15 mm does not exclude a vaccinal origin. For vaccinated subjects with a previous negative TT, it is necessary to exclude the booster effect.

Vaccinating parents experience vaccine anxiety too.

PubMed

Luthy, Karlen E; Beckstrand, Renea L; Asay, Whitney; Hewett, Carly

2013-12-01

To identify common causes of parental anxiety regarding childhood vaccinations among parents who vaccinate. Another purpose was to seek recommendations for healthcare providers to help parents overcome their anxiety when their children are immunized. Four 1-h focus groups were conducted, each consisting of 8-10 parents. Each focus group discussion was conducted by a moderator and an assistant moderator. The moderator facilitated discussion while the assistant moderator took notes. Each session was recorded on video. The data were transcribed and analyzed for themes. Parents identifying themselves as being compliant with childhood vaccination requirements reported anxiety that can be divided into five major themes: parental anxiety prior to vaccination, parental anxiety during the vaccination, parental anxiety after the vaccination, parental suggestions for healthcare providers, and informational issues. Making minor changes in office policies may help alleviate some parental anxiety regarding vaccinations. Providers should also create lists of credible sources about vaccination information. Because the cause of vaccine-related parental anxiety varies, targeted education is necessary to relieve common causes of vaccine anxiety, even among parents who vaccinate. ©2013 The Author(s) ©2013 American Association of Nurse Practitioners.

The vaccines consistency approach project: an EPAA initiative.

PubMed

De Mattia, F; Hendriksen, C; Buchheit, K H; Chapsal, J M; Halder, M; Lambrigts, D; Redhead, K; Rommel, E; Scharton-Kersten, T; Sesardic, T; Viviani, L; Ragan, I

2015-01-01

The consistency approach for release testing of established vaccines promotes the use of in vitro, analytical, non-animal based systems allowing the monitoring of quality parameters during the whole production process. By using highly sensitive non-animal methods, the consistency approach has the potential to improve the quality of testing and to foster the 3Rs (replacement, refinement and reduction of animal use) for quality control of established vaccines. This concept offers an alternative to the current quality control strategy which often requires large numbers of laboratory animals. In order to facilitate the introduction of the consistency approach for established human and veterinary vaccine quality control, the European Partnership for Alternatives to Animal Testing (EPAA) initiated a project, the "Vaccines Consistency Approach Project", aiming at developing and validating the consistency approach with stakeholders from academia, regulators, OMCLs, EDQM, European Commission and industry. This report summarises progress since the project's inception.

Evaluation of novel oral vaccine candidates and validation of a caprine model of Johne's disease

USDA-ARS?s Scientific Manuscript database

A Mycobacterium avium subspecies paratuberculosis (MAP) vaccine that reduced the incidence of clinical disease and/or reduced fecal shedding of MAP would aid control of Johne’s disease (JD). The objectives of this study were 1) to evaluate the efficacy of 5 attenuated strains of MAP as vaccine candi...

Vaccine decision-making begins in pregnancy: Correlation between vaccine concerns, intentions and maternal vaccination with subsequent childhood vaccine uptake.

PubMed

Danchin, M H; Costa-Pinto, J; Attwell, K; Willaby, H; Wiley, K; Hoq, M; Leask, J; Perrett, K P; O'Keefe, Jacinta; Giles, M L; Marshall, H

2017-08-12

Maternal and childhood vaccine decision-making begins prenatally. Amongst pregnant Australian women we aimed to ascertain vaccine information received, maternal immunisation uptake and attitudes and concerns regarding childhood vaccination. We also aimed to determine any correlation between a) intentions and concerns regarding childhood vaccination, (b) concerns about pregnancy vaccination, (c) socioeconomic status (SES) and (d) uptake of influenza and pertussis vaccines during pregnancy and routine vaccines during childhood. Women attending public antenatal clinics were recruited in three Australian states. Surveys were completed on iPads. Follow-up phone surveys were done three to six months post delivery, and infant vaccination status obtained via the Australian Childhood Immunisation Register (ACIR). Between October 2015 and March 2016, 975 (82%) of 1184 mothers consented and 406 (42%) agreed to a follow up survey, post delivery. First-time mothers (445; 49%) had significantly more vaccine concerns in pregnancy and only 73% had made a decision about childhood vaccination compared to 89% of mothers with existing children (p-value<0.001). 66% of mothers reported receiving enough information during pregnancy on childhood vaccination. In the post delivery survey, 46% and 82% of mothers reported receiving pregnancy influenza and pertussis vaccines respectively. The mother's degree of vaccine hesitancy and two attitudinal factors were correlated with vaccine uptake post delivery. There was no association between reported maternal vaccine uptake or SES and childhood vaccine uptake. First time mothers are more vaccine hesitant and undecided about childhood vaccination, and only two thirds of all mothers believed they received enough information during pregnancy. New interventions to improve both education and communication on childhood and maternal vaccines, delivered by midwives and obstetricians in the Australian public hospital system, may reduce vaccine hesitancy

Validity of the Modified Child Psychopathy Scale for Juvenile Justice Center Residents.

PubMed

Verschuere, Bruno; Candel, Ingrid; Van Reenen, Lique; Korebrits, Andries

2012-06-01

Adult psychopathy has proven to be an important clinical and forensic construct, but much less is known about juvenile psychopathy. In the present study, we examined the construct validity of the self report modified Child Psychopathy Scale mCPS; Lynam (Psychological Bulletin 120:(2), 209-234, 1997) in a sample of 57 adolescents residing in a Dutch juvenile justice center, aged between 13 and 22 years. The mCPS total score was reliably related to high externalizing problems, low empathy, high anger and aggression, high impulsivity, high (violent) delinquency, and high alcohol/drug use. Unique relations were found for the antisocial-impulsive (mCPS Factor 2), but not the callous-unemotional facet of psychopathy (mCPS Factor 1). Our findings support the validity of the mCPS in that it encompasses the antisocial-impulsive facet of psychopathy, but it is less clear whether the mCPS sufficiently captures the affective-interpersonal facet of psychopathy.

Developing VISO: Vaccine Information Statement Ontology for patient education.

PubMed

Amith, Muhammad; Gong, Yang; Cunningham, Rachel; Boom, Julie; Tao, Cui

2015-01-01

To construct a comprehensive vaccine information ontology that can support personal health information applications using patient-consumer lexicon, and lead to outcomes that can improve patient education. The authors composed the Vaccine Information Statement Ontology (VISO) using the web ontology language (OWL). We started with 6 Vaccine Information Statement (VIS) documents collected from the Centers for Disease Control and Prevention (CDC) website. Important and relevant selections from the documents were recorded, and knowledge triples were derived. Based on the collection of knowledge triples, the meta-level formalization of the vaccine information domain was developed. Relevant instances and their relationships were created to represent vaccine domain knowledge. The initial iteration of the VISO was realized, based on the 6 Vaccine Information Statements and coded into OWL2 with Protégé. The ontology consisted of 132 concepts (classes and subclasses) with 33 types of relationships between the concepts. The total number of instances from classes totaled at 460, along with 429 knowledge triples in total. Semiotic-based metric scoring was applied to evaluate quality of the ontology.

Immunogenicity and safety of a CRM-conjugated meningococcal ACWY vaccine administered concomitantly with routine vaccines starting at 2 months of age

PubMed Central

Nolan, Terry M; Nissen, Michael D; Naz, Aftab; Shepard, Julie; Bedell, Lisa; Hohenboken, Matthew; Odrljin, Tatjana; Dull, Peter M

2014-01-01

Background: Infants are at the highest risk for meningococcal disease and a broadly protective and safe vaccine is an unmet need in this youngest population. We evaluated the immunogenicity and safety of a 4-dose infant/toddler regimen of MenACWY-CRM given at 2, 4, 6, and 12 months of age concomitantly with pentavalent diphtheria-tetanus-acellular pertussis-Hemophilus influenzae type b-inactivated poliovirus-combination vaccine (DTaP-IPV/Hib), hepatitis B vaccine (HBV), 7- or 13-valent conjugate pneumococcal vaccine (PCV), and measles, mumps, and rubella vaccine (MMR). Results: Four doses of MenACWY-CRM induced hSBA titers ≥8 in 89%, 95%, 97%, and 96% of participants against serogroups A, C, W-135, and Y, respectively. hSBA titers ≥8 were present in 76–98% of participants after the first 3 doses. A categorical linear analysis incorporating vaccine group and study center showed responses to routine vaccines administered with MenACWY-CRM were non-inferior to routine vaccines alone, except for seroresponse to the pertussis antigen fimbriae. The reactogenicity profile was not affected when MenACWY-CRM was administered concomitantly with routine vaccines. Conclusion: MenACWY-CRM administered with routine concomitant vaccinations in young infants was well tolerated and induced highly immunogenic responses against each of the serogroups without significant interference with the immune responses to routine infant vaccinations. Methods: Healthy 2 month old infants were randomized to receive MenACWY-CRM with routine vaccines (n = 258) or routine vaccines alone (n = 271). Immunogenicity was assessed by serum bactericidal assay using human complement (hSBA). Medically attended adverse events (AEs), serious AEs (SAEs) and AEs leading to study withdrawal were collected throughout the study period. PMID:24220326

Vaccine coverage and determinants of incomplete vaccination in children aged 12-23 months in Dschang, West Region, Cameroon: a cross-sectional survey during a polio outbreak.

PubMed

Russo, Gianluca; Miglietta, Alessandro; Pezzotti, Patrizio; Biguioh, Rodrigue Mabvouna; Bouting Mayaka, Georges; Sobze, Martin Sanou; Stefanelli, Paola; Vullo, Vincenzo; Rezza, Giovanni

2015-07-10

distance from the vaccination centers was marginally significant (p = 0.05). Vaccination coverage was high; however, 1 out of 7 children was partially vaccinated, and 1 out of 4 did not complete timely the recommended vaccinations. In order to improve the immunization coverage, it is necessary to strengthen ANC services, and to improve parents' information and attitude towards immunization, targeting younger parents and families living far away from vaccination centers, using appropriate communication strategies. Finally, the estimated OPV-3 coverage is reassuring in relation to the ongoing polio outbreak.

Differential misclassification between self-reported status and official HPV vaccination records in Japan: Implications for evaluating vaccine safety and effectiveness.

PubMed

Yamaguchi, Manako; Sekine, Masayuki; Kudo, Risa; Adachi, Sosuke; Ueda, Yutaka; Miyagi, Etsuko; Hara, Megumi; Hanley, Sharon J B; Enomoto, Takayuki

2018-05-25

Japan has no national vaccine registry and approximately 1700 municipalities manage the immunization records independently. In June 2013, proactive recommendations for the human papillomavirus (HPV) vaccine were suspended after unconfirmed reports of adverse events following immunization in the media, despite no vaccine safety signal having been raised. Furthermore, studies assessing HPV vaccine safety and effectiveness published post suspension are predominantly based on self-reported information. Our aim was to examine the accuracy of self-reported vaccination status compared with official municipal records. Participants were women aged 20-22 yrs, who were attending for cervical screening in Niigata city. Among the 1230 eligible registrants, vaccine uptake, defined as any dose, was 75.0% and 77.2% according to a self-reported questionnaire and municipal records, respectively. The accuracy rate of self-reported information was as follows: positive predictive value (PPV) was 87.7%; negative predictive value (NPV) was 54.5%; sensitivity was 85.2%; and specificity was 59.8%. The validity of self-reported information was only moderate (Kappa statistic = 0.44, 95% confidence interval 0.37-0.50). This combined with the low NPV may lead to reduced estimation of effectiveness and safety. A more reliable method, such as a national HPV vaccine registry, needs to be established for assessing HPV immunization status in Japan. Copyright © 2018. Published by Elsevier B.V.

Validity of a reported history of chickenpox in targeting varicella vaccination at susceptible adolescents in England☆

PubMed Central

Field, Nigel; Amirthalingam, Gayatri; Waight, Pauline; Andrews, Nick; Ladhani, Shamez N.; van Hoek, Albert Jan; Maple, Peter A.C.; Brown, Kevin E.; Miller, Elizabeth

2014-01-01

Introduction In the UK, primary varicella is usually a mild infection in children, but can cause serious illness in susceptible pregnant women and adults. The UK Joint Committee on Vaccination and Immunisation is considering an adolescent varicella vaccination programme. Cost-effectiveness depends upon identifying susceptibles and minimising vaccine wastage, and chickenpox history is one method to screen for eligibility. To inform this approach, we estimated the proportion of adolescents with varicella antibodies by reported chickenpox history. Methods Recruitment occurred through secondary schools in England from February to September 2012. Parents were asked about their child's history of chickenpox, explicitly setting the context in terms of the implications for vaccination. 247 adolescents, whose parents reported positive (120), negative (77) or uncertain (50) chickenpox history provided oral fluid for varicella zoster virus-specific immunoglobulin-G (VZV-IgG) testing. Results 109 (90.8% [85.6–96.0%]) adolescents with a positive chickenpox history, 52 (67.5% [57.0–78.1%]) with a negative history and 42 (84.0% [73.7–94.3%]) with an uncertain history had VZV-IgG suggesting prior infection. Combining negative and uncertain histories, 74% had VZV-IgG (best-case). When discounting low total-IgG samples and counting equivocals as positive (worst-case), 84% had VZV-IgG. We also modelled outcomes by varying the negative predictive value (NPV) for the antibody assay, and found 74–87% under the best-case and 84–92% under the worst-case scenario would receive vaccine unnecessarily as NPV falls to 50%. Conclusion Reported chickenpox history discriminates between varicella immunity and susceptibility in adolescents, but significant vaccine wastage would occur if this approach alone were used to determine vaccine eligibility. A small but important proportion of those with positive chickenpox history would remain susceptible. These data are needed to determine

Validity of a reported history of chickenpox in targeting varicella vaccination at susceptible adolescents in England.

PubMed

Field, Nigel; Amirthalingam, Gayatri; Waight, Pauline; Andrews, Nick; Ladhani, Shamez N; van Hoek, Albert Jan; Maple, Peter A C; Brown, Kevin E; Miller, Elizabeth

2014-02-26

In the UK, primary varicella is usually a mild infection in children, but can cause serious illness in susceptible pregnant women and adults. The UK Joint Committee on Vaccination and Immunisation is considering an adolescent varicella vaccination programme. Cost-effectiveness depends upon identifying susceptibles and minimising vaccine wastage, and chickenpox history is one method to screen for eligibility. To inform this approach, we estimated the proportion of adolescents with varicella antibodies by reported chickenpox history. Recruitment occurred through secondary schools in England from February to September 2012. Parents were asked about their child's history of chickenpox, explicitly setting the context in terms of the implications for vaccination. 247 adolescents, whose parents reported positive (120), negative (77) or uncertain (50) chickenpox history provided oral fluid for varicella zoster virus-specific immunoglobulin-G (VZV-IgG) testing. 109 (90.8% [85.6-96.0%]) adolescents with a positive chickenpox history, 52 (67.5% [57.0-78.1%]) with a negative history and 42 (84.0% [73.7-94.3%]) with an uncertain history had VZV-IgG suggesting prior infection. Combining negative and uncertain histories, 74% had VZV-IgG (best-case). When discounting low total-IgG samples and counting equivocals as positive (worst-case), 84% had VZV-IgG. We also modelled outcomes by varying the negative predictive value (NPV) for the antibody assay, and found 74-87% under the best-case and 84-92% under the worst-case scenario would receive vaccine unnecessarily as NPV falls to 50%. Reported chickenpox history discriminates between varicella immunity and susceptibility in adolescents, but significant vaccine wastage would occur if this approach alone were used to determine vaccine eligibility. A small but important proportion of those with positive chickenpox history would remain susceptible. These data are needed to determine whether reported history, with or without oral fluid

Influenza vaccine acceptance among pregnant women in urban slum areas, Karachi, Pakistan.

PubMed

Khan, Afshin Alaf; Varan, Aiden Kennedy; Esteves-Jaramillo, Alejandra; Siddiqui, Mariam; Sultana, Shazia; Ali, Asad S; Zaidi, Anita K M; Omer, Saad B

2015-09-22

Facilitators and barriers to influenza vaccination among pregnant women in the developing world are poorly understood, particularly in South Asia. We assessed intention to accept influenza vaccine among ethnically diverse low-income pregnant women in Pakistan. From May to August 2013, we conducted a cross-sectional survey of pregnant women who visited health centers in urban slums in Karachi city. We assessed intention to accept influenza vaccine against socio-demographic factors, vaccination history, vaccine recommendation sources, and other factors. In an unvaccinated study population of 283 respondents, 87% were willing to accept the vaccine, if offered. All except two participants were aware of symptoms typically associated with influenza. Perceived vaccine safety, efficacy, and disease susceptibility were significantly associated with intention to accept influenza vaccine (p<0.05). Regardless of intention to accept influenza vaccine, 96% rated healthcare providers as highly reliable source of vaccine information. While a recommendation from a physician was critical for influenza vaccine acceptance, parents-in-law and husbands were often considered the primary decision-makers for pregnant women seeking healthcare including vaccination. Maternal influenza vaccination initiatives in South Asia should strongly consider counseling of key familial decision-makers and inclusion of healthcare providers to help implement new vaccination programs. Copyright © 2015 Elsevier Ltd. All rights reserved.

A Multi-Center, Qualitative Assessment of Pediatrician and Maternal Perspectives on Rotavirus Vaccines and the Detection of Porcine circovirus

PubMed Central

2011-01-01

Background In 2010, researchers using novel laboratory techniques found that US-licensed rotavirus vaccines contain DNA or DNA fragments from Porcine circovirus (PCV), a virus common among pigs but not believed to cause illness in humans. We sought to understand pediatricians' and mothers' perspectives on this finding. Methods We conducted three iterations of focus groups for pediatricians and non-vaccine hesitant mothers in Seattle, WA, Cincinnati, OH, and Rochester, NY. Focus groups explored perceptions of rotavirus disease, rotavirus vaccination, and attitudes about the detection of PCV material in rotavirus vaccines. Results Pediatricians understood firsthand the success of rotavirus vaccines in preventing severe acute gastroenteritis among infants and young children. They measured this benefit against the theoretical risk of DNA material from PCV in rotavirus vaccines, determining overall that the PCV finding was of no clinical significance. Particularly influential was the realization that the large, randomized clinical trials that found both vaccines to be highly effective and safe were conducted with DNA material from PCV already in the vaccines. Most mothers supported the ideal of full disclosure regarding vaccination risks and benefits. However, with a scientific topic of this complexity, simplified information regarding PCV material in rotavirus vaccines seemed frightening and suspicious, and detailed information was frequently overwhelming. Mothers often remarked that if they did not understand a medical or technical topic regarding their child's health, they relied on their pediatrician's guidance. Many mothers and pediatricians were also concerned that persons who abstain from pork consumption for religious or personal reasons may have unsubstantiated fears of the PCV finding. Conclusions Pediatricians considered the detection of DNA material from PCV in rotavirus vaccines a "non-issue" and reported little hesitation in continuing to recommend the

Human papillomavirus vaccines and vaccine implementation.

PubMed

de Sanjosé, Silvia; Alemany, Laia; Castellsagué, Xavier; Bosch, F Xavier

2008-11-01

Countries are now challenged by the rapid development of vaccines aimed at the primary prevention of infections. In the years to come, several vaccines will need to be considered as potential candidates in routine immunization programs. Recently, two new vaccines against two/four types of human papillomavirus (HPV) have been commercialized. Bivalent HPV 16 and 18 (Cervarix) and quadrivalent HPV 6, 11, 16 and 18 (Gardasil) vaccines are now extensively used in some countries. These vaccines will prevent infection and long-running complications, such as cervical cancer, other HPV-related cancers and genital warts (for the quadrivalent vaccine). The beneficial effect of these vaccines will be largely observed in women. This article summarizes the burden of HPV preventable disease worldwide and briefly describes the impact of secondary prevention and the most relevant aspects of the current available vaccines, their efficacy and safety. Finally, some major aspects that are likely to impact the introduction of these vaccines around the world are outlined, with particular emphasis on developing countries.

Emergency Preparedness in the Workplace: The Flulapalooza Model for Mass Vaccination

PubMed Central

Aliyu, Muktar H.; Byrne, Daniel W.; Qian, Keqin; McGown, Paula; Kinman, Patricia O.; Hanson, Katherine Louise; Culpepper, Demoyne; Cooley, Tamara J.; Yarbrough, Mary I.

2017-01-01

Objectives. To explore whether an emergency preparedness structure is a feasible, efficient, and sustainable way for health care organizations to manage mass vaccination events. Methods. We used the Hospital Incident Command System to conduct a 1-day annual mass influenza vaccination event at Vanderbilt University Medical Center over 5 successive years (2011–2015). Using continuous quality improvement principles, we assessed whether changes in layout, supply management, staffing, and documentation systems improved efficiency. Results. A total of 66 591 influenza vaccines were administered at 5 annual Flulapalooza events; 13 318 vaccines per event on average. Changes to the physical layout, staffing mix, and documentation processes improved vaccination efficiency 74%, from approximately 38 to 67 vaccines per hour per vaccinator, while reducing overall staffing needs by 38%. An unexpected finding was the role of social media in facilitating active engagement. Conclusions. Health care organizations can use a closed point-of-dispensing model and Hospital Incident Command System to conduct mass vaccination events, and can adopt the “Flulapalooza method” as a best practice model to enhance efficiency. PMID:28892449

Emergency Preparedness in the Workplace: The Flulapalooza Model for Mass Vaccination.

PubMed

Swift, Melanie D; Aliyu, Muktar H; Byrne, Daniel W; Qian, Keqin; McGown, Paula; Kinman, Patricia O; Hanson, Katherine Louise; Culpepper, Demoyne; Cooley, Tamara J; Yarbrough, Mary I

2017-09-01

To explore whether an emergency preparedness structure is a feasible, efficient, and sustainable way for health care organizations to manage mass vaccination events. We used the Hospital Incident Command System to conduct a 1-day annual mass influenza vaccination event at Vanderbilt University Medical Center over 5 successive years (2011-2015). Using continuous quality improvement principles, we assessed whether changes in layout, supply management, staffing, and documentation systems improved efficiency. A total of 66 591 influenza vaccines were administered at 5 annual Flulapalooza events; 13 318 vaccines per event on average. Changes to the physical layout, staffing mix, and documentation processes improved vaccination efficiency 74%, from approximately 38 to 67 vaccines per hour per vaccinator, while reducing overall staffing needs by 38%. An unexpected finding was the role of social media in facilitating active engagement. Health care organizations can use a closed point-of-dispensing model and Hospital Incident Command System to conduct mass vaccination events, and can adopt the "Flulapalooza method" as a best practice model to enhance efficiency.

Rotavirus genotypes in Malaysia and Universal rotavirus vaccination

PubMed Central

Lee, Way Seah; Lim, Benjamin Tze Ying; Chai, Pei Fan; Kirkwood, Carl D.; Lee, Jimmy Kok Foo

2012-01-01

Group A rotavirus (RV-A) genotypes isolated in Malaysia was studied to estimate the effectiveness of a universal RV-A vaccination in Malaysia. A simple mathematical model was used, with input from a two-year, two-center, prospective study on hospitalization of RV-A gastroenteritis (RVGE) in young children, published data on RV-A hospitalizations and genotypes, mortality on childhood GE and published genotype-specific efficacy data on two RV-A vaccines. Assuming a 95% vaccine coverage, the overall projected effectiveness was 75.7 to 88.1% for Rotateq® and 78.7 to 90.6% for Rotarix® against RVGE-related hospitalizations. The projected annual reduction in RVGE-related deaths was 27 to 32 deaths (from 34 deaths) for Rotateq® and 28 to 32 deaths annually forRotarix®. A universal RV-A vaccine is efficacious in reducing RVGE-related hospitalizations and mortality in Malaysia. PMID:23022710

Barriers of Influenza Vaccination Intention and Behavior – A Systematic Review of Influenza Vaccine Hesitancy, 2005 – 2016

PubMed Central

Schmid, Philipp; Rauber, Dorothee; Betsch, Cornelia; Lidolt, Gianni; Denker, Marie-Luisa

2017-01-01

Background Influenza vaccine hesitancy is a significant threat to global efforts to reduce the burden of seasonal and pandemic influenza. Potential barriers of influenza vaccination need to be identified to inform interventions to raise awareness, influenza vaccine acceptance and uptake. Objective This review aims to (1) identify relevant studies and extract individual barriers of seasonal and pandemic influenza vaccination for risk groups and the general public; and (2) map knowledge gaps in understanding influenza vaccine hesitancy to derive directions for further research and inform interventions in this area. Methods Thirteen databases covering the areas of Medicine, Bioscience, Psychology, Sociology and Public Health were searched for peer-reviewed articles published between the years 2005 and 2016. Following the PRISMA approach, 470 articles were selected and analyzed for significant barriers to influenza vaccine uptake or intention. The barriers for different risk groups and flu types were clustered according to a conceptual framework based on the Theory of Planned Behavior and discussed using the 4C model of reasons for non-vaccination. Results Most studies were conducted in the American and European region. Health care personnel (HCP) and the general public were the most studied populations, while parental decisions for children at high risk were under-represented. This study also identifies understudied concepts. A lack of confidence, inconvenience, calculation and complacency were identified to different extents as barriers to influenza vaccine uptake in risk groups. Conclusion Many different psychological, contextual, sociodemographic and physical barriers that are specific to certain risk groups were identified. While most sociodemographic and physical variables may be significantly related to influenza vaccine hesitancy, they cannot be used to explain its emergence or intensity. Psychological determinants were meaningfully related to uptake and should

Solar Refrigerators Store Life-Saving Vaccines

NASA Technical Reports Server (NTRS)

2014-01-01

Former Johnson Space Center engineer David Bergeron used his experience on the Advanced Refrigeration Technology Team to found SunDanzer Refrigeration Inc., a company specializing in solar-powered refrigerators. The company has created a battery-free unit that provides safe storage for vaccines in rural and remote areas around the world.

Vaccines today, vaccines tomorrow: a perspective.

PubMed

Loucq, Christian

2013-01-01

Vaccines are considered as one of the major contributions of the 20th century and one of the most cost effective public health interventions. The International Vaccine Institute has as a mission to discover, develop and deliver new and improved vaccines against infectious diseases that affects developing nations. If Louis Pasteur is known across the globe, vaccinologists like Maurice Hilleman, Jonas Salk and Charles Mérieux are known among experts only despite their contribution to global health. Thanks to a vaccine, smallpox has been eradicated, polio has nearly disappeared, Haemophilus influenzae B, measles and more recently meningitis A are controlled in many countries. While a malaria vaccine is undergoing phase 3, International Vaccine Institute, in collaboration with an Indian manufacturer has brought an oral inactivated cholera vaccine to pre-qualification. The field of vaccinology has undergone major changes thanks to philanthropists such as Bill and Melinda Gates, initiatives like the Decade of Vaccines and public private partnerships. Current researches on vaccines have more challenging targets like the dengue viruses, malaria, human immunodeficiency virus, the respiratory syncytial virus and nosocomial diseases. Exciting research is taking place on new adjuvants, nanoparticles, virus like particles and new route of administration. An overcrowded infant immunization program, anti-vaccine groups, immunizing a growing number of elderlies and delivering vaccines to difficult places are among challenges faced by vaccinologists and global health experts.

Vaccine risk assessment in children with a referred reaction to a previous vaccine dose: 2009-2011 retrospective report at the Bambino Gesu' children hospital, Rome, Italy.

PubMed

Nicolosi, Luciana; Vittucci, Annachiara; Mancini, Rossella; Bozzola, Elena; Cagigi, Alberto; Grandin, Annalisa; Villani, Alberto

2014-03-31

During the last century, mass vaccination programs have achieved considerable success across the world in immunizing against several serious infectious diseases. However, vaccinations are threatened by their own success after results have been obtained: the more the incidence of potentially devastating diseases decreases, thanks to the success of vaccination programs, the more public attention shifts towards real or alleged "side effects" of vaccines. We analyze the experience of 153 children with "reaction to a previous vaccine dose" continuing the vaccination protocol in the safe environment of the Center for risk vaccination at the Bambino Gesù Children's Hospital IRCCS in Rome, from 2009 to 2011. To assess the suitability for vaccination, a specialized pre-vaccination advice and a skin prick test (SPT) was undergone, according to Wood's guideline; 151 children were SPT negative and full vaccine was administered. Of the 153 children examined just 13 had symptoms suggestive of IgE-mediated reaction-type reactions with angioedema manifestations. Among them, 2 had positive STP, which required alternative measures of administration of the vaccine. No cases of post vaccination reaction was reported and no vaccination program was stopped due to a severe reaction. Inadequate levels of immunization against infectious diseases remain a significant problem for public health. However, the reasons for incomplete vaccination and non-adoption of vaccination services are manifold. To maintain public confidence in vaccines, advanced immunization programs must include activities for monitoring the safety of the vaccine at the individual level and pursuing specialized counseling pre-and post-vaccination for those at risk. Our results underlined a gap between true and referred adverse reactions and are consistent with vaccine safety. Anyway, a continuous assessment of the risks and benefits of vaccination is required and the results must be disclosed in order to strengthen

Predictors of seasonal influenza vaccination behaviour among nurses and implications for interventions to increase vaccination uptake: A cross-sectional survey.

PubMed

Kan, Ting; Ai, Jiaqi; Zhang, Jing; Liu, Xiaohong

2018-03-01

Vaccination has been proven the most effective method to prevent seasonal influenza. Nurses' vaccination can provide protection against influenza not only for themselves but also for patients they take care of. However, vaccination coverage of nurses is suboptimal worldwide, especially in China. The influencing factors need to be explored so as to develop specific, workable strategies to improve nurses' vaccination behaviour. To explore predictors of their vaccination behaviour, identify the motivators and barriers of vaccination, and provide implications for future interventions. A cross-sectional convenience sampling questionnaire survey. Nine hospitals including five tertiary hospitals, two secondary hospitals, and two primary hospitals in Shanghai, China. A total of 1000 nurses from the nine hospitals were invited to participate in this survey. Among them, 921 nurses responded and 895 returned valid questionnaires that were used in data analysis. The Chinese version of the King's Nurses' Influenza Vaccination Questionnaire was used as the survey instrument and distributed to the participants during February-November 2012. Descriptive statistics, univariate analyses, and multivariate analyses were conducted to explore the predictors of nurses' vaccination behaviour. Overall, 8.8% of the respondents received seasonal influenza vaccination in the past influenza season (2011/2012 season). Nurses had averagely received 0.38 ± 0.71 influenza vaccines during the past five influenza seasons (2007/2008 to 2011/2012 season). Predictors of nurses' vaccination status were clinical specialty, knowledge about influenza vaccination [1.331 (1.102, 1.608), p = 0.003], internal health locus of control [0.910 (0.845, 0.980), p = 0.013], chance health locus of control [1.075 (1.023, 1.130), p = 0.004]and powerful others health of locus control [1.166 (1.083, 1.255), p < 0.001]. Predictors of their vaccination times were hospital level, clinical specialty, and

Recommendations of the VAC2VAC workshop on the design of multi-centre validation studies.

PubMed

Halder, Marlies; Depraetere, Hilde; Delannois, Frédérique; Akkermans, Arnoud; Behr-Gross, Marie-Emmanuelle; Bruysters, Martijn; Dierick, Jean-François; Jungbäck, Carmen; Kross, Imke; Metz, Bernard; Pennings, Jeroen; Rigsby, Peter; Riou, Patrice; Balks, Elisabeth; Dobly, Alexandre; Leroy, Odile; Stirling, Catrina

2018-03-01

Within the Innovative Medicines Initiative 2 (IMI 2) project VAC2VAC (Vaccine batch to vaccine batch comparison by consistency testing), a workshop has been organised to discuss ways of improving the design of multi-centre validation studies and use the data generated for product-specific validation purposes. Moreover, aspects of validation within the consistency approach context were addressed. This report summarises the discussions and outlines the conclusions and recommendations agreed on by the workshop participants. Copyright © 2018.

Vaccination perceptions of school employees in a rural school district.

PubMed

Macintosh, Janelle; Luthy, Karlen E; Beckstrand, Renea L; Eden, Lacey M; Orton, Jennifer

2014-08-20

There continues to be a need for increases in adult vaccination rates, especially among those working in environments which may easily become communicable disease outbreak centers, such as school employees in the school environment. The purpose of this study was to evaluate why rural Utah school employees were non-compliant with the influenza and measles, mumps, and rubella (MMR) vaccines, as well as to identify their views on mandatory vaccination policies. A questionnaire was distributed to all school employees in a rural Utah school district. Data analysis included frequencies and measures of central tendency and dispersion for quantitative items and theme identification for qualitative items. Only 51% of school employees were adequately vaccinated for influenza. Reasons for noncompliance with the influenza vaccine included inconvenience, lack of perceived need, and questionable vaccine efficacy. There were 39.3% school employees who had not received an MMR during adulthood, which was commonly attributed to lack of knowledge regarding the need for this vaccine. Almost half (45.7%) of school employees believed a mandatory vaccination policy should be instituted, although 24.2% of school employees were opposed to mandatory adult vaccination policies. Reasons for opposing vaccination mandates included violation of personal choice, lack of perceived vaccination safety and efficacy, lack of perceived need for adult vaccines, and vaccine cost. Suboptimal vaccination rates of school employees may negatively affect the health and well-being of individuals in the school environment. School employees report a variety of beliefs regarding the influenza and MMR vaccines. While over half of school employees support mandatory vaccination policies for adults working in the school environment, those opposing such a policy report concerns regarding violation of personal choice. Public health officials and school administrators should coordinate efforts to increase vaccination

Pertussis, pertussis vaccine, and care of exposed persons.

PubMed

Zimmerman, R K; Wald, E R; Ahwesh, E R

1996-01-01

Pertussis is a highly contagious bacterial infection caused by Bordetella pertussis. Before routine vaccination against pertussis was available, most persons were infected during childhood. After widespread vaccination, however, the incidence of pertussis in the United States dropped by more than 95 percent, though localized outbreaks continue to occur. A multidisciplinary team developed a set of review articles as part of continuing medical education modules in the Teaching Immunization in Medical Education (TIME) Project. The team developed the materials using expert judgment and selected materials from the literature and the Centers for Disease Control and Prevention (CDC). The first step was the creation of specific learning objectives that used the spectrum of Bloom's taxonomy, when possible. After the materials were developed, they were pilot-tested and revised. Subsequently they underwent summative evaluation by field-testing the materials with 24 other primary care physicians. Then the materials were reviewed by the CDC and national vaccine experts and revised based on their comments. The efficacy of whole-cell pertussis vaccine is about 70 to 90 percent, though local adverse events are common. Since 1990 several purified, acellular pertussis vaccines have been developed that have one quarter to one half of the common adverse events associated with whole-cell vaccine and have similar efficacy rates. The incidence of pertussis can be further reduced by increasing age-appropriate vaccination rates.

What you don't know about vaccines can hurt you.

PubMed

Pace, Victor M

2015-01-01

As physicians, we've all learned in detail about the science behind vaccinations, but I suspect few of us have been taught about the history of vaccinations. Sure, we all know that Dr. Jonas Salk developed the poliovirus vaccine, but I wasn't aware that he inoculated himself, his wife, and his three children with his then experimental vaccine. When our editorial committee decided to focus on vaccinations as our theme for this month's Greene County Medical Society's Journal, I perused the internet for interesting topics. I came across a fascinating website, historyofvaccines.org; this website is a project of the College of Physicians of Philadelphia, touted as being the oldest professional medical organization in the United States. I credit the majority of the information in this article to the above website and the rest to the National Institutes of Health (nih.gov) website; I trust that the information is valid and true, based on the agencies behind these websites. Below are some interesting tidbits about vaccine preventable diseases that I found noteworthy to pass on to our readers.

Footrot vaccines and vaccination.

PubMed

Dhungyel, Om; Hunter, James; Whittington, Richard

2014-05-30

Research on footrot in small ruminants, which is caused by Dichelobacter nodosus, has led to development of vaccines and their application for control, treatment and eradication of the disease in sheep. Footrot vaccines have evolved over decades to contain monovalent whole cell, multivalent recombinant fimbrial, and finally mono or bivalent recombinant fimbrial antigens. Initially whole cell vaccines made against the few known serogroups of D. nodosus were found to be inefficient in control of the disease in the field, which was attributed to the presence of other unidentified serogroups and also the use of inefficient adjuvants. Fimbriae or pili, which are the basis for antigenic variation, were found to be the major protective and also curative antigens but they are not cross protective between the different serogroups. Multivalent vaccines incorporating all the known serogroups have been proven to be of limited efficacy due to the phenomenon of antigenic competition. Recent studies in Nepal, Bhutan and Australia have shown that outbreak-specific vaccination which involves targeting identified serogroups with mono- or bivalent recombinant fimbrial vaccines, can be very effective in sheep and goats. Where multiple serogroups are present in a flock, antigenic competition can be overcome by sequentially targeting the serogroups with different bivalent vaccines every 3 months. A common antigen which would confer immunity to all serogroups would be the ideal immunogen but the initial studies were not successful in this area. Until universal antigen/s are available, flock specific mono or bivalent fimbrial vaccines are likely to be the most effective tool for control and eradication of footrot in sheep and goats. Future research in footrot vaccines should be focused on improving the duration of prophylaxis by incorporating new and emerging immunomodulators or adjuvants with modified delivery vehicles, discovering a common antigen and understanding the mechanisms of

Activation of B Cells by a Dendritic Cell-Targeted Oral Vaccine

PubMed Central

Sahay, Bikash; Owen, Jennifer L.; Yang, Tao; Zadeh, Mojgan; Lightfoot, Yaíma L.; Ge, Jun-Wei; Mohamadzadeh, Mansour

2015-01-01

Production of long-lived, high affinity humoral immunity is an essential characteristic of successful vaccination and requires cognate interactions between T and B cells in germinal centers. Within germinal centers, specialized T follicular helper cells assist B cells and regulate the antibody response by mediating the differentiation of B cells into memory or plasma cells after exposure to T cell-dependent antigens. It is now appreciated that local immune responses are also essential for protection against infectious diseases that gain entry to the host by the mucosal route; therefore, targeting the mucosal compartments is the optimum strategy to induce protective immunity. However, because the gastrointestinal mucosae are exposed to large amounts of environmental and dietary antigens on a daily basis, immune regulatory mechanisms exist to favor tolerance and discourage autoimmunity at these sites. Thus, mucosal vaccination strategies must ensure that the immunogen is efficiently taken up by the antigen presenting cells, and that the vaccine is capable of activating humoral and cellular immunity, while avoiding the induction of tolerance. Despite significant progress in mucosal vaccination, this potent platform for immunotherapy and disease prevention must be further explored and refined. Here we discuss recent progress in the understanding of the role of different phenotypes of B cells in the development of an efficacious mucosal vaccine against infectious disease. PMID:24372255

[The vaccination coverage rate: why is it so low?].

PubMed

Wembonyama, O

1994-01-01

The problems hampering vaccination programs in Zaire include the inaccessibility of vaccination posts, the deplorable condition of vaccines and supplies, transport difficulties, and community disinterest. Most vaccination posts in Zaire are physically inaccessible and poorly stocked. They lack skilled staff and are unable to provide quality care. They do not have the means of providing themselves with vaccine; shortages are so common that vaccination schedules are difficult to follow. Refrigerators are usually not available in vaccination centers and are often diverted to other uses if they are available. The instructions for storing vaccines are often incorrectly followed. Single-use needles and syringes continue to be reused. Vehicles assigned to vaccination programs are often used for the private benefit of program officials or their families. Misuse of vehicles contributes to their short life expectancy. Local communities are disinterested in vaccination programs because they do not contribute to immediate survival. Moreover, the population regularly experiences the death of correctly vaccinated children. Some persons distrust vaccination as a trick to render women sterile or cause fever and convulsions in children. Mass vaccination programs are so poorly organized that their failure is predictable. The officials in charge spend most of their time in their offices rather than getting to know the target populations, and are often more interested in publicity for themselves than in the program. Press coverage is indispensable, but it should be devoted to furthering the program and not the careers of the officials in charge. Training of vaccinators, stocking of vaccination posts, and other essential tasks are often left until the last minute and improvised rather than carefully planned and implemented. The vaccinators are often unemployed persons who have little knowledge of correct techniques. Vaccination coverage could be improved if planners and health

Pneumococcal Vaccination Among Medicare Beneficiaries Occurring After the Advisory Committee on Immunization Practices Recommendation for Routine Use Of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine for Adults Aged ≥65 Years.

PubMed

Black, Carla L; Williams, Walter W; Warnock, Rob; Pilishvili, Tamara; Kim, David; Kelman, Jeffrey A

2017-07-14

On September 19, 2014, CDC published the Advisory Committee on Immunization Practices (ACIP) recommendation for the routine use of 13-valent pneumococcal conjugate vaccine (PCV13) among adults aged ≥65 years, to be used in series with 23-valent pneumococcal polysaccharide vaccine (PPSV23) (1). This replaced the previous recommendation that adults aged ≥65 years should be vaccinated with a single dose of PPSV23. As a proxy for estimating PCV13 and PPSV23 vaccination coverage among adults aged ≥65 years before and after implementation of these revised recommendations, CDC analyzed claims for vaccination submitted for reimbursement to the Centers for Medicare & Medicaid Services (CMS). Claims from any time during a beneficiary's enrollment in Medicare Parts A (hospital insurance) and B (medical insurance) since reaching age 65 years were assessed among beneficiaries continuously enrolled in Medicare Parts A and B during annual periods from September 19, 2009, through September 18, 2016. By September 18, 2016, 43.2% of Medicare beneficiaries aged ≥65 years had claims for at least 1 dose of PPSV23 (regardless of PCV13 status), 31.5% had claims for at least 1 dose of PCV13 (regardless of PPSV23 status), and 18.3% had claims for at least 1 dose each of PCV13 and PPSV23. Claims for either type of pneumococcal vaccine were highest among beneficiaries who were older, white, or with chronic and immunocompromising medical conditions than among healthy adults. Implementation of the National Vaccine Advisory Committee's standards for adult immunization practice to assess vaccination status at every patient encounter, recommend needed vaccines, and administer vaccination or refer to a vaccinating provider might help increase pneumococcal vaccination coverage and reduce the risk for pneumonia and invasive pneumococcal disease among older adults (2).

Monitoring temperatures in the vaccine cold chain in Bolivia.

PubMed

Nelson, Carib; Froes, Paulo; Dyck, Anne Mie Van; Chavarría, Jeaneth; Boda, Enrique; Coca, Alberto; Crespo, Gladys; Lima, Heinz

2007-01-05

This study monitored vaccine cold chain temperatures during routine DTP-HB-Hib vaccine shipments from central stores to 11 communities in 3 provinces of Bolivia. In all 11 monitored shipments, vaccines were exposed to freezing temperatures at one or more points. In each of the shipments, temperatures below 0 degrees C were recorded for 2-50% of the monitoring period. Freezing occurred at almost every level of the cold chain distribution system, especially during district and health center storage and during transport to the province and district levels. Seven of the 11 shipments were exposed to temperatures above 8 degrees C, although none were exposed to excessive heat longer than 1.3% of the total monitoring period.

Influenza vaccination competence of nurses in France: A survey in nursing schools.

PubMed

Desbouys, Lucille; Grison, Sabine; Launay, Odile; Loulergue, Pierre

2016-02-01

Since 2008, French nurses have been allowed to vaccinate against influenza without medical prescription. Our survey aimed at assessing nursing students' knowledge and perception of this prerogative. Among 213 responders, 61% were aware of this matter, and 47.5% were familiar with its requirements. Most (75.6%) were positive about it. Influenza vaccination without medical prescription is well-known and validated by nursing students. This new competence may improve vaccination coverage. Copyright © 2016 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Operational space weather product development and validation at the joint SMC-AFRL Rapid Prototyping Center

NASA Astrophysics Data System (ADS)

Quigley, S.

The Air Force Research Laboratory (AFRL/VSB) and Detachment 11, Space &Missile Systems Center (SMC, Det 11/CIT) have combined efforts to design, develop, test, and implement graphical products for the Air Force's space weather operations center. These products are generated to analyze, specify, and forecast the effects of the near-earth space environment on Department of Defense systems and communications. Jointly-developed products that have been, or will soon be added to real-time operations include: 1) the Operational Space Environment Network Display (OpSEND) suit - a set of four products that address HF communication, UHF satellite communication scintillation, radar auroral clutter, and GP S single- frequency errors; 2) a solar radio background and burst effects (SoRBE) product suite; and C) a meteor effects (ME) product suite. The RPC is also involved in a rather substantial "V&V" effort to produce multiple operational product verifications and validations, with an added end goal of a generalized validation software package. The presentation will provide a general overview of the RPC and each of the products mentioned above, to include background science, operational history, inputs, outputs, dissemination, and customer uses for each.

Current and future effects of varicella and herpes zoster vaccination in Germany - Insights from a mathematical model in a country with universal varicella vaccination.

PubMed

Horn, Johannes; Karch, André; Damm, Oliver; Kretzschmar, Mirjam E; Siedler, Anette; Ultsch, Bernhard; Weidemann, Felix; Wichmann, Ole; Hengel, Hartmut; Greiner, Wolfgang; Mikolajczyk, Rafael T

2016-07-02

Varicella zoster virus (VZV) is primarily known for causing varicella in childhood, but can reactivate again as herpes zoster (HZ) after a period of latency, mainly in persons older than 50 years. Universal varicella vaccination was introduced in Germany in 2004, while HZ vaccination has not been recommended yet. We aimed to quantify the potential long-term effects of universal childhood varicella vaccination and HZ vaccination of the elderly on varicella and HZ incidence in Germany over a time horizon of 100 years, using a transmission model calibrated to pre-vaccination data and validated against early post-vaccination data. Using current vaccination coverage rates of 87% (64%) with one (two) varicella vaccine dose(s), the model predicts a decrease in varicella cases by 89% for the year 2015. In the long run, the incidence reduction will stabilize at about 70%. Under the assumption of the boosting hypothesis of improved HZ protection caused by exposure to VZV, the model predicts a temporary increase in HZ incidence of up to 20% for around 50 years. HZ vaccination of the elderly with an assumed coverage of 20% has only limited effects in counteracting this temporary increase in HZ incidence. However, HZ incidence is shown to decrease in the long-term by 58% as vaccinated individuals get older and finally reach age-classes with originally high HZ incidence. Despite substantial uncertainties around several key variables, the model's results provide valuable insights that support decision-making regarding national VZV vaccination strategies.

How Influenza Vaccination Policy May affect Vaccine Logistics

PubMed Central

Assi, Tina-Marie; Rookkapan, Korngamon; Rajgopal, Jayant; Sornsrivichai, Vorasith; Brown, Shawn T.; Welling, Joel S.; Norman, Bryan A.; Connor, Diana L.; Chen, Sheng-I; Slayton, Rachel B.; Laosiritaworn, Yongjua; Wateska, Angela R.; Wisniewski, Stephen R.; Lee, Bruce Y.

2012-01-01

Background When policymakers make decision about the target populations and timing of influenza vaccination, they may not consider the impact on the vaccine supply chains, which may in turn affect vaccine availability. Purpose Our goal is to explore the effects on the Thailand vaccine supply chain of introducing influenza vaccines and varying the target populations and immunization time-frames. Methods Utilized our custom-designed software HERMES (Highly Extensible Resource for Modeling Supply Chains), we developed a detailed, computational discrete-event simulation model of the Thailand's National Immunization Program (NIP) supply chain in Trang Province, Thailand., A suite of experiments simulated introducing influenza vaccines for different target populations and over different time-frames prior to and during the annual influenza season. Results Introducing influenza vaccines creates bottlenecks that reduce the availability of both influenza vaccines as well as the other NIP vaccines, with provincial to district transport capacity being the primary constraint. Even covering only 25% of the Advisory Committee on Immunization Practice-recommended population while administering the vaccine over six months hinders overall vaccine availability so that only 62% of arriving patients can receive vaccines. Increasing the target population from 25% to 100% progressively worsens these bottlenecks, while increasing influenza vaccination time - frame from 1 to 6 months decreases these bottlenecks. Conclusion Since the choice of target populations for influenza vaccination and the time-frame to deliver this vaccine can substantially affect the flow of all vaccines, policy-makers may want to consider supply chain effects when choosing target populations for a vaccine. PMID:22537993

Facebook and Twitter vaccine sentiment in response to measles outbreaks.

PubMed

Deiner, Michael S; Fathy, Cherie; Kim, Jessica; Niemeyer, Katherine; Ramirez, David; Ackley, Sarah F; Liu, Fengchen; Lietman, Thomas M; Porco, Travis C

2017-11-01

Social media posts regarding measles vaccination were classified as pro-vaccination, expressing vaccine hesitancy, uncertain, or irrelevant. Spearman correlations with Centers for Disease Control and Prevention-reported measles cases and differenced smoothed cumulative case counts over this period were reported (using time series bootstrap confidence intervals). A total of 58,078 Facebook posts and 82,993 tweets were identified from 4 January 2009 to 27 August 2016. Pro-vaccination posts were correlated with the US weekly reported cases (Facebook: Spearman correlation 0.22 (95% confidence interval: 0.09 to 0.34), Twitter: 0.21 (95% confidence interval: 0.06 to 0.34)). Vaccine-hesitant posts, however, were uncorrelated with measles cases in the United States (Facebook: 0.01 (95% confidence interval: -0.13 to 0.14), Twitter: 0.0011 (95% confidence interval: -0.12 to 0.12)). These findings may result from more consistent social media engagement by individuals expressing vaccine hesitancy, contrasted with media- or event-driven episodic interest on the part of individuals favoring current policy.

Vaccination policies of immigrants in the EU/EEA Member States-the measles immunization example.

PubMed

Bica, Mihai A; Clemens, Ralf

2018-06-01

In 2015-16, the European Union/European Economic Area Member States (EU/EEA MSs) experienced an unprecedented volume and rate of migration, posing serious challenges to existing national immunization systems and strategies and raising the questions of where, when and who to vaccinate. We assessed existing strategies for vaccinating immigrant populations in the EU/EEA using measles as an example of the most important vaccine-preventable diseases. In this cross-sectional study, conducted from March to May 2016, an electronic questionnaire was sent to the Heads of National Immunization Technical Advisory Groups (NITAGs) or equivalent policy-making bodies in each of the 31 EU/EEA Member States. Responses were entered into a structured database and validated by survey responders for final analysis. Validated responses from all 31 EU/EEA NITAGs or equivalents showed that there is no common measles immunization policy for European immigrants. Policies vary widely from no policy at all (9 of 31, 29%) to vaccination of all comers (2 of 31, 6%), or vaccination of selected cohorts based on vaccination history (17 of 31, 55%) or serum antibody analysis (2 of 31, 6%). Further, the operational responsibilities for immigrant vaccination and documentation methods are not unified within the EU/EEA region. With some notable exceptions immunization policies to contain spread of infectious diseases through migration are either non-existent or vary widely between countries in the EU/EEA. With freedom of movement within the EU/EEA there ought to be harmonization and a common EU/EEA vaccination strategy to replace national policies for immigrant populations.

Development of a tool to measure person-centered maternity care in developing settings: validation in a rural and urban Kenyan population.

PubMed

Afulani, Patience A; Diamond-Smith, Nadia; Golub, Ginger; Sudhinaraset, May

2017-09-22

Person-centered reproductive health care is recognized as critical to improving reproductive health outcomes. Yet, little research exists on how to operationalize it. We extend the literature in this area by developing and validating a tool to measure person-centered maternity care. We describe the process of developing the tool and present the results of psychometric analyses to assess its validity and reliability in a rural and urban setting in Kenya. We followed standard procedures for scale development. First, we reviewed the literature to define our construct and identify domains, and developed items to measure each domain. Next, we conducted expert reviews to assess content validity; and cognitive interviews with potential respondents to assess clarity, appropriateness, and relevance of the questions. The questions were then refined and administered in surveys; and survey results used to assess construct and criterion validity and reliability. The exploratory factor analysis yielded one dominant factor in both the rural and urban settings. Three factors with eigenvalues greater than one were identified for the rural sample and four factors identified for the urban sample. Thirty of the 38 items administered in the survey were retained based on the factors loadings and correlation between the items. Twenty-five items load very well onto a single factor in both the rural and urban sample, with five items loading well in either the rural or urban sample, but not in both samples. These 30 items also load on three sub-scales that we created to measure dignified and respectful care, communication and autonomy, and supportive care. The Chronbach alpha for the main scale is greater than 0.8 in both samples, and that for the sub-scales are between 0.6 and 0.8. The main scale and sub-scales are correlated with global measures of satisfaction with maternity services, suggesting criterion validity. We present a 30-item scale with three sub-scales to measure person-centered

Making avian influenza vaccines available, an industry point of view (IFAH).

PubMed

van Aarle, P

2006-01-01

Vaccination against avian influenza (AI) has proved to be an efficient tool in the reduction of virus excretion and in increasing the threshold for infection. Vaccination in outbreaks, as part of a complete programme, has proved to be an essential component of control and eradication programmes. Avian influenza is a serious threat to public health. In contingency plans for outbreaks of highly pathogenic AI (HPAI), the option of emergency vaccination, using inactivated or recombinant vaccines, should be considered. The availability of suitable vaccines has to be ensured in 'peace time' in a contract for a vaccine or antigen bank. Unlike the human influenza vaccines, poultry AI vaccines have proved to provide protection against a wide range of strains within the same H-subtype. However, in case new H5 or H7 strains emerge in poultry, there is no regulatory guideline to support a swift reaction by the vaccine industry. Production of HPAI virus should take place in facilities with a Biosafety Level 3 (BSL3) to safeguard containment of virus and to prevent infection of manufacturing staff. Vaccine strains for inactivated vaccines should preferably be low pathogenicity AI (LPAI). In a new outbreak, it is essential to determine early which vaccine strain will provide protection against the field virus. Sequencing does not predict the protective capacity of vaccines. Challenge studies, providing essential information, take too much time and can be carried out only in BSL3 facilities. Serological matching of vaccine and field strains would provide a faster system. It is recommended that a matching system be developed and validated.

DNA vaccination for prostate cancer, from preclinical to clinical trials - where we stand?

PubMed Central

2012-01-01

Development of various vaccines for prostate cancer (PCa) is becoming an active research area. PCa vaccines are perceived to have less toxicity compared with the available cytotoxic agents. While various immune-based strategies can elicit anti-tumour responses, DNA vaccines present increased efficacy, inducing both humoural and cellular immunity. This immune activation has been proven effective in animal models and initial clinical trials are encouraging. However, to validate the role of DNA vaccination in currently available PCa management paradigms, strong clinical evidence is still lacking. This article provides an overview of the basic principles of DNA vaccines and aims to provide a summary of preclinical and clinical trials outlining the benefits of this immunotherapy in the management of PCa. PMID:23046944

Errors and correlates in parental recall of child immunizations: effects on vaccination coverage estimates.

PubMed

Suarez, L; Simpson, D M; Smith, D R

1997-05-01

We evaluated the accuracy of parental recall of children's immunization histories as compared with provider records and examined how errors in parental recall correlate with sociodemographic characteristics. The validation study was part of a population-based household survey designed to assess immunization levels among Texas children under age 2 years. For 72% (n = 3278), interviewers used vaccination records from the parent to copy dates for the diphtheria and tetanus toxoids and pertussis vaccine (DTP), oral polio vaccine (OPV), and measles, mumps, and rubella (MMR) shots. For parents without shot records (n = 1216), interviewers asked about each vaccine, whether the child had received the shot, how many, and at what age. Of these, 85% (n = 1029) were validated with health provider records. Measured against provider records, only 34% of parents accurately recalled the number of DTP shots a child had. More often (42%) parents underestimated the number of DTP shots than overestimated (24%). Agreement between parental recall and provider records was high (83%) for the single dose of MMR. Accuracy of parents' recall did not differ by race/ethnicity, education level, or type of health insurance coverage, but decreased as child's age increased. Having a vaccination record at home was associated with a higher immunization status. Hispanic, lower educated, and uninsured parents were more likely to have a vaccination record than non-Hispanic, higher educated, and privately insured parents. Validity of parental recall of children's immunization histories depends on the vaccine and the age of the child, which is highly correlated with the number of shots parents must recollect. Results suggest that inclusion of parent recall information from vaccination surveys underestimates DTP:OPV:MMR coverage. This underestimation is consistent across economic and race/ethnic groups. Thus, community surveys based on cards and recall should provide reliable conclusions about which

Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS)

PubMed Central

Shimabukuro, Tom T.; Nguyen, Michael; Martin, David; DeStefano, Frank

2015-01-01

The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) conduct post-licensure vaccine safety monitoring using the Vaccine Adverse Event Reporting System (VAERS), a spontaneous (or passive) reporting system. This means that after a vaccine is approved, CDC and FDA continue to monitor safety while it is distributed in the marketplace for use by collecting and analyzing spontaneous reports of adverse events that occur in persons following vaccination. Various methods and statistical techniques are used to analyze VAERS data, which CDC and FDA use to guide further safety evaluations and inform decisions around vaccine recommendations and regulatory action. VAERS data must be interpreted with caution due to the inherent limitations of passive surveillance. VAERS is primarily a safety signal detection and hypothesis generating system. Generally, VAERS data cannot be used to determine if a vaccine caused an adverse event. VAERS data interpreted alone or out of context can lead to erroneous conclusions about cause and effect as well as the risk of adverse events occurring following vaccination. CDC makes VAERS data available to the public and readily accessible online. We describe fundamental vaccine safety concepts, provide an overview of VAERS for healthcare professionals who provide vaccinations and might want to report or better understand a vaccine adverse event, and explain how CDC and FDA analyze VAERS data. We also describe strengths and limitations, and address common misconceptions about VAERS. Information in this review will be helpful for healthcare professionals counseling patients, parents, and others on vaccine safety and benefit-risk balance of vaccination. PMID:26209838

Assessment of vaccination-related information for consumers available on Facebook.

PubMed

Buchanan, Rachel; Beckett, Robert D

2014-09-01

To assess the magnitude, interest, purpose and validity of vaccination-related information on Facebook and to determine whether information varies by site viewpoint. The 10 largest vaccination-focused Facebook pages, groups and places in each category were identified and classified by viewpoint (i.e. anti-, pro-, neutral) and purpose. Number of members, posts per week, likes, comments and shares per post were recorded. Posts were assessed for concordance with CDC and FDA recommendations. Of 30 sites, 43% (n = 13) were anti-vaccination, 7% (n = 2) neutral and 50% (n = 15) pro-vaccination. Most sites were most popular with American users. Median members were similar between anti-vaccination (2703 members, range 337-33 631 members) and pro-vaccination sites (2142 members, range 456-61,565 members, P = 0.262); however, anti-vaccination sites accumulated more posts per week by authors (median 15 vs. 3, P = 0.031) and members (median 33 vs. 1, P < 0.001). Pro-vaccination sites more commonly had commercial purpose (53% [n = 8] vs. 8% [n = 1], P = 0.02). Anti-vaccination sites more commonly gave medical advice (54% [n = 7] vs. 0%, P = 0.004). Overall, 48% (n = 22) of author posts were concordant with regulatory recommendations; concordance was more common on pro-vaccination sites (78% [n = 21] vs. 5% [n = 1], P = 0.0002). Vaccination-related information is prevalent on Facebook regardless of viewpoint; however, anti-vaccination information generates more interest. Anti-vaccination sites were likely to provide medical advice and disagree with regulatory bodies. © 2014 The authors. Health Information and Libraries Journal © 2014 Health Libraries Group.

Human papilloma virus vaccination in Nepal: an initial experience in Nepal.

PubMed

Singh, Yogendra; Shah, Aarti; Singh, Meeta; Verma, Sheela; Shrestha, Bhakta Man; Vaidya, Prabhu; Nakarmi, Radha Pyari; Shrestha, Surendra Bb

2010-01-01

Cervical cancer is the most common cancer among women in Nepal. Human papilloma virus (HPV) infection, a recognized cause of cervical cancer, is very common in sexually active women and HPV vaccination has been recommended as a prophylactic therapy. If HPV infection is prevented by the HPV vaccination to the adolescent girls, cervical cancer is also prevented. We received 3,300 vials of quadrivalent human papilloma virus (types 6, 11, 16, 18) recombinant vaccine (Gardasil; Merck and Co.) as a gift from the Australian Cervical Cancer Foundation (ACCF) which has a mission to provide life-saving HPV cervical cancer vaccines for women in developing countries, who cannot otherwise afford vaccination. HPV vaccine was offered to 1,096 of 10 to 26 year aged girls attending 17 secondary schools. In total, 1,091 (99.5%) received the second dose and 1,089 (99.3%) received the third dose of the vaccine. The remaining 5 girls at second dose and 2 girls at third dose remained unvaccinated. No serious vaccine related adverse events were reported except mild pain at the injection site in 7.8% of the vaccine recipients. High cost and low public awareness are the key barriers for successful implementation of the vaccination program in resource limited developing countries. In conclusion, HPV vaccine is safe with high acceptability in Nepalese school girls. However a large population study for longer follow up is warranted to validate the findings of this vaccination program.

Simulated effect of pneumococcal vaccination in the Netherlands on existing rules constructed in a non-vaccinated cohort predicting sequelae after bacterial meningitis

PubMed Central

2010-01-01

Background Previously two prediction rules identifying children at risk of hearing loss and academic or behavioral limitations after bacterial meningitis were developed. Streptococcus pneumoniae as causative pathogen was an important risk factor in both. Since 2006 Dutch children receive seven-valent conjugate vaccination against S. pneumoniae. The presumed effect of vaccination was simulated by excluding all children infected by S. pneumoniae with the serotypes included in the vaccine, from both previous collected cohorts (between 1990-1995). Methods Children infected by one of the vaccine serotypes were excluded from both original cohorts (hearing loss: 70 of 628 children; academic or behavioral limitations: 26 of 182 children). All identified risk factors were included in multivariate logistic regression models. The discriminative ability of both new models was calculated. Results The same risk factors as in the original models were significant. The discriminative ability of the original hearing loss model was 0.84 and of the new model 0.87. In the academic or behavioral limitations model it was 0.83 and 0.84 respectively. Conclusion It can be assumed that the prediction rules will also be applicable on a vaccinated population. However, vaccination does not provide 100% coverage and evidence is available that serotype replacement will occur. The impact of vaccination on serotype replacement needs to be investigated, and the prediction rules must be validated externally. PMID:20815866

Marker vaccine strategies and candidate CSFV marker vaccines.

PubMed

Dong, Xiao-Nan; Chen, Ying-Hua

2007-01-04

Classical swine fever (CSF) is an economically important highly contagious disease of swine worldwide. Classical swine fever virus (CSFV) is its etiological agent, and the only natural hosts are domestic pigs and wild boars. Although field CSFV strains vary in the virulence, they all result in serious losses in pig industry. Highly virulent field strains generally cause acute disease and high mortality; moderately virulent field strains raise subacute or chronic infections; postnatal infection by low virulent field strains produces subclinical infection and mortality in the new-born piglets. CSFV can cross the placental barrier, and this transplacental transmission usually results in mortality of fetuses and birth of congenitally infected pigs with a late-onset disease and death. Two main strategies to control CSF epidemic are systematic prophylactic vaccination with live attenuated vaccines (such as C-strain) and non-vaccination stamping-out policy. But neither of them is satisfying enough. Marker vaccine and companion serological diagnostic test is thought to be a promising strategy for future control and eradication of CSF. During the past 15 years, various candidate marker vaccines were constructed and evaluated in the animal experiments, including recombinant chimeric vaccines, recombinant deletion vaccines, DNA vaccines, subunit vaccines and peptide vaccines. Among them, two subunit vaccines entered the large scale marker vaccine trial of EU in 1999. Although they failed to fulfil all the demands of the Scientific Veterinary Committee, they successfully induced solid immunity against CSFV in the vaccinated pigs. It can be expected that new potent marker vaccines might be commercially available and used in systematic prophylactic vaccination campaign or emergency vaccination in the next 15 years. Here, we summarized current strategies and candidate CSFV marker vaccines. These strategies and methods are also helpful for the development of new

Safety of a quadrivalent meningococcal serogroups A, C, W and Y conjugate vaccine (MenACWY-CRM) administered with routine infant vaccinations: results of an open-label, randomized, phase 3b controlled study in healthy infants.

PubMed

Abdelnour, Arturo; Silas, Peter E; Lamas, Marta Raquel Valdés; Aragón, Carlos Fernándo Grazioso; Chiu, Nan-Chang; Chiu, Cheng-Hsun; Acuña, Teobaldo Herrera; Castrejón, Tirza De León; Izu, Allen; Odrljin, Tatjana; Smolenov, Igor; Hohenboken, Matthew; Dull, Peter M

2014-02-12

The highest risk for invasive meningococcal disease (IMD) is in infants aged <1 year. Quadrivalent meningococcal conjugate vaccination has the potential to prevent IMD caused by serogroups A, C, W and Y. This phase 3b, multinational, open-label, randomized, parallel-group, multicenter study evaluated the safety of a 4-dose series of MenACWY-CRM, a quadrivalent meningococcal conjugate vaccine, concomitantly administered with routine vaccinations to healthy infants. Two-month-old infants were randomized 3:1 to receive MenACWY-CRM with routine vaccines or routine vaccines alone at ages 2, 4, 6 and 12 months. Adverse events (AEs) that were medically attended and serious adverse events (SAEs) were collected from all subjects from enrollment through 18 months of age. In a subset, detailed safety data (local and systemic solicited reactions and all AEs) were collected for 7 days post vaccination. The primary objective was a non-inferiority comparison of the percentages of subjects with ≥1 severe systemic reaction during Days 1-7 after any vaccination of MenACWY-CRM plus routine vaccinations versus routine vaccinations alone (criterion: upper limit of 95% confidence interval [CI] of group difference <6%). A total of 7744 subjects were randomized with 1898 in the detailed safety arm. The percentage of subjects with severe systemic reactions was 16% after MenACWY-CRM plus routine vaccines and 13% after routine vaccines alone (group difference 3.0% (95% CI -0.8, 6.4%). Although the non-inferiority criterion was not met, post hoc analysis controlling for significant center and group-by-center differences revealed that MenACWY-CRM plus routine vaccinations was non-inferior to routine vaccinations alone (group difference -0.1% [95% CI -4.9%, 4.7%]). Rates of solicited AEs, medically attended AEs, and SAEs were similar across groups. In a large multinational safety study, a 4-dose series of MenACWY-CRM concomitantly administered with routine vaccines was clinically acceptable

Removing the regional level from the Niger vaccine supply chain.

PubMed

Assi, Tina-Marie; Brown, Shawn T; Kone, Souleymane; Norman, Bryan A; Djibo, Ali; Connor, Diana L; Wateska, Angela R; Rajgopal, Jayant; Slayton, Rachel B; Lee, Bruce Y

2013-06-10

Since many of the world's vaccine supply chains contain multiple levels, the question remains of whether removing a level could bring efficiencies. We utilized HERMES to generate a detailed discrete-event simulation model of Niger's vaccine supply chain and compared the current four-tier (central, regional, district, and integrated health center levels) with a modified three-tier structure (removing the regional level). Different scenarios explored various accompanying shipping policies and frequencies. Removing the regional level and implementing a collection-based shipping policy from the district stores increases vaccine availability from a mean of 70-100% when districts could collect vaccines at least weekly. Alternatively, implementing a delivery-based shipping policy from the central store monthly in three-route and eight-route scenarios only increases vaccine availability to 87%. Restricting central-to district vaccine shipments to a quarterly schedule for three-route and eight-route scenarios reduces vaccine availability to 49%. The collection-based shipping policy from district stores reduces supply chain logistics cost per dose administered from US$0.14 at baseline to US$0.13 after removing the regional level. Removing the regional level from Niger's vaccine supply chain can substantially improve vaccine availability as long as certain concomitant adjustments to shipping policies and frequencies are implemented. Copyright © 2013 Elsevier Ltd. All rights reserved.

Removing the Regional Level from the Niger Vaccine Supply Chain

PubMed Central

Assi, Tina-Marie; Brown, Shawn T.; Kone, Souleymane; Norman, Bryan A.; Djibo, Ali; Connor, Diana L.; Wateska, Angela R.; Rajgopal, Jayant; Slayton, Rachel B.; Lee, Bruce Y.

2013-01-01

Objective Since many of the world’s vaccine supply chains contain multiple levels, the question remains of whether removing a level could bring efficiencies. Methods We utilized HERMES to generate a detailed discrete-event simulation model of Niger’s vaccine supply chain and compare the current four-tier (central, regional, district and integrated health center levels) with a modified three-tier structure (removing the regional level). Different scenarios explored various accompanying shipping policies and frequencies. Findings Removing the regional level and implementing a collection-based shipping policy from the district stores increases vaccine availability from a mean of 70% to 100% when districts could collect vaccines at least weekly. Alternatively, implementing a delivery-based shipping policy from the central store monthly in three-route and eight-route scenarios only increases vaccine availability to 87%. Restricting central-to district vaccine shipments to a quarterly schedule for three-route and eight-route scenarios reduces vaccine availability to 49%. The collection-based shipping policy from district stores reduces supply chain logistics cost per dose administered from US$0.14 at baseline to US$0.13 after removing the regional level. Conclusion Removing the regional level from Niger’s vaccine supply chain can substantially improve vaccine availability as long as certain concomitant adjustments to shipping policies and frequencies are implemented. PMID:23602666

Validity and reliability of self-reported arthritis: Georgia senior centers, 2000-2001.

PubMed

Bombard, Jennifer M; Powell, Kenneth E; Martin, Linda M; Helmick, Charles G; Wilson, William H

2005-04-01

Arthritis and other rheumatic conditions are a common cause of disability among adults in the United States. Telephone interviews of the state-based Behavioral Risk Factor Surveillance System (BRFSS) are used by states and territories to estimate the prevalence of arthritis. The purpose of this study was to assess the validity and reliability of the 1996-2001 BRFSS arthritis case definition in a senior center population. A total of 487 respondents at selected senior centers in Georgia were surveyed by telephone, evaluated 3 to 4 weeks later by board-certified rheumatologists, and completed a written survey in 2000 to 2001. Using the rheumatologists' summary assessment "Does this person have arthritis or a related condition" as the standard, the sensitivity and specificity of the BRFSS arthritis case definitions were calculated. Reliability for the BRFSS arthritis case definition was also calculated by comparing responses to the telephone survey with responses to a written survey. Sensitivity was 70.8% (95% confidence interval [CI]=65.9-75.6), and the specificity was 70.3% (95% CI=62.9-77.8). The agreement between the telephone and written responses indicating self-reported arthritis was high (kappa=0.68). Analyses were conducted in 2002 to 2004. Self-reported arthritis in the 1996-2001 BRFSS was highly reliable, and moderately sensitive and specific among these senior center participants.

A systematic review and meta-analysis for the adverse effects, immunogenicity and efficacy of Lyme disease vaccines: Guiding novel vaccine development.

PubMed

Badawi, Alaa; Shering, Maria; Rahman, Shusmita; Lindsay, L Robbin

2017-04-20

Lyme borreliosis (LB) is the most prevalent arthropod-borne infectious disease in North America. Currently, no vaccine is available to prevent LB in humans, although monovalent and multivalent vaccines have been developed in the past. The aim of the current study is to conduct a systematic review and meta-analysis to evaluate and compare the findings from these two classes of vaccines for their reactogenicity, immunogenicity and efficacy, in the hope this may assist in the development of future vaccines. A search strategy was developed for online databases (PubMed, Ovid MEDLINE, and Embase). Search terms used were "vaccine/vaccination", "Lyme disease/Borreliosis", "clinical trial(s)" and "efficacy". Only seven clinical trials were included to compare the results of the monovalent vaccines to those of the multivalent one. Meta-analyses were conducted to evaluate the reactogenicity and immunogenicity of the two vaccine classes. Odds ratio (OR) for LB (and 95% confidence intervals; 95% CI) were calculated for the efficacy of the monovalent vaccine from three different clinical trials at different dose schedules. Incidence of redness (local adverse effect) and fever (systemic side effect) were, respectively, 6.8- and 2.9-fold significantly lower (p < 0.05) in individuals who received multivalent vaccines compared to those receiving the monovalent one. Incidences of all other local and systemic adverse effects were non-significantly lower in the multivalent vaccine compared to the monovalent vaccines. Seroprotection was comparable among individuals who received the two vaccine classes at the 30 μg dose level. Efficacy in the prevention of LB was only evaluated for the monovalent vaccines. OR of LB ranged from 0.49 (95% CI: 0.14-0.70; p < 0.005, vs. placebo) to 0.31 (95% CI: 0.26-0.63; p < 0.005) for the initial and final doses respectively, with an overall OR of 0.4 (95% CI: 0.26-0.63, p < 0.001). The current study further validates that the monovalent and

Vaccine hesitancy

PubMed Central

Dubé, Eve; Laberge, Caroline; Guay, Maryse; Bramadat, Paul; Roy, Réal; Bettinger, Julie A.

2013-01-01

Despite being recognized as one of the most successful public health measures, vaccination is perceived as unsafe and unnecessary by a growing number of individuals. Lack of confidence in vaccines is now considered a threat to the success of vaccination programs. Vaccine hesitancy is believed to be responsible for decreasing vaccine coverage and an increasing risk of vaccine-preventable disease outbreaks and epidemics. This review provides an overview of the phenomenon of vaccine hesitancy. First, we will characterize vaccine hesitancy and suggest the possible causes of the apparent increase in vaccine hesitancy in the developed world. Then we will look at determinants of individual decision-making about vaccination. PMID:23584253

Comprehensive Serological Analysis of Two Successive Heterologous Vaccines against H5N1 Avian Influenza Virus in Exotic Birds in Zoos▿

PubMed Central

Vergara-Alert, Júlia; Fernández-Bellon, Hugo; Busquets, Núria; Alcántara, Gabriel; Delclaux, María; Pizarro, Bienvenido; Sánchez, Celia; Sánchez, Azucena; Majó, Natàlia; Darji, Ayub

2011-01-01

In 2005, European Commission directive 2005/744/EC allowed controlled vaccination against avian influenza (AI) virus of valuable avian species housed in zoos. In 2006, 15 Spanish zoos and wildlife centers began a vaccination program with a commercial inactivated H5N9 vaccine. Between November 2007 and May 2008, birds from 10 of these centers were vaccinated again with a commercial inactivated H5N3 vaccine. During these campaigns, pre- and postvaccination samples from different bird orders were taken to study the response against AI virus H5 vaccines. Sera prior to vaccinations with both vaccines were examined for the presence of total antibodies against influenza A nucleoprotein (NP) by a commercial competitive enzyme-linked immunosorbent assay (cELISA). Humoral responses to vaccination were evaluated using a hemagglutination inhibition (HI) assay. In some taxonomic orders, both vaccines elicited comparatively high titers of HI antibodies against H5. Interestingly, some orders, such as Psittaciformes, which did not develop HI antibodies to either vaccine formulation when used alone, triggered notable HI antibody production, albeit in low HI titers, when primed with H5N9 and during subsequent boosting with the H5N3 vaccine. Vaccination with successive heterologous vaccines may represent the best alternative to widely protect valuable and/or endangered bird species against highly pathogenic AI virus infection. PMID:21430124

Comprehensive serological analysis of two successive heterologous vaccines against H5N1 avian influenza virus in exotic birds in zoos.

PubMed

Vergara-Alert, Júlia; Fernández-Bellon, Hugo; Busquets, Núria; Alcántara, Gabriel; Delclaux, María; Pizarro, Bienvenido; Sánchez, Celia; Sánchez, Azucena; Majó, Natàlia; Darji, Ayub

2011-05-01

In 2005, European Commission directive 2005/744/EC allowed controlled vaccination against avian influenza (AI) virus of valuable avian species housed in zoos. In 2006, 15 Spanish zoos and wildlife centers began a vaccination program with a commercial inactivated H5N9 vaccine. Between November 2007 and May 2008, birds from 10 of these centers were vaccinated again with a commercial inactivated H5N3 vaccine. During these campaigns, pre- and postvaccination samples from different bird orders were taken to study the response against AI virus H5 vaccines. Sera prior to vaccinations with both vaccines were examined for the presence of total antibodies against influenza A nucleoprotein (NP) by a commercial competitive enzyme-linked immunosorbent assay (cELISA). Humoral responses to vaccination were evaluated using a hemagglutination inhibition (HI) assay. In some taxonomic orders, both vaccines elicited comparatively high titers of HI antibodies against H5. Interestingly, some orders, such as Psittaciformes, which did not develop HI antibodies to either vaccine formulation when used alone, triggered notable HI antibody production, albeit in low HI titers, when primed with H5N9 and during subsequent boosting with the H5N3 vaccine. Vaccination with successive heterologous vaccines may represent the best alternative to widely protect valuable and/or endangered bird species against highly pathogenic AI virus infection.

Integrating pharmacies into public health program planning for pandemic influenza vaccine response.

PubMed

Fitzgerald, Thomas J; Kang, Yoonjae; Bridges, Carolyn B; Talbert, Todd; Vagi, Sara J; Lamont, Brock; Graitcer, Samuel B

2016-11-04

During an influenza pandemic, to achieve early and rapid vaccination coverage and maximize the benefit of an immunization campaign, partnerships between public health agencies and vaccine providers are essential. Immunizing pharmacists represent an important group for expanding access to pandemic vaccination. However, little is known about nationwide coordination between public health programs and pharmacies for pandemic vaccine response planning. To assess relationships and planning activities between public health programs and pharmacies, we analyzed data from Centers for Disease Control and Prevention assessments of jurisdictions that received immunization and emergency preparedness funding from 2012 to 2015. Forty-seven (88.7%) of 53 jurisdictions reported including pharmacies in pandemic vaccine distribution plans, 24 (45.3%) had processes to recruit pharmacists to vaccinate, and 16 (30.8%) of 52 established formal relationships with pharmacies. Most jurisdictions plan to allocate less than 10% of pandemic vaccine supply to pharmacies. While most jurisdictions plan to include pharmacies as pandemic vaccine providers, work is needed to establish formalized agreements between public health departments and pharmacies to improve pandemic preparedness coordination and ensure that vaccinating pharmacists are fully utilized during a pandemic. Copyright © 2016 Elsevier Ltd. All rights reserved.

Immune Responses in Pigs Vaccinated with Adjuvanted and Non-Adjuvanted A(H1N1)pdm/09 Influenza Vaccines Used in Human Immunization Programmes

PubMed Central

Lefevre, Eric A.; Carr, B. Veronica; Inman, Charlotte F.; Prentice, Helen; Brown, Ian H.; Brookes, Sharon M.; Garcon, Fanny; Hill, Michelle L.; Iqbal, Munir; Elderfield, Ruth A.; Barclay, Wendy S.; Gubbins, Simon; Bailey, Mick; Charleston, Bryan

2012-01-01

Following the emergence and global spread of a novel H1N1 influenza virus in 2009, two A(H1N1)pdm/09 influenza vaccines produced from the A/California/07/09 H1N1 strain were selected and used for the national immunisation programme in the United Kingdom: an adjuvanted split virion vaccine and a non-adjuvanted whole virion vaccine. In this study, we assessed the immune responses generated in inbred large white pigs (Babraham line) following vaccination with these vaccines and after challenge with A(H1N1)pdm/09 virus three months post-vaccination. Both vaccines elicited strong antibody responses, which included high levels of influenza-specific IgG1 and haemagglutination inhibition titres to H1 virus. Immunisation with the adjuvanted split vaccine induced significantly higher interferon gamma production, increased frequency of interferon gamma-producing cells and proliferation of CD4−CD8+ (cytotoxic) and CD4+CD8+ (helper) T cells, after in vitro re-stimulation. Despite significant differences in the magnitude and breadth of immune responses in the two vaccinated and mock treated groups, similar quantities of viral RNA were detected from the nasal cavity in all pigs after live virus challenge. The present study provides support for the use of the pig as a valid experimental model for influenza infections in humans, including the assessment of protective efficacy of therapeutic interventions. PMID:22427834

Intranasal Live Influenza Vaccine Priming Elicits Localized B Cell Responses in Mediastinal Lymph Nodes.

PubMed

Jegaskanda, Sinthujan; Mason, Rosemarie D; Andrews, Sarah F; Wheatley, Adam K; Zhang, Ruijun; Reynoso, Glennys V; Ambrozak, David R; Santos, Celia P; Luke, Catherine J; Matsuoka, Yumiko; Brenchley, Jason M; Hickman, Heather D; Talaat, Kawsar R; Permar, Sallie R; Liao, Hua-Xin; Yewdell, Jonathan W; Koup, Richard A; Roederer, Mario; McDermott, Adrian B; Subbarao, Kanta

2018-05-01

Pandemic live attenuated influenza vaccines (pLAIV) prime subjects for a robust neutralizing antibody response upon subsequent administration of a pandemic inactivated subunit vaccine (pISV). However, a difference was not detected in H5-specific memory B cells in the peripheral blood between pLAIV-primed and unprimed subjects prior to pISV boost. To investigate the mechanism underlying pLAIV priming, we vaccinated groups of 12 African green monkeys (AGMs) with H5N1 pISV or pLAIV alone or H5N1 pLAIV followed by pISV and examined immunity systemically and in local draining lymph nodes (LN). The AGM model recapitulated the serologic observations from clinical studies. Interestingly, H5N1 pLAIV induced robust germinal center B cell responses in the mediastinal LN (MLN). Subsequent boosting with H5N1 pISV drove increases in H5-specific B cells in the axillary LN, spleen, and circulation in H5N1 pLAIV-primed animals. Thus, H5N1 pLAIV primes localized B cell responses in the MLN that are recalled systemically following pISV boost. These data provide mechanistic insights for the generation of robust humoral responses via prime-boost vaccination. IMPORTANCE We have previously shown that pandemic live attenuated influenza vaccines (pLAIV) prime for a rapid and robust antibody response on subsequent administration of inactivated subunit vaccine (pISV). This is observed even in individuals who had undetectable antibody (Ab) responses following the initial vaccination. To define the mechanistic basis of pLAIV priming, we turned to a nonhuman primate model and performed a detailed analysis of B cell responses in systemic and local lymphoid tissues following prime-boost vaccination with pLAIV and pISV. We show that the nonhuman primate model recapitulates the serologic observations from clinical studies. Further, we found that pLAIVs induced robust germinal center B cell responses in the mediastinal lymph node. Subsequent boosting with pISV in pLAIV-primed animals resulted in

Risk of venous thromboembolism following influenza vaccination in adults aged 50years and older in the Vaccine Safety Datalink.

PubMed

Vickers, Elizabeth R; McClure, David L; Naleway, Allison L; Jacobsen, Steven J; Klein, Nicola P; Glanz, Jason M; Weintraub, Eric S; Belongia, Edward A

2017-10-13

Influenza-like illness and inflammation are known risk factors for venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE). However, few studies have characterized the risk of VTE following influenza vaccination. We examined VTE risk after vaccination in adults 50years old and older within the Vaccine Safety Datalink (VSD). We used the self-controlled case series method to determine the risk of VTE among age-eligible adults who received influenza vaccine (with or without pandemic H1N1) and experienced a VTE during the months of September through December in 2007 through 2012. Presumptive VTE cases were identified among VSD participants using diagnostic codes, diagnostic tests, and oral anticoagulant prescription. Potential cases were validated by medical record review. The VTE incidence rate ratio was calculated among confirmed cases for the risk window 1 to 10days after vaccination relative to all other person-time from September through December. Of the 1,488 presumptive cases identified, 508 were reviewed, of which 492 (97%) were confirmed cases of VTE. The analysis included 396 incident, confirmed cases. Overall, there was no increased risk of VTE in the 1 to 10days after influenza vaccination (IRR=0.89, 95% CI 0.69-1.17) compared to the control period. Results were similar when all person-time was censored before vaccination. A post hoc analysis showed an increased risk among current tobacco smokers (IRR=2.57, 95% CI 1.06-6.23). No clustering of VTE was observed in the 1-42days after vaccination. Overall, there was no evidence that inactivated influenza vaccine was associated with VTE in adults ≥50years old. An increased risk was found among current smokers in a post hoc analysis. These findings are consistent with previous research and support the safety of annual vaccination in this population. Copyright © 2017 Elsevier Ltd. All rights reserved.

Vaccines.gov

MedlinePlus

... Vaccine Safety Vaccines Work Vaccine Types Vaccine Ingredients Vaccines by Disease Chickenpox ... Typhoid Fever Whooping Cough (Pertussis) Yellow Fever Who and When Infants, Children, and Teens ...

Vaccines for Children: Critical Issues in Design and Implementation. Report to Congressional Requesters [and] Vaccines for Children: Major Implementation Hurdles Remain. Testimony of Kwai-Cheung Chan, before the Subcommittee on Labor, Health, Human Services, and Education, Committee on Appropriations, United States Senate.

ERIC Educational Resources Information Center

General Accounting Office, Washington, DC. Program Evaluation and Methodology Div.

In response to congressional request, this report provides information on the implementation plans developed by the Center for Disease Control (CDC) for the Vaccines for Children (VFC) Program. Introductory material indicates that the VFC was created to increase vaccine coverage levels nationwide by creating an entitlement to free vaccine for…

A brief history of vaccines & vaccination in India.

PubMed

Lahariya, Chandrakant

2014-04-01

The challenges faced in delivering lifesaving vaccines to the targeted beneficiaries need to be addressed from the existing knowledge and learning from the past. This review documents the history of vaccines and vaccination in India with an objective to derive lessons for policy direction to expand the benefits of vaccination in the country. A brief historical perspective on smallpox disease and preventive efforts since antiquity is followed by an overview of 19 th century efforts to replace variolation by vaccination, setting up of a few vaccine institutes, cholera vaccine trial and the discovery of plague vaccine. The early twentieth century witnessed the challenges in expansion of smallpox vaccination, typhoid vaccine trial in Indian army personnel, and setting up of vaccine institutes in almost each of the then Indian States. In the post-independence period, the BCG vaccine laboratory and other national institutes were established; a number of private vaccine manufacturers came up, besides the continuation of smallpox eradication effort till the country became smallpox free in 1977. The Expanded Programme of Immunization (EPI) (1978) and then Universal Immunization Programme (UIP) (1985) were launched in India. The intervening events since UIP till India being declared non-endemic for poliomyelitis in 2012 have been described. Though the preventive efforts from diseases were practiced in India, the reluctance, opposition and a slow acceptance of vaccination have been the characteristic of vaccination history in the country. The operational challenges keep the coverage inequitable in the country. The lessons from the past events have been analysed and interpreted to guide immunization efforts.

A brief history of vaccines & vaccination in India

PubMed Central

Lahariya, Chandrakant

2014-01-01

The challenges faced in delivering lifesaving vaccines to the targeted beneficiaries need to be addressed from the existing knowledge and learning from the past. This review documents the history of vaccines and vaccination in India with an objective to derive lessons for policy direction to expand the benefits of vaccination in the country. A brief historical perspective on smallpox disease and preventive efforts since antiquity is followed by an overview of 19th century efforts to replace variolation by vaccination, setting up of a few vaccine institutes, cholera vaccine trial and the discovery of plague vaccine. The early twentieth century witnessed the challenges in expansion of smallpox vaccination, typhoid vaccine trial in Indian army personnel, and setting up of vaccine institutes in almost each of the then Indian States. In the post-independence period, the BCG vaccine laboratory and other national institutes were established; a number of private vaccine manufacturers came up, besides the continuation of smallpox eradication effort till the country became smallpox free in 1977. The Expanded Programme of Immunization (EPI) (1978) and then Universal Immunization Programme (UIP) (1985) were launched in India. The intervening events since UIP till India being declared non-endemic for poliomyelitis in 2012 have been described. Though the preventive efforts from diseases were practiced in India, the reluctance, opposition and a slow acceptance of vaccination have been the characteristic of vaccination history in the country. The operational challenges keep the coverage inequitable in the country. The lessons from the past events have been analysed and interpreted to guide immunization efforts. PMID:24927336

Commentary--Controversies surrounding mercury in vaccines: autism denial as impediment to universal immunisation.

PubMed

Chhawchharia, Ritika; Puliyel, Jacob M

2014-01-01

In 2004, the US Center for Disease Control (CDC) published a paper showing that there is no link between the age at which a child is vaccinated with MMR and the vaccinated children's risk of a subsequent diagnosis of autism. One of the authors, William Thompson, has now revealed that statistically significant information was deliberately omitted from the paper. Thompson first told Dr S Hooker, a researcher on autism, about the manipulation of the data. Hooker analysed the raw data from the CDC study afresh. He confirmed that the risk of autism among African American children vaccinated before the age of 2 years was 340% that of those vaccinated later.

Ethical and legal challenges of vaccines and vaccination: Reflections.

PubMed

Jesani, Amar; Johari, Veena

2017-01-01

Vaccines and vaccination have emerged as key medical scientific tools for prevention of certain diseases. Documentation of the history of vaccination shows that the initial popular resistance to universal vaccination was based on false assumptions and eventually gave way to acceptance of vaccines and trust in their ability to save lives. The successes of the global eradication of smallpox, and now of polio, have only strengthened the premier position occupied by vaccines in disease prevention. However, the success of vaccines and public trust in their ability to eradicate disease are now under challenge, as increasing numbers of people refuse vaccination, questioning the effectiveness of vaccines and the need to vaccinate.

Vaccine Hesitancy and Online Information: The Influence of Digital Networks.

PubMed

Getman, Rebekah; Helmi, Mohammad; Roberts, Hal; Yansane, Alfa; Cutler, David; Seymour, Brittany

2017-12-01

This article analyzes the digital childhood vaccination information network for vaccine-hesitant parents. The goal of this study was to explore the structure and influence of vaccine-hesitant content online by generating a database and network analysis of vaccine-relevant content. We used Media Cloud, a searchable big-data platform of over 550 million stories from 50,000 media sources, for quantitative and qualitative study of an online media sample based on keyword selection. We generated a hyperlink network map and measured indegree centrality of the sources and vaccine sentiment for a random sample of 450 stories. 28,122 publications from 4,817 sources met inclusion criteria. Clustered communities formed based on shared hyperlinks; communities tended to link within, not among, each other. The plurality of information was provaccine (46.44%, 95% confidence interval [39.86%, 53.20%]). The most influential sources were in the health community (National Institutes of Health, Centers for Disease Control and Prevention) or mainstream media ( New York Times); some user-generated sources also had strong influence and were provaccine (Wikipedia). The vaccine-hesitant community rarely interacted with provaccine content and simultaneously used primary provaccine content within vaccine-hesitant narratives. The sentiment of the overall conversation was consistent with scientific evidence. These findings demonstrate an online environment where scientific evidence online drives vaccine information outside of the vaccine-hesitant community but is also prominently used and misused within the robust vaccine-hesitant community. Future communication efforts should take current context into account; more information may not prevent vaccine hesitancy.

Tularemia vaccine: Safety, reactogenicity, "Take" skin reactions, and antibody responses following vaccination with a new lot of the Francisella tularensis live vaccine strain - A phase 2 randomized clinical Trial.

PubMed

Mulligan, Mark J; Stapleton, Jack T; Keitel, Wendy A; Frey, Sharon E; Chen, Wilbur H; Rouphael, Nadine; Edupuganti, Srilatha; Beck, Allison; Winokur, Patricia L; El Sahly, Hana M; Patel, Shital M; Atmar, Robert L; Graham, Irene; Anderson, Edwin; El-Kamary, Samer S; Pasetti, Marcela F; Sztein, Marcelo B; Hill, Heather; Goll, Johannes B

2017-08-24

Tularemia is caused by Francisella tularensis, a gram-negative bacterium that has been weaponized as an aerosol. For protection of personnel conducting biodefense research, the United States Army required clinical evaluation of a new lot of tularemia live vaccine strain manufactured in accordance with Current Good Manufacturing Practices. A phase 2 randomized clinical trial compared the new lot (DVC-LVS) to the existing vaccine that has been in use for decades (USAMRIID-LVS). The vaccines were delivered by scarification to 228 participants. Safety, reactogenicity, take and/or antibody levels were assessed on days 0, 1, 2, 8, 14, 28, 56, and 180. Both vaccines were safe and had acceptable reactogenicity profiles during six months of follow-up. There were no serious or grade 3 and 4 laboratory adverse events. Moderate systemic reactogenicity (mostly headache or feeling tired) was reported by ∼23% of participants receiving either vaccine. Injection site reactogenicity was mostly mild itchiness and pain. The frequencies of vaccine take skin reactions were 73% (95% CI, 64, 81) for DVC-LVS and 80% (95% CI, 71, 87) for USAMRIID-LVS. The 90% CI for the difference in proportions was -6.9% (-16.4, 2.6). The rates of seroconversion measured by microagglutination assay on days 28 or 56 were 94% (95% CI, 88, 98; n=98/104) for DVC-LVS and 94% (95% CI, 87, 97; n=103/110) for USAMRIID-LVS (p=1.00). Day 14 sera revealed more rapid seroconversion for DVC-LVS relative to USAMRIID-LVS: 82% (95% CI, 73, 89) versus 55% (95% CI, 45, 65), respectively (p<0.0001). The DVC-LVS vaccine had similar safety, reactogenicity, take and antibody responses compared to the older USAMRIID vaccine, and was superior for early (day 14) antibody production. Vaccination take was not a sensitive surrogate for seroconversion in a multi-center study where personnel at five research clinics performed assessments. ClinicalTrials.gov identifier NCT01150695. Copyright © 2017 The Authors. Published by Elsevier

HPV vaccine

MedlinePlus

... HPV; Gardasil; HPV2; HPV4; Vaccine to prevent cervical cancer; Genital warts - HPV vaccine; Cervical dysplasia - HPV vaccine; Cervical cancer - HPV vaccine; Cancer of the cervix - HPV vaccine; ...

[Results of Booster Vaccination in Children with Primary Vaccine Failure after Initial Varicella Vaccination].

PubMed

Ozakiv, Takao; Nishimura, Naoko; Gotoh, Kensei; Funahashi, Keiji; Yoshii, Hironori; Okuno, Yoshinobu

2016-05-01

In October 2014, the varicella vaccination policy in Japan was changed from a single voluntary inoculation to two routine inoculations. This paper reports the results of booster vaccination in children who did not show seroconversion after initial vaccination (i.e., primary vaccine failure : PVF) over a 7-year period prior to the introduction of routine varicella vaccination. Between November 2007 and May 2014, 273 healthy children aged between 1.1 and 14.5 years (median : 1.7 years) underwent varicella vaccination. Before and 4 to 6 weeks after vaccination, the antibody titers were measured using an immune adherence hemagglutination (IAHA) assay and a glycoprotein-based enzyme-linked immunosorbent assay (gpELISA). In addition, side reactions were examined during the four-week period after vaccination. Children who did not show IAHA seroconversion (PVF) were recommended to receive a booster vaccination, and the measurement of antibody titers and an assessment of side reactions were performed after the booster dose. In May 2015, a questionnaire was mailed to each of the 273 participants to investigate whether they had developed varicella and/or herpes zoster after vaccination. After initial vaccination, the IAHA seroconversion rate was 75% and the mean antibody titer (Log2) with seroconversion was 4.7, while the gpELISA seroconversion rate was 84% and the mean antibody titer (Log10) with seroconversion was 2.4. Among children with PVF, 54 received booster vaccination within 81 to 714 days (median : 139 days) after the initial vaccination. After booster vaccination, the IAHA seroconversion rate was 98% and the mean antibody titer (Log2) with seroconversion was 5.8. Both the seroconversion rate and the antibody titer were higher compared with the values after the initial vaccination (p < 0.01). After booster vaccination, the gpELISA seropositive rate was 100% and the mean positive antibody titer (Log 10) was 3.6 ; similar results were obtained for the IAHA assay, with

Questionnaire survey on mumps vaccination for parents in Nara prefecture, Japan.

PubMed

Kitano, Taito; Nishikawa, Hiroki; Onaka, Masayuki; Ishihara, Mariko; Nishiyama, Atsuko; Yoshida, Sayaka

2018-04-01

Although the mumps vaccine has not been included in the national immunization program (NIP) in Japan, it has been shown that a two-dose routine vaccine program would be highly cost-effective. In this study, we carried outa questionnaire-based study to investigate how many Japanese parents want the mumps vaccine to be included in the NIP with proper information. The questionnaire was given to parents who visited the Pediatrics or neonatal intensive care unit of Nara Prefecture General Medical Center, Nara City, Japan, between 1 March 2017 and 31 August 2017. The questionnaire consisted of information about mumps and six questions, for example (i) do parents know that mumps can be prevented by vaccine; (ii) do they know that they need to pay for mumps vaccines; and (iii) do they hope that the government will resume routine mumps vaccination. In total, 1,224 parents answered the questionnaire. A total of 81% and 75.4% of parents knew that mumps can be prevented by vaccination and that mumps vaccine is not included in the NIP, respectively, before reading the information. After reading the information, 95.0% of parents thought that mumps vaccine should be included in the NIP. While 61.7% of parents answered that they would choose two-dose vaccination without governmental financial support, 92.1% of them would choose two-dose vaccination with governmental financial support (P < 0.0001). Japanese parents want the mumps vaccine to be included in the NIP. Japan is able to start routine use of the mumps vaccine now. © 2017 Japan Pediatric Society.

Vaccine Hesitancy.

PubMed

Jacobson, Robert M; St Sauver, Jennifer L; Finney Rutten, Lila J

2015-11-01

Vaccine refusal received a lot of press with the 2015 Disneyland measles outbreak, but vaccine refusal is only a fraction of a much larger problem of vaccine delay and hesitancy. Opposition to vaccination dates back to the 1800 s, Edward Jenner, and the first vaccine ever. It has never gone away despite the public's growing scientific sophistication. A variety of factors contribute to modern vaccine hesitancy, including the layperson's heuristic thinking when it comes to balancing risks and benefits as well as a number of other features of vaccination, including falling victim to its own success. Vaccine hesitancy is pervasive, affecting a quarter to a third of US parents. Clinicians report that they routinely receive requests to delay vaccines and that they routinely acquiesce. Vaccine rates vary by state and locale and by specific vaccine, and vaccine hesitancy results in personal risk and in the failure to achieve or sustain herd immunity to protect others who have contraindications to the vaccine or fail to generate immunity to the vaccine. Clinicians should adopt a variety of practices to combat vaccine hesitancy, including a variety of population health management approaches that go beyond the usual call to educate patients, clinicians, and the public. Strategies include using every visit to vaccinate, the creation of standing orders or nursing protocols to provide vaccination without clinical encounters, and adopting the practice of stating clear recommendations. Up-to-date, trusted resources exist to support clinicians' efforts in adopting these approaches to reduce vaccine hesitancy and its impact. Copyright © 2015 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

Subviral Particle as Vaccine and Vaccine Platform

PubMed Central

Tan, Ming; Jiang, Xi

2014-01-01

Recombinant subvirual particles retain similar antigenic features of their authentic viral capsids and thus have been applied as nonreplicating subunit vaccines against viral infection and illness. Additionally, the self-assembled, polyvalent subviral particles are excellent platforms to display foreign antigens for immune enhancement for vaccine development. These subviral particle-based vaccines are noninfectious and thus safer than the conventional live attenuated and inactivated vaccines. While several VLP vaccines are available in the markets, numerous others, including dual vaccines against more than one pathogen, are under clinical or preclinical development. This article provides an update of these efforts. PMID:24662314

The Vaccine Safety Datalink: immunization research in health maintenance organizations in the USA.

PubMed Central

Chen, R. T.; DeStefano, F.; Davis, R. L.; Jackson, L. A.; Thompson, R. S.; Mullooly, J. P.; Black, S. B.; Shinefield, H. R.; Vadheim, C. M.; Ward, J. I.; Marcy, S. M.

2000-01-01

The Vaccine Safety Datalink is a collaborative project involving the National Immunization Program of the Centers for Disease Control and Prevention and several large health maintenance organizations in the USA. The project began in 1990 with the primary purpose of rigorously evaluating concerns about the safety of vaccines. Computerized data on vaccination, medical outcome (e.g. outpatient visits, emergency room visits, hospitalizations, and deaths) and covariates (e.g. birth certificates, census data) are prospectively collected and linked under joint protocol at multiple health maintenance organizations for analysis. Approximately 6 million persons (2% of the population of the USA) are now members of health maintenance organizations participating in the Vaccine Safety Datalink, which has proved to be a valuable resource providing important information on a number of vaccine safety issues. The databases and infrastructure created for the Vaccine Safety Datalink have also provided opportunities to address vaccination coverage, cost-effectiveness and other matters connected with immunization as well as matters outside this field. PMID:10743283

Impact of the CDC's Section 317 Immunization Grants Program funding on childhood vaccination coverage.

PubMed

Rein, David B; Honeycutt, Amanda A; Rojas-Smith, Lucia; Hersey, James C

2006-09-01

The Centers for Disease Control and Prevention's Section 317 Grants Program is the main source of funding for state and jurisdictional immunization programs, yet no study has evaluated its direct impact on vaccination coverage rates. Therefore, we used a fixed-effects model and data collected from 56 US jurisdictions to estimate the impact of Section 317 financial assistance immunization grants on childhood vaccination coverage rates from 1997 to 2003. Our results showed that increases in Section 317 funding were significantly and meaningfully associated with higher rates of vaccination coverage; a 10 dollars increase in per capita funding corresponded with a 1.6-percentage-point increase in vaccination coverage. Policymakers charged with funding public health programs should consider this study's findings, which indicate that money allocated to vaccine activities translates directly into higher vaccine coverage rates.

A model for estimating the impact of changes in children's vaccines.

PubMed

Simpson, K N; Biddle, A K; Rabinovich, N R

1995-12-01

To assist in strategic planning for the improvement of vaccines and vaccine programs, an economic model was developed and tested that estimates the potential impact of vaccine innovations on health outcomes and costs associated with vaccination and illness. A multistep, iterative process of data extraction/integration was used to develop the model and the scenarios. Parameter replication, sensitivity analysis, and expert review were used to validate the model. The greatest impact on the improvement of health is expected to result from the production of less reactogenic vaccines that require fewer inoculations for immunity. The greatest economic impact is predicted from improvements that decrease the number of inoculations required. Scenario analysis may be useful for integrating health outcomes and economic data into decision making. For childhood infections, this analysis indicates that large cost savings can be achieved in the future if we can improve vaccine efficacy so that the number of required inoculations is reduced. Such an improvement represents a large potential "payback" for the United States and might benefit other countries.

[Antibody responses in Japanese volunteers after immunization with yellow fever vaccine].

PubMed

Taga, Kenichiro; Imura, Shunro; Hayashi, Akihiro; Kamakura, Kazumasa; Hashimoto, Satoru; Takasaki, Tomohiko; Kurane, Ichiro; Uchida, Yukinori

2002-09-01

To monitor the development of specific and cross-reactive antibody response in twenty Japanese volunteers after vaccination with live yellow fever vaccine. Serum samples were collected on various days after vaccination and examined for hemagglutination inhibition (HI) antibodies against yellow fever virus (YFV), Japanese encephalitis virus (JEV) and dengue virus (DV), neutralizing antibodies against YFV and JEV, and IgM antibodies against YFV. None of the volunteers had been previously immunized with this vaccine. Fifteen of 20 had pre-vaccinated with JEV 7 to 40 years before. Ten of the 20 had neutralizing antibodies against JEV before immunization. None of the 20 had detectable antibodies against YFV or DV before vaccination. On day 10th after the vaccination, neutralizing antibodies to YFV were detected in 6 of 19 volunteers and IgM antibodies against YFV were detected in 7 of 19. On day 14th, HI, neutralizing, and IgM antibodies against YFV were detected in all the tested sera. Neutralizing antibodies against JEV were developed in 2 volunteers and HI antibodies against JEV were increased in 3 of 6 volunteers respectively. On day 29th, cross-reactive HI antibodies for JEV and DV were detected in all the tested sera. The results indicate that YF vaccine induces YFV-specific antibodies in all the tested volunteers and that it also induces HI antibodies cross-reactive for JEV and DV. The YF vaccine has a strong immunogenicity because it is a live vaccine, and induces antibody against YFV predominantly. The international certificate of yellow fever vaccination becomes valid 10 days after vaccination. On day 14th after vaccination, we detected neutralizing antibodies against YFV from all tested volunteers, however, only 6 of 19 volunteers had detectable neutralizing antibody on the 10th day after vaccination. Therefore, the vaccine may not be perfectly effective on day 10th after the vaccination.

Case-control vaccine effectiveness studies: Data collection, analysis and reporting results.

PubMed

Verani, Jennifer R; Baqui, Abdullah H; Broome, Claire V; Cherian, Thomas; Cohen, Cheryl; Farrar, Jennifer L; Feikin, Daniel R; Groome, Michelle J; Hajjeh, Rana A; Johnson, Hope L; Madhi, Shabir A; Mulholland, Kim; O'Brien, Katherine L; Parashar, Umesh D; Patel, Manish M; Rodrigues, Laura C; Santosham, Mathuram; Scott, J Anthony; Smith, Peter G; Sommerfelt, Halvor; Tate, Jacqueline E; Victor, J Chris; Whitney, Cynthia G; Zaidi, Anita K; Zell, Elizabeth R

2017-06-05

The case-control methodology is frequently used to evaluate vaccine effectiveness post-licensure. The results of such studies provide important insight into the level of protection afforded by vaccines in a 'real world' context, and are commonly used to guide vaccine policy decisions. However, the potential for bias and confounding are important limitations to this method, and the results of a poorly conducted or incorrectly interpreted case-control study can mislead policies. In 2012, a group of experts met to review recent experience with case-control studies evaluating vaccine effectiveness; we summarize the recommendations of that group regarding best practices for data collection, analysis, and presentation of the results of case-control vaccine effectiveness studies. Vaccination status is the primary exposure of interest, but can be challenging to assess accurately and with minimal bias. Investigators should understand factors associated with vaccination as well as the availability of documented vaccination status in the study context; case-control studies may not be a valid method for evaluating vaccine effectiveness in settings where many children lack a documented immunization history. To avoid bias, it is essential to use the same methods and effort gathering vaccination data from cases and controls. Variables that may confound the association between illness and vaccination are also important to capture as completely as possible, and where relevant, adjust for in the analysis according to the analytic plan. In presenting results from case-control vaccine effectiveness studies, investigators should describe enrollment among eligible cases and controls as well as the proportion with no documented vaccine history. Emphasis should be placed on confidence intervals, rather than point estimates, of vaccine effectiveness. Case-control studies are a useful approach for evaluating vaccine effectiveness; however careful attention must be paid to the collection

FY2017 Pilot Project Plan for the Nuclear Energy Knowledge and Validation Center Initiative

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ren, Weiju

To prepare for technical development of computational code validation under the Nuclear Energy Knowledge and Validation Center (NEKVAC) initiative, several meetings were held by a group of experts of the Idaho National Laboratory (INL) and the Oak Ridge National Laboratory (ORNL) to develop requirements of, and formulate a structure for, a transient fuel database through leveraging existing resources. It was concluded in discussions of these meetings that a pilot project is needed to address the most fundamental issues that can generate immediate stimulus to near-future validation developments as well as long-lasting benefits to NEKVAC operation. The present project is proposedmore » based on the consensus of these discussions. Analysis of common scenarios in code validation indicates that the incapability of acquiring satisfactory validation data is often a showstopper that must first be tackled before any confident validation developments can be carried out. Validation data are usually found scattered in different places most likely with interrelationships among the data not well documented, incomplete with information for some parameters missing, nonexistent, or unrealistic to experimentally generate. Furthermore, with very different technical backgrounds, the modeler, the experimentalist, and the knowledgebase developer that must be involved in validation data development often cannot communicate effectively without a data package template that is representative of the data structure for the information domain of interest to the desired code validation. This pilot project is proposed to use the legendary TREAT Experiments Database to provide core elements for creating an ideal validation data package. Data gaps and missing data interrelationships will be identified from these core elements. All the identified missing elements will then be filled in with experimental data if available from other existing sources or with dummy data if nonexistent. The resulting

Modification and Validation of the Treatment Self Regulation Questionnaire to Assess Parental Motivation for HPV Vaccination of Adolescents

PubMed Central

Denman, Deanna C.; Baldwin, Austin S.; Marks, Emily G.; Lee, Simon C.; Tiro, Jasmin A.

2016-01-01

Background According to Self-Determination Theory, the extent to which the motivation underlying behavior is self-determined or controlled influences its sustainability. This is particularly relevant for behaviors that must be repeated, such as completion of the human papillomavirus (HPV) vaccine series. To date, no measures of motivation for HPV vaccination have been developed. Methods As part of a larger study, parents (N=223) whose adolescents receive care at safety-net clinics completed a telephone questionnaire about HPV and the vaccine. We modified the Treatment Self-Regulation Questionnaire to assess parents’ motivation for HPV vaccination in both Spanish and English. We used confirmatory factor analysis to test a three-factor measurement model. Results The three-factor model fit the data well (RMSEA=.04, CFI=.98, TLI=.96), and the scales’ reliabilities were adequate (autonomous: α=.87; introjected: α=.72; external: α=.72). The factor loading strength for one item was stronger for Spanish- than English-speaking participants (p<.05); all others were equivalent. The intercorrelations among the scales ranged from −.17 to .32, suggesting discriminant factors. The scales displayed the expected pattern of correlations with other psychosocial determinants of behavior. Vaccination intentions showed a strong correlation with autonomous motivation (r= .52), but no correlation with external motivation (r=.02), suggesting autonomous motivation may be particularly important in vaccine decision-making. Conclusion Findings support the use of three subscales to measure motivation in HPV vaccination and suggest possible cultural differences in motivation. PMID:27595447

A child-centered scale of informal social control for Latino parents of preschool-age children: Development and validation

USDA-ARS?s Scientific Manuscript database

Perceived neighborhood informal social control may determine whether parents allow their young children to be physically active in the neighborhood. We developed and validated a scale of neighborhood child-centered informal social control appropriate for Latino parents of preschool-age children. The...

Awareness and acceptance of human papillomavirus vaccination among health sciences students in Malaysia.

PubMed

Rajiah, Kingston; Maharajan, Mari Kannan; Chin, Nang Sue; Num, Kelly Sze Fang

2015-12-01

The major cause of cervical cancer is human papillomavirus (HPV) for which vaccination is available. The success HPV vaccination programme largely depend on the degree of knowledge of the healthcare providers who can recommend to the public. Health sciences students as future healthcare providers play a major role in HPV vaccination initiatives. The objective of this study was to evaluate the knowledge, attitude, practice and to find out the willingness to pay for HPV vaccination among the health sciences students in a private university. The cross-sectional study was conducted among the university students studying health sciences program using a validated questionnaire to measure their awareness and acceptance of HPV vaccination. The students demonstrated moderate knowledge about HPV infection and vaccination with mean knowledge scores of 9.3 out of 17. Students were showing positive attitude towards HPV vaccination with mean scores of 3.80 out of 5. However, low HPV vaccination uptake rate was reported among the students. Most of the students were willing to recommend HPV vaccine. The participants felt that the cost is the major barrier towards HPV vaccination and they felt the government should cover the cost of vaccination for all. The results of this study may be helpful in establishing educational policies on cervical cancer-related topics in the universities.

Establishing a regional network of academic centers to support decision making for new vaccine introduction in Latin America and the Caribbean: the ProVac experience.

PubMed

Toscano, C M; Jauregui, B; Janusz, C B; Sinha, A; Clark, A D; Sanderson, C; Resch, S; Ruiz Matus, C; Andrus, J K

2013-07-02

The Pan American Health Organization's ProVac Initiative, designed to strengthen national decision making regarding the introduction of new vaccines, was initiated in 2004. Central to realizing ProVac's vision of regional capacity building, the ProVac Network of Centers of Excellence (CoEs) was established in 2010 to provide research support to the ProVac Initiative, leveraging existing capacity at Latin American and Caribbean (LAC) universities. We describe the process of establishing the ProVac Network of CoEs and its initial outcomes and challenges. A survey was sent to academic, not-for-profit institutions in LAC that had recently published work in the areas of clinical decision sciences and health economic analysis. Centers invited to join the Network were selected by an international committee on the basis of the survey results. Selection criteria included academic productivity in immunization-related work, team size and expertise, successful collaboration with governmental agencies and international organizations, and experience in training and education. The Network currently includes five academic institutions across LAC. Through open dialog and negotiation, specific projects were assigned to centers according to their areas of expertise. Collaboration among centers was highly encouraged. Faculty from ProVac's technical partners were assigned as focal points for each project. The resulting work led to the development and piloting of tools, methodological guides, and training materials that support countries in assessing existing evidence and generating new evidence on vaccine introduction. The evidence generated is shared with country-level decision makers and the scientific community. As the ProVac Initiative expands to other regions of the world with support from immunization and public health partners, the establishment of other regional and global networks of CoEs will be critical. The experience of LAC in creating the current network could benefit the

Changing HPV vaccination rates in bisexual and lesbian women.

PubMed

Polek, Carolee; Hardie, Thomas

2017-06-01

Human papillomavirus (HPV) vaccination rates continue to be below national targets for women and lower in some sexual minorities. HPV is a primary causal agent in cervical cancer, from which members of the lesbian and bisexual community mistakenly believe they are at low risk. This study characterized rates of HPV vaccination in women based on their sexual orientation. Data were obtained from the Centers for Disease Control and Prevention's National Health Interview Survey 2013-2014. This survey evaluated 5695 women-113 (2%) lesbian, 135 (2.4%) bisexual, and 5446 (95.6%) heterosexual women ages 18-26 in 2006-using logistic regression. A dependent variable of having had HPV vaccination and independent variable of sexual orientation was used. Significant differences were found in vaccine uptake based on sexual orientation. Bisexual women were most likely to be vaccinated, and differed significantly from heterosexual and lesbians which did not differ significantly from each other. The results suggest improvement in sexual minority rates but this finding is tempered by the low rates of vaccination in adult women. The low vaccination rates in adult women and sexual minorities merit further study. The low rates may be a function of the transition from pediatric to adult care and/or practice barriers perceived by sexual minorities. ©2017 American Association of Nurse Practitioners.

Evidence for single-dose protection by the bivalent HPV vaccine-Review of the Costa Rica HPV vaccine trial and future research studies.

PubMed

Kreimer, Aimée R; Herrero, Rolando; Sampson, Joshua N; Porras, Carolina; Lowy, Douglas R; Schiller, John T; Schiffman, Mark; Rodriguez, Ana Cecilia; Chanock, Stephen; Jimenez, Silvia; Schussler, John; Gail, Mitchell H; Safaeian, Mahboobeh; Kemp, Troy J; Cortes, Bernal; Pinto, Ligia A; Hildesheim, Allan; Gonzalez, Paula

2018-01-20

The Costa Rica Vaccine Trial (CVT), a phase III randomized clinical trial, provided the initial data that one dose of the HPV vaccine could provide durable protection against HPV infection. Although the study design was to administer all participants three doses of HPV or control vaccine, 20% of women did not receive the three-dose regimens, mostly due to involuntary reasons unrelated to vaccination. In 2011, we reported that a single dose of the bivalent HPV vaccine could be as efficacious as three doses of the vaccine using the endpoint of persistent HPV infection accumulated over the first four years of the trial; findings independently confirmed in the GSK-sponsored PATRICIA trial. Antibody levels after one dose, although lower than levels elicited by three doses, were 9-times higher than levels elicited by natural infection. Importantly, levels remained essentially constant over at least seven years, suggesting that the observed protection provided by a single dose might be durable. Much work has been done to assure these non-randomized findings are valid. Yet, the group of recipients who received one dose of the bivalent HPV vaccine in the CVT and PATRICIA trials was small and not randomly selected nor blinded to the number of doses received. The next phase of research is to conduct a formal randomized, controlled trial to evaluate the protection afforded by a single dose of HPV vaccine. Complementary studies are in progress to bridge our findings to other populations, and to further document the long-term durability of antibody response following a single dose. Published by Elsevier Ltd.

Influenza Vaccination Rate and Reasons for Nonvaccination in Children With Cardiac Disease.

PubMed

Livni, Gilat; Wainstein, Alina; Birk, Einat; Chodick, Gabriel; Levy, Itzhak

2017-11-01

Influenza is a major cause of respiratory morbidity worldwide. It poses a risk of complications in children with cardiac disease. Influenza vaccine is considered the most effective and safe means of preventing the disease. The aims of this study were to determine the rate of influenza vaccination in children with cardiac disease and to identify the reasons for failure to vaccinate in this patient population. The study group included 186 children and their parents who attended the cardiology institute of a tertiary pediatric medical center between September and October 2012. Parents were asked to complete a questionnaire covering demographics, clinical features, influenza vaccination, receipt of advice from medical professionals regarding vaccination and personal knowledge about and attitude toward the influenza vaccine. Median age of the children was 7.6 years. Thirty-six percent had been vaccinated in the previous influenza season. Vaccination was unrelated to the child's age or sex or the parents' education. Factors significantly affecting the decision of the parents to have their child vaccinated were their knowledge, beliefs and conceptions about the vaccine and their receipt of a recommendation to do so from the pediatrician or cardiologist (P < 0.001). The rate of vaccination against influenza is low in children with heart disease. Major factors encouraging vaccination are proper parental knowledge and the recommendation of the primary physician or cardiologist. Medical professionals caring for this patient population should be alerted to the need to routinely counsel parents on the importance of influenza vaccination.

Testing a West Nile virus vaccine in sandhill cranes (Grus canadensis)

USGS Publications Warehouse

Olsen, Glenn H.; Miller, K.; Docherty, D.; Sileo, L.; Chavez-Ramirez, Felipe

2005-01-01

Eight sandhill cranes (Grus canadensis) were vaccinated with a commercial equine West Nile virus vaccine (Fort Dodge Animal Health, Fort Dodge, Iowa, USA) at the USGS Patuxent Wildlife Research Center, Laurel, Maryland, USA. Three doses of the vaccine were given, the first dose (day 0) was followed by a second 21 days later and the third dose 7 days after the second day 28 after the first dose). All doses were 0.50 ml. In addition, 5 sandhill cranes were given injections of similar amounts of sterile water on the same schedule. Blood for complete blood counts, serum chemistries, and serological testing was collected at weekly intervals. Ten weeks after the first injection of the vaccine and 6 weeks after the last of the 3 injections of the vaccine, the cranes were shipped to the USGS National Wildlife Heath Center, Madison, Wisconsin, USA. After a two-week adjustment period, 11 of these cranes were injected intramuscularly with one mosquito dose of West Nile virus. Two of the vaccinated cranes were not challenged and acted as uninfected controls. One week post challenge the only abnormal findings were slight weight loss (average 6% loss since the time of challenge with West Nile virus) and elevated white blood cell counts (heterophilic leukocytosis). There were no deaths and no clinically ill cranes (unvaccinated or vaccinated cranes) among the 11 challenged birds. All cranes were euthanized 6 weeks post challenge, and necropsies were performed. Pre-challenge titers showed no titer response to the vaccinations. However, when challenged, vaccinated cranes developed titers more quickly (within 7-10 days), and were viremic and shed virus via the cloaca for a shorter period of time than the unvaccinated cranes (2-7 days for vaccinated cranes versus 2-10 days for unvaccinated cranes). No remarkable lesions were noted in any of the cranes during the necropsy examinations. Histopathological findings are available for only four of the cranes at this time. Three of those

Validation of the Center for Epidemiological Studies Depression Scale among Korean Adolescents.

PubMed

Heo, Eun-Hye; Choi, Kyeong-Sook; Yu, Je-Chun; Nam, Ji-Ae

2018-02-01

The Center for Epidemiological Studies Depression Scale (CES-D) is designed to measure the current level of depressive symptomatology in the general population. However, no review has examined whether the scale is reliable and valid among children and adolescents in Korea. The purpose of this study was to test whether the Korean form of the CES-D is valid in adolescents. Data were obtained from 1,884 adolescents attending grades 1-3 in Korean middle schools. Reliability was evaluated by internal consistency (Cronbach's alpha). Concurrent validity was evaluated by a correlation analysis between the CES-D and other scales. Construct validity was evaluated by exploratory factor and confirmatory factor analyses. The internal consistency coefficient for the entire group was 0.88. The CES-D was positively correlated with scales that measure negative psychological constructs, such as the State Anxiety Inventory for Children, the Korean Social Anxiety Scale for Children and Adolescents, and the Reynold Suicidal Ideation Questionnaire, but it was negatively correlated with scales that measure positive psychological constructs, such as the Korean version of the Rosenberg Self-Esteem Scale and the Connor-Davidson Resilience Scale-2. The CES-D was examined by three-dimensional exploratory factor analysis, and the three-factor structure of the scale explained 53.165% of the total variance. The variance explained by factor I was 24.836%, that explained by factor II was 15.988%, and that explained by factor III was 12.341%. The construct validity of the CES-D was tested by confirmatory factor analysis, and we applied the entire group's data using a three-factor hierarchical model. The fit index showed a level similar to those of other countries' adolescent samples. The CES-D has high internal consistency and addresses psychological constructs similar to those addressed by other scales. The CES-D showed a three-factor structure in an exploratory factor analysis. The present