Sponsored Programs.

ERIC Educational Resources Information Center

College and University Business Administration, 1980

1980-01-01

General administrative principles and procedures applicable to any type of program sponsored by external funds, including the federal government, are examined. Contracts, grants, and cooperative agreements are the devices for authorizing sponsored programs. Since the institutions assume full legal responsibility for the programs and for fulfilling…

Cattle tick vaccine researchers join forces in CATVAC.

PubMed

Schetters, Theo; Bishop, Richard; Crampton, Michael; Kopáček, Petr; Lew-Tabor, Alicja; Maritz-Olivier, Christine; Miller, Robert; Mosqueda, Juan; Patarroyo, Joaquín; Rodriguez-Valle, Manuel; Scoles, Glen A; de la Fuente, José

2016-02-24

A meeting sponsored by the Bill & Melinda Gates Foundation was held at the Avanti Hotel, Mohammedia, Morocco, July 14-15, 2015. The meeting resulted in the formation of the Cattle Tick Vaccine Consortium (CATVAC).

Cattle tick vaccine researchers join forces in CATVAC

USDA-ARS?s Scientific Manuscript database

A meeting sponsored by the Bill & Melinda Gates Foundation was held at the Avanti Hotel, Mohammedia, Morocco, July 14–15, 2015. The meeting resulted in the formation of the Cattle Tick Vaccine Consortium (CATVAC)....

76 FR 68768 - Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-07

... provides recommendations for the design of clinical trials for cancer vaccines conducted under an IND to... in this notice finalizes the draft guidance of the same title dated September 2009. DATES: Submit...), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike...

Low-Dose Priming before Vaccination with the Phase I Chloroform-Methanol Residue Vaccine against Q Fever Enhances Humoral and Cellular Immune Responses to Coxiella burnetii▿

PubMed Central

Waag, David M.; England, Marilyn J.; Bolt, Christopher R.; Williams, Jim C.

2008-01-01

Although the phase I Coxiella burnetii cellular vaccine is completely efficacious in humans, adverse local and systemic reactions may develop if immune individuals are inadvertently vaccinated. The phase I chloroform-methanol residue (CMRI) vaccine was developed as a potentially safer alternative. Human volunteers with no evidence of previous exposure to C. burnetii received a subcutaneous vaccination with the CMRI vaccine in phase I studies under protocol IND 3516 to evaluate the safety and immunogenicity of the vaccine. This clinical trial tested escalating doses of the CMRI vaccine, ranging from 0.3 to 60 μg, followed by a booster dose of 30 μg, in a placebo-controlled study. Although priming doses of the CMRI vaccine did not induce a specific antibody detectable by enzyme-linked immunosorbent assay, booster vaccination stimulated the production of significant levels of anti-C. burnetii antibody. Peripheral blood cells (PBCs) of vaccinees responded to C. burnetii cellular antigen in vitro in a vaccine dose-dependent manner. After the booster dose, PBCs were activated by recall antigen in vitro, regardless of the priming dose. These findings suggest that vaccination with the CMRI vaccine can effectively prime the immune system to mount significant anamnestic responses after infection. PMID:18701647

7 CFR 622.10 - Sponsors.

Code of Federal Regulations, 2013 CFR

2013-01-01

... AGRICULTURE WATER RESOURCES WATERSHED PROJECTS Qualifications § 622.10 Sponsors. (a) Watershed projects are sponsored by one or more local organizations qualifying as sponsors. All watershed plans shall be sponsored...

7 CFR 622.10 - Sponsors.

Code of Federal Regulations, 2012 CFR

2012-01-01

... AGRICULTURE WATER RESOURCES WATERSHED PROJECTS Qualifications § 622.10 Sponsors. (a) Watershed projects are sponsored by one or more local organizations qualifying as sponsors. All watershed plans shall be sponsored...

7 CFR 622.10 - Sponsors.

Code of Federal Regulations, 2011 CFR

2011-01-01

... AGRICULTURE WATER RESOURCES WATERSHED PROJECTS Qualifications § 622.10 Sponsors. (a) Watershed projects are sponsored by one or more local organizations qualifying as sponsors. All watershed plans shall be sponsored...

7 CFR 622.10 - Sponsors.

Code of Federal Regulations, 2014 CFR

2014-01-01

... AGRICULTURE WATER RESOURCES WATERSHED PROJECTS Qualifications § 622.10 Sponsors. (a) Watershed projects are sponsored by one or more local organizations qualifying as sponsors. All watershed plans shall be sponsored...

Examining dog owners' beliefs regarding rabies vaccination during government-funded vaccine clinics in Grenada to improve vaccine coverage rates.

PubMed

Thomas, D; Delgado, A; Louison, B; Lefrancois, T; Shaw, J

2013-07-01

Vaccination of domestic pets is an important component of rabies control and prevention in countries where the disease is maintained in a wildlife reservoir. In Grenada, vaccine coverage rates were low, despite extensive public education and advertising of government-sponsored vaccine clinics where rabies vaccine is administered to animals at no cost to animal owners. Information was needed on reasons for decreased dog owner participation in government-funded rabies vaccination clinics. A total of 120 dog owners from 6 different parishes were asked to complete a questionnaire assessing their currently held beliefs about rabies vaccination and perception of the risk posed by rabies. Over 70% of respondents believed that problems in the organization and management of clinic sites could allow for fighting between dogs or disease spread among dogs, while 35% of owners did not believe that they had the ability or adequate help to bring their dogs to the clinic sites. Recommendations for improving vaccine coverage rates included: improved scheduling of clinic sites and dates; increased biosecurity at clinic locations; focused advertising on the availability of home visits, particularly for aggressive dogs or dogs with visible skin-related diseases such as mange; and the recruitment of community volunteers to assist with bringing dogs to the clinic sites. Copyright © 2013. Published by Elsevier B.V.

7 CFR 654.14 - Duration of sponsor(s)' responsibility.

Code of Federal Regulations, 2010 CFR

2010-01-01

... performed by force account, division of work, or performance of work methods, the sponsor(s)' O&M responsibilities begin on the date the work or portion thereof is completed as determined by NRCS, except for completed work located on Federal lands which are subject to special-use permits. The O&M agreement shall...

Influvac, a trivalent inactivated subunit influenza vaccine.

PubMed

Zuccotti, Gian Vincenzo; Fabiano, Valentina

2011-01-01

Influenza represents a major sanitary and socio-economic burden and vaccination is universally considered the most effective strategy for preventing the disease and its complications. Traditional influenza vaccines have been on the market since the late 1940s, with million of doses administered annually worldwide, and demonstrated a substantial efficacy and safety. The trivalent inactivated subunit vaccine has been available for more than 25 years and has been studied in healthy children, adults and the elderly and in people affected by underlying chronic medical conditions. We describe vaccine technology focusing on subunit vaccine production procedures and mode of action and provide updated information on efficacy and safety available data. A review of efficacy and safety data in healthy subjects and in high risk populations from major sponsor- and investigator-driven studies. The vaccine showed a good immunogenicity and a favorable safety profile in all target groups. In the panorama of actually available influenza vaccines, trivalent inactivated subunit vaccine represents a well-established tool for preventing flu and the associated complications.

Smartphone app uses loyalty point incentives and push notifications to encourage influenza vaccine uptake.

PubMed

Dale, Leila Pfaeffli; White, Lauren; Mitchell, Marc; Faulkner, Guy

2018-04-23

Carrot Rewards is a free, incentive-based, smartphone health app available in participating provinces in Canada. One feature of Carrot was designed to incentivize influenza vaccine education messages and encourage vaccine uptake for users in the province of British Columbia. This study aimed to evaluate the uptake of the Carrot Flu Campaign educational quiz and to determine if mobile "push" notifications, plus loyalty point incentives, resulted in users visiting a sponsored pharmacy to discuss and receive the influenza vaccine. The Carrot Flu Campaign delivered an in-app quiz, educating users on the importance of the influenza vaccine. Push notifications were then sent to users when they came within 200 m of a sponsored pharmacy. Those who visited the pharmacy collected bonus points and completed a follow up quiz tracking influenza vaccine behaviour. A sub-sample of users completed the Flu Campaign between their baseline and follow up Health Risk Assessment (HRA), a survey which asked about influenza vaccine uptake behaviour. Descriptive statistics were summarized. A total of 38.1% (30,538/80,228) registered Carrot users completed the Flu Campaign quiz. Of those in participating cities (n = 21,469), 41% clicked on the map to show the nearest sponsored pharmacy and 78% enabled their smartphone's "locations" feature, allowing them to receive the push notifications. A small number of users spoke to a pharmacist (n = 96) and less than half reported receiving the influenza vaccine (38/96; 39.6%). From the HRA sub-sample (n = 3693), approximately 5% more users reported receiving the influenza vaccine during the 2017 influenza season compared to the previous year. Carrot Rewards used a novel delivery method to educate the general population and showed geolocation could be used to facilitate influenza vaccine uptake. Future iterations could tailor content to target those most at risk and should consider more robust evaluation methods to determine the app

Botulinum neurotoxin vaccines: Past history and recent developments.

PubMed

Rusnak, Janice M; Smith, Leonard A

2009-12-01

Botulinum toxin may cause a neuroparalytic illness that may result in respiratory failure and require prolonged mechanical ventilation. As medical resources needed for supportive care of botulism in a bioterrorist event may quickly overwhelm the local healthcare systems, biodefense research efforts have been directed towards the development of a vaccine to prevent botulism. While human botulism has been caused only by toxin serotypes A, B, and E (rarely serotype F), all seven known immunologically distinct toxin serotypes (A - G) may potentially cause intoxication in humans from a bioterrorist event. A pentavalent (ABCDE) botulinum toxoid (PBT) has been administered as an investigation new drug (IND) to at-risk individuals for nearly 50 years. Due to declining immunogenicity of the PBT, research efforts have been directed at development of both improved (less local reactogenicity) botulinum toxoids and recombinant vaccines as potential vaccine candidates to replace the PBT.

The Sponsored Film.

ERIC Educational Resources Information Center

Klein, Walter J.

For public relations professionals and would-be sponsors of films, this book provides guidelines for understanding the film medium and its potential as a persuasive force in industry, government, organizations, and religious orders. For filmmakers, it brings together practical information needed to survive in the sponsored-film industry and to…

Development and approval of vaccines in the United States.

PubMed

Botstein, P

1986-01-01

In the United States, vaccines and the establishments in which they are manufactured are required to be licensed by the Food and Drug Administration (FDA) before the vaccine can be marketed. This licensing process, as well as the development and investigation of vaccines, is regulated by the FDA's Office of Biologics Research and Review. An application for licensing must contain information supporting the safety, effectiveness, purity and potency of the product. These are data obtained during the investigational phase and then submitted by a commercial sponsor for review and approval. Inspections, surveillance and laboratory testing are performed by the FDA before and after issuance of a license for marketing. The procedures and policies in the investigational and licensing phases of vaccine development are described.

Effectiveness of worksite interventions to increase influenza vaccination rates among employees and families.

PubMed

Ofstead, Cori L; Sherman, Bruce W; Wetzler, Harry P; Dirlam Langlay, Alexandra M; Mueller, Natalie J; Ward, Jeremy M; Ritter, Daniel R; Poland, Gregory A

2013-02-01

To increase influenza vaccination rates among industrial employees and their families through a campaign at a large corporation. This prospective, multisite study used employee surveys and claims data to evaluate an evidence-based worksite vaccination program. Vaccination rates among insured employees and dependents (N = 13,520) increased significantly after the intervention (P < 0.001). More than 90% of vaccinated employees received vaccine at employer-sponsored events. There was a strong association between employee and family vaccination status. Primary reasons for receiving the vaccine were economic (free 84%; convenient 80%; avoid absenteeism 82%), rather than health-related. Knowledge was associated with vaccination, but customized education did not change beliefs. Worksite programs can demonstrably increase vaccination rates among industrial employees and families. Consideration should be given to repositioning vaccination from medical treatment to community initiatives offered with other worksite health promotion programs.

21 CFR 312.22 - General principles of the IND submission.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false General principles of the IND submission. 312.22... (IND) § 312.22 General principles of the IND submission. (a) FDA's primary objectives in reviewing an... likelihood that the investigations will yield data capable of meeting statutory standards for marketing...

Santa Claus, Ga./Ind.

NASA Image and Video Library

2002-12-23

The towns of Santa Claus, Ga., (top) and Santa Claus, Ind. (bottom), are shown in these two images from the Advanced Spaceborne Thermal Emission and Reflection Radiometer (ASTER) instrument on NASA's Terra satellite. They are the only two Santa Claus towns in the United States with post offices and zip codes, although there are 11 towns with this name in the United States. Santa Claus, Ga. is located in Toombs County, and has a population of 237. Santa Claus, Ind. is located in Spencer County, and has a population of 2,041. Its name was accepted by the United States Postal Service in 1856. The images were acquired on July 3, 2000 (top) and June 16, 2001 (bottom), respectively. http://photojournal.jpl.nasa.gov/catalog/PIA03891

Vaccination and public trust: A model for the dissemination of vaccination behaviour with external intervention

NASA Astrophysics Data System (ADS)

Dorso, Claudio O.; Medus, Andrés; Balenzuela, Pablo

2017-09-01

Vaccination is widely recognized as the most effective way of immunization against many infectious diseases. However, unfounded claims about supposed side effects of some vaccines have contributed to spread concern and fear among people, thus inducing vaccination refusal. MMR (Measles, Mumps and Rubella) vaccine coverage has undergone an important decrease in a large part of Europe and US as a consequence of erroneously alleged side effects, leading to recent measles outbreaks. There is evidence that clusterization of unvaccinated individuals may lead to epidemics way larger that the ones that might appear in the case that unvaccinated agents are distributed at random in the population. In this work we explore the emergence of those clusters as a consequence of the social interaction driven mainly by homophily, where vaccination behaviour is part of a process of cultural dissemination in the spirit of Axelrod's model. The ingredients of this calculation encompass: (i) interacting agents which are to decide if they vaccinate or not their children, (ii) their interaction with a small subset of stubborn agents who believe that the MMR vaccine is not safe and (iii) government sponsored propaganda trying to convince people of the benefits of vaccination. We find that these clusters, which emerge as a dynamical outcome of the model, are the responsible of the increasing probability of the occurrence of measles outbreaks, even in scenarios where the WHO (World Health Organization) recommendation of 95% vaccine coverage is fulfilled. However, we also illustrate that the mitigating effect of a public health campaign, could effectively reduce the impact and size of outbreaks.

77 FR 46612 - New Animal Drugs; Change of Sponsor; Change of Sponsor Address; Azaperone; Miconazole, Polymyxin...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-06

... 524 [Docket No. FDA-2012-N-0002] New Animal Drugs; Change of Sponsor; Change of Sponsor Address.... ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two new animal drug applications (NADAs) from Janssen...

UNION-SPONSORED RETRAINING PROGRAMS.

ERIC Educational Resources Information Center

HOOS, IDA R.

UNION-SPONSORED TRAINING PROGRAMS WERE PROVIDED IN THE SAN FRANCISCO BAY AREA TO UPGRADE SKILLS OF MARINE COOKS AND STEWARDS, SHIPS' RADIO OPERATORS, JOURNEYMAN PLUMBERS AND GASFITTERS, AND MEMBERS OF THE INTERNATIONAL BROTHERHOOD OF ELECTRICAL WORKERS (IBEW). THESE PROGRAMS WERE THE ONLY COHESIVE UNION SPONSORED CURRICULA IN THAT AREA. MAJOR…

48 CFR 970.3501-1 - Sponsoring agreements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 5 2013-10-01 2013-10-01 false Sponsoring agreements. 970... Sponsoring agreements. (a) The contract award document constitutes the sponsoring agreement between the... the purpose and mission of the FFRDC. (c) Other elements of the sponsoring agreement which shall be...

48 CFR 970.3501-1 - Sponsoring agreements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 5 2014-10-01 2014-10-01 false Sponsoring agreements. 970... Sponsoring agreements. (a) The contract award document constitutes the sponsoring agreement between the... the purpose and mission of the FFRDC. (c) Other elements of the sponsoring agreement which shall be...

48 CFR 970.3501-1 - Sponsoring agreements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Sponsoring agreements. 970... Sponsoring agreements. (a) The contract award document constitutes the sponsoring agreement between the... the purpose and mission of the FFRDC. (c) Other elements of the sponsoring agreement which shall be...

45 CFR 1226.12 - Sponsor employees.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 4 2010-10-01 2010-10-01 false Sponsor employees. 1226.12 Section 1226.12 Public Welfare Regulations Relating to Public Welfare (Continued) CORPORATION FOR NATIONAL AND COMMUNITY SERVICE PROHIBITIONS ON ELECTORAL AND LOBBYING ACTIVITIES Sponsor Employee Activities § 1226.12 Sponsor employees...

17 CFR 229.1104 - (Item 1104) Sponsors.

Code of Federal Regulations, 2010 CFR

2010-04-01

... describe the sponsor's form of organization. (b) Describe the general character of the sponsor's business... regarding the size, composition and growth of the sponsor's portfolio of assets of the type to be...

Effect of Aluminum Hydroxide Adjuvant and Formaldehyde in the Formulation of rPA Anthrax Vaccine

DTIC Science & Technology

2007-01-02

Research Institute of Infectious Diseases , Bacteriology Division, 1425 Porter Street, Fort Detrick, Frederick, MD 21702-5033, USA b Goldbelt Raven, LLC...States Army Medical Research Institute of Infectious Diseases , Fort Detrick, MD 8. PERFORMING ORGANIZATION REPORT NUMBER TR-06-124 9. SPONSORING...27] Hambleton P, Carman JA, Melling J. Anthrax: the disease in relation to vaccines. Vaccine 1984;2:125–32. 28] Little SF, Webster WM, Ivins BE

7 CFR 622.10 - Sponsors.

Code of Federal Regulations, 2010 CFR

2010-01-01

... AGRICULTURE WATER RESOURCES WATERSHED PROJECTS Qualifications § 622.10 Sponsors. (a) Watershed projects are... the use of nonstructural or structural measures shall be sponsored by organizations that, individually... project cost and all operation and maintenance costs. (b) To receive Federal assistance for project...

Melanoma Vaccine--AVAX Technologies: DNP-VACC, M-Vax.

PubMed

2003-01-01

. Clinical development: M-Vax was in a pivotal phase III trial for treatment of stage III melanoma in the US, and a multicentre phase II trial in the US for treatment of patients with stage IV melanoma with lung metastases. However, in late March 2001, AVAX announced that the FDA had suspended these trials until the agency had further reviewed them. Subsequently, AVAX received written communication from the FDA indicating that the suspension is related to manufacturing issues. These events triggered the resignations of AVAX's executive Vice-President and Vice-President of operations, at the request of the company's board of directors. AVAX met with the FDA in October 2001 to discuss the clinical holds on M-Vax and O-Vax. AVAX's proposed improvements involving a frozen vaccine were also discussed at the meeting. Following the meeting AVAX was told by the FDA that selected characterisation work would have to be carried out on the new products, and new INDs submitted. In December 2001 AVAX announced that the development of a frozen vaccine and changes to various policies and procedures would ensure that the company complied with the FDA regulations. A new IND was submitted to the FDA for M-Vax in September 2002. In August 2002, AVAX had been unsure whether following approval of its new IND it would re-initiate clinical development for both M-Vax and O-Vax in parallel, or advance one of the agents and wait for further funding for the other. However, in September it indicated that clinical trials of both vaccines would be conducted following approval of the IND. A total of 42 patients are to be enrolled in each trial. In October 2002, AVAX announced that the US FDA had no outstanding issues regarding the IND. AVAX can now proceed with clinical trials as planned. AVAX Technologies was enrolling patients with stage III melanoma in the pivotal US phase III trial for registration of M-Vax trade ed, multicentre trial designed to compare the efficacy of the vaccine against high

IndeCut evaluates performance of network motif discovery algorithms.

PubMed

Ansariola, Mitra; Megraw, Molly; Koslicki, David

2018-05-01

Genomic networks represent a complex map of molecular interactions which are descriptive of the biological processes occurring in living cells. Identifying the small over-represented circuitry patterns in these networks helps generate hypotheses about the functional basis of such complex processes. Network motif discovery is a systematic way of achieving this goal. However, a reliable network motif discovery outcome requires generating random background networks which are the result of a uniform and independent graph sampling method. To date, there has been no method to numerically evaluate whether any network motif discovery algorithm performs as intended on realistically sized datasets-thus it was not possible to assess the validity of resulting network motifs. In this work, we present IndeCut, the first method to date that characterizes network motif finding algorithm performance in terms of uniform sampling on realistically sized networks. We demonstrate that it is critical to use IndeCut prior to running any network motif finder for two reasons. First, IndeCut indicates the number of samples needed for a tool to produce an outcome that is both reproducible and accurate. Second, IndeCut allows users to choose the tool that generates samples in the most independent fashion for their network of interest among many available options. The open source software package is available at https://github.com/megrawlab/IndeCut. megrawm@science.oregonstate.edu or david.koslicki@math.oregonstate.edu. Supplementary data are available at Bioinformatics online.

Academic investigator-initiated trials and the challenge of sponsor responsibility: the Cologne Sponsor Model.

PubMed

Georgias, Christine; Grunow, Andrea; Olderog, Miriam; May, Alexander; Paulus, Ursula

2012-12-01

With the amendment to the German Drug Law in 2004, the conduct of clinical trials changed by at least two main aspects: (1) The principles of Good Clinical Practice (GCP) were implemented in the national legislation, and (2) for the first time, the function of the sponsor of a clinical trial and the clinical trial itself have become legally binding definitions. By that, legal differences between industrial and academic clinical trials no longer exist. Clinical trials initiated by investigators have to fulfil the same requirements while the entire sponsor responsibility has to be carried out by the Coordinating Investigator or his institution including implementation of a quality management system according to the GCP. The Cologne Sponsor Model is an effective approach with settings, structures, basic features, action, and reporting lines, as well as funding for clinical trials initiated in an academic environment. The University of Cologne assumes the sponsor responsibility for clinical trials organised by the university researchers according to law. Sponsor's duties are delegated to a central operational unit of the sponsor - the Clinical Trials Center Cologne - which further delegates duties to the Coordinating Investigator. Clinical Trials Center Cologne was established in 2002 to support the performance of clinical trials at the university by offering comprehensive advisory and practical services covering all aspects of study planning and conduct. Furthermore, a specialised division of its quality management department acts as an independent sponsor's Quality Assurance Unit. The Clinical Trials Center Cologne has established a quality management system consisting of different components (1) to enable a reasoned decision to subsequent delegation, (2) for risk-based surveillance of trial conduct (audits, monitoring-checks, and reports), and (3) support and training of the Coordinating Investigator. Double functions of persons and departments in the university

21 CFR 312.305 - Requirements for all expanded access uses.

Code of Federal Regulations, 2012 CFR

2012-04-01

... contained in an existing IND if the sponsor of the existing IND grants a right of reference to the IND. (2... therapeutic options that would ordinarily be tried before resorting to the investigational drug or an...

21 CFR 312.305 - Requirements for all expanded access uses.

Code of Federal Regulations, 2011 CFR

2011-04-01

... contained in an existing IND if the sponsor of the existing IND grants a right of reference to the IND. (2... therapeutic options that would ordinarily be tried before resorting to the investigational drug or an...

21 CFR 312.305 - Requirements for all expanded access uses.

Code of Federal Regulations, 2014 CFR

2014-04-01

... contained in an existing IND if the sponsor of the existing IND grants a right of reference to the IND. (2... therapeutic options that would ordinarily be tried before resorting to the investigational drug or an...

21 CFR 312.305 - Requirements for all expanded access uses.

Code of Federal Regulations, 2013 CFR

2013-04-01

... contained in an existing IND if the sponsor of the existing IND grants a right of reference to the IND. (2... therapeutic options that would ordinarily be tried before resorting to the investigational drug or an...

INDES User's guide multistep input design with nonlinear rotorcraft modeling

NASA Technical Reports Server (NTRS)

1979-01-01

The INDES computer program, a multistep input design program used as part of a data processing technique for rotorcraft systems identification, is described. Flight test inputs base on INDES improve the accuracy of parameter estimates. The input design algorithm, program input, and program output are presented.

48 CFR 235.017-1 - Sponsoring agreements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 3 2012-10-01 2012-10-01 false Sponsoring agreements. 235.017-1 Section 235.017-1 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM... Sponsoring agreements. (c)(4) DoD-sponsoring FFRDCs that function primarily as research laboratories (C3I...

Head-to-head randomized trials are mostly industry sponsored and almost always favor the industry sponsor.

PubMed

Flacco, Maria Elena; Manzoli, Lamberto; Boccia, Stefania; Capasso, Lorenzo; Aleksovska, Katina; Rosso, Annalisa; Scaioli, Giacomo; De Vito, Corrado; Siliquini, Roberta; Villari, Paolo; Ioannidis, John P A

2015-07-01

To map the current status of head-to-head comparative randomized evidence and to assess whether funding may impact on trial design and results. From a 50% random sample of the randomized controlled trials (RCTs) published in journals indexed in PubMed during 2011, we selected the trials with ≥ 100 participants, evaluating the efficacy and safety of drugs, biologics, and medical devices through a head-to-head comparison. We analyzed 319 trials. Overall, 238,386 of the 289,718 randomized subjects (82.3%) were included in the 182 trials funded by companies. Of the 182 industry-sponsored trials, only 23 had two industry sponsors and only three involved truly antagonistic comparisons. Industry-sponsored trials were larger, more commonly registered, used more frequently noninferiority/equivalence designs, had higher citation impact, and were more likely to have "favorable" results (superiority or noninferiority/equivalence for the experimental treatment) than nonindustry-sponsored trials. Industry funding [odds ratio (OR) 2.8; 95% confidence interval (CI): 1.6, 4.7] and noninferiority/equivalence designs (OR 3.2; 95% CI: 1.5, 6.6), but not sample size, were strongly associated with "favorable" findings. Fifty-five of the 57 (96.5%) industry-funded noninferiority/equivalence trials got desirable "favorable" results. The literature of head-to-head RCTs is dominated by the industry. Industry-sponsored comparative assessments systematically yield favorable results for the sponsors, even more so when noninferiority designs are involved. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Tax-exempt bonds and sponsored research.

PubMed

Ballard, Frederic L

2003-01-01

"Sponsored research," wherein a business corporation or the government pays a portion of the cost of research activities carried out by a university or hospital, is increasingly important both for state institutions and for Section 510(c)(3) organizations. Sponsored research arrangements that are not properly structured can jeopardize the status of tax-exempt bonds issued to finance the facility at which the sponsored research occurs. While these rules have been difficult to apply in practice, properly structured agreements can provide funding for research without undue risk. This Article discusses the multiple pieces of guidance put forth by the Internal Revenue Service to clarify the many issues and tiers of analysis necessary to ensure a properly-structured sponsored research agreement.

Team sponsors in community-based health leadership programs.

PubMed

Patterson, Tracy Enright; Dinkin, Donna R; Champion, Heather

2017-05-02

Purpose The purpose of this article is to share the lessons learned about the role of team sponsors in action-learning teams as part of community-based health leadership development programs. Design/methodology/approach This case study uses program survey results from fellow participants, action learning coaches and team sponsors to understand the value of sponsors to the teams, the roles they most often filled and the challenges they faced as team sponsors. Findings The extent to which the sponsors were perceived as having contributed to the work of the action learning teams varied greatly from team to team. Most sponsors agreed that they were well informed about their role. The roles sponsors most frequently played were to provide the teams with input and support, serve as a liaison to the community and serve as a sounding board, motivator and cheerleader. The most common challenges or barriers team sponsors faced in this role were keeping engaged in the process, adjusting to the role and feeling disconnected from the program. Practical implications This work provides insights for program developers and community foundations who are interested in building the capacity for health leadership by linking community sponsors with emerging leaders engaged in an action learning experience. Originality/value This work begins to fill a gap in the literature. The role of team sponsors has been studied for single organization work teams but there is a void of understanding about the role of sponsors with multi-organizational teams working to improve health while also learning about leadership.

A systematic review of serious video games used for vaccination.

PubMed

Ohannessian, Robin; Yaghobian, Sarina; Verger, Pierre; Vanhems, Philippe

2016-08-31

Vaccination is an effective and proven method of preventing infectious diseases. However, uptake has not been optimal with available vaccines partly due to vaccination hesitancy. Various public health approaches have adressed vaccination hesitancy. Serious video games involving vaccination may represent an innovative public health approach. The aim of this study was to identify, describe, and review existing serious video games on vaccination. A systematic review was performed. Various databases were used to find data on vaccination-related serious video games published from January 1st 2000 to May 15th 2015. Data including featured medical and vaccination content, publication characteristics and games classification were collected for each identified serious game. Sixteen serious video games involved in vaccination were identified. All games were developed in high-income countries between 2003 and 2014. The majority of games were available online and were sponsored by educational/health institutions. All games were free of charge to users. Edugame was the most prevalent serious game subcategory. Twelve games were infectious disease-specific and the majority concerned influenza. The main objective of the games was disease control with a collective perspective. Utilization data was available for two games. Two games were formally evaluated. The use of serious video games for vaccination is an innovative tool for public health. Evaluation of vaccination related serious video games should be encouraged to demonstrate their efficacy and utility. Copyright © 2016 Elsevier Ltd. All rights reserved.

Next Generation Vaccine Biomarkers workshop October 30–31, 2014 – Ottawa, Canada

PubMed Central

Twine, Susan M; Fulton, Kelly M; Spika, John; Ouellette, Marc; Raven, Jennifer F; Conlan, J Wayne; Krishnan, Lakshmi; Barreto, Luis; Richards, James C

2015-01-01

Vaccine biomarkers are critical to many aspects of vaccine development and licensure, including bridging findings in pre-clinical studies to clinical studies, predicting potential adverse events, and predicting vaccine efficacy. Despite advances in our understanding of various biological pathways, and advances in systems analyses of the immune response, there remains much to learn about qualitative and quantitative aspects of the human host response to vaccination. To stimulate discussion and identify opportunities for collaborative ways to advance the field of vaccine biomarkers, A Next Generation Vaccine Biomarker workshop was held in Ottawa. The two day workshop, sponsored by the National Research Council Canada, Canadian Institutes of Health Research, Public Health Agency of Canada, Pfizer, and Medicago, brought together stakeholders from Canadian and international industry, government and academia. The workshop was grouped in themes, covering vaccine biomarker challenges in the pre-clinical and clinical spaces, veterinary vaccines, regulatory challenges, and development of biomarkers for adjuvants and cancer vaccines. The use of case studies allowed participants to identify the needs and gaps requiring innovation. The workshop concluded with a discussion on opportunities for vaccine biomarker discovery, the Canadian context, and approaches for moving forward. This article provides a synopsis of these discussions and identifies steps forward for advancing vaccine biomarker research in Canada. PMID:26383909

AGU Sponsors Two Congressional Science Fellows

NASA Astrophysics Data System (ADS)

Chell, Kaitlin

2010-06-01

AGU will sponsor not one, but two Congressional Science Fellows (CSF) for the 2010-2011 fellowship term. Beginning in September, Jason Day and Ilya Fischhoff each will spend a year working in the congressional office of a U.S. senator or representative or in the office of a congressional committee. Both fellows were selected in March by AGU's Committee on Public Affairs after a competitive interview process. Their terms will mark the 33rd year AGU has sponsored a CSF and the first year AGU has ever sponsored two CSFs at one time.

8. Photograph of post card, 'Cicotte Street Bridge, Logansport, Ind.' ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

8. Photograph of post card, 'Cicotte Street Bridge, Logansport, Ind.' Logansport News Agency, Logansport, Ind., Curteich-Chicago 'C.T. American Art' post card {Reg. U.S. Pat. Off.}, postmarked October 17, 1949. Card in the Cass County photograph file at the Indiana State Library, Indianapolis. - Cicott Street Bridge, Spanning Wabash River at State Road 25, Logansport, Cass County, IN

Emergence of an exotic strain of serotype O foot-and-mouth disease virus O/ME-SA/Ind-2001d in South-East Asia in 2015.

PubMed

Qiu, Y; Abila, R; Rodtian, P; King, D P; Knowles, N J; Ngo, L T; Le, V T; Khounsy, S; Bounma, P; Lwin, S; Verin, B C; Widders, P

2018-02-01

The O/Middle East-South Asia (ME-SA)/Ind-2001 lineage of foot-and-mouth disease virus (FMDV) is endemic in the Indian subcontinent and has been reported in the Middle East and North Africa, but it had not been detected in South-East Asia (SEA) before 2015. This study reports the recent incursions of this viral lineage into SEA, which caused outbreaks in Vientiane Capital of Lao People's Democratic Republic (PDR) in April 2015, in Dak Nong, Dak Lak and Ninh Thuan Provinces of Vietnam from May to October 2015, and in Rakhine State of Myanmar in October 2015. Disease investigations were conducted during the outbreaks and followed up after laboratory results confirmed the involvement of FMDV O/ME-SA/Ind-2001 sublineage d (O/ME-SA/Ind-2001d). Affected host species included cattle, buffalo and pig, and all the outbreaks resolved within 2 months. Animals with clinical signs were separated, and affected premises were disinfected. However, strict movement restrictions were not enforced, and emergency vaccinations were only implemented in Vientiane Capital of Lao PDR and Dak Nong and Ninh Thuan Provinces of Vietnam. Clinical samples were collected from each outbreak and examined by nucleotide sequencing of the FMDV viral protein 1 coding region. Sequence analysis revealed that the O/ME-SA/Ind-2001d isolates from Lao PDR and Vietnam were closely related to each other and similar to viruses previously circulating in India in 2013. Viruses collected from Myanmar were divergent from viruses of the same sublineage recovered from Lao PDR and Vietnam but were closely related to viruses present in Bangladesh in 2015. These findings imply that at least two independent introductions of O/ME-SA/Ind-2001d into SEA have occurred. Our study highlights the transboundary nature of foot-and-mouth disease (FMD) and reinforces the importance of improved FMD surveillance and promotion of safer cross-border trade in SEA to control the risk of introduction and spread of exotic FMDV strains. �

Schistosomiasis elimination strategies and potential role of a vaccine in achieving global health goals.

PubMed

Mo, Annie X; Agosti, Jan M; Walson, Judd L; Hall, B Fenton; Gordon, Lance

2014-01-01

In March 2013, the National Institute of Allergy and Infectious Diseases and the Bill and Melinda Gates Foundation co-sponsored a meeting entitled "Schistosomiasis Elimination Strategy and Potential Role of a Vaccine in Achieving Global Health Goals" to discuss the potential role of schistosomiasis vaccines and other tools in the context of schistosomiasis control and elimination strategies. It was concluded that although schistosomiasis elimination in some focal areas may be achievable through current mass drug administration programs, global control and elimination will face several significant scientific and operational challenges, and will require an integrated approach with other, additional interventions. These challenges include vector (snail) control; environmental modification; water, sanitation, and hygiene; and other future innovative tools such as vaccines. Defining a clear product development plan that reflects a vaccine strategy as complementary to the existing control programs to combat different forms of schistosomiasis will be important to develop a vaccine effectively.

The role of vaccines and vaccine decision-making to achieve the goals of the Grand Convergence in public health.

PubMed

Kaslow, David C; Kalil, Jorge; Bloom, David; Breghi, Gianluca; Colucci, Anna Maria; De Gregorio, Ennio; Madhavan, Guru; Meier, Genevieve; Seabrook, Richard; Xu, Xiaoning

2017-01-20

On 17 and 18 July 2015, a meeting in Siena jointly sponsored by ADITEC and GlaxoSmithKline (GSK) was held to review the goals of the Global Health 2035 Grand Convergence, to discuss current vaccine evaluation methods, and to determine the feasibility of reaching consensus on an assessment framework for comprehensively and accurately capturing the full benefits of vaccines. Through lectures and workshops, participants reached a consensus that Multi-Criteria-Decision-Analysis is a method suited to systematically account for the many variables needed to evaluate the broad benefits of vaccination, which include not only health system savings, but also societal benefits, including benefits to the family and increased productivity. Participants also agreed on a set of "core values" to be used in future assessments of vaccines for development and introduction. These values include measures of vaccine efficacy and safety, incident cases prevented per year, the results of cost-benefit analyses, preventable mortality, and the severity of the target disease. Agreement on this set of core assessment parameters has the potential to increase alignment between manufacturers, public health agencies, non-governmental organizations (NGOs), and policy makers (see Global Health 2035 Mission Grand Convergence [1]). The following sections capture the deliberations of a workshop (Working Group 4) chartered to: (1) review the list of 24 parameters selected from SMART vaccines (see the companion papers by Timmis et al. and Madhavan et al., respectively) to determine which represent factors (see Table 1) that should be taken into account when evaluating the role of vaccines in maximizing the success of the Global Health 2035 Grand Convergence; (2) develop 3-5 "core values" that should be taken into account when evaluating vaccines at various stages of development; and (3) determine how vaccines can best contribute to the Global Health 2035 Grand Convergence effort. Copyright © 2016.

Identification of Ind transcription activation and repression domains required for dorsoventral patterning of the CNS.

PubMed

Von Ohlen, Tonia L; Moses, Cade

2009-07-01

Specification of cell fates across the dorsoventral axis of the central nervous system in Drosophila involves the subdivision of the neuroectoderm into three domains that give rise to three columns of neural precursor cells called neuroblasts. Ventral nervous system defective (Vnd), intermediate neuroblasts defective (Ind) and muscle segment homeobox (Msh) are expressed in the three columns from ventral to dorsal, respectively. The products of these genes play multiple important roles in formation and specification of the embryonic nervous system. Ind, for example, is known to play roles in two important processes. First, Ind is essential for formation of neuroblasts conjunction with SoxB class transcription factors. Sox class transcription factors are known to specify neural stem cells in vertebrates. Second, Ind plays an important role in patterning the CNS in conjunction with, vnd and msh, which is also similar to how vertebrates pattern their neural tube. This work focuses two important aspects of Ind function. First, we used multiple approaches to identify and characterize specific domains within the protein that confer repressor or activator ability. Currently, little is known about the presence of activation or repression domains within Ind. Here, we show that transcriptional repression by Ind requires multiple conserved domains within the protein, and that Ind has a transcriptional activation domain. Specifically, we have identified a novel domain, the Pst domain, that has transcriptional repression ability and appears to act independent of interaction with the co-repressor Groucho. This domain is highly conserved among insect species, but is not found in vertebrate Gsh class homeodomain proteins. Second, we show that Ind can and does repress vnd expression, but does so in a stage specific manner. We conclude from this that the function of Ind in regulating vnd expression is one of refinement and maintenance of the dorsal border.

Accelerating vaccine development and deployment: report of a Royal Society satellite meeting

PubMed Central

Bregu, Migena; Draper, Simon J.; Hill, Adrian V. S.; Greenwood, Brian M.

2011-01-01

The Royal Society convened a meeting on the 17th and 18th November 2010 to review the current ways in which vaccines are developed and deployed, and to make recommendations as to how each of these processes might be accelerated. The meeting brought together academics, industry representatives, research sponsors, regulators, government advisors and representatives of international public health agencies from a broad geographical background. Discussions were held under Chatham House rules. High-throughput screening of new vaccine antigens and candidates was seen as a driving force for vaccine discovery. Multi-stakeholder, small-scale manufacturing facilities capable of rapid production of clinical grade vaccines are currently too few and need to be expanded. In both the human and veterinary areas, there is a need for tiered regulatory standards, differentially tailored for experimental and commercial vaccines, to allow accelerated vaccine efficacy testing. Improved cross-fertilization of knowledge between industry and academia, and between human and veterinary vaccine developers, could lead to more rapid application of promising approaches and technologies to new product development. Identification of best-practices and development of checklists for product development plans and implementation programmes were seen as low-cost opportunities to shorten the timeline for vaccine progression from the laboratory bench to the people who need it. PMID:21893549

14 CFR 151.37 - Sponsor eligibility.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false Sponsor eligibility. 151.37 Section 151.37 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRPORTS... particular airport a sponsor must— (a) Be a public agency, which includes for the purposes of this part only...

14 CFR 151.37 - Sponsor eligibility.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Sponsor eligibility. 151.37 Section 151.37 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRPORTS... particular airport a sponsor must— (a) Be a public agency, which includes for the purposes of this part only...

Evaluating alcoholics anonymous sponsor attributes using conjoint analysis.

PubMed

Stevens, Edward B; Jason, Leonard A

2015-12-01

Alcoholics Anonymous (AA) considers sponsorship an important element of the AA program, especially in early recovery. 225 adult individuals who had experience as either a sponsor, sponsee, or both, participated in a hypothetical sponsor ranking exercise where five attributes were varied across three levels. Conjoint analysis was used to compute part-worth utility of the attributes and their levels for experience, knowledge, availability, confidentiality, and goal-setting. Differences in utilities by attribute were found where confidentiality had the greatest overall possible impact on utility and sponsor knowledge had the least. These findings suggest qualitative differences in sponsors may impact their effectiveness. Future research on AA should continue to investigate sponsor influence on an individual's overall recovery trajectory. Copyright © 2015 Elsevier Ltd. All rights reserved.

[Clinical safety data management in company non-sponsored trials].

PubMed

Saito, Akiko; Sakai, Junko; Kurihara, Masaaki; Kami, Masahiro; Kanda, Yoshinobu; Mori, Shin-ichiro; Takaue, Yoichi; Ohashi, Yasuo

2003-09-01

There is currently no harmonized way in Japan to manage safety data which are obtained during clinical trials supported by Government funds. There are two types of clinical trials, 'sponsored trials(sponsored by industrial companies)' and 'non-sponsored trials(funded by the Government, etc.)'. The Japanese Ministry of Health and Welfare has issued many of pharmaceutical laws(GCP, GPMSP etc.) for the regulation of sponsored trials, while none has ever established for non-sponsored trials, thus leaving the most important quality control/assurance unregulated. In this manuscript we discuss that the simple application of pharmaceutical laws to government-sponsored trials can not be a proper answer because of the different nature of the two types of trials.

A review of malaria vaccine clinical projects based on the WHO rainbow table

PubMed Central

2012-01-01

Development and Phase 3 testing of the most advanced malaria vaccine, RTS,S/AS01, indicates that malaria vaccine R&D is moving into a new phase. Field trials of several research malaria vaccines have also confirmed that it is possible to impact the host-parasite relationship through vaccine-induced immune responses to multiple antigenic targets using different platforms. Other approaches have been appropriately tested but turned out to be disappointing after clinical evaluation. As the malaria community considers the potential role of a first-generation malaria vaccine in malaria control efforts, it is an apposite time to carefully document terminated and ongoing malaria vaccine research projects so that lessons learned can be applied to increase the chances of success for second-generation malaria vaccines over the next 10 years. The most comprehensive resource of malaria vaccine projects is a spreadsheet compiled by WHO thanks to the input from funding agencies, sponsors and investigators worldwide. This spreadsheet, available from WHO's website, is known as "the rainbow table". By summarizing the published and some unpublished information available for each project on the rainbow table, the most comprehensive review of malaria vaccine projects to be published in the last several years is provided below. PMID:22230255

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.

45 CFR 233.51 - Eligibility of sponsored aliens.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 2 2011-10-01 2011-10-01 false Eligibility of sponsored aliens. 233.51 Section... CONDITIONS OF ELIGIBILITY IN FINANCIAL ASSISTANCE PROGRAMS § 233.51 Eligibility of sponsored aliens... affidavit(s) of support or similar agreement on behalf of an alien (who is not the child of the sponsor or...

45 CFR 233.51 - Eligibility of sponsored aliens.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 2 2012-10-01 2012-10-01 false Eligibility of sponsored aliens. 233.51 Section... CONDITIONS OF ELIGIBILITY IN FINANCIAL ASSISTANCE PROGRAMS § 233.51 Eligibility of sponsored aliens... affidavit(s) of support or similar agreement on behalf of an alien (who is not the child of the sponsor or...

45 CFR 233.51 - Eligibility of sponsored aliens.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 2 2010-10-01 2010-10-01 false Eligibility of sponsored aliens. 233.51 Section... CONDITIONS OF ELIGIBILITY IN FINANCIAL ASSISTANCE PROGRAMS § 233.51 Eligibility of sponsored aliens... affidavit(s) of support or similar agreement on behalf of an alien (who is not the child of the sponsor or...

Ethos and Vision Realization in Sponsored Academy Schools

ERIC Educational Resources Information Center

Gibson, Mark T.

2015-01-01

This article investigates the realization of ethos and vision in the early stages of sponsored academy schools in England. It is a qualitative nested case study of ten academies. Nineteen key actors were interviewed, including principals and sponsor representatives. The nests were organized by sponsor type. Key themes are discussed within the…

Schistosomiasis Elimination Strategies and Potential Role of a Vaccine in Achieving Global Health Goals

PubMed Central

Mo, Annie X.; Agosti, Jan M.; Walson, Judd L.; Hall, B. Fenton; Gordon, Lance

2014-01-01

In March 2013, the National Institute of Allergy and Infectious Diseases and the Bill and Melinda Gates Foundation co-sponsored a meeting entitled “Schistosomiasis Elimination Strategy and Potential Role of a Vaccine in Achieving Global Health Goals” to discuss the potential role of schistosomiasis vaccines and other tools in the context of schistosomiasis control and elimination strategies. It was concluded that although schistosomiasis elimination in some focal areas may be achievable through current mass drug administration programs, global control and elimination will face several significant scientific and operational challenges, and will require an integrated approach with other, additional interventions. These challenges include vector (snail) control; environmental modification; water, sanitation, and hygiene; and other future innovative tools such as vaccines. Defining a clear product development plan that reflects a vaccine strategy as complementary to the existing control programs to combat different forms of schistosomiasis will be important to develop a vaccine effectively. PMID:24402703

45 CFR 233.51 - Eligibility of sponsored aliens.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 2 2014-10-01 2012-10-01 true Eligibility of sponsored aliens. 233.51 Section 233... CONDITIONS OF ELIGIBILITY IN FINANCIAL ASSISTANCE PROGRAMS § 233.51 Eligibility of sponsored aliens... affidavit(s) of support or similar agreement on behalf of an alien (who is not the child of the sponsor or...

45 CFR 233.51 - Eligibility of sponsored aliens.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 2 2013-10-01 2012-10-01 true Eligibility of sponsored aliens. 233.51 Section 233... CONDITIONS OF ELIGIBILITY IN FINANCIAL ASSISTANCE PROGRAMS § 233.51 Eligibility of sponsored aliens... affidavit(s) of support or similar agreement on behalf of an alien (who is not the child of the sponsor or...

Modified Vaccinia virus Ankara-based vaccines in the era of personalized immunotherapy of cancer.

PubMed

Bendjama, Kaïdre; Quemeneur, Eric

2017-09-02

While interest in immunotherapies is renewed by the successful introduction of immune checkpoint blocking agent in the clinic, advances in genome sequencing are opening new possibilities in the design of increasingly personalized vaccines. Personalization of medicine can now be realistically contemplated at the single patient level. Unlike the previous generation of cancer vaccines, neoantigen directed vaccines would target truly specific tumor antigens resulting from acquired tumor genome mutations. Immune response induced by this next generation vaccine would not be subject to self-tolerance and will likely result to enhanced efficacy. Nevertheless, this new technologies can hold to their promises only if sponsors manage to meet several scientific, technical, logistical and regulatory challenges. In particular manufacturers will have to design, manufacture, and deliver to the patient a new pharmaceutical grade in a matters of weeks. In this paper, we briefly review current technologies currently tried at the translation of personalized vaccines and explore the possibilities offered by the Modified Vaccinia virus Ankara in this next wave of cancer vaccines.

Challenges and opportunities in RSV vaccine development: Meeting report from FDA/NIH workshop.

PubMed

Roberts, Jeffrey N; Graham, Barney S; Karron, Ruth A; Munoz, Flor M; Falsey, Ann R; Anderson, Larry J; Marshall, V; Kim, Sonnie; Beeler, Judy A

2016-09-22

Respiratory syncytial virus (RSV) is the most common cause of serious acute lower respiratory illness in infants and young children and a significant cause of disease burden in the elderly and immunocompromised. There are no licensed RSV vaccines to address this significant public health need. While advances in vaccine technologies have led to a recent resurgence in RSV vaccine development, the immune correlates of protection against RSV and the immunology of vaccine-associated enhanced respiratory disease (ERD) remain poorly understood. FDA's Center for Biologics Evaluation and Research (CBER) and NIH's National Institute of Allergy and Infectious Diseases (NIAID) organized and co-sponsored an RSV Vaccines Workshop in Bethesda, Maryland on June 1 and 2, 2015. The goal of the conference was to convene scientists, regulators, and industry stakeholders to discuss approaches to RSV vaccine development within the context of three target populations - infants and children, pregnant women, and individuals >60years of age. The agenda included topics related to RSV vaccine development in general, as well as considerations specific to each target population, such as clinical and serological endpoints. The meeting focused on vaccine development for high income countries (HIC), because issues relevant to vaccine development for low and middle income countries (LMIC) have been discussed in other forums. This manuscript summarizes the discussion of clinical, scientific, and regulatory perspectives, research gaps, and lessons learned. Copyright © 2016.

14 CFR 152.103 - Sponsors: Airport development.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false Sponsors: Airport development. 152.103 Section 152.103 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION... Sponsors: Airport development. (a) To be eligible to apply for a project for airport development with...

14 CFR 152.103 - Sponsors: Airport development.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Sponsors: Airport development. 152.103 Section 152.103 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION... Sponsors: Airport development. (a) To be eligible to apply for a project for airport development with...

45 CFR 1226.13 - Obligations of sponsors.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 4 2010-10-01 2010-10-01 false Obligations of sponsors. 1226.13 Section 1226.13 Public Welfare Regulations Relating to Public Welfare (Continued) CORPORATION FOR NATIONAL AND COMMUNITY SERVICE PROHIBITIONS ON ELECTORAL AND LOBBYING ACTIVITIES Sponsor Employee Activities § 1226.13...

48 CFR 35.017-1 - Sponsoring agreements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Sponsoring agreements. 35... CATEGORIES OF CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 35.017-1 Sponsoring agreements. (a) In order... mission, and ensure a periodic reevaluation of the FFRDC, a written agreement of sponsorship between the...

48 CFR 35.017-1 - Sponsoring agreements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Sponsoring agreements. 35... CATEGORIES OF CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 35.017-1 Sponsoring agreements. (a) In order... mission, and ensure a periodic reevaluation of the FFRDC, a written agreement of sponsorship between the...

48 CFR 35.017-1 - Sponsoring agreements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 1 2014-10-01 2014-10-01 false Sponsoring agreements. 35... CATEGORIES OF CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 35.017-1 Sponsoring agreements. (a) In order... mission, and ensure a periodic reevaluation of the FFRDC, a written agreement of sponsorship between the...

14 CFR 152.103 - Sponsors: Airport development.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Sponsors: Airport development. 152.103... (CONTINUED) AIRPORTS AIRPORT AID PROGRAM Eligibility Requirements and Application Procedures § 152.103 Sponsors: Airport development. (a) To be eligible to apply for a project for airport development with...

14 CFR 152.103 - Sponsors: Airport development.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 3 2013-01-01 2013-01-01 false Sponsors: Airport development. 152.103... (CONTINUED) AIRPORTS AIRPORT AID PROGRAM Eligibility Requirements and Application Procedures § 152.103 Sponsors: Airport development. (a) To be eligible to apply for a project for airport development with...

14 CFR 152.103 - Sponsors: Airport development.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 3 2012-01-01 2012-01-01 false Sponsors: Airport development. 152.103... (CONTINUED) AIRPORTS AIRPORT AID PROGRAM Eligibility Requirements and Application Procedures § 152.103 Sponsors: Airport development. (a) To be eligible to apply for a project for airport development with...

42 CFR 423.401 - General requirements for PDP sponsors.

Code of Federal Regulations, 2010 CFR

2010-10-01

... with State Law and Preemption by Federal Law § 423.401 General requirements for PDP sponsors. (a... sponsor is organized and licensed under State law as a risk bearing entity eligible to offer health... otherwise licensed, the sponsor obtains certification from the State that the organization meets a level of...

Sponsor-Imposed Publication Restrictions Disclosed on ClinicalTrials.gov.

PubMed

Stretton, Serina; Lew, Rebecca A; Ely, Julie A; Snape, Mark J; Carey, Luke C; Haley, Cassandra; Woolley, Mark J; Woolley, Karen L

2016-01-01

We investigated whether sponsor-imposed publication restrictions for ClinicalTrials.gov trials were reasonable, based on consistency with Good Publication Practice 2 (GPP2). ClinicalTrials.gov trial record data were electronically imported (October 7, 2012) and screened for eligibility (phase 2-4, interventional, recruitment closed, results available, first received for registration after November 10, 2009, any sponsor type, investigators not sponsor employees). Two authors categorized restrictions information as consistent or not consistent with GPP2, resolving discrepancies by consensus. Of the eligible trials (388/484, n = 81,768 participants), 80.7% (313/388) had restrictions disclosed, and 92.5% (311/388) were industry-sponsored. Significantly more trials had restrictions that were consistent with GPP2 than not (74.1% [232/313], n = 55,280 participants vs. 25.9% [81/313], n = 19,677 participants; P < .001). Reasons for inconsistency were insufficient, unclear, or ambiguous information (48.1%, 39/81), sponsor-required approval for publication (35.8%, 29/81), sponsor-required text changes (8.6%, 7/81), and outright bans (7.4%, 6/81). Follow-up of trials with insufficient information and a contact email (response rate, 46.9% [15/32]) revealed 2 additional bans. A total of 776 participants had consented to trials that had publication bans. Many, but not all, sponsor-imposed publication restrictions disclosed on ClinicalTrials.gov may be considered reasonable. Sponsors should ensure restrictions are appropriately disclosed. Volunteers should be alerted to any restrictions before consenting to participate in a clinical trial.

7 CFR 225.12 - Claims against sponsors.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 4 2010-01-01 2010-01-01 false Claims against sponsors. 225.12 Section 225.12 Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS SUMMER FOOD SERVICE PROGRAM State Agency Provisions § 225.12 Claims against sponsors. (a) The State agency...

Can the ministry collaborate to form the "next generation" of sponsors?

PubMed

Stanley, Teresa

2007-01-01

In looking to the future of sponsored ministry of Catholic institutions, the formation of future sponsors--both religious and lay alike--is an important issue. As this ministry continues to evolve, and sponsoring groups determine how best to prepare new sponsors, might it not be time to think about how to pool the ministry's collective wisdom on formation? Sponsors act not only in the name of the health care institution (or other ministry) but on behalf of the faith community engaged in continuing the compassionate healing ministry of Jesus. In Catholic ministry, and particularly health care ministry, sponsors carry out their responsibilities through a multiplicity of organizational relationships. Just as structures differ, so too do criteria that guide who will be called to join a sponsoring group. There are several core elements that are incorporated in the majority of sponsor competency sets. Elements identified by a committee of ministry members, and reviewed by hundreds of sponsors and other ministry leaders are: mission oriented, animated, theologically grounded, collaborative, church related, and accountable. If one is looking at the potential for convening dialogues about possible areas of collaboration in formation, these core elements, with examples of how they are lived out, may offer an outline of areas new sponsors might need to learn more about for their personal and professional development. Our Catholic health ministry depends on leaders who can create and steward organizational cultures that incarnate Jesus' healing. The possibilities for collaboration in the formation of future sponsors are endless, but there are challenges. If you are a member of a sponsor body/council/corporate member in Catholic health care, and are interested in nominating potential persons to take part in a representative group that would discuss possibilities for collaboration in sponsor formation, please go to www.chausa.org/sponsorformation and complete all sections of the

Cross-sectional study of Pfizer-sponsored clinical trials: assessment of time to publication and publication history.

PubMed

Mooney, LaVerne A; Fay, Lorna

2016-07-18

To estimate the proportion of Pfizer-sponsored clinical trials that completed in 2010 and are published as manuscripts in the peer-reviewed literature, and to assess the manuscript development history. Retrospective, cross-sectional analysis. Clinical trials registered in ClinicalTrials.gov that completed in 2010 for approved, Pfizer prescription products in patients or vaccines in healthy participants. The proportion of studies for which the primary outcome(s) was published and the median time from study completion to publication. The manuscript development history included the number of times a manuscript was submitted before it was accepted for publication. Among registered clinical trials for which Pfizer was the sponsor that completed in 2010, 76 met all inclusion criteria. The primary outcome(s) for 65 (85%) studies was published in 71 manuscripts; the median time to publication was 31 months (range 3-63 months). Of the remaining 11 studies, 2 had been submitted to at least one journal, 2 had not yet been submitted and 7 had no plans to publish because the study had terminated early due to recruitment challenges. Manuscripts accepted at the first choice journal were published at median time of 28 months (range 8-63, n=31), those accepted at second choice journal were published at 32 months (3-45, n=19), and for those accepted at third choice journal, it was 40 months (range 24-53, n=13). The publication rate and median time to publication from study completion for Pfizer-sponsored studies were comparable to those previously reported for combined analyses of industry and non-industry sectors. Opportunities exist for sponsors, authors and journals to explore ideas that would facilitate more timely publication for clinical trial results. However, to be effective, such changes may need to revisit the entire publication process. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to

78 FR 55262 - Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Investigational...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-10

... Applications--Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug...)--Determining Whether Human Research Studies Can Be Conducted Without an IND.'' The guidance is intended to... research studies must be conducted under an IND. The guidance describes the basic criteria for determining...

Mass vaccination with a two-dose oral cholera vaccine in a long-standing refugee camp, Thailand.

PubMed

Phares, Christina R; Date, Kashmira; Travers, Philippe; Déglise, Carole; Wongjindanon, Nuttapong; Ortega, Luis; Bhuket, Ponchanok Rattanadilok Na

2016-01-02

During 2005-2012, surveillance in Maela refugee camp, Thailand, identified four cholera outbreaks, with rates up to 10.7 cases per 1000 refugees. In 2013, the Thailand Ministry of Public Health sponsored a two-dose oral cholera vaccine (OCV) campaign for the approximately 46,000 refugees living in Maela. We enumerated the target population (refugees living in Maela who are ≥1 year old and not pregnant) in a census three months before the campaign and issued barcoded OCV cards to each individual. We conducted the campaign using a fixed-post strategy during two eight-day rounds plus one two-day round for persons who had missed their second dose and recorded vaccine status for each individual. To identify factors associated with no vaccination (versus at least one dose) and those associated with adverse events following immunization (AEFI), we used separate marginal log-binomial regression models with robust variance estimates to account for household clustering. A total of 63,057 OCV doses were administered to a target population of 43,485 refugees. An estimated 35,399 (81%) refugees received at least one dose and 27,658 (64%) received two doses. A total of 993 additional doses (1.5%) were wasted including 297 that were spat out. Only 0.05% of refugees, mostly children, could not be vaccinated due to repeated spitting. Characteristics associated with no vaccination (versus at least one dose) included age ≥15 years (versus 1-14 years), Karen ethnicity (versus any other ethnicity) and, only among adults 15-64 years old, male sex. Passive surveillance identified 84 refugees who experienced 108 AEFI including three serious but coincidental events. The most frequent AEFI were nausea (49%), dizziness (38%), and fever (30%). Overall, AEFI were more prevalent among young children and older adults. Our results suggest that mass vaccination in refugee camps with a two-dose OCV is readily achievable and AEFI are few. Published by Elsevier Ltd.

22 CFR 211.5 - Obligations of cooperating sponsor.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Standards promulgated by the International Organization of Supreme Audit Institutions or International... provisions of this regulation. (c) Audits—(1) By nongovernmental cooperating sponsors. A nongovernmental cooperating sponsor shall arrange for periodic audits to be conducted in accordance with OMB Circular A-133...

22 CFR 211.5 - Obligations of cooperating sponsor.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Standards promulgated by the International Organization of Supreme Audit Institutions or International... provisions of this regulation. (c) Audits—(1) By nongovernmental cooperating sponsors. A nongovernmental cooperating sponsor shall arrange for periodic audits to be conducted in accordance with OMB Circular A-133...

22 CFR 211.5 - Obligations of cooperating sponsor.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Standards promulgated by the International Organization of Supreme Audit Institutions or International... provisions of this regulation. (c) Audits—(1) By nongovernmental cooperating sponsors. A nongovernmental cooperating sponsor shall arrange for periodic audits to be conducted in accordance with OMB Circular A-133...

22 CFR 211.5 - Obligations of cooperating sponsor.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Standards promulgated by the International Organization of Supreme Audit Institutions or International... provisions of this regulation. (c) Audits—(1) By nongovernmental cooperating sponsors. A nongovernmental cooperating sponsor shall arrange for periodic audits to be conducted in accordance with OMB Circular A-133...

22 CFR 211.5 - Obligations of cooperating sponsor.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Standards promulgated by the International Organization of Supreme Audit Institutions or International... provisions of this regulation. (c) Audits—(1) By nongovernmental cooperating sponsors. A nongovernmental cooperating sponsor shall arrange for periodic audits to be conducted in accordance with OMB Circular A-133...

Should Sponsors and DSMBs Share Interim Results Across Trials?

PubMed Central

Shah, Seema K.; Dawson, Liza; Dixon, Dennis O.; Lie, Reidar K.

2011-01-01

Increasing numbers of multinational clinical trials have generated new ethical obligations of research sponsors and their DSMBs. Although sponsors and DSMBs clearly have ethical obligations to protect subjects in their trials, future patients, and the integrity of their trial, the obligations they have to protect subjects in other trials have been overlooked. When interim results from clinical trials can significantly affect the conduct of other trials and the welfare of the subjects in those trials, sponsors and DSMBs may have obligations to disclose results to the relevant parties. We propose that sponsors and DSMBs routinely work together in advance to develop a plan for disclosing relevant information in cases where it is necessary to protect the welfare of subjects in other trials. Channels of communication between sponsors, DSMBs, IRBs, and others involved in similar and concurrent trials will better protect both research participants and the integrity of the research enterprise. PMID:21937922

45 CFR 149.600 - Sponsor's duty to report data inaccuracies.

Code of Federal Regulations, 2014 CFR

2014-10-01

... HEALTH CARE ACCESS REQUIREMENTS FOR THE EARLY RETIREE REINSURANCE PROGRAM Disclosure of Data Inaccuracies § 149.600 Sponsor's duty to report data inaccuracies. A sponsor is required to disclose any data... 45 Public Welfare 1 2014-10-01 2014-10-01 false Sponsor's duty to report data inaccuracies. 149...

45 CFR 149.600 - Sponsor's duty to report data inaccuracies.

Code of Federal Regulations, 2012 CFR

2012-10-01

... HEALTH CARE ACCESS REQUIREMENTS FOR THE EARLY RETIREE REINSURANCE PROGRAM Disclosure of Data Inaccuracies § 149.600 Sponsor's duty to report data inaccuracies. A sponsor is required to disclose any data... 45 Public Welfare 1 2012-10-01 2012-10-01 false Sponsor's duty to report data inaccuracies. 149...

Government-Sponsored Programs on Structures Technology

NASA Technical Reports Server (NTRS)

Noor, Ahmed K. (Compiler); Malone, John B. (Compiler)

1997-01-01

This document contains the presentations from the joint UVA/AIAA workshops on Government-Sponsored Programs on Structures Technology, held on April 6, 1997 in Kissimmee, Florida and on September 4, 1997 in Hampton, Virginia. Workshop attendees were the Members and Friends of the AIAA Structures Technical Committee. The objectives of the workshops were to: (a) provide a forum for discussion of current government-sponsored programs in the structures area; (b) identify high-potential research areas for future aerospace systems; and (c) initiate suitable interaction mechanisms with the managers of structures programs.

The Sponsors of Literacy. Report Series 7.12.

ERIC Educational Resources Information Center

Brandt, Deborah

Intuitively, "sponsors" seems a fitting term for the figures who turned up most typically in people's memories of literacy learning: older relatives, teachers, priests, supervisors, military officers, editors, influential authors. The concept of sponsors helps to explain a range of human relationships and ideological pressures that turn…

Differential Globalization of Industry- and Non-Industry-Sponsored Clinical Trials.

PubMed

Atal, Ignacio; Trinquart, Ludovic; Porcher, Raphaël; Ravaud, Philippe

2015-01-01

Mapping the international landscape of clinical trials may inform global health research governance, but no large-scale data are available. Industry or non-industry sponsorship may have a major influence in this mapping. We aimed to map the global landscape of industry- and non-industry-sponsored clinical trials and its evolution over time. We analyzed clinical trials initiated between 2006 and 2013 and registered in the WHO International Clinical Trials Registry Platform (ICTRP). We mapped single-country and international trials by World Bank's income groups and by sponsorship (industry- vs. non- industry), including its evolution over time from 2006 to 2012. We identified clusters of countries that collaborated significantly more than expected in industry- and non-industry-sponsored international trials. 119,679 clinical trials conducted in 177 countries were analysed. The median number of trials per million inhabitants in high-income countries was 100 times that in low-income countries (116.0 vs. 1.1). Industry sponsors were involved in three times more trials per million inhabitants than non-industry sponsors in high-income countries (75.0 vs. 24.5) and in ten times fewer trials in low- income countries (0.08 vs. 1.08). Among industry- and non-industry-sponsored trials, 30.3% and 3.2% were international, respectively. In the industry-sponsored network of collaboration, Eastern European and South American countries collaborated more than expected; in the non-industry-sponsored network, collaboration among Scandinavian countries was overrepresented. Industry-sponsored international trials became more inter-continental with time between 2006 and 2012 (from 54.8% to 67.3%) as compared with non-industry-sponsored trials (from 42.4% to 37.2%). Based on trials registered in the WHO ICTRP we documented a substantial gap between the globalization of industry- and non-industry-sponsored clinical research. Only 3% of academic trials but 30% of industry trials are

Differential Globalization of Industry- and Non-Industry–Sponsored Clinical Trials

PubMed Central

Atal, Ignacio; Trinquart, Ludovic; Porcher, Raphaël; Ravaud, Philippe

2015-01-01

Background Mapping the international landscape of clinical trials may inform global health research governance, but no large-scale data are available. Industry or non-industry sponsorship may have a major influence in this mapping. We aimed to map the global landscape of industry- and non-industry–sponsored clinical trials and its evolution over time. Methods We analyzed clinical trials initiated between 2006 and 2013 and registered in the WHO International Clinical Trials Registry Platform (ICTRP). We mapped single-country and international trials by World Bank's income groups and by sponsorship (industry- vs. non- industry), including its evolution over time from 2006 to 2012. We identified clusters of countries that collaborated significantly more than expected in industry- and non-industry–sponsored international trials. Results 119,679 clinical trials conducted in 177 countries were analysed. The median number of trials per million inhabitants in high-income countries was 100 times that in low-income countries (116.0 vs. 1.1). Industry sponsors were involved in three times more trials per million inhabitants than non-industry sponsors in high-income countries (75.0 vs. 24.5) and in ten times fewer trials in low- income countries (0.08 vs. 1.08). Among industry- and non-industry–sponsored trials, 30.3% and 3.2% were international, respectively. In the industry-sponsored network of collaboration, Eastern European and South American countries collaborated more than expected; in the non-industry–sponsored network, collaboration among Scandinavian countries was overrepresented. Industry-sponsored international trials became more inter-continental with time between 2006 and 2012 (from 54.8% to 67.3%) as compared with non-industry–sponsored trials (from 42.4% to 37.2%). Conclusions Based on trials registered in the WHO ICTRP we documented a substantial gap between the globalization of industry- and non-industry–sponsored clinical research. Only 3% of

Access, Education and Policy Awareness: Predictors of Influenza Vaccine Acceptance Among VHA Healthcare Workers.

PubMed

Eaton, Jennifer Lipkowitz; Mohr, David C; McPhaul, Kathleen M; Kaslow, Richard A; Martinello, Richard A

2017-08-01

OBJECTIVE To identify predictors of influenza vaccine acceptance among VHA healthcare workers (HCWs), with emphasis on modifiable factors related to promotion campaigns. DESIGN Survey. SETTING National single-payer healthcare system with 140 hospitals and 321,000 HCWs. PARTICIPANTS National voluntary sample of HCWs in the Veterans Health Administration (VHA) system. METHODS We invited a random sample of 5% of all VHA HCWs to participate. An 18-item intranet-based survey inquired about occupation, vaccination status, employer policy, and local campaign efforts. RESULTS The response rate was 17.4%. Of 2,502 initial respondents, 2,406 (96.2%) provided usable data. This sample includes respondents from all 140 VA hospitals. Self-reported influenza vaccination rates were highest among physicians (95.6%) and licensed independent providers (88.3%). Nonclinical staff (80.7%) reported vaccine uptake similar to other certified but nonlicensed providers (81.2%). The strongest predictor of vaccine acceptance among VHA HCWs was individual awareness of organizational policy. Vaccine acceptance was also higher among HCWs who reported more options for access to vaccination and among those in facilities with more education activities. CONCLUSIONS Influenza vaccine acceptance varied significantly by employee awareness of employer policy and on-site access to vaccine. Employer-sponsored activities to increase access continue to show positive returns across occupations. Local influenza campaign efforts to educate HCWs may have reached saturation in this target group. These results suggest that focused communications to increase HCW awareness and understanding of employer policy can drive further increase in influenza vaccination acceptance. Infect Control Hosp Epidemiol 2017;38:970-975.

Immunologic monitoring of cancer vaccine therapy: results of a workshop sponsored by the Society for Biological Therapy.

PubMed

Keilholz, Ulrich; Weber, Jeffrey; Finke, James H; Gabrilovich, Dmitry I; Kast, W Martin; Disis, Mary L; Kirkwood, John M; Scheibenbogen, Carmen; Schlom, Jeff; Maino, Vernon C; Lyerly, H Kim; Lee, Peter P; Storkus, Walter; Marincola, Franceso; Worobec, Alexandra; Atkins, Michael B

2002-01-01

The Society for Biological Therapy held a Workshop last fall devoted to immune monitoring for cancer immunotherapy trials. Participants included members of the academic and pharmaceutical communities as well as the National Cancer Institute and the Food and Drug Administration. Discussion focused on the relative merits and appropriate use of various immune monitoring tools. Six breakout groups dealt with assays of T-cell function, serologic and proliferation assays to assess B cell and T helper cell activity, and enzyme-linked immunospot assay, tetramer, cytokine flow cytometry, and reverse transcription polymerase chain reaction assays of T-cell immunity. General conclusions included: (1) future vaccine studies should be designed to determine whether T-cell dysfunction (tumor-specific and nonspecific) correlated with clinical outcome; (2) tetramer-based assays yield quantitative but not functional data (3) enzyme-linked immunospot assays have the lowest limit of detection (4) cytokine flow cytometry have a higher limit of detection than enzyme-linked immunospot assay, but offer the advantages of speed and the ability to identify subsets of reactive cells; (5) antibody tests are simple and accurate and should be incorporated to a greater extent in monitoring plans; (6) proliferation assays are imprecise and should not be emphasized in future studies; (7) the reverse transcription polymerase chain reaction assay is a promising research approach that is not ready for widespread application; and (8)there is a critical need to validate these assays as surrogates for vaccine potency and clinical effect. Current data and opinion support the use of a functional assay like the enzyme-linked immunospot assay or cytokine flow cytometry in combination with a quantitative assay like tetramers for immune monitoring. At present, assays appear to be most useful as measures of vaccine potency. Careful immune monitoring in association with larger scale clinical trials ultimately

33 CFR 117.441 - D'Inde Bayou.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false D'Inde Bayou. 117.441 Section 117.441 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY BRIDGES DRAWBRIDGE... railroad bridge, mile 4.3, shall open on signal if at least 72 hours notice is given to the Defense Plant...

33 CFR 117.441 - D'Inde Bayou.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 33 Navigation and Navigable Waters 1 2014-07-01 2014-07-01 false D'Inde Bayou. 117.441 Section 117.441 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY BRIDGES DRAWBRIDGE... railroad bridge, mile 4.3, shall open on signal if at least 72 hours notice is given to the Defense Plant...

33 CFR 117.441 - D'Inde Bayou.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 33 Navigation and Navigable Waters 1 2011-07-01 2011-07-01 false D'Inde Bayou. 117.441 Section 117.441 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY BRIDGES DRAWBRIDGE... railroad bridge, mile 4.3, shall open on signal if at least 72 hours notice is given to the Defense Plant...

33 CFR 117.441 - D'Inde Bayou.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 33 Navigation and Navigable Waters 1 2013-07-01 2013-07-01 false D'Inde Bayou. 117.441 Section 117.441 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY BRIDGES DRAWBRIDGE... railroad bridge, mile 4.3, shall open on signal if at least 72 hours notice is given to the Defense Plant...

33 CFR 117.441 - D'Inde Bayou.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 33 Navigation and Navigable Waters 1 2012-07-01 2012-07-01 false D'Inde Bayou. 117.441 Section 117.441 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY BRIDGES DRAWBRIDGE... railroad bridge, mile 4.3, shall open on signal if at least 72 hours notice is given to the Defense Plant...

Employer-Sponsored Child Care Models and Related Issues.

ERIC Educational Resources Information Center

Renfroe, Martha Lou

This study was designed to describe the different models of Employer-Sponsored Child Care (ESCC) available to employers and child care professionals. Examples of specific child care programs sponsored by employers are described, and five ESCC models are identified: on-site and off-site centers for a single employer, off-site centers for multiple…

An Exploratory Investigation of Important Qualities and Characteristics of Alcoholics Anonymous Sponsors.

PubMed

Stevens, Edward B; Jason, Leonard A

Alcoholics Anonymous recommends members to have sponsors, especially those early in their recovery, yet little research has been done on the qualities of an effective sponsor. 245 adults (117 females, 128 males) currently in substance use disorder recovery participated. 231 of these individuals had experience as a sponsor, sponsee or both (109 had experience as a sponsor). Qualitative results suggest effective sponsors are currently engaged in the program on a personal level, are trustworthy, and are available although a wide variety of attributes were cited. In a choice and ranking exercise, 12- step engagement and qualities of character were also most often ranked highly. No significant differences were found between genders or sponsor/sponsee roles. Implications based on breadth of responses and dominant themes are discussed as well as the need for further research on sponsor/sponsee characteristics, satisfaction, and recovery outcomes.

First detection of foot-and-mouth disease virus O/ME-SA/Ind2001 in China.

PubMed

Zhu, Z; Yang, F; He, J; Li, J; Cao, W; Li, J; Xia, Y; Guo, J; Jin, Y; Zhang, K; Zheng, H; Liu, X

2018-05-09

Foot-and-mouth disease (FMD) is endemic in China and is predominantly due to foot-and-mouth disease virus (FMDV) serotype O Mya-98 lineage. In recent years, FMDV O/ME-SA/Ind2001 lineage has spread from the Indian subcontinent to South-East Asia, Middle East and Africa, which may pose potential threats for future trans-regional livestock movements. In this study, we identified the appearance of FMDV O/ME-SA/Ind2001 in China; the first time that this virus lineage has been found there. Sequencing and phylogenetic analysis of VP1 sequences revealed that this newly determined strain belongs to O/ME-SA/Ind2001 sublineage d and is closely related to strains that have caused recent outbreaks of FMD in Nepal, Myanmar, Russia and South Korea. The results suggest extensive movements of the current O/ME-SA/Ind2001 sublineage d viruses and provide essential information for an effective national FMDV control programme in China. © 2018 Blackwell Verlag GmbH.

An Experiential Social Media Project: Comparing Client-Sponsored and Non-Client-Sponsored Alternatives

ERIC Educational Resources Information Center

Vinuales, Gema; Harris, Judy

2017-01-01

Students implemented social media campaigns to raise awareness and funds for nonprofit organizations. Teams in one section of the course worked on a designated client-sponsored project (CSP), while teams in another section chose their own nonprofit organizations. Although both the CSPs and non-CSPs were evaluated favorably, students who worked on…

42 CFR 423.510 - Termination of contract by the Part D sponsor.

Code of Federal Regulations, 2010 CFR

2010-10-01

... to the Part D plan sponsor ends as of the first day of the month after the last month for which the... 42 Public Health 3 2010-10-01 2010-10-01 false Termination of contract by the Part D sponsor. 423... Procedures and Contracts with Part D plan sponsors § 423.510 Termination of contract by the Part D sponsor...

Student agreement regarding adequacy of didactic content and practical experiences of vaccination clinic business operations.

PubMed

George, David L; Johnson, Eric J; O'Neal, Katherine S; Smith, Michael J

2018-04-01

To report student perceived adequacy regarding didactic content and practical experiences of vaccination clinic business operations. Didactic content, a case study, and practical experiences regarding vaccination clinic business operations were implemented in related lectures of a Pharmacy Business and Entrepreneurship (PBE) elective and the college of pharmacy sponsored vaccination clinics. An online survey was used to evaluate student perceived adequacy of didactic content and practical experiences of vaccination clinic business operations. Mean scaled agreement was compared between students in the PBE elective versus those not in the elective. Student confidence in performing business operations was also assessed. Students in the PBE had higher mean confidence than non-elective students regarding staff management (3.23 vs. 2.73, p = 0.04). Success of the interventions may be attributed to students in the PBE elective that reported a higher mean perceived adequacy of content and practical experiences and confidence in performing nearly all business operations. Still, further evaluation of interventions is being considered to assess effectiveness of learning. Published by Elsevier Inc.

Rational design of HIV vaccines and microbicides: report of the EUROPRISE network annual conference 2010

PubMed Central

2011-01-01

Novel, exciting intervention strategies to prevent infection with HIV have been tested in the past year, and the field is rapidly evolving. EUROPRISE is a network of excellence sponsored by the European Commission and concerned with a wide range of activities including integrated developmental research on HIV vaccines and microbicides from discovery to early clinical trials. A central and timely theme of the network is the development of the unique concept of co-usage of vaccines and microbicides. This review, prepared by the PhD students of the network captures much of the research ongoing between the partners. The network is in its 5th year and involves over 50 institutions from 13 European countries together with 3 industrial partners; GSK, Novartis and Sanofi-Pasteur. EUROPRISE is involved in 31 separate world-wide trials of Vaccines and Microbicides including 6 in African countries (Tanzania, Mozambique, South Africa, Kenya, Malawi, Rwanda), and is directly supporting clinical trials including MABGEL, a gp140-hsp70 conjugate trial and HIVIS, vaccine trials in Europe and Africa. PMID:21486446

Rational design of HIV vaccines and microbicides: report of the EUROPRISE network annual conference 2010.

PubMed

Brinckmann, Sarah; da Costa, Kelly; van Gils, Marit J; Hallengärd, David; Klein, Katja; Madeira, Luisa; Mainetti, Lara; Palma, Paolo; Raue, Katharina; Reinhart, David; Reudelsterz, Marc; Ruffin, Nicolas; Seifried, Janna; Schäfer, Katrein; Sheik-Khalil, Enas; Sköld, Annette; Uchtenhagen, Hannes; Vabret, Nicolas; Ziglio, Serena; Scarlatti, Gabriella; Shattock, Robin; Wahren, Britta; Gotch, Frances

2011-04-12

Novel, exciting intervention strategies to prevent infection with HIV have been tested in the past year, and the field is rapidly evolving. EUROPRISE is a network of excellence sponsored by the European Commission and concerned with a wide range of activities including integrated developmental research on HIV vaccines and microbicides from discovery to early clinical trials. A central and timely theme of the network is the development of the unique concept of co-usage of vaccines and microbicides. This review, prepared by the PhD students of the network captures much of the research ongoing between the partners. The network is in its 5th year and involves over 50 institutions from 13 European countries together with 3 industrial partners; GSK, Novartis and Sanofi-Pasteur. EUROPRISE is involved in 31 separate world-wide trials of Vaccines and Microbicides including 6 in African countries (Tanzania, Mozambique, South Africa, Kenya, Malawi, Rwanda), and is directly supporting clinical trials including MABGEL, a gp140-hsp70 conjugate trial and HIVIS, vaccine trials in Europe and Africa.

Unfulfilled translation opportunities in industry sponsored clinical trials.

PubMed

Smed, Marie; Getz, Kenneth A

2013-05-01

Knowledge generated by site representatives through their participation in clinical trials is valuable for testing new products in use and obtaining final market approval. The leverage of this important knowledge is however challenged as the former direct relationships between in-house staff in the industry and site representatives are changing. The process of clinical trials has increased in complexity over the years, resulting in additional management layers. Besides an increase in internal management layers, sponsors often also outsource various tasks related to clinical trials to a CRO (Contract Research Organization) and thereby adding another link in the relationships between site and sponsor. These changes are intended to optimize the time-consuming and costly trial phases; however, there is a need to study whether valuable knowledge and experience is compromised in the process. Limited research exists on the full range of clinical practice insights obtained by investigators during and after clinical trials and how well these insights are transferred to study sponsors. This study explores the important knowledge-transfer processes between sites and sponsors and to what extent sites' knowledge gained in clinical trials is utilized by the industry. Responses from 451 global investigative site representatives are included in the study. The analysis of the extensive dataset reveals that the current processes of collaboration between sites and the industry restrict the leverage of valuable knowledge gained by physicians in the process of clinical trials. These restrictions to knowledge-transfer between site and sponsor are further challenged if CRO partners are integrated in the trial process. Copyright © 2013 Elsevier Inc. All rights reserved.

42 CFR 440.350 - Employer-sponsored insurance health plans.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 4 2014-10-01 2014-10-01 false Employer-sponsored insurance health plans. 440.350 Section 440.350 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN... Benchmark-Equivalent Coverage § 440.350 Employer-sponsored insurance health plans. (a) A State may provide...

42 CFR 440.350 - Employer-sponsored insurance health plans.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 4 2012-10-01 2012-10-01 false Employer-sponsored insurance health plans. 440.350 Section 440.350 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN... Benchmark-Equivalent Coverage § 440.350 Employer-sponsored insurance health plans. (a) A State may provide...

Diabetes in employer-sponsored health insurance.

PubMed

Peele, Pamela B; Lave, Judith R; Songer, Thomas J

2002-11-01

To examine medical and mental health care expenditures for large numbers of individuals with diabetes enrolled in employment-sponsored insurance plans. Health insurance billing data for approximately 1.3 million individuals enrolled in health insurance plans sponsored by 862 large self-insured employers nationwide were used to examine employer expenditures and consumer out-of-pocket payments for 20,937 people identified with diabetes. These expenditures were compared with expenditures for individuals with other chronic illnesses. Main outcome measures were covered charges, insurance plan reimbursements, and estimated consumer out-of-pocket payments for both medical and mental health services. A total of 1.7% of enrollees were identified as having diabetes and approximately 11% of those used at least one mental health service during 1996. Health care expenditures were three times higher for those with diabetes compared with all health care consumers in these insurance plans, but when compared with individuals with other chronic illnesses such as heart disease, HIV/AIDS, cancer, and asthma, those with diabetes were not more expensive for employers' insurance plans. Diabetes accounts for 6.5% of total health plan expenditures. Diabetes is not more expensive for either consumers or their employer-sponsored insurance plans than other chronic illnesses.

Anthrax vaccine-induced antibodies provide cross-species prediction of survival to aerosol challenge.

PubMed

Fay, Michael P; Follmann, Dean A; Lynn, Freyja; Schiffer, Jarad M; Stark, Gregory V; Kohberger, Robert; Quinn, Conrad P; Nuzum, Edwin O

2012-09-12

Because clinical trials to assess the efficacy of vaccines against anthrax are not ethical or feasible, licensure for new anthrax vaccines will likely involve the Food and Drug Administration's "Animal Rule," a set of regulations that allow approval of products based on efficacy data only in animals combined with immunogenicity and safety data in animals and humans. U.S. government-sponsored animal studies have shown anthrax vaccine efficacy in a variety of settings. We examined data from 21 of those studies to determine whether an immunological bridge based on lethal toxin neutralization activity assay (TNA) can predict survival against an inhalation anthrax challenge within and across species and genera. The 21 studies were classified into 11 different settings, each of which had the same animal species, vaccine type and formulation, vaccination schedule, time of TNA measurement, and challenge time. Logistic regression models determined the contribution of vaccine dilution dose and TNA on prediction of survival. For most settings, logistic models using only TNA explained more than 75% of the survival effect of the models with dose additionally included. Cross-species survival predictions using TNA were compared to the actual survival and shown to have good agreement (Cohen's κ ranged from 0.55 to 0.78). In one study design, cynomolgus macaque data predicted 78.6% survival in rhesus macaques (actual survival, 83.0%) and 72.6% in rabbits (actual survival, 64.6%). These data add support for the use of TNA as an immunological bridge between species to extrapolate data in animals to predict anthrax vaccine effectiveness in humans.

Response to Indacaterol/Glycopyrronium (IND/GLY) by Sex in Patients with COPD: A Pooled Analysis from the IGNITE Program.

PubMed

Tsiligianni, Ioanna; Mezzi, Karen; Fucile, Sebastian; Kostikas, Konstantinos; Shen, Steven; Banerji, Donald; Fogel, Robert

2017-08-01

In this pooled analysis, we compared the effect of indacaterol/glycopyrronium (IND/GLY) by sex versus other commonly used chronic obstructive pulmonary disease (COPD) treatments and placebo. Male and female patients with moderate-to-very-severe COPD who had participated in six randomized controlled trials were included in the analysis. Baseline demographics and disease characteristics were analyzed by sex, and any differences noted. The effects of IND/GLY versus salmeterol/fluticasone (SFC), glycopyrronium, tiotropium and placebo, on lung function and the patient-reported outcomes (health status, dyspnea, rescue medication use and symptoms) were assessed by sex after 26 weeks treatment. The analysis population comprised 4719 men and 1389 women. Most baseline parameters differed significantly between men and women. Nonetheless, despite these differences in baseline characteristics, IND/GLY significantly improved lung function versus placebo (p < 0.0001) and all active comparators (p < 0.01) in men and women. Overall, IND/GLY showed better improvement in dyspnea and health status compared with all other treatments in both sex. Greater reduction of rescue medication use was observed with IND/GLY versus placebo and other treatments (all p < 0.01 expect IND/GLY versus SFC). Although some variability was observed, improvements in health status, dyspnea, rescue medication use and symptoms were generally larger in women than in men. Irrespective of sex, IND/GLY provided superior efficacy to monotherapy or SFC in both men and women. Small differences in efficacy response by sex were observed, which should be evaluated further in prospective clinical studies. Nevertheless, the benefits observed with IND/GLY confirm dual bronchodilator as the preferred therapy in patients with moderate-to-very-severe COPD regardless of sex.

State law and influenza vaccination of health care personnel.

PubMed

Stewart, Alexandra M; Cox, Marisa A

2013-01-21

Nosocomial influenza outbreaks, attributed to the unvaccinated health care workforce, have contributed to patient complications or death, worker illness and absenteeism, and increased economic costs to the health care system. Since 1981, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) has recommended that all HCP receive an annual influenza vaccination. Health care employers (HCE) have adopted various strategies to encourage health care personnel (HCP) to voluntarily receive influenza vaccination, including: sponsoring educational and promotional campaigns, increasing access to seasonal influenza vaccine, permitting the use of declination statements, and combining multiple approaches. However, these measures failed to significantly increase uptake among HCP. As a result, beginning in 2004, health care facilities and local health departments began to require certain HCP to receive influenza vaccination as a condition of employment and annually. Today, hundreds of facilities throughout the country have developed and implemented similar policies. Mandatory vaccination programs have been endorsed by professional and non-profit organizations, state health departments, and public health. These programs have been more effective at increasing coverage rates than any voluntary strategy, with some health systems reporting coverage rates up to 99.3%. Several states have enacted laws requiring HCEs to implement vaccination programs for the workforce. These laws present an example of how states will respond to threats to the public's health and constrain personal choice in order to protect vulnerable populations. This study analyzes laws in twenty states that address influenza vaccination requirements for HCP who practice in acute or long-term care facilities in the United States. The laws vary in the extent to which they incorporate the six elements of a mandatory HCP influenza vaccination program. Four of the

Characteristics of NIH- and industry-sponsored head and neck cancer clinical trials.

PubMed

Devaiah, Anand; Murchison, Charles

2016-09-01

Compare U.S. clinical trials sponsored by the National Institutes of Health (NIH) and industry, especially with regard to trial design, interventions studied, and results reporting rates. U.S. head and neck cancer clinical trials. We used information from ClinicalTrials.gov to compare NIH- and industry-sponsored head and neck cancer clinical trials, specifically analyzing differences in trial design and interventions studied. We examined publication rates and positive results rates using PubMed.gov. About 50% of NIH- and industry-sponsored clinical trials have their results reported in peer-reviewed literature. Industry-sponsored trials had higher rates of positive results than NIH-sponsored trials. NIH- and industry-sponsored clinical trials had similar trial designs, although industry-sponsored trials had significantly lower rates of randomization. Industry trials utilized radiation in 19% of trials and surgery in 2% of trials. NIH trials also had low utilization of both radiation and surgery (27% and 12% of trials, respectively). NIH- and industry-sponsored trials published their results in journals with comparable impact factors. There is significant underreporting of results in U.S. head and neck cancer clinical trials, whether sponsored by NIH or industry. Industry trials have significantly higher rates of positive results, although it is unclear what contributes to this. Both NIH- and industry-sponsored trials underutilize surgery and radiation as treatment modalities, despite the fact that these are standard-of-care therapies for head and neck cancer. We recommend that the NIH and industry report all results from clinical trials and use surgery and radiation as treatment arms in order to arrive at more balanced therapeutic recommendations. N/A. Laryngoscope, 126:E300-E303, 2016. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

14 CFR 151.113 - Advance planning proposals: Sponsor eligibility.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Engineering Proposals § 151.113 Advance planning proposals: Sponsor eligibility. The sponsor of an advance planning and engineering proposal must be a public agency, as defined in § 151.37(a), and must be legally... agreement; (c) Provide enough funds to pay all estimated proposal costs not borne by the United States; and...

14 CFR 151.113 - Advance planning proposals: Sponsor eligibility.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Engineering Proposals § 151.113 Advance planning proposals: Sponsor eligibility. The sponsor of an advance planning and engineering proposal must be a public agency, as defined in § 151.37(a), and must be legally... agreement; (c) Provide enough funds to pay all estimated proposal costs not borne by the United States; and...

Evaluating a County-Sponsored Social Marketing Campaign to Increase Mothers' Initiation of HPV Vaccine for their Pre-teen Daughters in a Primarily Rural Area.

PubMed

Cates, Joan R; Shafer, Autumn; Diehl, Sandra J; Deal, Allison M

2011-01-01

Routine vaccination against human papillomavirus (HPV), the main cause of cervical cancer, is recommended for 11-12 year old girls, yet vaccine uptake is low. This study evaluates a social marketing campaign initiated by 13 North Carolina counties to raise awareness among parents and reduce barriers to accessing the vaccine in a primarily rural area. The 3-month campaign targeted mothers of girls ages 11-12 and healthcare practices serving pre-teen girls in four counties. Principles of social marketing were: product (recommended vaccine against HPV), price (cost, perception of safety and efficacy, and access), promotion (posters, brochures, website, news releases, doctor's recommendation), and place (doctors' offices, retail outlets). We analyzed (1) website traffic, hotline calls, and media placement; (2) cross-sectional surveys of mothers and providers; and (3) HPV immunization rates in intervention versus non-intervention counties. Of respondent mothers (n=225), 82% heard or saw campaign messages or materials. Of respondent providers (n=35), 94% used campaign brochures regularly or occasionally in conversations with parents. HPV vaccination rates within six months of campaign launch were 2% higher for 9-13 year old girls in two of the four intervention counties compared to 96 non-intervention counties. This evaluation supports campaign use in other primarily rural and underserved areas.

21 CFR 312.22 - General principles of the IND submission.

Code of Federal Regulations, 2014 CFR

2014-04-01

... other human studies as appropriate. Annual reports to the IND should serve as the focus for reporting...-investigator who uses, as a research tool, an investigational new drug that is already subject to a...

21 CFR 312.22 - General principles of the IND submission.

Code of Federal Regulations, 2013 CFR

2013-04-01

... other human studies as appropriate. Annual reports to the IND should serve as the focus for reporting...-investigator who uses, as a research tool, an investigational new drug that is already subject to a...

21 CFR 312.22 - General principles of the IND submission.

Code of Federal Regulations, 2011 CFR

2011-04-01

... other human studies as appropriate. Annual reports to the IND should serve as the focus for reporting...-investigator who uses, as a research tool, an investigational new drug that is already subject to a...

21 CFR 312.22 - General principles of the IND submission.

Code of Federal Regulations, 2012 CFR

2012-04-01

... other human studies as appropriate. Annual reports to the IND should serve as the focus for reporting...-investigator who uses, as a research tool, an investigational new drug that is already subject to a...

76 FR 2807 - New Animal Drugs; Change of Sponsor; Follicle Stimulating Hormone

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-18

... [Docket No. FDA-2010-N-0002] New Animal Drugs; Change of Sponsor; Follicle Stimulating Hormone AGENCY...) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug... currently listed in the animal drug regulations as a sponsor of an approved application. Accordingly, Sec...

The State-Sponsored Student Entrepreneur

ERIC Educational Resources Information Center

Mars, Matthew M.; Slaughter, Sheila; Rhoades, Gary

2008-01-01

This paper introduces the emergent role of the state-sponsored student entrepreneur within the academic capitalist knowledge/learning regime. Drawing on two clarifying cases of such entrepreneurship, the study explores the shifting boundaries between public and private sectors, the creation of new circuits of knowledge, and the entrepreneurial…

Emergency medicine leadership in industry-sponsored clinical trials.

PubMed

Newgard, Craig D; Kim, Sunghye; Camargo, Carlos A

2003-02-01

To identify and characterize emergency medicine (EM) researchers who, since 1990, have served on a steering committee (SC) or as overall principal investigator (PI) of an industry-sponsored, multicenter clinical trial involving a pharmaceutical or device. North American EM research directors (RDs) and other prominent EM investigators (for those hospitals without a RD) were identified from eight sources, including the Society for Academic Emergency Medicine RD Interest Group and the Multicenter Airway Research Collaboration (MARC) database. The identified investigators were sent a screening survey requesting information regarding industry-sponsored clinical research at their site. The individual EM investigators identified by this screening survey were then interviewed by telephone (validation survey) to further explore their leadership experience in industry-sponsored clinical trials. Of 153 identified RDs and prominent EM researchers, 138 responded to the screening survey (90% response rate). Eighty-five EM investigators reportedly had served on a SC or as overall PI for an industry-sponsored clinical trial. Of these 85 North American EM investigators, 77 were available for a structured telephone interview (91% response rate). Although 41 (53%) of the investigators confirmed their leadership role, 36 (47%) had not served in either role. Among the 41 confirmed investigators, 19 (25%) had served as a SC member, 10 (13%) had served as overall PI, and 12 (16%) had experience in both roles. Individual responses provided suggestions for pursuing such leadership positions. These data suggest the opportunity to expand EM leadership in industry-sponsored clinical trials and demonstrate the need for validation of reports obtained by a departmental research contact. The suggestions from EM researchers who have attained these leadership roles may provide strategies for investigators interested in pursuing these positions.

Evaluating a County-Sponsored Social Marketing Campaign to Increase Mothers’ Initiation of HPV Vaccine for their Pre-teen Daughters in a Primarily Rural Area

PubMed Central

Cates, Joan R.; Shafer, Autumn; Diehl, Sandra J.; Deal, Allison M.

2011-01-01

Routine vaccination against human papillomavirus (HPV), the main cause of cervical cancer, is recommended for 11–12 year old girls, yet vaccine uptake is low. This study evaluates a social marketing campaign initiated by 13 North Carolina counties to raise awareness among parents and reduce barriers to accessing the vaccine in a primarily rural area. The 3-month campaign targeted mothers of girls ages 11–12 and healthcare practices serving pre-teen girls in four counties. Principles of social marketing were: product (recommended vaccine against HPV), price (cost, perception of safety and efficacy, and access), promotion (posters, brochures, website, news releases, doctor’s recommendation), and place (doctors’ offices, retail outlets). We analyzed (1) website traffic, hotline calls, and media placement; (2) cross-sectional surveys of mothers and providers; and (3) HPV immunization rates in intervention versus non-intervention counties. Of respondent mothers (n=225), 82% heard or saw campaign messages or materials. Of respondent providers (n=35), 94% used campaign brochures regularly or occasionally in conversations with parents. HPV vaccination rates within six months of campaign launch were 2% higher for 9–13 year old girls in two of the four intervention counties compared to 96 non-intervention counties. This evaluation supports campaign use in other primarily rural and underserved areas. PMID:21804767

Rational design of HIV vaccine and microbicides: report of the EUROPRISE annual conference.

PubMed

Wahren, Britta; Biswas, Priscilla; Borggren, Marie; Coleman, Adam; Da Costa, Kelly; De Haes, Winni; Dieltjens, Tessa; Dispinseri, Stefania; Grupping, Katrijn; Hallengärd, David; Hornig, Julia; Klein, Katja; Mainetti, Lara; Palma, Paolo; Reudelsterz, Marc; Seifried, Janna; Selhorst, Philippe; Sköld, Annette; Uchtenhagen, Hannes; van Gils, Marit J; Weber, Caroline; Shattock, Robin; Scarlatti, Gabriella

2010-07-26

EUROPRISE is a Network of Excellence sponsored from 2007 to 2011 by the European Commission within the 6th Framework Program. The Network encompasses a wide portfolio of activities ranging from an integrated research program in the field of HIV vaccines and microbicides to training, dissemination and advocacy. The research program covers the whole pipeline of vaccine and microbicide development from discovery to early clinical trials. The Network is composed of 58 partners representing more than 65 institutions from 13 European countries; it also includes three major pharmaceutical companies (GlaxoSmithKline, Novartis and Sanofi-Pasteur) involved in HIV microbicide and vaccine research. The Network displays a dedicated and informative web page: http://www.europrise.org. Finally, a distinguishing trait of EUROPRISE is its PhD School of students from across Europe, a unique example in the world of science aimed at spreading excellence through training. EUROPRISE held its second annual conference in Budapest in November, 2009. The conference had 143 participants and their presentations covered aspects of vaccine and microbicide research, development and discovery. Since training is a major task of the Network, the students of the EUROPRISE PhD program summarized certain presentations and their view of the conference in this paper.

Rational design of HIV vaccine and microbicides: report of the EUROPRISE annual conference

PubMed Central

2010-01-01

EUROPRISE is a Network of Excellence sponsored from 2007 to 2011 by the European Commission within the 6th Framework Program. The Network encompasses a wide portfolio of activities ranging from an integrated research program in the field of HIV vaccines and microbicides to training, dissemination and advocacy. The research program covers the whole pipeline of vaccine and microbicide development from discovery to early clinical trials. The Network is composed of 58 partners representing more than 65 institutions from 13 European countries; it also includes three major pharmaceutical companies (GlaxoSmithKline, Novartis and Sanofi-Pasteur) involved in HIV microbicide and vaccine research. The Network displays a dedicated and informative web page: http://www.europrise.org. Finally, a distinguishing trait of EUROPRISE is its PhD School of students from across Europe, a unique example in the world of science aimed at spreading excellence through training. EUROPRISE held its second annual conference in Budapest in November, 2009. The conference had 143 participants and their presentations covered aspects of vaccine and microbicide research, development and discovery. Since training is a major task of the Network, the students of the EUROPRISE PhD program summarized certain presentations and their view of the conference in this paper. PMID:20659333

45 CFR 2552.61 - May a sponsor serve as a volunteer station?

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 4 2012-10-01 2012-10-01 false May a sponsor serve as a volunteer station? 2552... NATIONAL AND COMMUNITY SERVICE FOSTER GRANDPARENT PROGRAM Responsibilities of a Volunteer Station § 2552.61 May a sponsor serve as a volunteer station? Yes, a sponsor may serve as a volunteer station, provided...

45 CFR 2551.61 - May a sponsor serve as a volunteer station?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 4 2011-10-01 2011-10-01 false May a sponsor serve as a volunteer station? 2551... NATIONAL AND COMMUNITY SERVICE SENIOR COMPANION PROGRAM Responsibilities of a Volunteer Station § 2551.61 May a sponsor serve as a volunteer station? Yes, a sponsor may serve as a volunteer station, provided...

45 CFR 2552.61 - May a sponsor serve as a volunteer station?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 4 2013-10-01 2013-10-01 false May a sponsor serve as a volunteer station? 2552... NATIONAL AND COMMUNITY SERVICE FOSTER GRANDPARENT PROGRAM Responsibilities of a Volunteer Station § 2552.61 May a sponsor serve as a volunteer station? Yes, a sponsor may serve as a volunteer station, provided...

45 CFR 2552.61 - May a sponsor serve as a volunteer station?

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 4 2014-10-01 2014-10-01 false May a sponsor serve as a volunteer station? 2552... NATIONAL AND COMMUNITY SERVICE FOSTER GRANDPARENT PROGRAM Responsibilities of a Volunteer Station § 2552.61 May a sponsor serve as a volunteer station? Yes, a sponsor may serve as a volunteer station, provided...

45 CFR 2551.61 - May a sponsor serve as a volunteer station?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 4 2013-10-01 2013-10-01 false May a sponsor serve as a volunteer station? 2551... NATIONAL AND COMMUNITY SERVICE SENIOR COMPANION PROGRAM Responsibilities of a Volunteer Station § 2551.61 May a sponsor serve as a volunteer station? Yes, a sponsor may serve as a volunteer station, provided...

45 CFR 2551.61 - May a sponsor serve as a volunteer station?

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 4 2014-10-01 2014-10-01 false May a sponsor serve as a volunteer station? 2551... NATIONAL AND COMMUNITY SERVICE SENIOR COMPANION PROGRAM Responsibilities of a Volunteer Station § 2551.61 May a sponsor serve as a volunteer station? Yes, a sponsor may serve as a volunteer station, provided...

45 CFR 2551.61 - May a sponsor serve as a volunteer station?

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 4 2012-10-01 2012-10-01 false May a sponsor serve as a volunteer station? 2551... NATIONAL AND COMMUNITY SERVICE SENIOR COMPANION PROGRAM Responsibilities of a Volunteer Station § 2551.61 May a sponsor serve as a volunteer station? Yes, a sponsor may serve as a volunteer station, provided...

45 CFR 2551.61 - May a sponsor serve as a volunteer station?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 4 2010-10-01 2010-10-01 false May a sponsor serve as a volunteer station? 2551... NATIONAL AND COMMUNITY SERVICE SENIOR COMPANION PROGRAM Responsibilities of a Volunteer Station § 2551.61 May a sponsor serve as a volunteer station? Yes, a sponsor may serve as a volunteer station, provided...

45 CFR 2552.61 - May a sponsor serve as a volunteer station?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 4 2011-10-01 2011-10-01 false May a sponsor serve as a volunteer station? 2552... NATIONAL AND COMMUNITY SERVICE FOSTER GRANDPARENT PROGRAM Responsibilities of a Volunteer Station § 2552.61 May a sponsor serve as a volunteer station? Yes, a sponsor may serve as a volunteer station, provided...

45 CFR 2552.61 - May a sponsor serve as a volunteer station?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 4 2010-10-01 2010-10-01 false May a sponsor serve as a volunteer station? 2552... NATIONAL AND COMMUNITY SERVICE FOSTER GRANDPARENT PROGRAM Responsibilities of a Volunteer Station § 2552.61 May a sponsor serve as a volunteer station? Yes, a sponsor may serve as a volunteer station, provided...

"Food company sponsors are kind, generous and cool": (mis)conceptions of junior sports players.

PubMed

Kelly, Bridget; Baur, Louise A; Bauman, Adrian E; King, Lesley; Chapman, Kathy; Smith, Ben J

2011-09-05

Children's exposure to unhealthy food marketing influences their food knowledge, preferences and consumption. Sport sponsorship by food companies is widespread and industry investment in this marketing is increasing. This study aimed to assess children's awareness of sport sponsors and their brand-related attitudes and purchasing intentions in response to this marketing. Sports clubs known to have food sponsors and representing the most popular sports for Australian children across a range of demographic areas were recruited. Interview-based questionnaires were conducted at clubs with children aged 10-14 years (n = 103) to examine their recall of local sports club and elite sport sponsors, and their attitudes towards sponsors and sponsorship activities. Most children (68%) could recall sponsors of their sports club, naming a median of two sponsors, including a median of one food company sponsor each. Almost half (47%) of children could recall any sponsors of their favourite elite sporting team. Children aged 10-11 years were more likely than older children to report that they thought about sponsors when buying something to eat or drink (P < 0.01); that they liked to return the favour to sponsors by buying their products (P < 0.01); and that sponsors were 'cool' (P = 0.02). Most children had received a voucher or certificate from a food or beverage company to reward sport performance (86% and 76%, respectively). Around one-third of children reported liking the company more after receiving these rewards. Children's high recall of food and beverage company sport sponsors and their positive attitudes towards these sponsors and their promotions is concerning as this is likely to be linked to children's food preferences and consumption. Limiting children's exposure to this marketing is an important initiative to improve children's nutrition.

"Food company sponsors are kind, generous and cool": (Mis)conceptions of junior sports players

PubMed Central

2011-01-01

Background Children's exposure to unhealthy food marketing influences their food knowledge, preferences and consumption. Sport sponsorship by food companies is widespread and industry investment in this marketing is increasing. This study aimed to assess children's awareness of sport sponsors and their brand-related attitudes and purchasing intentions in response to this marketing. Methods Sports clubs known to have food sponsors and representing the most popular sports for Australian children across a range of demographic areas were recruited. Interview-based questionnaires were conducted at clubs with children aged 10-14 years (n = 103) to examine their recall of local sports club and elite sport sponsors, and their attitudes towards sponsors and sponsorship activities. Results Most children (68%) could recall sponsors of their sports club, naming a median of two sponsors, including a median of one food company sponsor each. Almost half (47%) of children could recall any sponsors of their favourite elite sporting team. Children aged 10-11 years were more likely than older children to report that they thought about sponsors when buying something to eat or drink (P < 0.01); that they liked to return the favour to sponsors by buying their products (P < 0.01); and that sponsors were 'cool' (P = 0.02). Most children had received a voucher or certificate from a food or beverage company to reward sport performance (86% and 76%, respectively). Around one-third of children reported liking the company more after receiving these rewards. Conclusions Children's high recall of food and beverage company sport sponsors and their positive attitudes towards these sponsors and their promotions is concerning as this is likely to be linked to children's food preferences and consumption. Limiting children's exposure to this marketing is an important initiative to improve children's nutrition. PMID:21888675

Understanding the reporting practices of CAHPS sponsors.

PubMed

Teleki, Stephanie S; Kanouse, David E; Elliott, Marc N; Hiatt, Liisa; de Vries, Han; Quigley, Denise D

2007-01-01

This article examines the reporting of Consumer Assessment of Healthcare Providers and Systems (CAHPSO) consumer experience data by sponsors, those that fund data collection and decide how information is summarized and disseminated. We found that sponsors typically publicly reported comparative data to consumers, employers, and/or purchasers. They presented health plan-level data in print and online at least annually, usually in combination with non-CAHPS information. Many provided trend data, comparisons to individual plans, and summary scores. Most shared information consistent with known successful reporting practices. Areas meriting attention include: tailoring reports to specific audiences, assessing literacy, planning dissemination, educating vendors, and evaluating products and programs.

Smallpox vaccination and adverse reactions. Guidance for clinicians.

PubMed

Cono, Joanne; Casey, Christine G; Bell, David M

2003-02-21

The guidance in this report is for evaluation and treatment of patients with complications from smallpox vaccination in the preoutbreak setting. Information is also included related to reporting adverse events and seeking specialized consultation and therapies for these events. The frequencies of smallpox vaccine-associated adverse events were identified in studies of the 1960s. Because of the unknown prevalence of risk factors among today's population, precise predictions of adverse reaction rates after smallpox vaccination are unavailable. The majority of adverse events are minor, but the less-frequent serious adverse reactions require immediate evaluation for diagnosis and treatment. Agents for treatment of certain vaccine-associated severe adverse reactions are vaccinia immune globulin (VIG), the first-line therapy, and cidofovir, the second-line therapy. These agents will be available under Investigational New Drug (IND) protocols from CDC and the U.S. Department of Defense (DoD). Smallpox vaccination in the preoutbreak setting is contraindicated for persons who have the following conditions or have a close contact with the following conditions: 1) a history of atopic dermatitis (commonly referred to as eczema), irrespective of disease severity or activity; 2) active acute, chronic, or exfoliative skin conditions that disrupt the epidermis; 3) pregnant women or women who desire to become pregnant in the 28 days after vaccination; and 4) persons who are immunocompromised as a result of human immunodeficiency virus or acquired immunodeficiency syndrome, autoimmune conditions, cancer, radiation treatment, immunosuppressive medications, or other immunodeficiencies. Additional contraindications that apply only to vaccination candidates but do not include their close contacts are persons with smallpox vaccine-component allergies, women who are breastfeeding, those taking topical ocular steroid medications, those with moderate-to-severe intercurrent illness, and

Introduction in IND and recursive partitioning

NASA Technical Reports Server (NTRS)

Buntine, Wray; Caruana, Rich

1991-01-01

This manual describes the IND package for learning tree classifiers from data. The package is an integrated C and C shell re-implementation of tree learning routines such as CART, C4, and various MDL and Bayesian variations. The package includes routines for experiment control, interactive operation, and analysis of tree building. The manual introduces the system and its many options, gives a basic review of tree learning, contains a guide to the literature and a glossary, and lists the manual pages for the routines and instructions on installation.

14 CFR 152.105 - Sponsors and planning agencies: Airport planning.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 3 2013-01-01 2013-01-01 false Sponsors and planning agencies: Airport... TRANSPORTATION (CONTINUED) AIRPORTS AIRPORT AID PROGRAM Eligibility Requirements and Application Procedures § 152.105 Sponsors and planning agencies: Airport planning. (a) To be eligible to apply for a project for...

14 CFR 152.105 - Sponsors and planning agencies: Airport planning.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false Sponsors and planning agencies: Airport... TRANSPORTATION (CONTINUED) AIRPORTS AIRPORT AID PROGRAM Eligibility Requirements and Application Procedures § 152.105 Sponsors and planning agencies: Airport planning. (a) To be eligible to apply for a project for...

14 CFR 152.105 - Sponsors and planning agencies: Airport planning.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 3 2012-01-01 2012-01-01 false Sponsors and planning agencies: Airport... TRANSPORTATION (CONTINUED) AIRPORTS AIRPORT AID PROGRAM Eligibility Requirements and Application Procedures § 152.105 Sponsors and planning agencies: Airport planning. (a) To be eligible to apply for a project for...

14 CFR 152.105 - Sponsors and planning agencies: Airport planning.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Sponsors and planning agencies: Airport... TRANSPORTATION (CONTINUED) AIRPORTS AIRPORT AID PROGRAM Eligibility Requirements and Application Procedures § 152.105 Sponsors and planning agencies: Airport planning. (a) To be eligible to apply for a project for...

45 CFR 2552.22 - What are the responsibilities of a sponsor?

Code of Federal Regulations, 2010 CFR

2010-10-01

... § 2552.22 What are the responsibilities of a sponsor? A sponsor is responsible for fulfilling all project management requirements necessary to accomplish the purposes of the Foster Grandparent Program as specified...

45 CFR 2552.22 - What are the responsibilities of a sponsor?

Code of Federal Regulations, 2013 CFR

2013-10-01

... § 2552.22 What are the responsibilities of a sponsor? A sponsor is responsible for fulfilling all project management requirements necessary to accomplish the purposes of the Foster Grandparent Program as specified...

45 CFR 2552.22 - What are the responsibilities of a sponsor?

Code of Federal Regulations, 2014 CFR

2014-10-01

... § 2552.22 What are the responsibilities of a sponsor? A sponsor is responsible for fulfilling all project management requirements necessary to accomplish the purposes of the Foster Grandparent Program as specified...

45 CFR 2552.22 - What are the responsibilities of a sponsor?

Code of Federal Regulations, 2012 CFR

2012-10-01

... § 2552.22 What are the responsibilities of a sponsor? A sponsor is responsible for fulfilling all project management requirements necessary to accomplish the purposes of the Foster Grandparent Program as specified...

45 CFR 2552.22 - What are the responsibilities of a sponsor?

Code of Federal Regulations, 2011 CFR

2011-10-01

... § 2552.22 What are the responsibilities of a sponsor? A sponsor is responsible for fulfilling all project management requirements necessary to accomplish the purposes of the Foster Grandparent Program as specified...

State-of-the-Art Workshops on Medical Countermeasures Potentially Available for Human Use Following Accidental Exposures to Ebola Virus.

PubMed

Jahrling, Peter B; Hensley, Lisa E; Barrett, Kevin; Lane, Henry Clifford; Davey, Richard T

2015-10-01

The ongoing outbreak of Ebola in West Africa has raised a general awareness that at present there are no Ebola-specific medical countermeasures (MCMs) with proven effectiveness. This paper recapitulates discussions held at the 6th International Filovirus Symposium in March 2014 as well as the subsequent design of a randomized clinical trial design for treating Ebola virus-infected patients evacuated from West Africa to the United States. A number of different drugs or biologics were critically reviewed and 3 different postexposure strategies were identified as being farthest along in development; passive immunotherapy with monoclonal antibodies, postexposure vaccination with constructs involving viral vectors (such as vesicular stomatitis virus), and antisense compounds directly targeting the viral genome such as modified phosphorodiamidate morpholino oligomer-based compounds and small interfering RNA products. At the time of the meetings, there were no investigational new drugs (INDs) in place for the candidate MCMs. Developers and sponsors of these candidate products were strongly encouraged to prepare pre-IND packets and submit pre-IND meeting requests to the Food and Drug Administration. Some of these investigational products have already been used under emergency authorizations to treat patients in Africa as well as patients evacuated to the United States or Western Europe. Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2015. This work is written by (a) US Government employee(s) and is in the public domain in the US.

31 CFR 1030.210 - Anti-money laundering programs for housing government sponsored enterprises.

Code of Federal Regulations, 2014 CFR

2014-07-01

... activities. The program must be approved by senior management. A housing government sponsored enterprise... housing government sponsored enterprises. 1030.210 Section 1030.210 Money and Finance: Treasury... TREASURY RULES FOR HOUSING GOVERNMENT SPONSORED ENTERPRISES Programs § 1030.210 Anti-money laundering...

14 CFR 152.105 - Sponsors and planning agencies: Airport planning.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Sponsors and planning agencies: Airport planning. 152.105 Section 152.105 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF....105 Sponsors and planning agencies: Airport planning. (a) To be eligible to apply for a project for...

45 CFR 2551.22 - What are the responsibilities of a sponsor?

Code of Federal Regulations, 2010 CFR

2010-10-01

... § 2551.22 What are the responsibilities of a sponsor? A sponsor is responsible for fulfilling all project management requirements necessary to accomplish the purposes of the Senior Companion Program as specified in...

45 CFR 2551.22 - What are the responsibilities of a sponsor?

Code of Federal Regulations, 2011 CFR

2011-10-01

... § 2551.22 What are the responsibilities of a sponsor? A sponsor is responsible for fulfilling all project management requirements necessary to accomplish the purposes of the Senior Companion Program as specified in...

45 CFR 2551.22 - What are the responsibilities of a sponsor?

Code of Federal Regulations, 2014 CFR

2014-10-01

... § 2551.22 What are the responsibilities of a sponsor? A sponsor is responsible for fulfilling all project management requirements necessary to accomplish the purposes of the Senior Companion Program as specified in...

45 CFR 2551.22 - What are the responsibilities of a sponsor?

Code of Federal Regulations, 2012 CFR

2012-10-01

... § 2551.22 What are the responsibilities of a sponsor? A sponsor is responsible for fulfilling all project management requirements necessary to accomplish the purposes of the Senior Companion Program as specified in...

45 CFR 2551.22 - What are the responsibilities of a sponsor?

Code of Federal Regulations, 2013 CFR

2013-10-01

... § 2551.22 What are the responsibilities of a sponsor? A sponsor is responsible for fulfilling all project management requirements necessary to accomplish the purposes of the Senior Companion Program as specified in...

78 FR 27859 - New Animal Drugs; Change of Sponsor's Name and Address; Change of Sponsor

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 558... Purina Mills, Inc., to Purina Nutrition LLC, and a change of sponsor for a new animal drug application (NADA) from Land O'Lakes Purina Feed LLC to Purina Nutrition LLC. The regulations are also being amended...

The evolution of Japanese employer-sponsored retirement plans.

PubMed

Rajnes, David

2007-01-01

This article examines the development of Japanese voluntary employer-sponsored retirement plans with an emphasis on recent trends. Until 2001, companies in Japan offered retirement benefits as lump-sum severance payments and/or benefits from one of two types of defined benefit (DB) pension plans. One type of DB plan was based on the occupational pension model used in the United States before the adoption of the Employee Retirement Income Security Act of 1974 (ERISA), but lacked the funding, vesting, and other protective features contained in ERISA. The other type of DB plan allowed companies to opt out of the earnings-related portion of social security, commonly referred to as "contracting out." Landmark laws passed in 2001 introduced a new generation of occupational retirement plans to employers and employees. One law increased funding requirements and enhanced employee protections for employer-sponsored DB plans, while a second law introduced defined contribution (DC) plans for several reasons, chiefly to increase retirement savings and help boost Japanese financial markets. These laws complemented earlier changes in the tax code and financial accounting standards already affecting employer-sponsored retirement plans. As a result, new retirement plan designs will replace most prereform era company retirement plans by 2012. In 2001, the experience of 401(k) plans in the United States, where 42 million participants had accumulated more than $1.8 trillion in assets over 20 years, attracted considerable attention among Japanese lawmakers finalizing provisions of the DC pension law. Even with government support and encouragement from the financial services industry, Japanese companies have not adopted these new DC plans in large numbers. As a result, occupational retirement plans in Japan have remained predominantly DB-a surprising development in light of the shift in a number of countries from DB to DC plans observed in recent decades. However, recent proposals to

Immunogenicity and safety results from a randomized multicenter trial comparing a Tdap-IPV vaccine (REPEVAX®) and a tetanus monovalent vaccine in healthy adults

PubMed Central

Laurichesse, Henri; Zimmermann, Ulrich; Galtier, Florence; Launay, Odile; Duval, Xavier; Richard, Patrick; Sadorge, Christine; Soubeyrand, Benoit

2012-01-01

In adults with a tetanus-prone injury, combined vaccines such as Tdap-IPV (REPEVAX®) can boost immunity against several diseases simultaneously. This Phase IIIb, parallel-group, open-label trial compared antibody responses to Tdap-IPV and tetanus monovalent vaccine (TMV; Vaccin Tétanique Pasteur® or Tetavax®) against tetanus toxoid 10 and 28 d post-vaccination. Between July and December 2009, four centers in France and five in Germany recruited healthy adults who had received a tetanus-containing vaccine 5−10 y previously. Participants were randomized 1:1 to receive at the first visit a single dose (0.5 mL) of Tdap-IPV or TMV, with follow-up visits at Day 10 and Day 28. Outcomes: per protocol (PP) population immunogenicity at Day 10 (primary) and at Day 28 (secondary); safety throughout the study. Of 456 adults randomized, 223 received Tdap-IPV and 233 received TMV (PP population: 183 and 199 participants, respectively). All participants receiving Tdap-IPV and 99.0% receiving TMV had an anti-tetanus antibody concentration ≥ 0.1 IU/mL, confirming non-inferiority of Tdap-IPV to TMV (95% confidence interval of the difference: –1.2, 3.6). Number of adverse events reported was comparable in each group. Injection-site reactions were reported by 76.6% participants receiving Tdap-IPV and 74.6% receiving TMV. Systemic events (e.g., malaise, myalgia and headache) were reported in 47.7% and 39.7% of the Tdap-IPV and the TMV groups, respectively. Tdap-IPV is effective and well-tolerated for use in the management of tetanus-prone injuries in emergency settings in persons for whom a booster against diphtheria, pertussis and poliomyelitis is also needed. ClinicalTrials.gov identifier: NCT00928785. Research sponsored by Sanofi Pasteur MSD. PMID:23032160

Marker vaccine potential of foot-and-mouth disease virus with large deletion in the non-structural proteins 3A and 3B.

PubMed

Biswal, Jitendra K; Subramaniam, Saravanan; Ranjan, Rajeev; Sharma, Gaurav K; Misri, Jyoti; Pattnaik, Bramhadev

2015-11-01

Foot-and-mouth disease (FMD) is a highly contagious, economically important disease of transboundary importance. Regular vaccination with chemically inactivated FMD vaccine is the major means of controlling the disease in endemic countries like India. However, the traditional inactivated vaccines may sometimes contain traces of FMD viral (FMDV) non-structural protein (NSP), therefore, interfering with the NSP-based serological discrimination between infected and vaccinated animals. The availability of marker vaccine for differentiating FMD infected from vaccinated animals (DIVA) would be crucial for the control and subsequent eradication of FMD in India. In this study, we constructed a negative marker FMDV serotype O virus (vaccine strain O IND R2/1975), containing dual deletions of amino acid residues 93-143 and 10-37 in the non-structural proteins 3A and 3B, respectively through reverse genetics approach. The negative marker virus exhibited similar growth kinetics and plaque morphology in cell culture as compared to the wild type virus. In addition, we also developed and evaluated an indirect ELISA (I-ELISA) targeted to the deleted 3AB NSP region (truncated 3AB) which could be used as a companion differential diagnostic assay. The diagnostic sensitivity and specificity of the truncated 3AB I-ELISA were found to be 95.5% and 96%, respectively. The results from this study suggest that the availability negative marker virus and companion diagnostic assay could open a promising new avenue for the application of DIVA compatible marker vaccine for the control of FMD in India. Copyright © 2015 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

Academic Internship Program: Sponsor's Handbook.

ERIC Educational Resources Information Center

Charlotte-Mecklenburg Public Schools, Charlotte, NC.

Since its beginning in 1975 at the West Charlotte High School in North Carolina, the Academic Internship Program has joined over 6,000 high school students in partnerships with more than 600 sponsors from the business community. The program is intended to: (1) provide opportunities for high school students to explore areas of academic, career, or…

Tulsa's IndEx Program. A Business-Led Initiative for Welfare Reform and Economic Development. Connections To Work.

ERIC Educational Resources Information Center

Buck, Maria L.

In 1992, the Metropolitan Tulsa Chamber of Commerce in Oklahoma established a welfare-to-work program called Industrial Exchange, Inc. (IndEx). IndEx provides welfare recipients with a combination of education activities and work experience. By contracting with local companies to perform light manufacturing and packaging work at a central site,…

The Complex Dynamics of Sponsored Search Markets

NASA Astrophysics Data System (ADS)

Robu, Valentin; La Poutré, Han; Bohte, Sander

This paper provides a comprehensive study of the structure and dynamics of online advertising markets, mostly based on techniques from the emergent discipline of complex systems analysis. First, we look at how the display rank of a URL link influences its click frequency, for both sponsored search and organic search. Second, we study the market structure that emerges from these queries, especially the market share distribution of different advertisers. We show that the sponsored search market is highly concentrated, with less than 5% of all advertisers receiving over 2/3 of the clicks in the market. Furthermore, we show that both the number of ad impressions and the number of clicks follow power law distributions of approximately the same coefficient. However, we find this result does not hold when studying the same distribution of clicks per rank position, which shows considerable variance, most likely due to the way advertisers divide their budget on different keywords. Finally, we turn our attention to how such sponsored search data could be used to provide decision support tools for bidding for combinations of keywords. We provide a method to visualize keywords of interest in graphical form, as well as a method to partition these graphs to obtain desirable subsets of search terms.

45 CFR 149.600 - Sponsor's duty to report data inaccuracies.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 1 2013-10-01 2013-10-01 false Sponsor's duty to report data inaccuracies. 149.600 Section 149.600 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES REQUIREMENTS RELATING TO HEALTH CARE ACCESS REQUIREMENTS FOR THE EARLY RETIREE REINSURANCE PROGRAM Disclosure of Data Inaccuracies § 149.600 Sponsor's duty to report data...

Making history: Thomas Francis, Jr, MD, and the 1954 Salk Poliomyelitis Vaccine Field Trial.

PubMed

Lambert, S M; Markel, H

2000-05-01

This article focuses on the poliomyelitis vaccine field trial directed by Thomas Francis,Jr, MD, of the University of Michigan Vaccine Evaluation Center and sponsored by the National Foundation for Infantile Paralysis (NFIP) or, as it was better known to the public, the March of Dimes. It was a landmark in the widescale testing of a vaccine and the ethical use of human subjects. Millions of American parents readily volunteered their healthy children to participate. A total of 150,000 volunteers, including schoolteachers, physicians, nurses, and health officers all endorsed the study and donated their time and effort to make it successful. Avoiding the use of marginalized groups, the field trial purposefully did not involve institutionalized children; instead, it was based in 15,000 public schools in 44 of the 48 states as clinic sites. A group of 650,000 children received some type of injection, either the vaccine or a placebo, and another 1.18 million served as controls. The field trial depended, most essentially, on both public support and the participation of millions of children who remained enrolled in a study that required a series of 3 injections and a 6-month evaluation period. Enlisting the huge number of participants presented practical examples of the difficulties in experimenting on human subjects. On April 26, 1954, Randy Kerr, a participant or "Polio Pioneer" as the children involved were called, received the first inoculation of the Salk poliomyelitis vaccine. The nationwide study "designed to test the safety and efficacy" of the Salk vaccine had officially begun.

45 CFR 2553.61 - When may a sponsor serve as a volunteer station?

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 4 2012-10-01 2012-10-01 false When may a sponsor serve as a volunteer station... FOR NATIONAL AND COMMUNITY SERVICE THE RETIRED AND SENIOR VOLUNTEER PROGRAM Responsibilities of a Volunteer Station § 2553.61 When may a sponsor serve as a volunteer station? The sponsor may function as a...

45 CFR 2553.61 - When may a sponsor serve as a volunteer station?

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 4 2014-10-01 2014-10-01 false When may a sponsor serve as a volunteer station... FOR NATIONAL AND COMMUNITY SERVICE THE RETIRED AND SENIOR VOLUNTEER PROGRAM Responsibilities of a Volunteer Station § 2553.61 When may a sponsor serve as a volunteer station? The sponsor may function as a...

45 CFR 2553.61 - When may a sponsor serve as a volunteer station?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 4 2013-10-01 2013-10-01 false When may a sponsor serve as a volunteer station... FOR NATIONAL AND COMMUNITY SERVICE THE RETIRED AND SENIOR VOLUNTEER PROGRAM Responsibilities of a Volunteer Station § 2553.61 When may a sponsor serve as a volunteer station? The sponsor may function as a...

45 CFR 2553.61 - When may a sponsor serve as a volunteer station?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 4 2010-10-01 2010-10-01 false When may a sponsor serve as a volunteer station... FOR NATIONAL AND COMMUNITY SERVICE THE RETIRED AND SENIOR VOLUNTEER PROGRAM Responsibilities of a Volunteer Station § 2553.61 When may a sponsor serve as a volunteer station? The sponsor may function as a...

45 CFR 2553.61 - When may a sponsor serve as a volunteer station?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 4 2011-10-01 2011-10-01 false When may a sponsor serve as a volunteer station... FOR NATIONAL AND COMMUNITY SERVICE THE RETIRED AND SENIOR VOLUNTEER PROGRAM Responsibilities of a Volunteer Station § 2553.61 When may a sponsor serve as a volunteer station? The sponsor may function as a...

Asthma: NIH-Sponsored Research and Clinical Trials | NIH MedlinePlus the Magazine

MedlinePlus

... turn Javascript on. Feature: Asthma Asthma: NIH-Sponsored Research and Clinical Trials Past Issues / Fall 2011 Table of Contents NIH-Sponsored Research Asthma in the Inner City: Recognizing that asthma ...

[Criminal implication of sponsoring in medicine: legal ramifactions and recommendations].

PubMed

Mahnken, A H; Theilmann, M; Bolenz, M; Günther, R W

2005-08-01

As a consequence of the so-called "Heart-Valve-Affair" in 1994, the German public became aware of the potential criminal significance of industrial sponsoring and third-party financial support in medicine. Since 1997, when the German Anti-Corruption Law came into effect, the penal regulations regarding bribery and benefits for public officers were tightened. Due to the lack of explicit and generally accepted guidelines in combination with regional differences of jurisdiction, there is a lingering uncertainty regarding the criminal aspects of third-party funding and industrial sponsoring. The aim of this review is to summarize the penal and professional implications of third-party funding and sponsoring in medicine including recent aspects of jurisdiction. The currently available recommendations on this issue are introduced.

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.

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

14 CFR 151.51 - Performance of construction work: Sponsor force account.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false Performance of construction work: Sponsor force account. 151.51 Section 151.51 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT... Development Projects § 151.51 Performance of construction work: Sponsor force account. (a) Before undertaking...

14 CFR 151.51 - Performance of construction work: Sponsor force account.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Performance of construction work: Sponsor force account. 151.51 Section 151.51 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT... Development Projects § 151.51 Performance of construction work: Sponsor force account. (a) Before undertaking...

14 CFR 151.51 - Performance of construction work: Sponsor force account.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 3 2013-01-01 2013-01-01 false Performance of construction work: Sponsor force account. 151.51 Section 151.51 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT... Development Projects § 151.51 Performance of construction work: Sponsor force account. (a) Before undertaking...

14 CFR 151.51 - Performance of construction work: Sponsor force account.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Performance of construction work: Sponsor force account. 151.51 Section 151.51 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT... Development Projects § 151.51 Performance of construction work: Sponsor force account. (a) Before undertaking...

14 CFR 151.51 - Performance of construction work: Sponsor force account.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 3 2012-01-01 2012-01-01 false Performance of construction work: Sponsor force account. 151.51 Section 151.51 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT... Development Projects § 151.51 Performance of construction work: Sponsor force account. (a) Before undertaking...

Sponsored Research & the Freedom of Publication.

ERIC Educational Resources Information Center

Packham, David

This paper examines conflicts and collaboration between industry and universities regarding sponsored research and freedom of publication, particularly in the United Kingdom. An opening section notes that the values of the market and the university are in fundamental conflict which presents problems for institutions attempting to work in…

17 CFR 229.1104 - (Item 1104) Sponsors.

Code of Federal Regulations, 2011 CFR

2011-04-01

... regarding the size, composition and growth of the sponsor's portfolio of assets of the type to be... representation or warranty, provide in the body of the prospectus for the prior three years, the information...

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.

29 CFR 4043.29 - Change in contributing sponsor or controlled group.

Code of Federal Regulations, 2010 CFR

2010-07-01

... the plan's contributing sponsor before the effective date of the transaction is a public company, 30... the structure of Company Q's controlled group. On the effective date of the sale, Company R will... become effective, Company Q has the reporting obligation. If the change in the contributing sponsor has...

Characterization of Three Novel SXT/R391 Integrating Conjugative Elements ICE MfuInd1a and ICE MfuInd1b, and ICE MprChn1 Identified in the Genomes of Marinomonas fungiae JCM 18476 T and Marinomonas profundimaris Strain D104

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

Badhai, Jhasketan; Das, Subrata K.

The genus Marinomonas comprises Gram negative bacteria which are widespread in the marine environment and there is no report on the genomic analysis of SXT/R391 ICEs derived from this group of bacteria. This study describes the genomic features of three new SXT/R391 integrating conjugating elements (ICEs) identified in the genome of Marinomonas fungiae JCM 18476 T (ICE MfuInd1a and ICE MfuInd1b) and in Marinomonas profundimaris strain D104 (ICE MprChn1). Structural organizations of the three ICEs were similar to the typical SXT/R391 family of ICEs and showed high degree of conservation in the core genes. Sequence analysis revealed ICE MfuInd1b andmore » ICE MprChn1 were inserted into the genome at 5'-end of an typical host prfC gene, while ICE MfuInd1a was inserted at 5'-end of an atypical hipA-like gene. Despite their coexistence, the ICE MfuInd1a and ICE MfuInd1b were not present in a tandem fashion in the genome of M. fungiae. Phylogenetic analyses revealed the three ICEs either evolved independently or high degrees of recombination events had masked their evolution from a common SXT ancestor. Further, we found that the typical entry exclusion mechanism mediated by the TraG/EeX protein pair was likely defective in preventing the conjugative transfer of a second copy of the same S (SXT) group ICE into the M. fungiae genome due to mutations. Our analysis showed the presence of 16, 25, and 27 variable genes in the hotspots of ICE MfuInd1a, ICE MfuInd1b, and ICE MprChn1, respectively, many of which were not reported earlier for SXT/R391 ICEs. Sequence analysis predicted these hot spot regions were shaped by acquisition of genes through homologous recombination between the SXT and R391 related ICEs or mobile genetic elements present in disparate marine bacteria. Multidrug resistance genes which are hallmark feature of SXT/R391 ICEs were not present in either of the two ICEs from M. fungiae but were present within a transposon cassette in the HS-1 of the ICE MprChn1

Characterization of Three Novel SXT/R391 Integrating Conjugative Elements ICE MfuInd1a and ICE MfuInd1b, and ICE MprChn1 Identified in the Genomes of Marinomonas fungiae JCM 18476 T and Marinomonas profundimaris Strain D104

DOE PAGES

Badhai, Jhasketan; Das, Subrata K.

2016-11-25

The genus Marinomonas comprises Gram negative bacteria which are widespread in the marine environment and there is no report on the genomic analysis of SXT/R391 ICEs derived from this group of bacteria. This study describes the genomic features of three new SXT/R391 integrating conjugating elements (ICEs) identified in the genome of Marinomonas fungiae JCM 18476 T (ICE MfuInd1a and ICE MfuInd1b) and in Marinomonas profundimaris strain D104 (ICE MprChn1). Structural organizations of the three ICEs were similar to the typical SXT/R391 family of ICEs and showed high degree of conservation in the core genes. Sequence analysis revealed ICE MfuInd1b andmore » ICE MprChn1 were inserted into the genome at 5'-end of an typical host prfC gene, while ICE MfuInd1a was inserted at 5'-end of an atypical hipA-like gene. Despite their coexistence, the ICE MfuInd1a and ICE MfuInd1b were not present in a tandem fashion in the genome of M. fungiae. Phylogenetic analyses revealed the three ICEs either evolved independently or high degrees of recombination events had masked their evolution from a common SXT ancestor. Further, we found that the typical entry exclusion mechanism mediated by the TraG/EeX protein pair was likely defective in preventing the conjugative transfer of a second copy of the same S (SXT) group ICE into the M. fungiae genome due to mutations. Our analysis showed the presence of 16, 25, and 27 variable genes in the hotspots of ICE MfuInd1a, ICE MfuInd1b, and ICE MprChn1, respectively, many of which were not reported earlier for SXT/R391 ICEs. Sequence analysis predicted these hot spot regions were shaped by acquisition of genes through homologous recombination between the SXT and R391 related ICEs or mobile genetic elements present in disparate marine bacteria. Multidrug resistance genes which are hallmark feature of SXT/R391 ICEs were not present in either of the two ICEs from M. fungiae but were present within a transposon cassette in the HS-1 of the ICE MprChn1

White, affluent, educated parents are least likely to choose HPV vaccination for their children: a cross-sectional study of the National Immunization Study - teen.

PubMed

Warner, Echo L; Ding, Qian; Pappas, Lisa M; Henry, Kevin; Kepka, Deanna

2017-12-01

Human Papillomavirus (HPV) vaccination coverage is below national goals in the United States. Research is needed to inform strategically designed interventions that target sociodemographic groups with underutilization of HPV vaccination. Secondary data analysis of the National Immunization Survey-Teen 2013 measured association of sociodemographic factors (e.g., ethnicity/race, insurance) with HPV vaccination among females and males ages 13-17 (N = 18,959). Chi-square and multivariable Poisson regressions were conducted using survey-weighted statistics. Having a mother ≥35 years, a mother with some college, being of "Other" ethnicity/race, and having no providers who order vaccines from health departments was negatively associated with females initiating HPV vaccination. Having a mother with some college, being of Non-Hispanic White or "Other" ethnicity/race, and having some or no providers who order vaccines from health departments was negatively associated with males initiating HPV vaccination. These same factors were negatively associated with males completing HPV vaccination with the exception of "Other" ethnicity/race. In contrast, having an unmarried mother, being ages 15-17, having a hospital based provider, and receiving other adolescent vaccinations were positively associated with females initiating and completing HPV vaccination. Having an unmarried mother, health insurance that is not employer or union sponsored, and influenza and meningitis vaccinations was positively associated with male's initiating HPV vaccination. For males, being 15 or 17 years old and having other adolescent vaccinations was positively associated with vaccine completion. All findings p ≤ 0.05. Future HPV vaccination interventions may benefit from targeting certain sociodemographic groups that were negatively associated with HPV vaccination in this study.

76 FR 79064 - New Animal Drugs; Change of Sponsor; Zinc Gluconate

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-21

... [Docket No. FDA-2011-N-0003] New Animal Drugs; Change of Sponsor; Zinc Gluconate AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) for zinc...

75 FR 66304 - New Animal Drugs; Change of Sponsor; Monensin Blocks

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-28

... [Docket No. FDA-2010-N-0002] New Animal Drugs; Change of Sponsor; Monensin Blocks AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal... animal drug regulations as a sponsor of an approved application. Accordingly, Sec. 510.600 is being...

Reporting of Navy Sponsor Owned Material Stored at the Naval Air Systems Command Activities

DTIC Science & Technology

2007-04-23

Who Should Read This Report and Why? Navy personnel responsible for reporting the amount and value of Sponsor Owned Material stored at Navy facilities should read this report. It discusses the financial reporting and control of Sponsor Owned Material stored by Naval Air Systems Command activities. Background. The Department of the Navy reported $58.8 billion of Operating Materials and Supplies on its first quarter FY 2006 financial statements. This included a sub-category of supplies and materials termed Sponsor Owned Material. The Navy defines Sponsor

Report on Department of Homeland Security Sponsored Research Project at Lawrence Livermore National Laboratory on Preparation for an Improvised Nuclear Device Event

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

A., B

2008-07-31

Following the events of September 11th, a litany of imaginable horribles was trotted out before an anxious and concerned public. To date, government agencies and academics are still grappling with how to best respond to such catastrophes, and as Senator Lieberman's quote says above, now is the time to plan and prepare for such events. One of the nation's worst fears is that terrorists might detonate an improvised nuclear device (IND) in an American city. With 9/11 serving as the catalyst, the government and many NGOs have invested money into research and development of response capabilities throughout the country. Yet,more » there is still much to learn about how to best respond to an IND event. My summer 2008 internship at Lawrence Livermore National Laboratory afforded me the opportunity to look in depth at the preparedness process and the research that has been conducted on this issue. While at the laboratory I was tasked to collect, combine, and process research on how cities and the federal government can best prepare for the horrific prospect of an IND event. Specific projects that I was involved with were meeting reports, research reviews, and a full project report. Working directly with Brooke Buddemeier and his support team at the National Atmospheric Release Advisory Center, I was able to witness first hand, preparation for meetings with response planners to inform them of the challenges that an IND event would pose to the affected communities. In addition, I supported the Homeland Security Institute team (HSI), which was looking at IND preparation and preparing a Congressional report. I participated in meetings at which local responders expressed their concerns and contributed valuable information to the response plan. I specialized in the psycho-social aspects of an IND event and served as a technical advisor to some of the research groups. Alongside attending and supporting these meetings, I worked on an independent research project which collected

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.

Cost effectiveness of pneumococcal conjugate vaccination against acute otitis media in children: a review.

PubMed

Boonacker, Chantal W B; Broos, Pieter H; Sanders, Elisabeth A M; Schilder, Anne G M; Rovers, Maroeska M

2011-03-01

While pneumococcal conjugate vaccines have shown to be highly effective against invasive pneumococcal disease, their potential effectiveness against acute otitis media (AOM) might become a major economic driver for implementing these vaccines in national immunization programmes. However, the relationship between the costs and benefits of available vaccines remains a controversial topic. Our objective is to systematically review the literature on the cost effectiveness of pneumococcal conjugate vaccination against AOM in children. We searched PubMed, Cochrane and the Centre for Reviews and Dissemination databases (Database of Abstracts of Reviews of Effects [DARE], NHS Economic Evaluation Database [NHS EED] and Health Technology Assessment database [HTA]) from inception until 18 February 2010. We used the following keywords with their synonyms: 'otitis media', 'children', 'cost-effectiveness', 'costs' and 'vaccine'. Costs per AOM episode averted were calculated based on the information in this literature. A total of 21 studies evaluating the cost effectiveness of pneumococcal conjugate vaccines were included. The quality of the included studies was moderate to good. The cost per AOM episode averted varied from &U20AC;168 to &U20AC;4214, and assumed incidence rates varied from 20,952 to 118,000 per 100,000 children aged 0-10 years. Assumptions regarding direct and indirect costs varied between studies. The assumed vaccine efficacy of the 7-valent pneumococcal CRM197-conjugate vaccine was mainly adopted from two trials, which reported 6-8% efficacy. However, some studies assumed additional effects such as herd immunity or only took into account AOM episodes caused by serotypes included in the vaccine, which resulted in efficacy rates varying from 12% to 57%. Costs per AOM episode averted were inversely related to the assumed incidence rates of AOM and to the estimated costs per AOM episode. The median costs per AOM episode averted tended to be lower in industry-sponsored

Summer Food Service Program for Children. 1991 Sponsor's Handbook. (Revised Edition).

ERIC Educational Resources Information Center

Food and Nutrition Service (USDA), Washington, DC.

This handbook is a reference for sponsors of food service programs for children during school vacation periods. It is not applicable to academic year operations. Issues relating to planning a food service program are discussed. These include sponsor eligibility, the determination of the need of recipient children, requirements of kinds and amounts…

Effects of Disclosing Sponsored Content in Blogs

PubMed Central

van Reijmersdal, Eva A.; Fransen, Marieke L.; van Noort, Guda; Opree, Suzanna J.; Vandeberg, Lisa; Reusch, Sanne; van Lieshout, Floor; Boerman, Sophie C.

2016-01-01

This article presents two studies examining the effects of disclosing online native advertising (i.e., sponsored content in blogs) on people’s brand attitude and purchase intentions. To investigate the mechanisms underlying these effects, we integrated resistance theories with the persuasion knowledge model. We theorize that disclosures activate people’s persuasion knowledge, which in turn evokes resistance strategies that people use to cope with the persuasion attempt made in the blog. We tested our predications with two experiments (N = 118 and N = 134). We found that participants indeed activated persuasion knowledge in response to disclosures, after which they used both cognitive (counterarguing) and affective (negative affect) resistance strategies to decrease persuasion. The obtained insights do not only advance our theoretical understanding of how disclosures of sponsored blogs affect persuasion but also provide valuable insights for legislators, advertisers, and bloggers. PMID:27721511

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

What Teachers Want from Sponsored Films.

ERIC Educational Resources Information Center

Modern Talking Picture Service, New Hyde Park, NY.

This collection of six pamphlets reports the results of a survey intended to supply information about what teachers in various fields desire in classroom films to sponsors and producers of 16mm motion pictures. A separate pamphlet is included for each of the following fields: (1) vocational agriculture, (2) physical education, (3) home economics,…

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

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.

A Compilation of Articles Reporting Research Sponsored by the Office of Naval Research

DTIC Science & Technology

1980-07-01

i-A /VGR P Technical Reports Nos 378,379,380,381 and 382 A COMPILATION OF ARTICLES REPORTING RESEARCH SPONSORED BY THE OFFICE OF NAVAL RESEARCH...SPONSORED BY ( THE OFFICE OF NAVAL RESEARCH#’ "I ZIP Office o ---- Contract JINY(601-Z.7-OO502IProject N 1 __ terge C, Anderson Associate Chairman for...SPONSORED BY THE OFFICE OF NAVAL RESEARCH TECHNICAL REPORT NO. 378 The Depth Variability of Meridional Gradients of Temperature, Salinity and Sound

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

NASA-sponsored containerless processing experiments

NASA Technical Reports Server (NTRS)

Hofmeister, William H.

1990-01-01

An outline is presented of containerless processing and facilities at Intersonics which is sponsored by NASA. There are electromagnetic, acoustic, and aerodynamic levitation facilities. There are also laser beam and arc lamp heating systems along with state of the art noncontact temperature and optical property measurement facilities. Nonintrusive diagnostic techniques with Laser Induced Fluorescence and mass spectrometer are also available. Controlled atmosphere processing, gas quenching, and proven microgravity processing technology is part of the Intersonics capabilities.

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

Committees and sponsors

NASA Astrophysics Data System (ADS)

2011-10-01

International Advisory Committee Richard F CastenYale, USA Luiz Carlos ChamonSão Paulo, Brazil Osvaldo CivitareseLa Plata, Argentina Jozsef CsehATOMKI, Hungary Jerry P DraayerLSU, USA Alfredo Galindo-UribarriORNL & UT, USA James J KolataNotre Dame, USA Jorge López UTEP, USA Joseph B NatowitzTexas A & M, USA Ma Esther Ortiz IF-UNAM Stuart PittelDelaware, USA Andrés SandovalIF-UNAM Adam SzczepaniakIndiana, USA Piet Van IsackerGANIL, France Michael WiescherNotre Dame, USA Organizing Committee Libertad Barrón-Palos (Chair)IF-UNAM Roelof BijkerICN-UNAM Ruben FossionICN-UNAM David LizcanoININ Sponsors Instituto de Ciencias Nucleares, UNAMInstituto de Física, UNAMInstituto Nacional de Investigaciones NuclearesDivisión de Física Nuclear de la SMFCentro Latinoamericano de Física

14 CFR 60.7 - Sponsor qualification requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 2 2014-01-01 2014-01-01 false Sponsor qualification requirements. 60.7 Section 60.7 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE § 60.7...

14 CFR 60.7 - Sponsor qualification requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 2 2011-01-01 2011-01-01 false Sponsor qualification requirements. 60.7 Section 60.7 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE § 60.7...

14 CFR 60.7 - Sponsor qualification requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 2 2012-01-01 2012-01-01 false Sponsor qualification requirements. 60.7 Section 60.7 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE § 60.7...

14 CFR 60.7 - Sponsor qualification requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 2 2013-01-01 2013-01-01 false Sponsor qualification requirements. 60.7 Section 60.7 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE § 60.7...

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 ...

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

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.

Efficacy of a bivalent HPV 16/18 vaccine against anal HPV16/18 infection among young women: a nested analysis within the Costa Rica Vaccine Trial

PubMed Central

Kreimer, Aimée R.; Gonzalèz, Paula; Katki, Hormuzd A.; Porras, Carolina; Schiffman, Mark; Rodriguez, Ana Cecilia; Solomon, Diane; Jimenez, Silvia; Schiller, John T.; Lowy, Douglas R.; van Doorn, Leen-Jan; Struijk, Linda; Quint, Wim; Chen, Sabrina; Wacholder, Sholom; Hildesheim, Allan; Herrero, Rolando

2011-01-01

Background Anal cancer remains rare (incidence of ∼1.5 per 100,000 women annually) but rates are increasing in many countries. Human papillomavirus-16 (HPV16) infection causes most cases. We evaluated vaccine efficacy (VE) of an ASO4-adjuvanted HPV16/18 vaccine against anal HPV16/18 infection. Methods In a randomized double-blind controlled trial designed to evaluate VE against persistent cervical HPV16/18 infections and associated precancerous lesions in Costa Rica, 4210 healthy women underwent anal specimen collection (4224 of 5968= 70.8% of eligible women) at the final blinded study visit 4 years after vaccination to evaluate anal HPV16/18 VE. Cervical HPV16/18 VE among the same women at the same visit was calculated as a comparator. For this ancillary work, analyses were conducted in a restricted cohort of women both cervical HPV16/18 DNA negative and HPV 16/18 seronegative prior at enrollment (N=1989), and in the full cohort (all women with an anal specimen). Findings In the restricted cohort, VE against prevalent HPV16/18 anal infection measured one-time, four-years post-vaccination was 83.6% (95%CI 66.7% to 92.8%), which was comparable to cervical HPV16/18 VE (87.9%, 95%CI 77.4% to 94.0%). In the full cohort, HPV16/18 VE was statistically lower at the anus (62.0%, 95%CI 47.1% to 73.1%) compared to the cervix (76.4%, 95%CI 67.0% to 83.5%) (p for anatomic-site interaction =0.03). Significant and comparable VE estimates against a composite endpoint of HPV31/33/45 (i.e.: cross-protection) was observed at the anus and cervix. Interpretation The ASO4-adjuvanted vaccine affords strong protection against anal HPV, particularly among women more likely to be HPV naïve at vaccination. Funding. The Costa Rica HPV Vaccine Trial is sponsored and funded by the NCI (contract N01-CP-11005), with funding support from the National Institutes of Health Office of Research on Women's Health, and conducted with support from the Ministry of Health of Costa Rica. Vaccine was

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; ...

Advance market commitments for vaccines against neglected diseases: estimating costs and effectiveness.

PubMed

Berndt, Ernst R; Glennerster, Rachel; Kremer, Michael R; Lee, Jean; Levine, Ruth; Weizsäcker, Georg; Williams, Heidi

2007-05-01

The G8 is considering committing to purchase vaccines against diseases concentrated in low-income countries (if and when desirable vaccines are developed) as a way to spur research and development on vaccines for these diseases. Under such an 'advance market commitment,' one or more sponsors would commit to a minimum price to be paid per person immunized for an eligible product, up to a certain number of individuals immunized. For additional purchases, the price would eventually drop to close to marginal cost. If no suitable product were developed, no payments would be made. We estimate the offer size which would make revenues similar to the revenues realized from investments in typical existing commercial pharmaceutical products, as well as the degree to which various model contracts and assumptions would affect the cost-effectiveness of such a commitment. We make adjustments for lower marketing costs under an advance market commitment and the risk that a developer may have to share the market with subsequent developers. We also show how this second risk could be reduced, and money saved, by introducing a superiority clause to a commitment. Under conservative assumptions, we document that a commitment comparable in value to sales earned by the average of a sample of recently launched commercial products (adjusted for lower marketing costs) would be a highly cost-effective way to address HIV/AIDS, malaria, and tuberculosis. Sensitivity analyses suggest most characteristics of a hypothetical vaccine would have little effect on the cost-effectiveness, but that the duration of protection conferred by a vaccine strongly affects potential cost-effectiveness. Readers can conduct their own sensitivity analyses employing a web-based spreadsheet tool. Copyright (c) 2006 John Wiley & Sons, Ltd.

[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

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

76 FR 40229 - Oral Dosage Form New Animal Drugs; Change of Sponsor

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-08

.... FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Change of Sponsor AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Virbac AH...

7 CFR 225.12 - Claims against sponsors.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 4 2013-01-01 2013-01-01 false Claims against sponsors. 225.12 Section 225.12 Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS SUMMER FOOD SERVICE PROGRAM State Agency Provisions § 225.12 Claims...

7 CFR 225.12 - Claims against sponsors.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 4 2011-01-01 2011-01-01 false Claims against sponsors. 225.12 Section 225.12 Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS SUMMER FOOD SERVICE PROGRAM State Agency Provisions § 225.12 Claims...

7 CFR 225.12 - Claims against sponsors.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 4 2014-01-01 2014-01-01 false Claims against sponsors. 225.12 Section 225.12 Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS SUMMER FOOD SERVICE PROGRAM State Agency Provisions § 225.12 Claims...

7 CFR 225.12 - Claims against sponsors.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 4 2012-01-01 2012-01-01 false Claims against sponsors. 225.12 Section 225.12 Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS SUMMER FOOD SERVICE PROGRAM State Agency Provisions § 225.12 Claims...

22 CFR 42.31 - Family-sponsored immigrants.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Family-sponsored immigrants. 42.31 Section 42.31 Foreign Relations DEPARTMENT OF STATE VISAS VISAS: DOCUMENTATION OF IMMIGRANTS UNDER THE IMMIGRATION AND NATIONALITY ACT, AS AMENDED Immigrants Subject to Numerical Limitations § 42.31 Family...

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.

Institutionalizing Entrepreneurship: A History of Sponsored Research at the University of Michigan

ERIC Educational Resources Information Center

DeGraff, Staney

2006-01-01

This paper examines the history of sponsored research and industrial relationships at the University of Michigan. For the purposes of this paper, sponsored research is defined as research performed by the university that is funded by an outside constituent. Although this paper covers events from the start of the twentieth century, it concentrates…

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

Current status of registry of vaccine clinical trials conducted by Korean investigators in ClinicalTrials.gov, database of US National Institutes of Health.

PubMed

Cho, Jahyang; Kim, Bo Bae; Bae, Chong-Woo; Cha, Sung-Ho

2013-01-01

PubMed is not only includes international medical journals but also has a registration site for the ongoing clinical trials, such as ClinicalTrials.gov, under the supervision of US National Institutes of Health. We analyzed current status of vaccine clinical trials conducted by Korean investigators in database of ClinicalTrial.gov. As of October 2012, there are total of 72 trials found on registry of vaccine clinical trials conducted by Korean investigators in database of ClinicalTrial.gov. These trials were analyzed and classified by conditions of vaccine clinical trials, biologicals or drugs used in vaccine clinical trials, status of proceeding research, and list of sponsor and collaborators. Total 72 trials of vaccine clinical trials conducted by Korean investigators are classified by groups of infection (64 trials), cancer (4 trials), and others (4 trials). Infections group shown are as follows: poliomyelitis, pertussis, diphtheria, tetanus, and Haemophilus influenzae type b (10), influenza (9), human papillomavirus infection (8), pneumococcal vaccine (6), herpes zoster (4), smallpox (4), hepatitis B (4), etc. One trial of each in lung cancer, breast cancer, prostate cancer, and colorectal cancer are shown in cancer group. One trial of each in Crohn's disease, ulcerative colitis, renal failure, and rheumatoid arthritis are shown in other group. Vaccine clinical trials conducted by Korean investigators in ClinicalTrial.gov reflects the current status of Korean research on vaccine clinical trials at the international level and can indicate research progress. It is hoped that this aids the development of future vaccine clinical trials in Korea.

Employer-Sponsored Training: Current Status, Future Possibilities.

ERIC Educational Resources Information Center

Vaughan, Roger J.; Berryman, Sue E.

This document summarizes the conclusions of research papers and participant discussions at a conference on employer-sponsored training in 1988. Following an introduction, the first section offers support for the statement that employers invest heavily in training their best-educated and trained employees. The following are among the conclusions…

Recycling: Establishing a Citizen-Sponsored Reclamation Center.

ERIC Educational Resources Information Center

Keep America Beautiful, Inc., New York, NY.

This booklet applies the Clean Community System (CCS) of Keep America Beautiful, Inc. to the development of citizen-sponsored recycling projects. Six initial steps in establishing a reclamation center are given and include information gathering, market analysis, legal requirements, and site location. Suggestions are included for recruiting staff…

Vaccine exemptions and the kindergarten vaccination coverage gap.

PubMed

Smith, Philip J; Shaw, Jana; Seither, Ranee; Lopez, Adriana; Hill, Holly A; Underwood, Mike; Knighton, Cynthia; Zhao, Zhen; Ravanam, Megha Shah; Greby, Stacie; Orenstein, Walter A

2017-09-25

Vaccination requirements for kindergarten entry vary by state, but all states require 2 doses of measles containing vaccine (MCV) at kindergarten entry. To assess (i) national MCV vaccination coverage for children who had attended kindergarten; (ii) the extent to which undervaccination after kindergarten entry is attributable to parents' requests for an exemption; (iii) the extent to which undervaccinated children had missed opportunities to be administered missing vaccine doses among children whose parent did not request an exemption; and (iv) the vaccination coverage gap between the "highest achievable" MCV coverage and actual MCV coverage among children who had attended kindergarten. A national survey of 1465 parents of 5-7year-old children was conducted during October 2013 through March 2014. Vaccination coverage estimates are based provider-reported vaccination histories. Children have a "missed opportunity" for MCV if they were not up-to-date and if there were dates on which other vaccines were administered but not MCV. The "highest achievable" MCV vaccination coverage rate is 100% minus the sum of the percentages of (i) undervaccinated children with parents who requested an exemption; and (ii) undervaccinated children with parents who did not request an exemption and whose vaccination statuses were assessed during a kindergarten grace period or period when they were provisionally enrolled in kindergarten. Among all children undervaccinated for MCV, 2.7% were attributable to having a parent who requested an exemption. Among children who were undervaccinated for MCV and whose parent did not request an exemption, 41.6% had a missed opportunity for MCV. The highest achievable MCV coverage was 98.6%, actual MCV coverage was 90.9%, and the kindergarten vaccination gap was 7.7%. Vaccination coverage may be increased by schools fully implementing state kindergarten vaccination laws, and by providers assessing children's vaccination status at every clinic visit, and

Formative research and development of an evidence-based communication strategy: the introduction of Vi typhoid fever vaccine among school-aged children in Karachi, Pakistan.

PubMed

Pach, Alfred; Tabbusam, Ghurnata; Khan, M Imran; Suhag, Zamir; Hussain, Imtiaz; Hussain, Ejaz; Mumtaz, Uzma; Haq, Inam Ul; Tahir, Rehman; Mirani, Amjad; Yousafzai, Aisha; Sahastrabuddhe, Sushant; Ochiai, R Leon; Soofi, Sajid; Clemens, John D; Favorov, Michael O; Bhutta, Zulfiqar A

2013-01-01

The authors conducted formative research (a) to identify stakeholders' concerns related to typhoid fever and the need for disease information and (b) to develop a communication strategy to inform stakeholders and address their concerns and motivate for support of a school-based vaccination program in Pakistan. Data were collected during interactive and semi-structured focus group discussions and interviews, followed by a qualitative analysis and multidisciplinary consultative process to identify an effective social mobilization strategy comprised of relevant media channels and messages. The authors conducted 14 focus group discussions with the parents of school-aged children and their teachers, and 13 individual interviews with school, religious, and political leaders. Parents thought that typhoid fever was a dangerous disease, but were unsure of their children's risk. They were interested in vaccination and were comfortable with a school-based vaccination if conducted under the supervision of trained and qualified staff. Teachers and leaders needed information on typhoid fever, the vaccine, procedures, and sponsors of the vaccination program. Meetings were considered the best form of information dissemination, followed by printed materials and mass media. This study shows how qualitative research findings can be translated into an effective social mobilization and communication approach. The findings of the research indicated the importance of increasing awareness of typhoid fever and the benefits of vaccination against the disease. Identification and dissemination of relevant, community-based disease and vaccination information will increase demand and use of vaccination.

42 CFR 410.57 - Pneumococcal vaccine and flu vaccine.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 2 2012-10-01 2012-10-01 false Pneumococcal vaccine and flu vaccine. 410.57... § 410.57 Pneumococcal vaccine and flu vaccine. (a) Medicare Part B pays for pneumococcal vaccine and its administration when reasonable and necessary for the prevention of disease, if the vaccine is ordered by a doctor...

42 CFR 410.57 - Pneumococcal vaccine and flu vaccine.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 2 2013-10-01 2013-10-01 false Pneumococcal vaccine and flu vaccine. 410.57... § 410.57 Pneumococcal vaccine and flu vaccine. (a) Medicare Part B pays for pneumococcal vaccine and its administration when reasonable and necessary for the prevention of disease, if the vaccine is ordered by a doctor...

42 CFR 410.57 - Pneumococcal vaccine and flu vaccine.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 2 2014-10-01 2014-10-01 false Pneumococcal vaccine and flu vaccine. 410.57... § 410.57 Pneumococcal vaccine and flu vaccine. (a) Medicare Part B pays for pneumococcal vaccine and its administration when reasonable and necessary for the prevention of disease, if the vaccine is ordered by a doctor...

42 CFR 410.57 - Pneumococcal vaccine and flu vaccine.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false Pneumococcal vaccine and flu vaccine. 410.57... § 410.57 Pneumococcal vaccine and flu vaccine. (a) Medicare Part B pays for pneumococcal vaccine and its administration when reasonable and necessary for the prevention of disease, if the vaccine is ordered by a doctor...

42 CFR 410.57 - Pneumococcal vaccine and flu vaccine.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 2 2011-10-01 2011-10-01 false Pneumococcal vaccine and flu vaccine. 410.57... § 410.57 Pneumococcal vaccine and flu vaccine. (a) Medicare Part B pays for pneumococcal vaccine and its administration when reasonable and necessary for the prevention of disease, if the vaccine is ordered by a doctor...

A public-professional web-bridge for vaccines and vaccination: user concerns about vaccine safety.

PubMed

García-Basteiro, Alberto L; Alvarez-Pasquín, María-José; Mena, Guillermo; Llupià, Anna; Aldea, Marta; Sequera, Victor-Guillermo; Sanz, Sergi; Tuells, Jose; Navarro-Alonso, José-Antonio; de Arísteguí, Javier; Bayas, José-María

2012-05-28

Vacunas.org (http://www.vacunas.org), a website founded by the Spanish Association of Vaccinology offers a personalized service called Ask the Expert, which answers any questions posed by the public or health professionals about vaccines and vaccination. The aim of this study was to analyze the factors associated with questions on vaccination safety and determine the characteristics of questioners and the type of question asked during the period 2008-2010. A total of 1341 questions were finally included in the analysis. Of those, 30% were related to vaccine safety. Questions about pregnant women had 5.01 higher odds of asking about safety (95% CI 2.82-8.93) than people not belonging to any risk group. Older questioners (>50 years) were less likely to ask about vaccine safety compared to younger questioners (OR: 0.44, 95% CI 0.25-0.76). Questions made after vaccination or related to influenza (including H1N1) or travel vaccines were also associated with a higher likelihood of asking about vaccine safety. These results identify risk groups (pregnant women), population groups (older people) and some vaccines (travel and influenza vaccines, including H1N1) where greater efforts to provide improved, more-tailored vaccine information in general and on the Internet are required. Copyright © 2011 Elsevier Ltd. All rights reserved.

The influence of vaccine-critical websites on perceiving vaccination risks.

PubMed

Betsch, Cornelia; Renkewitz, Frank; Betsch, Tilmann; Ulshöfer, Corina

2010-04-01

This large-scale Internet-experiment tests whether vaccine-critical pages raise perceptions of the riskiness of vaccinations and alter vaccination intentions. We manipulated the information environment (vaccine-critical website, control, both) and the focus of search (on vaccination risks, omission risks, no focus). Our analyses reveal that accessing vaccine-critical websites for five to 10 minutes increases the perception of risk of vaccinating and decreases the perception of risk of omitting vaccinations as well as the intentions to vaccinate. In line with the 'risk-as-feelings' approach, the affect elicited by the vaccine-critical websites was positively related to changes in risk perception.

The Latest in Vaccine Policies: Selected Issues in School Vaccinations, Healthcare Worker Vaccinations, and Pharmacist Vaccination Authority Laws.

PubMed

Barraza, Leila; Schmit, Cason; Hoss, Aila

2017-03-01

This paper discusses recent changes to state legal frameworks for mandatory vaccination in the context of school and healthcare worker vaccination. It then discusses state laws that allow pharmacists the authority to vaccinate.

Japanese encephalitis vaccines: current vaccines and future prospects.

PubMed

Monath, T P

2002-01-01

Vaccination against JE ideally should be practiced in all areas of Asia where the virus is responsible for human disease. The WHO has placed a high priority on the development of a new vaccine for prevention of JE. Some countries in Asia (Japan, South Korea, North Korea, Taiwan, Vietnam, Thailand, and the PRC) manufacture JE vaccines and practice childhood immunization, while other countries suffering endemic or epidemic disease (India, Nepal, Laos, Cambodia, Bangladesh, Myanmar, Malaysia, Indonesia and the Philippines) have no JE vaccine manufacturing or policy for use. With the exception of the PRC, all countries practicing JE vaccination use formalin inactivated mouse brain vaccines, which are relatively expensive and are associated with rare but clinically significant allergic and neurological adverse events. New inactivated JE vaccines manufactured in Vero cells are in advanced preclinical or early clinical development in Japan, South Korea, Taiwan, and the PRC. An empirically derived, live attenuated vaccine (SA14-14-2) is widely used in the PRC. Trials in the PRC have shown SA14-14-2 to be safe and effective when administered in a two-dose regimen, but regulatory concerns over manufacturing and control have restricted international distribution. The genetic basis of attenuation of SA14-14-2 has been partially defined. A new live attenuated vaccine (ChimeriVax-JE) that uses a reliable flavivirus vaccine--yellow fever 17D--as a live vector for the envelope genes of SA14-14-2 virus is in early clinical trials and appears to be well tolerated and immunogenic after a single dose. Vaccinia and avipox vectored vaccines have also been tested clinically, but are no longer being pursued due to restricted effectiveness mediated by anti-vector immunity. Other approaches to JE vaccines--including naked DNA, oral vaccination, and recombinant subunit vaccines--have been reviewed.

Santa Claus, Ga./Ind.

NASA Technical Reports Server (NTRS)

2002-01-01

The towns of Santa Claus, Ga., (top) and Santa Claus, Ind. (bottom), are shown in these two images from the Advanced Spaceborne Thermal Emission and Reflection Radiometer (ASTER) instrument on NASA's Terra satellite. They are the only two Santa Claus towns in the United States with post offices and zip codes, although there are 11 towns with this name in the United States. Santa Claus, Ga. is located in Toombs County, and has a population of 237. Santa Claus, Ind. is located in Spencer County, and has a population of 2,041. Its name was accepted by the United States Postal Service in 1856. The images were acquired on July 3, 2000 (top) and June 16, 2001 (bottom), respectively.

With its 14 spectral bands from the visible to the thermal infrared wavelength region, and its high spatial resolution of 15 to 90 meters (about 50 to 300 feet), ASTER images Earth to map and monitor the changing surface of our planet.

ASTER is one of five Earth-observing instruments launched December 18, 1999, on NASA's Terra satellite. The instrument was built by Japan's Ministry of Economy, Trade and Industry. A joint U.S./Japan science team is responsible for validation and calibration of the instrument and the data products.

The broad spectral coverage and high spectral resolution of ASTER will provide scientists in numerous disciplines with critical information for surface mapping, and monitoring of dynamic conditions and temporal change. Example applications are: monitoring glacial advances and retreats; monitoring potentially active volcanoes; identifying crop stress; determining cloud morphology and physical properties; wetlands evaluation; thermal pollution monitoring; coral reef degradation; surface temperature mapping of soils and geology; and measuring surface heat balance.

Dr. Anne Kahle at NASA's Jet Propulsion Laboratory, Pasadena, Calif., is the U.S. science team leader; Bjorn Eng of JPL is the project manager. The Terra mission is part of NASA's Earth Science

7 CFR 226.12 - Administrative payments to sponsoring organizations for day care homes.

Code of Federal Regulations, 2012 CFR

2012-01-01

... (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS CHILD AND ADULT... organization's budget, or (3) the sum of the products obtained by multiplying each month the sponsoring... administrative budget detailing the costs which the sponsoring organization shall incur, document, and claim...

7 CFR 226.12 - Administrative payments to sponsoring organizations for day care homes.

Code of Federal Regulations, 2013 CFR

2013-01-01

... (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS CHILD AND ADULT... organization's budget, or (3) the sum of the products obtained by multiplying each month the sponsoring... administrative budget detailing the costs which the sponsoring organization shall incur, document, and claim...

7 CFR 226.12 - Administrative payments to sponsoring organizations for day care homes.

Code of Federal Regulations, 2014 CFR

2014-01-01

... (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS CHILD AND ADULT... organization's budget, or (3) the sum of the products obtained by multiplying each month the sponsoring... administrative budget detailing the costs which the sponsoring organization shall incur, document, and claim...

7 CFR 226.12 - Administrative payments to sponsoring organizations for day care homes.

Code of Federal Regulations, 2010 CFR

2010-01-01

... (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS CHILD AND ADULT... organization's budget, or (3) the sum of the products obtained by multiplying each month the sponsoring... administrative budget detailing the costs which the sponsoring organization shall incur, document, and claim...

7 CFR 226.12 - Administrative payments to sponsoring organizations for day care homes.

Code of Federal Regulations, 2011 CFR

2011-01-01

... (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS CHILD AND ADULT... organization's budget, or (3) the sum of the products obtained by multiplying each month the sponsoring... administrative budget detailing the costs which the sponsoring organization shall incur, document, and claim...

Marital status, spousal coverage, and the gender gap in employer-sponsored health insurance.

PubMed

Buchmueller, T C

Not only do men who work full time earn more than women, but they are more likely to receive employer-sponsored health benefits. This paper provides evidence on the gender gap in employer-sponsored health insurance. The results indicate that the gap is driven largely by the tendency of married women to decline employer-sponsored insurance in favor of being covered through their husbands. Indeed, among single workers, women are more likely than men to be offered insurance. These findings call into question the conclusion made by previous researchers that employers discriminate against women in the provision of health insurance.

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

7 CFR 226.16 - Sponsoring organization provisions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... a meals times rates payment system. In those States which implement this optional method of reimbursement, such disbursements may not exceed the rates times the number of meals documented at each facility...-time staff person for each 50 to 150 day care homes it sponsors. As part of its management plan, a...

7 CFR 226.16 - Sponsoring organization provisions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... a meals times rates payment system. In those States which implement this optional method of reimbursement, such disbursements may not exceed the rates times the number of meals documented at each facility...-time staff person for each 50 to 150 day care homes it sponsors. As part of its management plan, a...

The impact of making vaccines thermostable in Niger's vaccine supply chain.

PubMed

Lee, Bruce Y; Cakouros, Brigid E; Assi, Tina-Marie; Connor, Diana L; Welling, Joel; Kone, Souleymane; Djibo, Ali; Wateska, Angela R; Pierre, Lionel; Brown, Shawn T

2012-08-17

Determine the effects on the vaccine cold chain of making different types of World Health Organization (WHO) Expanded Program on Immunizations (EPI) vaccines thermostable. Utilizing a detailed computational, discrete-event simulation model of the Niger vaccine supply chain, we simulated the impact of making different combinations of the six current EPI vaccines thermostable. Making any EPI vaccine thermostable relieved existing supply chain bottlenecks (especially at the lowest levels), increased vaccine availability of all EPI vaccines, and decreased cold storage and transport capacity utilization. By far, the most substantial impact came from making the pentavalent vaccine thermostable, increasing its own vaccine availability from 87% to 97% and the vaccine availabilities of all other remaining non-thermostable EPI vaccines to over 93%. By contrast, making each of the other vaccines thermostable had considerably less effect on the remaining vaccines, failing to increase the vaccine availabilities of other vaccines to more than 89%. Making tetanus toxoid vaccine along with the pentavalent thermostable further increased the vaccine availability of all EPI vaccines by at least 1-2%. Our study shows the potential benefits of making any of Niger's EPI vaccines thermostable and therefore supports further development of thermostable vaccines. Eliminating the need for refrigerators and freezers should not necessarily be the only benefit and goal of vaccine thermostability. Rather, making even a single vaccine (or some subset of the vaccines) thermostable could free up significant cold storage space for other vaccines, and thereby help alleviate supply chain bottlenecks that occur throughout the world. Copyright © 2012 Elsevier Ltd. All rights reserved.

Vaccine history, gender and influenza vaccination in a household context.

PubMed

Mamelund, Svenn-Erik; Riise Bergsaker, Marianne A

2011-11-28

Few studies have investigated the effect of the history of vaccination on the current influenza vaccine uptake. The objective of this paper is to study the effects of vaccine history, for each sex separately, on the likelihood of vaccine uptake among single-head households and two-person households, controlling not only for the respondents' own prior vaccination history but also the history of vaccination among possible co-residents. We used logistic regression and data from a nationally representative telephone survey of the non-institutionalized Norwegian population aged ≥ 65 years to estimate our models (N=354). The survey was carried out in November 2008. The lowest vaccine uptake was found among those who live alone with no prior history of vaccination and among those who live in two-person households where both members had no prior history of vaccination (10-22%). Those who live in two-person households where both members had previously been vaccinated had the highest vaccine uptake (86%). While a man who has previously been vaccinated has a higher likelihood of continued vaccination if his wife also has a prior history of vaccination, a woman with a prior history of vaccination is not dependent on her husband's prior practice with respect to the probability of continued vaccination. Of those who have no history of vaccination, more women than men are vaccinated for the first time when they have a spouse who has a history of vaccination. Our study shows that the history of vaccination of a co-resident/spouse has an effect above and beyond the respondent's own vaccination history. The results indicate that there are gender differences in the willingness to encourage family members to be vaccinated or to embark upon a familial vaccination regime in order to protect the individual's own personal health and that of other family members from influenza. To the best of our knowledge such gender differences have never been shown before in research on influenza

Association of serum anti-rotavirus immunoglobulin A antibody seropositivity and protection against severe rotavirus gastroenteritis: analysis of clinical trials of human rotavirus vaccine.

PubMed

Cheuvart, Brigitte; Neuzil, Kathleen M; Steele, A Duncan; Cunliffe, Nigel; Madhi, Shabir A; Karkada, Naveen; Han, Htay Htay; Vinals, Carla

2014-01-01

Clinical trials of the human rotavirus vaccine Rotarix™ (RV1) have demonstrated significant reductions in severe rotavirus gastroenteritis (RVGE) in children worldwide. However, no correlate of vaccine efficacy (VE) has yet been established. This paper presents 2 analyses which aimed to investigate whether serum anti-RV IgA measured by ELISA 1 or 2 mo post-vaccination can serve as a correlate of efficacy against RVGE: (1) In a large Phase III efficacy trial (Rota-037), the Prentice criteria for surrogate endpoints was applied to anti-RV IgA seropositivity 1 mo post-vaccination. These criteria determine whether a significant vaccine group effect can be predicted from the surrogate, namely seropositivity (anti-RV IgA concentration>20 U/mL); (2) Among other GSK-sponsored RV1 VE studies, 8 studies which assessed immunogenicity at 1 or 2 mo post-vaccination in all or a sub-cohort of enrolled subjects and had at least 10 RVGE episodes were included in a meta-analysis to measure the regression between clinical VE and VE predicted from immunogenicity (VE1). In Rota-037, anti-RV IgA seropositivity post-vaccination was associated with a lower incidence of any or severe RVGE, however, the proportion of vaccine group effect explained by seropositivity was only 43.6% and 32.7% respectively. This low proportion was due to the vaccine group effect observed in seronegative subjects. In the meta-analysis, the slope of the regression between clinical VE and VE1 was statistically significant. These two independent analyses support the hypothesis that post-vaccination anti-RV IgA seropositivity (antibody concentration ≥20 U/mL) may serve as a useful correlate of efficacy in clinical trials of RV1 vaccines.

Hepatitis Vaccines

PubMed Central

Ogholikhan, Sina; Schwarz, Kathleen B.

2016-01-01

Viral hepatitis is a serious health problem all over the world. However, the reduction of the morbidity and mortality due to vaccinations against hepatitis A and hepatitis B has been a major component in the overall reduction in vaccine preventable diseases. We will discuss the epidemiology, vaccine development, and post-vaccination effects of the hepatitis A and B virus. In addition, we discuss attempts to provide hepatitis D vaccine for the 350 million individuals infected with hepatitis B globally. Given the lack of a hepatitis C vaccine, the many challenges facing the production of a hepatitis C vaccine will be shown, along with current and former vaccination trials. As there is no current FDA-approved hepatitis E vaccine, we will present vaccination data that is available in the rest of the world. Finally, we will discuss the existing challenges and questions facing future endeavors for each of the hepatitis viruses, with efforts continuing to focus on dramatically reducing the morbidity and mortality associated with these serious infections of the liver. PMID:26978406

The University Campus: Why Military Sponsored Research.

ERIC Educational Resources Information Center

Messing, Aubrey E.

Military-sponsored research on the university campus has been a major issue during the past several years. Opposition has come from radicals, who wish to destroy the university itself, to critics, who feel such activities take needed funds and personnel from the more important task of solving our nation's social problems. These viewpoints and the…

Imperfect Vaccine Aggravates the Long-Standing Dilemma of Voluntary Vaccination

PubMed Central

Wu, Bin; Fu, Feng; Wang, Long

2011-01-01

Achieving widespread population immunity by voluntary vaccination poses a major challenge for public health administration and practice. The situation is complicated even more by imperfect vaccines. How the vaccine efficacy affects individuals' vaccination behavior has yet to be fully answered. To address this issue, we combine a simple yet effective game theoretic model of vaccination behavior with an epidemiological process. Our analysis shows that, in a population of self-interested individuals, there exists an overshooting of vaccine uptake levels as the effectiveness of vaccination increases. Moreover, when the basic reproductive number, , exceeds a certain threshold, all individuals opt for vaccination for an intermediate region of vaccine efficacy. We further show that increasing effectiveness of vaccination always increases the number of effectively vaccinated individuals and therefore attenuates the epidemic strain. The results suggest that ‘number is traded for efficiency’: although increases in vaccination effectiveness lead to uptake drops due to free-riding effects, the impact of the epidemic can be better mitigated. PMID:21687680

The effects of anti-vaccine conspiracy theories on vaccination intentions.

PubMed

Jolley, Daniel; Douglas, Karen M

2014-01-01

The current studies investigated the potential impact of anti-vaccine conspiracy beliefs, and exposure to anti-vaccine conspiracy theories, on vaccination intentions. In Study 1, British parents completed a questionnaire measuring beliefs in anti-vaccine conspiracy theories and the likelihood that they would have a fictitious child vaccinated. Results revealed a significant negative relationship between anti-vaccine conspiracy beliefs and vaccination intentions. This effect was mediated by the perceived dangers of vaccines, and feelings of powerlessness, disillusionment and mistrust in authorities. In Study 2, participants were exposed to information that either supported or refuted anti-vaccine conspiracy theories, or a control condition. Results revealed that participants who had been exposed to material supporting anti-vaccine conspiracy theories showed less intention to vaccinate than those in the anti-conspiracy condition or controls. This effect was mediated by the same variables as in Study 1. These findings point to the potentially detrimental consequences of anti-vaccine conspiracy theories, and highlight their potential role in shaping health-related behaviors.

Contaminant exposure of barn swallows nesting on Bayou d'Inde, Calcasieu Estuary, Louisiana, USA.

USGS Publications Warehouse

Custer, T.W.; Custer, Christine M.; Goatcher, B.L.; Melancon, M.J.; Matson, C.W.; Bickham, J.W.

2006-01-01

Current and historical point source discharges, storm water runoff, and accidental spills have contaminated the water, sediment, and biota within the Calcasieu Estuary in southwestern Louisiana. In 2003, barn swallow (Hirundo rustica) eggs and nestlings were collected beneath two bridges that cross Bayou d'Inde, the most contaminated waterway within the Calcasieu Estuary. Samples were also collected from a bridge over Bayou Teche, a reference site in south central Louisiana. Polychlorinated biphenyl (PCB) concentrations in barn swallow eggs and nestlings were significantly higher at the downstream site on Bayou d'Inde (2.8 micro g/g PCBs in eggs and 1.5 micro g/g PCBs in nestlings) than at the other two sites (< 0.2 micro g/g PCBs in eggs and nestlings at both sites). Ethoxyresorufin-O-dealkylase activity in nestling livers was significantly higher at the downstream site on Bayou d'Inde (50 pmol/min/mg) compared to the other two locations (24 pmol/min/mg, each), probably because of exposure to PCBs. Polychlorinated dibenzo-p-dioxin and polychlorinated dibenzofuran concentrations in eggs and polycyclic aromatic hydrocarbons in nestlings were at background concentrations at all sites. Trace element concentrations in barn swallow eggs and nestling livers were at background levels and did not differ among the three sites. A biomarker of DNA damage did not differ among sites.

Contaminant exposure of barn swallows nesting on Bayou d'Inde, Calcasieu Estuary, Louisiana, USA

USGS Publications Warehouse

Custer, T.W.; Custer, Christine M.; Goatcher, B.L.; Melancon, M.J.; Matson, C.W.; Bickham, J.W.

2006-01-01

Current and historical point source discharges, storm water runoff, and accidental spills have contaminated the water, sediment, and biota within the Calcasieu Estuary in southwestern Louisiana. In 2003, barn swallow (Hirundo rustica) eggs and nestlings were collected beneath two bridges that cross Bayou d'Inde, the most contaminated waterway within the Calcasieu Estuary. Samples were also collected from a bridge over Bayou Teche, a reference site in south central Louisiana. Polychlorinated biphenyl (PCB) concentrations in barn swallow eggs and nestlings were significantly higher at the downstream site on Bayou d'Inde (2.8 mu g/g PCBs in eggs and 1.5 mu g/g PCBs in nestlings) than at the other two sites (< 0.2 mu g/g PCBs in eggs and nestlings at both sites). Ethoxyresorufin-O-dealkylase activity in nestling livers was significantly higher at the downstream site on Bayou d'Inde (50 pmol/min/mg) compared to the other two locations (24 pmol/min/mg, each), probably because of exposure to PCBs. Polychlorinated dibenzo-p-dioxin and polychlorinated dibenzofuran concentrations in eggs and polycyclic aromatic hydrocarbons in nestlings were at background concentrations at all sites. Trace element concentrations in barn swallow eggs and nestling livers were at background levels and did not differ among the three sites. A biomarker of DNA damage did not differ among sites.

Efficacy and Safety of Indacaterol/Glycopyrronium (IND/GLY) Versus Salmeterol/Fluticasone in Chinese Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease: The Chinese Cohort from the LANTERN Study.

PubMed

Zhong, Nanshan; Wang, Changzheng; Zhou, Xiangdong; Zhang, Nuofu; Humphries, Michael; Wang, Linda; Patalano, Francesco; Banerji, Donald

2016-12-01

Inhaled indacaterol/glycopyrronium fixed-dose combination (IND/GLY) is approved in over 80 countries, including the EU, Japan, Australia and Switzerland and the US. The LANTERN study evaluated the efficacy of IND/GLY compared with inhaled long-acting β 2 -agonist (LABA)/inhaled corticosteroid (ICS) or salmeterol/fluticasone (SFC) in patients with moderate-to-severe COPD with a history of ≤1 exacerbation in the previous year. Here we present the efficacy and safety of IND/GLY versus SFC in the Chinese cohort from the LANTERN study. LANTERN was a 26-week, multicenter, randomized, double-blind, double-dummy, parallel-group study conducted in patients with moderate-to-severe COPD with a history of ≤1 exacerbation in the previous year. The patients were randomized (1:1) to once-daily IND/GLY (110/50 μg) or twice-daily SFC (50/500 μg). The primary endpoint was non-inferiority of IND/GLY versus SFC in terms of trough FEV 1 . Of the total 744 patients randomized in the LANTERN study, 598 (80.4%) were from Mainland China and randomized to IND/GLY (n = 298) or SFC (n = 300), and 553 (92.5%) completed the study. IND/GLY showed superiority over SFC with a statistically significant and clinically meaningful improvement in trough FEV 1 , FEV 1 AUC 0-4h , peak FEV 1 and trough forced vital capacity (FVC) change from the baseline. Annualized rate of moderate or severe COPD exacerbations was significantly lower (43%) with IND/GLY compared with SFC (rate ratio: 0.57, p = 0.015). Overall, adverse events were lower for IND/GLY (34.6%) versus SFC (43.1%). IND/GLY was superior in achieving bronchodilation versus SFC in a Chinese subgroup of patients from this study. Clinicaltrials.gov identifier: NCT01709903.

Summary and Recommendations from the National Institute of Allergy and Infectious Diseases (NIAID) Workshop "Gonorrhea Vaccines: the Way Forward".

PubMed

Wetzler, Lee M; Feavers, Ian M; Gray-Owen, Scott D; Jerse, Ann E; Rice, Peter A; Deal, Carolyn D

2016-08-01

There is an urgent need for the development of an antigonococcal vaccine due to the increasing drug resistance found in this pathogen. The U.S. Centers for Disease Control (CDC) have identified multidrug-resistant gonococci (GC) as among 3 "urgent" hazard-level threats to the U.S. In light of this, on 29 to 30 June 2015, the National Institute for Allergy and Infectious Diseases (NIAID) sponsored a workshop entitled "Gonorrhea Vaccines: the Way Forward." The goal of the workshop was to gather leaders in the field to discuss several key questions on the current status of gonorrhea vaccine research and the path forward to a licensed gonorrhea vaccine. Representatives from academia, industry, U.S. Government agencies, and a state health department were in attendance. This review summarizes each of the 4 scientific sessions and a series of 4 breakout sessions that occurred during the one and a half days of the workshop. Topics raised as high priority for future development included (i) reinvigoration of basic research to understand gonococcal infection and immunity to allow intervention in processes essential for infection; (ii) clinical infection studies to establish parallels and distinctions between in vitro and animal infection models versus natural human genital and pharyngeal infection and to inform in silico modeling of vaccine impact; and (iii) development of an integrated pipeline for preclinical and early clinical evaluation and direct comparisons of potential vaccine antigens and adjuvants and routes of delivery. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

20 CFR 416.1204 - Deeming of resources of the sponsor of an alien.

Code of Federal Regulations, 2014 CFR

2014-04-01

... alien. 416.1204 Section 416.1204 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL... of the sponsor of an alien. The resources of an alien who first applies for SSI benefits after September 30, 1980, are deemed to include the resources of the alien's sponsor for 3 years after the alien's...

20 CFR 416.1204 - Deeming of resources of the sponsor of an alien.

Code of Federal Regulations, 2011 CFR

2011-04-01

... alien. 416.1204 Section 416.1204 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL... of the sponsor of an alien. The resources of an alien who first applies for SSI benefits after September 30, 1980, are deemed to include the resources of the alien's sponsor for 3 years after the alien's...

20 CFR 416.1204 - Deeming of resources of the sponsor of an alien.

Code of Federal Regulations, 2010 CFR

2010-04-01

... alien. 416.1204 Section 416.1204 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL... of the sponsor of an alien. The resources of an alien who first applies for SSI benefits after September 30, 1980, are deemed to include the resources of the alien's sponsor for 3 years after the alien's...

20 CFR 416.1204 - Deeming of resources of the sponsor of an alien.

Code of Federal Regulations, 2013 CFR

2013-04-01

... alien. 416.1204 Section 416.1204 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL... of the sponsor of an alien. The resources of an alien who first applies for SSI benefits after September 30, 1980, are deemed to include the resources of the alien's sponsor for 3 years after the alien's...

20 CFR 416.1204 - Deeming of resources of the sponsor of an alien.

Code of Federal Regulations, 2012 CFR

2012-04-01

... alien. 416.1204 Section 416.1204 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL... of the sponsor of an alien. The resources of an alien who first applies for SSI benefits after September 30, 1980, are deemed to include the resources of the alien's sponsor for 3 years after the alien's...

Rotavirus vaccines

PubMed Central

Yen, Catherine; Tate, Jacqueline E; Hyde, Terri B; Cortese, Margaret M; Lopman, Benjamin A; Jiang, Baoming; Glass, Roger I; Parashar, Umesh D

2014-01-01

Rotavirus is the leading cause of severe diarrhea among children <5 years worldwide. Currently licensed rotavirus vaccines have been efficacious and effective, with many countries reporting substantial declines in diarrheal and rotavirus-specific morbidity and mortality. However, the full public health impact of these vaccines has not been realized. Most countries, including those with the highest disease burden, have not yet introduced rotavirus vaccines into their national immunization programs. Research activities that may help inform vaccine introduction decisions include (1) establishing effectiveness, impact, and safety for rotavirus vaccines in low-income settings; (2) identifying potential strategies to improve performance of oral rotavirus vaccines in developing countries, such as zinc supplementation; and (3) pursuing alternate approaches to oral vaccines, such as parenteral immunization. Policy- and program-level barriers, such as financial implications of new vaccine introductions, should be addressed to ensure that countries are able to make informed decisions regarding rotavirus vaccine introduction. PMID:24755452

Vaccination Perceptions of College Students: With and without Vaccination Waiver.

PubMed

Jadhav, Emmanuel D; Winkler, Danielle L; Anderson, Billie S

2018-01-01

The resurgence of vaccine preventable diseases occurs more often among intentionally unvaccinated individuals, placing at direct risk young adults not caught up on vaccinations. The objectives of this study were to characterize the sociodemographic characteristics of young adults with and without vaccination waivers and identify their perceived benefits, barriers, and influencers of vaccination. Young adults ( n  = 964) from a Midwestern rural university responded to a survey (fall 2015-spring 2016) designed to identify their perception toward vaccination. Instrument consistency was measured using the Cronbach α-scores. The Chi-square test was used to test any sociodemographic differences and Mann-Whitney U -tests results for differences between exempt and non-exempt students. Analysis occurred in spring 2017. A little over one-third of young adults with a vaccination waiver were not up to date on their vaccinations, and think that vaccinations can cause autism. The biggest identifiable benefit was effective control against disease. The surveyed young adults ranked the out of pocket cost associated with vaccination as the most important barrier and safe and easy to use vaccines as the most important influencer of vaccination. Young adults who have had a vaccination waiver appear to not be up to date on their vaccinations. Vaccine administration programs, such as university campus clinics, would benefit from addressing perceptions unique to young adults with and without a vaccine waiver. This would subsequently better provide young adults a second shot for getting appropriately caught up on vaccinations.

Sponsorship, ambushing, and counter-strategy: effects upon memory for sponsor and event.

PubMed

Humphreys, Michael S; Cornwell, T Bettina; McAlister, Anna R; Kelly, Sarah J; Quinn, Emerald A; Murray, Krista L

2010-03-01

Corporate sponsorship of sports, causes, and the arts has become a mainstream communications tool worldwide. The unique marketing opportunities associated with major events also attract nonsponsoring companies seeking to form associations with the event (ambushing). There are strategies available to brands and events which have been ambushed; however, there is only limited information about the effects of those strategies on attainment of sponsorship objectives. In Experiment 1, university staff and students participated by studying paragraphs linking a sponsor to a novel event. Relative to each sponsor-event pair, they then studied one of three different messages about a competitor. Results find a message which linked the competitor and the event increased competitor recall given the event as a cue and event recall given the competitor as a cue. These effects were moderated if there was information about the competitor not being the sponsor. In Experiment 2 ambushing and counter-ambushing information was presented over 2 days. Both types of messages increased competitor recall given the event as a cue and event recall given the competitor as a cue. In addition, "not sponsor" information was not always used even when it should have been recallable. The results can be explained if participants are using three cues: a specific cue such as a brand name, a contextual cue, and a category cue, such as the concept of an event. Findings suggest to sponsoring firms and event properties that counter-ambushing communications may have the unintended effect of strengthening an ambusher-event relationship in memory.

Use and Misuse of Industry Sponsored Materials.

ERIC Educational Resources Information Center

DuVall, Charles R.; Krepel, Wayne J.

A review of educational research reveals that free and inexpensive materials are used today to a much greater extent than they had been in the past. Two studies, sponsored by the American Iron and Steel Institute, are evidence of the producer's interest in determining the strengths and weaknesses of the materials being sent into classrooms and…

HPV Vaccine

MedlinePlus

... Safe Videos for Educators Search English Español HPV Vaccine KidsHealth / For Teens / HPV Vaccine What's in this ... starting at age 9. How Does the HPV Vaccine Work? The HPV vaccine is approved for people ...

[From new vaccine to new target: revisiting influenza vaccination].

PubMed

Gérard, M

2011-09-01

Annual vaccination is since many years the corner stone of Influenza control strategy. Because conventional vaccine are needle-based, are less immunogenic in old people and induce only systemic IgG production, intranasal and intradermal vaccines that are recently or will be soon available in Belgium will offer distinct advantages. Intradermal vaccination is on the Belgian market since 2010. A stronger immune response that allows an antigen sparing strategy is elicited because antigens are delivered near the dermal dendritic cells. Local side effects are more pronounced than after intramuscular injection. The needle-free intranasal vaccine that has been approved for use in people less than 18 years old by the EMEA in October 2010 induces also a mucosal IgA response. Improved clinical results than with intramuscular vaccine has been documented in several studies in children. Several conditions are contraindication to nasal vaccination because of patterns of side effects and because the vaccine is an live-attenuated vaccine. Pregnant women has become a top priority for Influenza vaccination in the recommendations of the High Council of Health in Belgium since the 2009 H1N1 pandemic. Several studies has since then documented the increased risk for Influenza-related morbidity in pregnant women especially during the third trimester and independently of the presence of other comorbidities. Reduced incidence of documented Influenza and of Influenza-related hospitalizations are observed in the new born of vaccinated women until 6 months of age. Availability of new vaccines for Influenza and better knowledge of the benefit of vaccination in target populations are important tools to optimize vaccine coverage of the population.

A review of NASA-sponsored technology assessment projects

NASA Technical Reports Server (NTRS)

Mascy, A. C.; Alexander, A. D., III; Wood, R. D.

1978-01-01

Recent technology assessment studies sponsored by NASA are reviewed, and a summary of the technical results as well as a critique of the methodologies are presented. The reviews include Assessment of Lighter-Than-Air Technology, Technology Assessment of Portable Energy RDT&P, Technology Assessment of Future Intercity Passenger Transportation Systems, and Technology Assessment of Space Disposal of Radioactive Nuclear Waste. The use of workshops has been introduced as a unique element of some of these assessments. Also included in this report is a brief synopsis of a method of quantifying opinions obtained through such group interactions. Representative of the current technology assessments, these studies cover a broad range of socio-political factors and issues in greater depth than previously considered in NASA sponsored studies. In addition to the lessons learned through the conduct of these studies, a few suggestions for improving the effectiveness of future technology assessments are provided.

The Effects of Anti-Vaccine Conspiracy Theories on Vaccination Intentions

PubMed Central

Jolley, Daniel; Douglas, Karen M.

2014-01-01

The current studies investigated the potential impact of anti-vaccine conspiracy beliefs, and exposure to anti-vaccine conspiracy theories, on vaccination intentions. In Study 1, British parents completed a questionnaire measuring beliefs in anti-vaccine conspiracy theories and the likelihood that they would have a fictitious child vaccinated. Results revealed a significant negative relationship between anti-vaccine conspiracy beliefs and vaccination intentions. This effect was mediated by the perceived dangers of vaccines, and feelings of powerlessness, disillusionment and mistrust in authorities. In Study 2, participants were exposed to information that either supported or refuted anti-vaccine conspiracy theories, or a control condition. Results revealed that participants who had been exposed to material supporting anti-vaccine conspiracy theories showed less intention to vaccinate than those in the anti-conspiracy condition or controls. This effect was mediated by the same variables as in Study 1. These findings point to the potentially detrimental consequences of anti-vaccine conspiracy theories, and highlight their potential role in shaping health-related behaviors. PMID:24586574

[VACCINES].

PubMed

Bellver Capella, Vincente

2015-10-01

Vaccines are an extraordinary instrument of immunization of the population against infectious diseases. Around them there are many ethical issues. One of the most debated is what to do with certain groups opposition to vaccination of their children. States have managed in different ways the conflict between the duty of vaccination and the refusal to use vaccines: some impose the vaccination and others simply promote it. In this article we deal with which of these two approaches is the most suitable from an ethical and legal point of view. We stand up for the second option, which is the current one in Spain, and we propose some measures which should be kept in mind to improve immunization programs.

The Emmanuel Schools Foundation: Sponsoring and Leading Transformation at England's Most Improved Academy

ERIC Educational Resources Information Center

Pike, Mark A.

2009-01-01

The Emmanuel Schools Foundation (ESF) has so far sponsored four schools in England. Beginning with Emmanuel College in Gateshead in 1990 (which remains a City Technology College) the Foundation sponsors the King's Academy in Middlesbrough, which opened in 2003, and Trinity Academy in Thorne near Doncaster, which opened in 2005. The Foundation's…

Ability of immunodiagnostic tests to differentiate between dogs naturally infected with Leishmania infantum and Leishmune(®)-vaccinated dogs.

PubMed

Ribeiro, R A N; Teixeira-Neto, R G; Belo, V S; Ferreira, E C; Schallig, H D F H; Silva, E S

2015-06-01

Visceral leishmaniasis (VL) is a serious chronic disease with a lethality rate of up to 10% in humans. In urban areas of Brazil, dogs are the main reservoirs of the etiological agent (Leishmania infantum) of VL, and the Brazilian Ministry of Health recommends the euthanasia of animals that are seropositive in both the immunochromatographic dual path platform rapid test (DPP(®); Bio-Manguinhos) and the enzyme-linked immunosorbent assay (ELISA) with an L. major-like antigen (Bio-Manguinhos). Vaccination is an additional tool in the control of canine VL, but the use of Leishmune(®) (Zoetis Indústria de Produtos Veterinários, São Paulo, SP, Brazil), which contains the fucose mannose ligand (FML) isolated from L. donovani, is not currently recommended by the Brazilian Ministry of Health because vaccinated animals may exhibit positive serology and there are reservations regarding the efficacy of the vaccine. The aims of the present study were: (i) to verify the abilities of the fast agglutination screening test (FAST), the direct agglutination test (DAT), the indirect fluorescent-antibody test (IFAT), the DPP rapid test, and ELISA tests with L. major-like and FML antigens to differentiate between L. infantum-infected and Leishmune(®)-vaccinated dogs, and (ii) to analyze the sensitivities and specificities of the different methods. The reactivities to these tests of Leishmune(®)-vaccinated dogs (n = 71), asymptomatic (n = 20) and symptomatic (n = 20) naturally infected dogs, and unvaccinated healthy control dogs (n = 5) were compared. None of the Leishmune(®)-vaccinated dogs tested seropositive in FAST and DAT, although one dog was reactive to DPP and four dogs to ELISA/L. major-like and IFAT tests. While 69 (97%) of vaccinated dogs reacted to ELISA/FML, only one was seropositive in both ELISA/L. major-like and IFAT tests. Individually, all immunodiagnostic tests presented high specificities and positive likelihood ratios (LR+), and high specificity values were

Enhancing diversity in the public health research workforce: the research and mentorship program for future HIV vaccine scientists.

PubMed

Sopher, Carrie J; Adamson, Blythe Jane S; Andrasik, Michele P; Flood, Danna M; Wakefield, Steven F; Stoff, David M; Cook, Ryan S; Kublin, James G; Fuchs, Jonathan D

2015-04-01

We developed and evaluated a novel National Institutes of Health-sponsored Research and Mentorship Program for African American and Hispanic medical students embedded within the international, multisite HIV Vaccine Trials Network, and explored its impact on scientific knowledge, acquired skills, and future career plans. Scholars conducted social, behavioral, clinical, or laboratory-based research projects with HIV Vaccine Trials Network investigators over 8 to 16 weeks (track 1) or 9 to 12 months (track 2). We conducted an in-depth, mixed-methods evaluation of the first 2 cohorts (2011-2013) to identify program strengths, areas for improvement, and influence on professional development. A pre-post program assessment demonstrated increases in self-reported knowledge, professional skills, and interest in future HIV vaccine research. During in-depth interviews, scholars reported that a supportive, centrally administered program; available funding; and highly involved mentors and staff were keys to the program's early success. A multicomponent, mentored research experience that engages medical students from underrepresented communities and is organized within a clinical trials network may expand the pool of diverse public health scientists. Efforts to sustain scholar interest over time and track career trajectories are warranted.

Survey of Australian inpatients on vaccination status and perceptions of influenza vaccination.

PubMed

Loke, Xin Yee; Tran, Winnie; Alderman, Christopher P

2012-08-01

To assess vaccination status, potential influences upon vaccination status, and attitudes and beliefs about vaccination among hospital inpatients. This prospective, cross-sectional audit assessed vaccination status for important communicable diseases, patient perceptions about the influenza vaccination, and possible influences on vaccination status. Information was collected during face-to-face interviews using a structured questionnaire. This study was undertaken in a general teaching hospital in suburban Adelaide, South Australia. The study participants comprised a convenience sample of 50 inpatients at the hospital from April 25, 2011, to May 18, 2011. Interview and structured questionnaire at bedside. Vaccination status for seasonal influenza, pneumococcal vaccine, diphtheriatetanus-pertussis/diphtheria-tetanus vaccination, herpes zoster virus, and hepatitis B were assessed for inpatients. Qualitative information regarding patient perceptions about the influenza vaccination was also surveyed. Possible influences on vaccination status including comorbidities or high-risk conditions, area of residence, age, and gender were also assessed. The self-reported vaccination rates were: seasonal influenza vaccine 2010 (64%), seasonal influenza vaccine 2011 (52%), pneumococcal vaccine (46%), diphtheria-tetanuspertussis/ diphtheria-tetanus vaccination (70%), herpes zoster vaccination (34%), and hepatitis B vaccination (40%). Vaccination was significantly more common among those older than 64 years of age (P = 0.01), with 46% of patients older than 64 years vaccinated against influenza. There was no significant association between vaccination status and other characteristics such as gender, number of risk factors, recent hospital admission, and living in a residential facility. Regarding perceptions toward the influenza vaccine, the only factor associated with significantly increased likelihood of vaccination was self-reported risk perception (P = 0.03). The majority of

7 CFR 225.9 - Program assistance to sponsors.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS SUMMER FOOD SERVICE PROGRAM State Agency Provisions § 225.9 Program... of the sponsor's approved administrative budget. The amount of the start-up payment shall be deducted...

7 CFR 225.9 - Program assistance to sponsors.

Code of Federal Regulations, 2013 CFR

2013-01-01

... Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS SUMMER FOOD SERVICE PROGRAM State Agency Provisions § 225.9 Program... of the sponsor's approved administrative budget. The amount of the start-up payment shall be deducted...

7 CFR 225.9 - Program assistance to sponsors.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS SUMMER FOOD SERVICE PROGRAM State Agency Provisions § 225.9 Program... of the sponsor's approved administrative budget. The amount of the start-up payment shall be deducted...

7 CFR 225.9 - Program assistance to sponsors.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE CHILD NUTRITION PROGRAMS SUMMER FOOD SERVICE PROGRAM State Agency Provisions § 225.9 Program... of the sponsor's approved administrative budget. The amount of the start-up payment shall be deducted...

Repeated annual influenza vaccination and vaccine effectiveness: review of evidence.

PubMed

Belongia, Edward A; Skowronski, Danuta M; McLean, Huong Q; Chambers, Catharine; Sundaram, Maria E; De Serres, Gaston

2017-07-01

Studies in the 1970s and 1980s signaled concern that repeated influenza vaccination could affect vaccine protection. The antigenic distance hypothesis provided a theoretical framework to explain variability in repeat vaccination effects based on antigenic similarity between successive vaccine components and the epidemic strain. Areas covered: A meta-analysis of vaccine effectiveness studies from 2010-11 through 2014-15 shows substantial heterogeneity in repeat vaccination effects within and between seasons and subtypes. When negative effects were observed, they were most pronounced for H3N2, especially in 2014-15 when vaccine components were unchanged and antigenically distinct from the epidemic strain. Studies of repeated vaccination across multiple seasons suggest that vaccine effectiveness may be influenced by more than one prior season. In immunogenicity studies, repeated vaccination blunts the hemagglutinin antibody response, particularly for H3N2. Expert commentary: Substantial heterogeneity in repeated vaccination effects is not surprising given the variation in study populations and seasons, and the variable effects of antigenic distance and immunological landscape in different age groups and populations. Caution is required in the interpretation of pooled results across multiple seasons, since this can mask important variation in repeat vaccination effects between seasons. Multi-season clinical studies are needed to understand repeat vaccination effects and guide recommendations.

Vaccine preventable disease incidence as a complement to vaccine efficacy for setting vaccine policy

PubMed Central

Gessner, Bradford D.; Feikin, Daniel R.

2015-01-01

Traditionally, vaccines have been evaluated in clinical trials that establish vaccine efficacy (VE) against etiology-confirmed disease outcomes, a measure important for licensure. Yet, VE does not reflect a vaccine’s public health impact because it does not account for relative disease incidence. An additional measure that more directly establishes a vaccine’s public health value is the vaccine preventable disease incidence (VPDI), which is the incidence of disease preventable by vaccine in a given context. We describe how VE and VPDI can vary, sometimes in inverse directions, across disease outcomes and vaccinated populations. We provide examples of how VPDI can be used to reveal the relative public health impact of vaccines in developing countries, which can be masked by focus on VE alone. We recommend that VPDI be incorporated along with VE into the analytic plans of vaccine trials, as well as decisions by funders, ministries of health, and regulatory authorities. PMID:24731817

The Impact of Making Vaccines Thermostable in Niger’s Vaccine Supply Chain

PubMed Central

Lee, Bruce Y.; Cakouros, Brigid E.; Assi, Tina-Marie; Connor, Diana L.; Welling, Joel; Kone, Souleymane; Djibo, Ali; Wateska, Angela R.; Pierre, Lionel; Brown, Shawn T.

2012-01-01

Objective Determine the effects on the vaccine cold chain of making different types of World Health Organization (WHO) Expanded Program on Immunizations (EPI) vaccines thermostable. Methods Utilizing a detailed computational, discrete-event simulation model of the Niger vaccine supply chain, we simulated the impact of making different combinations of the six current EPI vaccines thermostable. Findings Making any EPI vaccine thermostable relieved existing supply chain bottlenecks (especially at the lowest levels), increased vaccine availability of all EPI vaccines, and decreased cold storage and transport capacity utilization. By far, the most substantial impact came from making the pentavalent vaccine thermostable, increasing its own vaccine availability from 87% to 97% and the vaccine availabilities of all other remaining non-thermostable EPI vaccines to over 93%. By contrast, making each of the other vaccines thermostable had considerably less effect on the remaining vaccines, failing to increase the vaccine availabilities of other vaccines to more than 89%. Making tetanus toxoid vaccine along with the pentavalent thermostable further increased the vaccine availability of all EPI vaccines by at least 1–2%. Conclusion Our study shows the potential benefits of making any of Niger’s EPI vaccines thermostable and therefore supports further development of thermostable vaccines. Eliminating the need for refrigerators and freezers should not necessarily be the only benefit and goal of vaccine thermostability. Rather, making even a single vaccine (or some subset of the vaccines) thermostable could free up significant cold storage space for other vaccines, and thereby help alleviate supply chain bottlenecks that occur throughout the world. PMID:22789507

Biopharmaceutical industry-sponsored global clinical trials in emerging countries.

PubMed

Alvarenga, Lenio Souza; Martins, Elisabeth Nogueira

2010-01-01

To evaluate biopharmaceutical industry-sponsored clinical trials placed in countries previously described as emerging regions for clinical research, and potential differences for those placed in Brazil. Data regarding recruitment of subjects for clinical trials were retrieved from www.clinicaltrials.gov on February 2nd 2009. Proportions of sites in each country were compared among emerging countries. Multiple logistic regressions were performed to evaluate whether trial placement in Brazil could be predicted by trial location in other countries and/or by trial features. A total of 8,501 trials were then active and 1,170 (13.8%) included sites in emerging countries (i.e., Argentina, Brazil, China, Czech Republic, Hungary, India, Mexico, Poland, Russia, South Korea, and South Africa). South Korea and China presented a significantly higher proportion of sites when compared to other countries (p<0.05). Multiple logistic regressions detected no negative correlation between placement in other countries when compared to Brazil. Trials involving subjects with less than 15 years of age, those with targeted recruitment of at least 1,000 subjects, and seven sponsors were identified as significant predictors of trial placement in Brazil. No clear direct competition between Brazil and other emerging countries was detected. South Korea showed the higher proportion of sites and ranked third in total number of trials, appearing as a major player in attractiveness for biopharmaceutical industry-sponsored clinical trials.

Universal fungal vaccines

PubMed Central

Hamad, Mawieh

2012-01-01

The complex nature of fungal pathogens, the intricate host-pathogen relationship and the health status of subjects in need of antifungal vaccination continue to hamper efforts to develop fungal vaccines for clinical use. That said, the rise of the universal vaccine concept is hoped to revive fungal vaccine research by expanding the pool of vaccine candidates worthy of clinical evaluation. It can do so through antigenic commonality-based screening for vaccine candidates from a wide range of pathogens and by reassessing the sizable collection of already available experimental and approved vaccines. Development of experimental vaccines protective against multiple fungal pathogens is evidence of the utility of this concept in fungal vaccine research. However, universal fungal vaccines are not without difficulties; for instance, development of vaccines with differential effectiveness is an issue that should be addressed. Additionally, rationalizing the development of universal fungal vaccines on health or economic basis could be contentious. Herein, universal fungal vaccines are discussed in terms of their potential usefulness and possible drawbacks. PMID:22922769

Drug company-sponsored patient assistance programs: a viable safety net?

PubMed

Choudhry, Niteesh K; Lee, Joy L; Agnew-Blais, Jessica; Corcoran, Colleen; Shrank, William H

2009-01-01

Drug company-sponsored patient assistance programs (PAPs) provide access to brand-name medications at little or no cost and have been advocated as a safety net for inadequately insured patients. Yet little is known about these programs. We surveyed drug company-sponsored PAPs and found much variability in their structures and application processes. Most cover one or two drugs. Only 4 percent disclosed how many patients they had directly helped, and half would not disclose their income eligibility criteria. A better understanding of PAPs might clarify their role in improving access to medications, the adequacy of existing public programs, and their impact on cost-effective medication use.

Vaccines against poverty

PubMed Central

MacLennan, Calman A.; Saul, Allan

2014-01-01

With the 2010s declared the Decade of Vaccines, and Millennium Development Goals 4 and 5 focused on reducing diseases that are potentially vaccine preventable, now is an exciting time for vaccines against poverty, that is, vaccines against diseases that disproportionately affect low- and middle-income countries (LMICs). The Global Burden of Disease Study 2010 has helped better understand which vaccines are most needed. In 2012, US$1.3 billion was spent on research and development for new vaccines for neglected infectious diseases. However, the majority of this went to three diseases: HIV/AIDS, malaria, and tuberculosis, and not neglected diseases. Much of it went to basic research rather than development, with an ongoing decline in funding for product development partnerships. Further investment in vaccines against diarrheal diseases, hepatitis C, and group A Streptococcus could lead to a major health impact in LMICs, along with vaccines to prevent sepsis, particularly among mothers and neonates. The Advanced Market Commitment strategy of the Global Alliance for Vaccines and Immunisation (GAVI) Alliance is helping to implement vaccines against rotavirus and pneumococcus in LMICs, and the roll out of the MenAfriVac meningococcal A vaccine in the African Meningitis Belt represents a paradigm shift in vaccines against poverty: the development of a vaccine primarily targeted at LMICs. Global health vaccine institutes and increasing capacity of vaccine manufacturers in emerging economies are helping drive forward new vaccines for LMICs. Above all, partnership is needed between those developing and manufacturing LMIC vaccines and the scientists, health care professionals, and policy makers in LMICs where such vaccines will be implemented. PMID:25136089

Physician communication about adolescent vaccination: How is human papillomavirus vaccine different?

PubMed

Gilkey, Melissa B; Moss, Jennifer L; Coyne-Beasley, Tamera; Hall, Megan E; Shah, Parth D; Brewer, Noel T

2015-08-01

Low human papillomavirus (HPV) vaccination coverage stands in stark contrast to our success in delivering other adolescent vaccines. To identify opportunities for improving physicians' recommendations for HPV vaccination, we sought to understand how the communication context surrounding adolescent vaccination varies by vaccine type. A national sample of 776 U.S. physicians (53% pediatricians, 47% family medicine physicians) completed our online survey in 2014. We assessed physicians' perceptions and communication practices related to recommending adolescent vaccines for 11- and 12-year-old patients. About three-quarters of physicians (73%) reported recommending HPV vaccine as highly important for patients, ages 11-12. More physicians recommended tetanus, diphtheria, and acellular pertussis (Tdap) (95%) and meningococcal vaccines (87%, both p<0.001) as highly important for this age group. Only 13% of physicians perceived HPV vaccine as being highly important to parents, which was far fewer than perceived parental support for Tdap (74%) and meningococcal vaccines (62%, both p<0.001). Physicians reported that discussing HPV vaccine took almost twice as long as discussing Tdap. Among physicians with a preferred order for discussing adolescent vaccines, most (70%) discussed HPV vaccine last. Our findings suggest that primary care physicians perceived HPV vaccine discussions to be burdensome, requiring more time and engendering less parental support than other adolescent vaccines. Perhaps for this reason, physicians in our national study recommended HPV vaccine less strongly than other adolescent vaccines, and often chose to discuss it last. Communication strategies are needed to support physicians in recommending HPV vaccine with greater confidence and efficiency. Copyright © 2015 Elsevier Inc. All rights reserved.

Randomized Trials Comparing Inactivated Vaccine After Medium- or High-titer Measles Vaccine With Standard Titer Measles Vaccine After Inactivated Vaccine: A Meta-analysis.

PubMed

Aaby, Peter; Ravn, Henrik; Benn, Christine S; Rodrigues, Amabelia; Samb, Badara; Ibrahim, Salah A; Libman, Michael D; Whittle, Hilton C

2016-11-01

Observational studies have suggested that girls have higher mortality if their most recent immunization is an inactivated vaccine rather than a live vaccine. We therefore reanalyzed 5 randomized trials of early measles vaccine (MV) in which it was possible to compare an inactivated vaccines [after medium-titer MV (MTMV) or high-titer MV (HTMV)] and a live standard titer MV (after an initial inactivated vaccine). The trials were conducted in Sudan, Senegal, The Gambia and Guinea-Bissau. The intervention group received live MTMV or HTMV from 4 to 5 months and then an inactivated vaccine from 9 to 10 months of age; the control children received inactivated vaccine/placebo from 4 to 5 months and standard titer MV from 9 to 10 months of age. We compared mortality from 9 months until end of study at 3 to 5 years of age for children who received inactivated vaccine (after MTMV or HTMV) and standard titer MV (after inactivated vaccine), respectively. The original datasets were analyzed using a Cox proportional hazards model stratified by trial. The mortality rate ratio (MRR) was 1.38 (95% confidence interval: 1.05-1.83) after an inactivated vaccine (after MTMV or HTMV) compared with a standard titer MV (after inactivated vaccine). Girls had a MRR of 1.89 (1.27-2.80), whereas there was no effect for boys, the sex-differential effect being significant (P = 0.02). Excluding measles cases did not alter these conclusions, the MRR after inactivated vaccines (after MTMV or HTMV) being 1.40 (1.06-1.86) higher overall and 1.92 (1.29-2.86) for girls. Control for variations in national immunization schedules for other vaccines did not modify these results. After 9 months of age, all children had been immunized against measles, and mortality in girls was higher when they had received inactivated vaccines (after MTMV or HTMV) rather than live standard titer MV (after an inactivated vaccine).

Consumer Perceptions of Sponsors of Disease Awareness Advertising

ERIC Educational Resources Information Center

Hall, Danika V.; Jones, Sandra C.; Iverson, Donald C.

2011-01-01

Purpose: In many countries there is emerging concern regarding alliances between the pharmaceutical industry and health non-profit organizations (NPOs), and the increase of co-sponsored marketing activities such as disease awareness advertising. The current study aims to explore Australian women's perceptions of disease awareness advertising with…

A Planning Model for American-Sponsored Overseas Schools.

ERIC Educational Resources Information Center

Baron, Mark A.

The main reason for the establishment of American-Sponsored Overseas Schools (ASOS) was to offer the dependents of Americans living abroad educational opportunities similar to what was available at home. ASOS have several general characteristics, including being privately controlled, nonprofit, nonsectarian, and American or binational in…

14 CFR 152.309 - Availability of sponsor's records.

Code of Federal Regulations, 2010 CFR

2010-01-01

... (CONTINUED) AIRPORTS AIRPORT AID PROGRAM Accounting and Reporting Requirements § 152.309 Availability of... the purposes of accounting and audit. (b) The sponsor or planning agency shall allow appropriate FAA...-term retention value, the FAA may require transfer of custody of those records to the FAA. ...

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

Vaccines and vaccination strategies against human cutaneous leishmaniasis.

PubMed

Okwor, Ifeoma; Uzonna, Jude

2009-05-01

One might think that the development of a vaccine against cutaneous leishmaniasis would be relatively straightforward because the type of immune response required for protection is known and natural immunity occurs following recovery from primary infection. However, there is as yet no effective vaccine against the disease in humans. Although vaccination in murine studies has yielded promising results, these vaccines have failed miserably when tested in primates or humans. The reasons behind these failures are unknown and remain a major hurdle for vaccine design and development against cutaneous leishmaniasis. In contrast, recovery from natural, deliberate or experimental infections results in development of long-lasting immunity to re-infection. This so called infection-induced resistance is the strongest anti-Leishmania immunity known. Here, we briefly review the different approaches to vaccination against cutaneous leishmaniasis and argue that vaccines composed of genetically modified (attenuated) parasites, which induce immunity akin to infection-induced resistance, may provide best protection against cutaneous leishmaniasis in humans.

European Vaccine Initiative: lessons from developing malaria vaccines.

PubMed

Geels, Mark J; Imoukhuede, Egeruan B; Imbault, Nathalie; van Schooten, Harry; McWade, Terry; Troye-Blomberg, Marita; Dobbelaer, Roland; Craig, Alister G; Leroy, Odile

2011-12-01

For over 10 years, the European Vaccine Initiative (EVI; European Malaria Vaccine Initiative until 2009) has contributed to the development of 24 malaria candidate vaccine antigens with 13 vaccine candidates being advanced into Phase I clinical trials, two of which have been transitioned for further clinical development in sub-Saharan Africa. Since its inception the EVI organization has operated as a funding agency, but with a clear service-oriented strategy. The scientific successes and difficulties encountered during these years and how these efforts have led to standardization and harmonization in vaccine development through large-scale European consortia are discussed. In the future, the EVI will remain instrumental in the pharmaceutical and clinical development of vaccines against 'diseases of poverty' with a continued focus on malaria. EVI will continue to focus on funding and managing preclinical evaluation up to Phase I/II clinical trials and strengthening the vaccine-development infrastructure in Europe, albeit with a global orientation.

Characteristics of project management at institutions sponsoring National Library of Medicine MedlinePlus Go Local*

PubMed Central

Olney, Cynthia A.; Backus, Joyce E. B.; Klein, Lori J.

2010-01-01

Objectives: Through interviews with the National Library of Medicine's MedlinePlus Go Local collaborators, an evaluation team sought to identify process characteristics that are critical for long-term sustainability of Go Local projects and to describe the impact that Go Local projects have on sponsoring institutions. Methods: Go Local project coordinators (n = 44) at 31 sponsor institutions participated in semi-structured interviews about their experiences developing and maintaining Go Local sites. Interviews were summarized, checked for accuracy by the participating librarians, and analyzed using a general inductive methodology. Results: Institutional factors that support Go Local projects were identified through the interviews, as well as strategies for staffing and partnerships with external organizations. Positive outcomes for sponsoring institutions also were identified. Conclusions: The findings may influence the National Library of Medicine team's decisions about improvements to its Go Local system and the support it provides to sponsoring institutions. The findings may benefit current sponsoring institutions as well as those considering or planning a Go Local project. PMID:20098657

[Analysis of projects of schistosomiasis sponsored by National Science Foundation of China].

PubMed

Wen-di, Zhou; Liang, Shi; Xue-Dan, Ke; Jie, Wang

2017-07-27

To summarize the present development by analysis of projects in schistosomiasis funded by National Science Foundation of China (NSFC). Based on the ISIS database of NFSC, the projects in the studies of schistosomiasis from 2005 to 2016 were analyzed. The distributions of sponsored numbers, amounts, types, agencies, disciplines and changes in research topics by means of network profiles were described. During the study period, 198 projects were funded by NSFC totally with 76.05 million yuan in which the general and youth projects were main types. The main sponsored agencies were research institutes and medical colleges. The top three fields sponsored were medical pathogenic microbes and infection, veterinary and medical immunology. The funding on schistosomiasis researches has a downward trend, but studies are continuing in depth. In this situation, innovative and interdisciplinary researches need to be encouraged to promote the development of schistosomiasis.

Understanding vaccine hesitancy around vaccines and vaccination from a global perspective: a systematic review of published literature, 2007-2012.

PubMed

Larson, Heidi J; Jarrett, Caitlin; Eckersberger, Elisabeth; Smith, David M D; Paterson, Pauline

2014-04-17

Vaccine "hesitancy" is an emerging term in the literature and discourse on vaccine decision-making and determinants of vaccine acceptance. It recognizes a continuum between the domains of vaccine acceptance and vaccine refusal and de-polarizes previous characterization of individuals and groups as either anti-vaccine or pro-vaccine. The primary aims of this systematic review are to: 1) identify research on vaccine hesitancy; 2) identify determinants of vaccine hesitancy in different settings including its context-specific causes, its expression and its impact; and 3) inform the development of a model for assessing determinants of vaccine hesitancy in different settings as proposed by the Strategic Advisory Group of Experts Working Group (SAGE WG) for dealing with vaccine hesitancy. A broad search strategy, built to capture multiple dimensions of public trust, confidence and hesitancy around vaccines, was applied across multiple databases. Peer-reviewed studies were selected for inclusion if they focused on childhood vaccines [≤ 7 years of age], used multivariate analyses, and were published between January 2007 and November 2012. Our results show a variety of factors as being associated with vaccine hesitancy but they do not allow for a complete classification and confirmation of their independent and relative strength of influence. Determinants of vaccine hesitancy are complex and context-specific - varying across time, place and vaccines. Copyright © 2014 Elsevier Ltd. All rights reserved.

Prevention of pneumonic plague in mice, rats, guinea pigs and non-human primates with clinical grade rV10, rV10-2 or F1-V vaccines

PubMed Central

Quenee, Lauriane E.; Ciletti, Nancy A.; Elli, Derek; Hermanas, Timothy M.; Schneewind, Olaf

2012-01-01

Yersinia pestis causes plague, a disease with high mortality in humans that can be transmitted by fleabite or aerosol. A US Food and Drug Administration (FDA)-licensed plague vaccine is currently not available. Vaccine developers have focused on two subunits of Y. pestis: LcrV, a protein at the tip of type III secretion needles, and F1, the fraction 1 pilus antigen. F1-V, a hybrid generated via translational fusion of both antigens, is being developed for licensure as a plague vaccine. The rV10 vaccine is a non-toxigenic variant of LcrV lacking residues 271–300. Here we developed Current Good Manufacturing Practice (cGMP) protocols for rV10. Comparison of clinical grade rV10 with F1-V did not reveal significant differences in plague protection in mice, guinea pigs or cynomolgus macaques. We also developed cGMP protocols for rV10-2, a variant of rV10 with an altered affinity tag. Immunization with rV10-2 adsorbed to aluminum hydroxide elicited antibodies against LcrV and conferred pneumonic plague protection in mice, rats, guinea pigs, cynomolgus macaques and African Green monkeys. The data support further development of rV10-2 for FDA Investigational New Drug (IND) authorization review and clinical testing. PMID:21763383

Timeliness of MMR vaccination and barriers to vaccination in preschool children.

PubMed

Jeong, Y W; Park, B H; Kim, K H; Han, Y R; Go, U Y; Choi, W S; Kong, K A; Park, H

2011-02-01

The documented vaccine coverage rate of measles-mumps-rubella (MMR) vaccination is almost 99% in Korea, but measles cases are constantly being reported. This study evaluated the vaccine coverage, timeliness, and barriers to immunization of measles vaccination in preschool children in Korea. We assessed 452 children aged 15-23 months and 300 children aged 4-6 years in September 2007. Questionnaires were administered in order to estimate measles vaccination rate, its timeliness and barriers to vaccine uptake. Being unaware of the necessity for vaccination and its schedule, child being sick during the recommended vaccination period, and recommended vaccination period not being over were significant preventive factors to timely vaccination (P < 0·05). Children with working mothers, single parents, those not being cared for by their parents, and those younger among siblings were at a higher risk of not being vaccinated on time. In order to increase timely vaccination, accurate information should be delivered and a systematic approach should be targeted to high-risk groups.

Safety and efficacy of the RTS,S/AS01E candidate malaria vaccine given with expanded-programme-on-immunisation vaccines: 19 month follow-up of a randomised, open-label, phase 2 trial.

PubMed

Asante, Kwaku Poku; Abdulla, Salim; Agnandji, Selidji; Lyimo, John; Vekemans, Johan; Soulanoudjingar, Solange; Owusu, Ruth; Shomari, Mwanajaa; Leach, Amanda; Jongert, Erik; Salim, Nahya; Fernandes, Jose F; Dosoo, David; Chikawe, Maria; Issifou, Saadou; Osei-Kwakye, Kingsley; Lievens, Marc; Paricek, Maria; Möller, Tina; Apanga, Stephen; Mwangoka, Grace; Dubois, Marie-Claude; Madi, Tigani; Kwara, Evans; Minja, Rose; Hounkpatin, Aurore B; Boahen, Owusu; Kayan, Kingsley; Adjei, George; Chandramohan, Daniel; Carter, Terrell; Vansadia, Preeti; Sillman, Marla; Savarese, Barbara; Loucq, Christian; Lapierre, Didier; Greenwood, Brian; Cohen, Joe; Kremsner, Peter; Owusu-Agyei, Seth; Tanner, Marcel; Lell, Bertrand

2011-10-01

-adjusted according-to-protocol analysis) was 53% (95% CI 26-70; p=0·0012) against first malaria episodes and 59% (36-74; p=0·0001) against all malaria episodes. For the entire study period, (total vaccinated cohort) vaccine efficacy against all malaria episodes was higher with the 0, 1, 2 month schedule (57%, 95% CI 33-73; p=0·0002) than with the 0, 1, 7 month schedule (32% CI 16-45; p=0·0003). 1 year after dose three, vaccine efficacy against first malaria episodes was similar for both schedules (0, 1, 2 month group, 61·6% [95% CI 35·6-77·1], p<0·001; 0, 1, 7 month group, 63·8% [40·4-78·0], p<0·001, according-to-protocol cohort). Vaccine efficacy was consistent with the target put forward by the WHO-sponsored malaria vaccine technology roadmap for a first-generation malaria vaccine. The 0, 1, 2 month vaccine schedule has been selected for phase 3 candidate vaccine assessment. Program for Appropriate Technology in Health Malaria Vaccine Initiative; GlaxoSmithKline Biologicals. Copyright © 2011 Elsevier Ltd. All rights reserved.

Governments, off-patent vaccines, smallpox and universal childhood vaccination.

PubMed

Music, Stanley

2010-01-22

WHO is now celebrating more than 30 years of freedom from smallpox. What was originally seen as a victory over an ancient scourge can now be viewed as an epidemiologically driven programme to overcome governmental inertia and under-achievement in delivering an off-patent vaccine. Though efforts are accelerating global vaccine use, a plea is made to push the world's governments to commit to universal childhood vaccination via a proposed new programme. The latter should begin by exploiting a long list of ever more affordable off-patent vaccines, vaccines that can virtually eliminate the bulk of the world's current vaccine-preventable disease burden.

Optimal vaccination choice, vaccination games, and rational exemption: an appraisal.

PubMed

Manfredi, Piero; Posta, Pompeo Della; d'Onofrio, Alberto; Salinelli, Ernesto; Centrone, Francesca; Meo, Claudia; Poletti, Piero

2009-12-10

A threat for vaccination policies might be the onset of "rational" exemption, i.e. the family's decision not to vaccinate children after a seemingly rational comparison between the perceived risk of infection and the perceived risk of vaccine side effects. We study the implications of rational exemption by models of vaccination choice. By a simple model of individual choice we first prove the "elimination impossible" result in presence of informed families, i.e. aware of herd immunity, and suggest that limited information might explain patterns of universal vaccination. Next, we investigate vaccination choice in a game-theoretic framework for communities stratified into two groups, "pro" and "anti" vaccinators, having widely different perceived costs of infection and of vaccine side effects. We show that under informed families neither a Nash nor a Stackelberg behaviour (characterized, respectively, by players acting simultaneously and by an asymmetric situation with a "leader" and a "follower) allow elimination, unless "pro-vaccinators" assign no costs to vaccine side effects. Elimination turns out to be possible when cooperation is encouraged by a social planner, provided, however, he incorporates in the "social loss function" the preferences of anti-vaccinators only. This allows an interpretation of the current Italian vaccination policy.

Rotavirus vaccines

PubMed Central

Tate, Jacqueline E; Patel, Manish M; Cortese, Margaret M; Lopman, Benjamin; Fleming, Jessica; Lewis, Kristen; Jiang, Baoming; Gentsch, Jon; Steele, Duncan; Parashar, Umesh D

2011-01-01

Early rotavirus vaccine adopter countries in the Americas, Europe, and in Australia have documented substantial declines in rotavirus disease burden following the introduction of vaccination. However, the full public health impact of rotavirus vaccines has not been realized as they have not been introduced into routine immunization programs in countries of Africa and Asia with the highest rotavirus disease morbidity and mortality burden. In this article, we review the epidemiology of rotavirus disease, the development and current status of rotavirus vaccines including newly available vaccine impact data from early-introducer countries, and future priorities for implementation and monitoring of rotavirus vaccination programs in developing countries. PMID:22108032

Vaxjo: a web-based vaccine adjuvant database and its application for analysis of vaccine adjuvants and their uses in vaccine development.

PubMed

Sayers, Samantha; Ulysse, Guerlain; Xiang, Zuoshuang; He, Yongqun

2012-01-01

Vaccine adjuvants are compounds that enhance host immune responses to co-administered antigens in vaccines. Vaxjo is a web-based central database and analysis system that curates, stores, and analyzes vaccine adjuvants and their usages in vaccine development. Basic information of a vaccine adjuvant stored in Vaxjo includes adjuvant name, components, structure, appearance, storage, preparation, function, safety, and vaccines that use this adjuvant. Reliable references are curated and cited. Bioinformatics scripts are developed and used to link vaccine adjuvants to different adjuvanted vaccines stored in the general VIOLIN vaccine database. Presently, 103 vaccine adjuvants have been curated in Vaxjo. Among these adjuvants, 98 have been used in 384 vaccines stored in VIOLIN against over 81 pathogens, cancers, or allergies. All these vaccine adjuvants are categorized and analyzed based on adjuvant types, pathogens used, and vaccine types. As a use case study of vaccine adjuvants in infectious disease vaccines, the adjuvants used in Brucella vaccines are specifically analyzed. A user-friendly web query and visualization interface is developed for interactive vaccine adjuvant search. To support data exchange, the information of vaccine adjuvants is stored in the Vaccine Ontology (VO) in the Web Ontology Language (OWL) format.

Vaxjo: A Web-Based Vaccine Adjuvant Database and Its Application for Analysis of Vaccine Adjuvants and Their Uses in Vaccine Development

PubMed Central

Sayers, Samantha; Ulysse, Guerlain; Xiang, Zuoshuang; He, Yongqun

2012-01-01

Vaccine adjuvants are compounds that enhance host immune responses to co-administered antigens in vaccines. Vaxjo is a web-based central database and analysis system that curates, stores, and analyzes vaccine adjuvants and their usages in vaccine development. Basic information of a vaccine adjuvant stored in Vaxjo includes adjuvant name, components, structure, appearance, storage, preparation, function, safety, and vaccines that use this adjuvant. Reliable references are curated and cited. Bioinformatics scripts are developed and used to link vaccine adjuvants to different adjuvanted vaccines stored in the general VIOLIN vaccine database. Presently, 103 vaccine adjuvants have been curated in Vaxjo. Among these adjuvants, 98 have been used in 384 vaccines stored in VIOLIN against over 81 pathogens, cancers, or allergies. All these vaccine adjuvants are categorized and analyzed based on adjuvant types, pathogens used, and vaccine types. As a use case study of vaccine adjuvants in infectious disease vaccines, the adjuvants used in Brucella vaccines are specifically analyzed. A user-friendly web query and visualization interface is developed for interactive vaccine adjuvant search. To support data exchange, the information of vaccine adjuvants is stored in the Vaccine Ontology (VO) in the Web Ontology Language (OWL) format. PMID:22505817

Undergraduates with Employer-Sponsored Aid: Comparing Group Differences

ERIC Educational Resources Information Center

Faulk, Dagney G.; Wang, Zhenlei

2014-01-01

Tuition assistance offered by employers is an understudied area of financial aid research. The purpose of this study is to compare the demographic, socioeconomic, academic and financial aid characteristics of college students who receive employer-sponsored financial aid with students who receive traditional financial aid (institutional, state, or…

Introduction to IND and recursive partitioning, version 1.0

NASA Technical Reports Server (NTRS)

Buntine, Wray; Caruana, Rich

1991-01-01

This manual describes the IND package for learning tree classifiers from data. The package is an integrated C and C shell re-implementation of tree learning routines such as CART, C4, and various MDL and Bayesian variations. The package includes routines for experiment control, interactive operation, and analysis of tree building. The manual introduces the system and its many options, gives a basic review of tree learning, contains a guide to the literature and a glossary, lists the manual pages for the routines, and instructions on installation.

Experiements with an inactivated hepatitis leptospirosis vaccine in vaccination programmes for dogs.

PubMed

Wilson, J H; Hermann-Dekkers, W M; Leemans-Dessy, S; Meijer, J W

1977-06-25

A fluid adjuvanted vaccine consisting of inactivated hepatitis virus (iH) and leptospirae antigens (L) was developed. The vaccine (Kavak iHL; Duphar) was tested in several vaccination programmes both alone and in combination with freeze dried measles (M) or distemper (D) vaccines. The results demonstrate that this new vaccine is also effective in pups with maternally derived antibodies, although a second vaccination at 14 weeks of age is recommended to boost the first vaccination. For the booster vaccination either the iHL-vaccine or the liver attenuated hepatitis vaccine (H) can be used.

Rhodococcus equi (Prescottella equi) vaccines; the future of vaccine development.

PubMed

Giles, C; Vanniasinkam, T; Ndi, S; Barton, M D

2015-09-01

For decades researchers have been targeting prevention of Rhodococcus equi (Rhodococcus hoagui/Prescottella equi) by vaccination and the horse breeding industry has supported the ongoing efforts by researchers to develop a safe and cost effective vaccine to prevent disease in foals. Traditional vaccines including live, killed and attenuated (physical and chemical) vaccines have proved to be ineffective and more modern molecular-based vaccines including the DNA plasmid, genetically attenuated and subunit vaccines have provided inadequate protection of foals. Newer, bacterial vector vaccines have recently shown promise for R. equi in the mouse model. This article describes the findings of key research in R. equi vaccine development and looks at alternative methods that may potentially be utilised. © 2014 EVJ Ltd.

DNA vaccines

NASA Astrophysics Data System (ADS)

Gregersen, Jens-Peter

2001-12-01

Immunization by genes encoding immunogens, rather than with the immunogen itself, has opened up new possibilities for vaccine research and development and offers chances for new applications and indications for future vaccines. The underlying mechanisms of antigen processing, immune presentation and regulation of immune responses raise high expectations for new and more effective prophylactic or therapeutic vaccines, particularly for vaccines against chronic or persistent infectious diseases and tumors. Our current knowledge and experience of DNA vaccination is summarized and critically reviewed with particular attention to basic immunological mechanisms, the construction of plasmids, screening for protective immunogens to be encoded by these plasmids, modes of application, pharmacokinetics, safety and immunotoxicological aspects. DNA vaccines have the potential to accelerate the research phase of new vaccines and to improve the chances of success, since finding new immunogens with the desired properties is at least technically less demanding than for conventional vaccines. However, on the way to innovative vaccine products, several hurdles have to be overcome. The efficacy of DNA vaccines in humans appears to be much less than indicated by early studies in mice. Open questions remain concerning the persistence and distribution of inoculated plasmid DNA in vivo, its potential to express antigens inappropriately, or the potentially deleterious ability to insert genes into the host cell's genome. Furthermore, the possibility of inducing immunotolerance or autoimmune diseases also needs to be investigated more thoroughly, in order to arrive at a well-founded consensus, which justifies the widespread application of DNA vaccines in a healthy population.

7 CFR 226.13 - Food service payments to sponsoring organizations for day care homes.

Code of Federal Regulations, 2010 CFR

2010-01-01

... day care homes. 226.13 Section 226.13 Agriculture Regulations of the Department of Agriculture... CARE FOOD PROGRAM Payment Provisions § 226.13 Food service payments to sponsoring organizations for day care homes. (a) Payments shall be made only to sponsoring organizations operating under an agreement...

Parents with doubts about vaccines: which vaccines and reasons why.

PubMed

Gust, Deborah A; Darling, Natalie; Kennedy, Allison; Schwartz, Ben

2008-10-01

The goals were (1) to obtain national estimates of the proportions of parents with indicators of vaccine doubt, (2) to identify factors associated with those parents, compared with parents reporting no vaccine doubt indicators, (3) to identify the specific vaccines that prompted doubt and the reasons why, and (4) to describe the main reasons parents changed their minds about delaying or refusing a vaccine for their child. Data were from the National Immunization Survey (2003-2004). Groups included parents who ever got a vaccination for their child although they were not sure it was the best thing to do ("unsure"), delayed a vaccination for their child ("delayed"), or decided not to have their child get a vaccination ("refused"). A total of 3924 interviews were completed. Response rates were 57.9% in 2003 and 65.0% in 2004. Twenty-eight percent of parents responded yes to ever experiencing >or=1 of the outcome measures listed above. In separate analyses for each outcome measure, vaccine safety concern was a predictor for unsure, refused, and delayed parents. The largest proportions of unsure and refused parents chose varicella vaccine as the vaccine prompting their concern, whereas delayed parents most often reported "not a specific vaccine" as the vaccine prompting their concern. Most parents who delayed vaccines for their child did so for reasons related to their child's illness, unlike the unsure and refused parents. The largest proportion of parents who changed their minds about delaying or not getting a vaccination for their child listed "information or assurances from health care provider" as the main reason. Parents who exhibit doubts about immunizations are not all the same. This research suggests encouraging children's health care providers to solicit questions about vaccines, to establish a trusting relationship, and to provide appropriate educational materials to parents.

Framework for Optimal Global Vaccine Stockpile Design for Vaccine-Preventable Diseases: Application to Measles and Cholera Vaccines as Contrasting Examples.

PubMed

Thompson, Kimberly M; Duintjer Tebbens, Radboud J

2016-07-01

Managing the dynamics of vaccine supply and demand represents a significant challenge with very high stakes. Insufficient vaccine supplies can necessitate rationing, lead to preventable adverse health outcomes, delay the achievements of elimination or eradication goals, and/or pose reputation risks for public health authorities and/or manufacturers. This article explores the dynamics of global vaccine supply and demand to consider the opportunities to develop and maintain optimal global vaccine stockpiles for universal vaccines, characterized by large global demand (for which we use measles vaccines as an example), and nonuniversal (including new and niche) vaccines (for which we use oral cholera vaccine as an example). We contrast our approach with other vaccine stockpile optimization frameworks previously developed for the United States pediatric vaccine stockpile to address disruptions in supply and global emergency response vaccine stockpiles to provide on-demand vaccines for use in outbreaks. For measles vaccine, we explore the complexity that arises due to different formulations and presentations of vaccines, consideration of rubella, and the context of regional elimination goals. We conclude that global health policy leaders and stakeholders should procure and maintain appropriate global vaccine rotating stocks for measles and rubella vaccine now to support current regional elimination goals, and should probably also do so for other vaccines to help prevent and control endemic or epidemic diseases. This work suggests the need to better model global vaccine supplies to improve efficiency in the vaccine supply chain, ensure adequate supplies to support elimination and eradication initiatives, and support progress toward the goals of the Global Vaccine Action Plan. © 2014 Society for Risk Analysis.

[Influenza vaccination. Effectiveness of current vaccines and future challenges].

PubMed

Ortiz de Lejarazu, Raúl; Tamames, Sonia

2015-01-01

Seasonal influenza is an annual challenge for health-care systems, due to factors such as co-circulation of 2 influenza A subtypes jointly with 2 influenza B lineages; the antigenic drift of these virus, which eludes natural immunity, as well as immunity conferred by vaccination; together with influenza impact in terms of morbidity and mortality. Influenza vaccines have been available for more than 70 years and they have progressed in formulation, production and delivery route. Recommendations on vaccination are focused on those with a higher probability of severe disease, and have a progressively wider coverage, and classically based on inactivated vaccines, but with an increasing importance of attenuated live vaccines. More inactivated vaccines are becoming available, from adyuvanted and virosomal vaccines to intradermal delivery, cell-culture or quadrivalent. Overall vaccine effectiveness is about 65%, but varies depending on characteristics of vaccines, virus, population and the outcomes to be prevented, and ranges from less than 10% to almost 90%. Future challenges are formulations that confer more extensive and lasting protection, as well as increased vaccination coverage, especially in groups such as pregnant women and health-care professionals, as well as being extended to paediatrics. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

Vaccination of carp against SVCV with an oral DNA vaccine or an insect cells-based subunit vaccine.

PubMed

Embregts, C W E; Rigaudeau, D; Tacchi, L; Pijlman, G P; Kampers, L; Veselý, T; Pokorová, D; Boudinot, P; Wiegertjes, G F; Forlenza, M

2018-03-19

We recently reported on a successful vaccine for carp against SVCV based on the intramuscular injection of a DNA plasmid encoding the SVCV glycoprotein (SVCV-G). This shows that the intramuscular (i.m.) route of vaccination is suitable to trigger protective responses against SVCV, and that the SVCV G-protein is a suitable vaccine antigen. Yet, despite the general success of DNA vaccines, especially against fish rhabdoviruses, their practical implementation still faces legislative as well as consumer's acceptance concerns. Furthermore, the i.m. route of plasmid administration is not easily combined with most of the current vaccination regimes largely based on intraperitoneal or immersion vaccination. For this reason, in the current study we evaluated possible alternatives to a DNA-based i.m. injectable vaccine using the SVCV-G protein as the vaccine antigen. To this end, we tested two parallel approaches: the first based on the optimization of an alginate encapsulation method for oral delivery of DNA and protein antigens; the second based on the baculovirus recombinant expression of transmembrane SVCV-G protein in insect cells, administered as whole-cell subunit vaccine through the oral and injection route. In addition, in the case of the oral DNA vaccine, we also investigated the potential benefits of the mucosal adjuvants Escherichia coli lymphotoxin subunit B (LTB). Despite the use of various vaccine types, doses, regimes, and administration routes, no protection was observed, contrary to the full protection obtained with our reference i.m. DNA vaccine. The limited protection observed under the various conditions used in this study, the nature of the host, of the pathogen, the type of vaccine and encapsulation method, will therefore be discussed in details to provide an outlook for future vaccination strategies against SVCV. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Computerized Management Information and Reporting Systems for Sponsored Projects.

ERIC Educational Resources Information Center

Rodman, John A.; Peters, Carl M.

1980-01-01

The effective management of the university depends on the research office providing usable, accurate, timely, and accessible information regarding sponsored programs. The utilization of automated systems to store, access, and manage information is seen as essential. (MLW)

Parasite Carbohydrate Vaccines.

PubMed

Jaurigue, Jonnel A; Seeberger, Peter H

2017-01-01

Vaccination is an efficient means of combating infectious disease burden globally. However, routine vaccines for the world's major human parasitic diseases do not yet exist. Vaccines based on carbohydrate antigens are a viable option for parasite vaccine development, given the proven success of carbohydrate vaccines to combat bacterial infections. We will review the key components of carbohydrate vaccines that have remained largely consistent since their inception, and the success of bacterial carbohydrate vaccines. We will then explore the latest developments for both traditional and non-traditional carbohydrate vaccine approaches for three of the world's major protozoan parasitic diseases-malaria, toxoplasmosis, and leishmaniasis. The traditional prophylactic carbohydrate vaccine strategy is being explored for malaria. However, given that parasite disease biology is complex and often arises from host immune responses to parasite antigens, carbohydrate vaccines against deleterious immune responses in host-parasite interactions are also being explored. In particular, the highly abundant glycosylphosphatidylinositol molecules specific for Plasmodium, Toxoplasma , and Leishmania spp. are considered exploitable antigens for this non-traditional vaccine approach. Discussion will revolve around the application of these protozoan carbohydrate antigens for vaccines currently in preclinical development.

Parasite Carbohydrate Vaccines

PubMed Central

Jaurigue, Jonnel A.; Seeberger, Peter H.

2017-01-01

Vaccination is an efficient means of combating infectious disease burden globally. However, routine vaccines for the world's major human parasitic diseases do not yet exist. Vaccines based on carbohydrate antigens are a viable option for parasite vaccine development, given the proven success of carbohydrate vaccines to combat bacterial infections. We will review the key components of carbohydrate vaccines that have remained largely consistent since their inception, and the success of bacterial carbohydrate vaccines. We will then explore the latest developments for both traditional and non-traditional carbohydrate vaccine approaches for three of the world's major protozoan parasitic diseases—malaria, toxoplasmosis, and leishmaniasis. The traditional prophylactic carbohydrate vaccine strategy is being explored for malaria. However, given that parasite disease biology is complex and often arises from host immune responses to parasite antigens, carbohydrate vaccines against deleterious immune responses in host-parasite interactions are also being explored. In particular, the highly abundant glycosylphosphatidylinositol molecules specific for Plasmodium, Toxoplasma, and Leishmania spp. are considered exploitable antigens for this non-traditional vaccine approach. Discussion will revolve around the application of these protozoan carbohydrate antigens for vaccines currently in preclinical development. PMID:28660174

[Conjugated vaccines].

PubMed

Fritzell, Bernard

2005-01-01

Encapsulated bacterial pathogens (e.g. Haemophilus influenzae type b [Hib], Neisseria meningitidis, or Streptococcus pneumoniae) target infants and young children who have lost any protective anti-capsular antibodies supplied maternally and whose immune systems are ineffective against T-independent antigens such as the polysaccharides of the capsule. The polysaccharide-protein conjugate vaccines overcome this limitation by converting the polysaccharide to a T-dependent antigen, which allows a vaccinated infant to mount a protective immune response. Where conjugated vaccines have been introduced into paediatric vaccination schedules, the incidence of invasive diseases caused by Hib, the group C meningococcus, or the pneumococcus has plummeted by at least 80%, a major public health success. Furthermore, surveillance has demonstrated that the conjugate vaccines provide 'herd protection' through their beneficial impact on nasopharyngeal colonisation among vaccinated children. Promising future approaches include enhancement of the number of capsular serogroups targeted by the meningococcal or pneumococcal conjugate vaccines.

Report of a consultation on the optimization of clinical challenge trials for evaluation of candidate blood stage malaria vaccines, 18-19 March 2009, Bethesda, MD, USA.

PubMed

Moorthy, V S; Diggs, C; Ferro, S; Good, M F; Herrera, S; Hill, A V; Imoukhuede, E B; Kumar, S; Loucq, C; Marsh, K; Ockenhouse, C F; Richie, T L; Sauerwein, R W

2009-09-25

Development and optimization of first generation malaria vaccine candidates has been facilitated by the existence of a well-established Plasmodium falciparum clinical challenge model in which infectious sporozoites are administered to human subjects via mosquito bite. While ideal for testing pre-erythrocytic stage vaccines, some researchers believe that the sporozoite challenge model is less appropriate for testing blood stage vaccines. Here we report a consultation, co-sponsored by PATH MVI, USAID, EMVI and WHO, where scientists from all institutions globally that have conducted such clinical challenges in recent years and representatives from regulatory agencies and funding agencies met to discuss clinical malaria challenge models. Participants discussed strengthening and harmonizing the sporozoite challenge model and considered the pros and cons of further developing a blood stage challenge possibly better suited for evaluating the efficacy of blood stage vaccines. This report summarizes major findings and recommendations, including an update on the Plasmodium vivax clinical challenge model, the prospects for performing experimental challenge trials in malaria endemic countries and an update on clinical safety data. While the focus of the meeting was on the optimization of clinical challenge models for evaluation of blood stage candidate malaria vaccines, many of the considerations are relevant for the application of challenge trials to other purposes.

42 CFR 403.806 - Sponsor requirements for eligibility for endorsement.

Code of Federal Regulations, 2013 CFR

2013-10-01

... provides customer telephone service, including to pharmacists, in accordance with standard business..., such as pharmacist services. (j) Grievance process. An endorsed sponsor must establish and maintain a...

42 CFR 403.806 - Sponsor requirements for eligibility for endorsement.

Code of Federal Regulations, 2012 CFR

2012-10-01

... provides customer telephone service, including to pharmacists, in accordance with standard business..., such as pharmacist services. (j) Grievance process. An endorsed sponsor must establish and maintain a...

42 CFR 403.806 - Sponsor requirements for eligibility for endorsement.

Code of Federal Regulations, 2011 CFR

2011-10-01

... provides customer telephone service, including to pharmacists, in accordance with standard business..., such as pharmacist services. (j) Grievance process. An endorsed sponsor must establish and maintain a...

42 CFR 403.806 - Sponsor requirements for eligibility for endorsement.

Code of Federal Regulations, 2014 CFR

2014-10-01

... provides customer telephone service, including to pharmacists, in accordance with standard business..., such as pharmacist services. (j) Grievance process. An endorsed sponsor must establish and maintain a...

42 CFR 403.806 - Sponsor requirements for eligibility for endorsement.

Code of Federal Regulations, 2010 CFR

2010-10-01

... provides customer telephone service, including to pharmacists, in accordance with standard business..., such as pharmacist services. (j) Grievance process. An endorsed sponsor must establish and maintain a...

MeNZB vaccine and epidemic control: when do you stop vaccinating?

PubMed

Loring, Belinda J; Turner, Nikki; Petousis-Harris, Helen

2008-11-05

New Zealand developed a strain-specific group B meningococcal vaccine to control an epidemic. Following a mass vaccination campaign of three doses to the population under 20 years of age, commencing in July 2004, the vaccine continued to be offered routinely as a four-dose schedule from 6 weeks of age. There is little international data on when to cease epidemic vaccination campaigns. The decision to stop using this vaccine needed to take into account a range of factors. These included epidemiology, vaccine effectiveness and duration of immunity, vaccine coverage, concomitant use with other vaccinations being added to the infant schedule, vaccine supply and cost-benefit criteria. This paper discusses these issues, along with the potential challenges for communication to both health professionals and the public.

Immune Interference After Sequential Alphavirus Vaccine Vaccinations

DTIC Science & Technology

2009-01-01

education use, including for instruction at the authors institution and sharing with colleagues. Other uses, including reproduction and distribution, or...western equine encephalitis (EEE and WEE) vaccines before live attenuated Venezuelan (VEE) vaccine had significantly lower rates of antibody response than...Venezuelan equine encephalitis virus, VEE, vaccines, alphavirus, antibody responses, human studies 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF

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 Vaccination Strategies: Comparing Inactivated and Live Attenuated Influenza Vaccines

PubMed Central

Sridhar, Saranya; Brokstad, Karl A.; Cox, Rebecca J.

2015-01-01

Influenza is a major respiratory pathogen causing annual outbreaks and occasional pandemics. Influenza vaccination is the major method of prophylaxis. Currently annual influenza vaccination is recommended for groups at high risk of complications from influenza infection such as pregnant women, young children, people with underlying disease and the elderly, along with occupational groups such a healthcare workers and farm workers. There are two main types of vaccines available: the parenteral inactivated influenza vaccine and the intranasal live attenuated influenza vaccine. The inactivated vaccines are licensed from 6 months of age and have been used for more than 50 years with a good safety profile. Inactivated vaccines are standardized according to the presence of the viral major surface glycoprotein hemagglutinin and protection is mediated by the induction of vaccine strain specific antibody responses. In contrast, the live attenuated vaccines are licensed in Europe for children from 2–17 years of age and provide a multifaceted immune response with local and systemic antibody and T cell responses but with no clear correlate of protection. Here we discuss the immunological immune responses elicited by the two vaccines and discuss future work to better define correlates of protection. PMID:26343192

Rotavirus vaccine strain transmission by vaccinated infants in the foster home.

PubMed

Miura, Hiroki; Kawamura, Yoshiki; Sugata, Ken; Koshiyama, Nozomi; Yoshikawa, Akiko; Komoto, Satoshi; Taniguchi, Koki; Ihira, Masaru; Yoshikawa, Tetsushi

2017-01-01

Previous studies have demonstrated the transmission of rotavirus vaccine strains from vaccinated children to nonvaccinated siblings. We sought to fully elucidate the safety of rotavirus (RV) vaccination in closed contact circumstance, such as the foster home for future assessment of the vaccine safety in an neonatal intensive care unit. Stool samples were collected from 4 RV vaccinated (160 samples) and 23 unvaccinated (766 samples) infants. RV viral RNA loads were measured using real-time reverse transcription polymerase chain reaction (RT-PCR). RV vaccine strain RNA was persistently detected in stool samples collected from the four vaccine recipients and one unvaccinated infant, but not in the stool samples collected from the 22 other unvaccinated infants. The unvaccinated infant who tested positive for the RV vaccine strain was vaccinated prior to enrollment in this study. The quantitative real-time RT-PCR data revealed a peak viral RNA load 1 week after vaccination followed by a gradual decrease. The current study suggests that RV vaccination may be safe in a close contact environment because there was limited transmission from RV vaccinated to unvaccinated infants. J. Med. Virol. 89:79-84, 2017. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Trivalent MDCK cell culture-derived influenza vaccine Optaflu (Novartis Vaccines).

PubMed

Doroshenko, Alexander; Halperin, Scott A

2009-06-01

Annual influenza epidemics continue to have a considerable impact in both developed and developing countries. Vaccination remains the principal measure to prevent seasonal influenza and reduce associated morbidity and mortality. The WHO recommends using established mammalian cell culture lines as an alternative to egg-based substrates in the manufacture of influenza vaccine. In June 2007, the EMEA approved Optaflu, a Madin Darby canine kidney cell culture-derived influenza vaccine manufactured by Novartis Vaccines. This review examines the advantages and disadvantages of cell culture-based technology for influenza vaccine production, compares immunogenicity and safety data for Optaflu with that of currently marketed conventional egg-based influenza vaccines, and considers the prospects for wider use of cell culture-based influenza vaccines.

Identifying ethical issues in the development of vaccines and in vaccination.

PubMed

Johari, Veena

2017-01-01

Vaccines are a widely accepted public health intervention. They are also a profitable tool for pharmaceutical companies manufacturing vaccines. There are many vaccines in the pipeline, for various diseases, or as combination vaccines for several diseases. However, there is also a growing concern about vaccines and the manner in which they are developed and approved by the authorities. Approvals are fast tracked and adverse events and serious adverse events following vaccination are seldom reported once the vaccine gets its marketing approval. Thus, vaccines have been clouded with many controversies and their use as a public health tool to prevent diseases is constantly under challenge.

Vaccination of broiler chickens with dispersed dry powder vaccines as an alternative for liquid spray and aerosol vaccination.

PubMed

Corbanie, E A; Vervaet, C; van Eck, J H H; Remon, J P; Landman, W J M

2008-08-18

Vaccination of chickens with dispersable dry powder vaccines was compared with commercial liquid vaccines. A Clone 30 Newcastle disease vaccine virus was spray dried with mannitol or with a mixture of trehalose, polyvinylpyrrolidone and bovine serum albumin. A coarse (+/-30 microm) and fine (+/-7 microm) powder were produced with both formulations. A commercial reconstituted Clone 30 vaccine was applied as coarse liquid spray (+/-222 microm) or fine liquid aerosol (+/-24 microm). Reduction of virus concentration in the air after dispersion/nebulization was monitored by air sampling and was explained by sedimentation of coarse particles/droplets and evaporation of fine droplets. The vaccine formulations induced high haemagglutination inhibition antibody titres in the serum of 4-week-old broilers (2(7) at 4 weeks post-vaccination). The good serum antibody response with the fine liquid aerosol despite extensive inactivation of virus due to evaporation of droplets, suggested that powder formulations (without inactivation due to evaporation) might allow a significant reduction of vaccine dose, thereby offering new options for fine aerosol vaccination with low-titre vaccines.

Sustainable vaccine development: a vaccine manufacturer's perspective.

PubMed

Rappuoli, Rino; Hanon, Emmanuel

2018-05-08

Vaccination remains the most cost-effective public health intervention after clean water, and the benefits impressively outweigh the costs. The efforts needed to fulfill the steadily growing demands for next-generation and novel vaccines designed for emerging pathogens and new indications are only realizable in a sustainable business model. Vaccine development can be fast-tracked through strengthening international collaborations, and the continuous innovation of technologies to accelerate their design, development, and manufacturing. However, these processes should be supported by a balanced project portfolio, and by managing sustainable vaccine procurement strategies for different types of markets. Collectively this will allow a gradual shift to a more streamlined and profitable vaccine production, which can significantly contribute to the worldwide effort to shape global health. Copyright © 2018 GlaxoSmithKine Biologicals SA. Published by Elsevier Ltd.. All rights reserved.

The Importance of Employer-Sponsored Job-Related Training.

ERIC Educational Resources Information Center

Medoff, James L.

Employer-sponsored, job-related training as a means of satisfying labor demands has potentially profound implications for the operation of the nation's economic system. The alternatives of bidding for desired workers and downgrading job requirements tend to increase inflation and lessen productivity. Since the end of the 1960's, the ability of…

Tax Exempt Organizations and Commercially Sponsored Scientific Research.

ERIC Educational Resources Information Center

Kertz, Consuelo Lauda

1982-01-01

Several related tax issues important to both the commercial sponsors and tax-exempt recipients of research funding are addressed: what type of activity qualified as scientific research; how acceptance of commercial funding affects tax-exempt status; and when the receipt of such funding generates a liability for tax on unrelated business income.…

77 FR 69631 - Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-20

...://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances...] Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the... IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of...

Vaccination coverage and reasons for non-vaccination in a district of Istanbul

PubMed Central

Torun, Sebahat D; Bakırcı, Nadi

2006-01-01

Background In order to control and eliminate the vaccine preventable diseases it is important to know the vaccination coverage and reasons for non-vaccination. The primary objective of this study was to determine the complete vaccination rate; the reasons for non-vaccination and the predictors that influence vaccination of children. The other objective was to determine coverage of measles vaccination of the Measles Immunization Days (MID) 2005 for children aged 9 month to 6 years in a region of Umraniye, Istanbul, Turkey. Methods A '30 × 7' cluster sampling design was used as the sampling method. Thirty streets were selected at random from study area. Survey data were collected by a questionnaire which was applied face to face to parents of 221 children. A Chi-square test and logistic regression was used for the statistical analyses. Content analysis method was used to evaluate the open-ended questions. Results The complete vaccination rate for study population was 84.5% and 3.2% of all children were totally non-vaccinated. The siblings of non-vaccinated children were also non-vaccinated. Reasons for non-vaccination were as follows: being in the village and couldn't reach to health care services; having no knowledge about vaccination; the father of child didn't allow vaccination; intercurrent illness of child during vaccination time; missed opportunities like not to shave off a vial for only one child. In logistic regression analysis, paternal and maternal levels of education and immigration time of both parents to Istanbul were found to influence whether children were completely vaccinated or non-vaccinated. Measles vaccination coverage during MID was 79.3%. Conclusion Efforts to increase vaccination coverage should take reasons for non-vaccination into account. PMID:16677375

Vaccine chronicle in Japan.

PubMed

Nakayama, Tetsuo

2013-10-01

The concept of immunization was started in Japan in 1849 when Jenner's cowpox vaccine seed was introduced, and the current immunization law was stipulated in 1948. There have been two turning points for amendments to the immunization law: the compensation remedy for vaccine-associated adverse events in 1976, and the concept of private vaccination in 1994. In 1992, the regional Court of Tokyo, not the Supreme Court, decided the governmental responsibility on vaccine-associated adverse events, which caused the stagnation of vaccine development. In 2010, many universal vaccines became available as the recommended vaccines, but several vaccines, including mumps, zoster, hepatitis B, and rota vaccines, are still voluntary vaccines, not universal routine applications. In this report, immunization strategies and vaccine development are reviewed for each vaccine item and future vaccine concerns are discussed.

Human Vaccines & Immunotherapeutics

PubMed Central

Riedmann, Eva M.

2012-01-01

Two therapeutic HPV vaccine candidates successful in phase 1 Flu shot may prevent heart attacks and stroke CDX-1401 combined with TLR agonist: Positive phase 1 results Three MRSA vaccines in early clincial trials Ovarian cancer vaccine candidate DPX-Survivac: Positive interim results from phase 1 Chinese biotech partnership brings first hepatitis E vaccine to the market Therapeutic vaccine for treatment of genital herpes enters phase 2 Visionary concept: Printable vaccines PMID:23817319

42 CFR 475.102 - Eligibility of physician-sponsored organizations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... AND HUMAN SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS QUALITY IMPROVEMENT ORGANIZATIONS Utilization and Quality Control Quality Improvement Organizations § 475.102 Eligibility of physician-sponsored..., during the contract evaluation process, a set number of bonus points. [49 FR 7207, Feb. 27, 1984...

1,5 iodonaphthyl Azide Inactivated V3526 Protects against Aerosol Challenge with Virulent Venezuelan Equine Encephalitis Virus.

DTIC Science & Technology

2016-06-02

against VEEV. VEEV is highly infectious in aerosolized form and has been identified as a bio -terrorism agent. The current IND vaccine is poorly...protective response as well as residual virulence associated with the live attenuated vaccine candidates [1]. VEEV is also a bio -threat agent, thereby; any

Measles Vaccination

MedlinePlus

... World Health Organization Pan American Health Organization Measles Vaccination Pronounced (MEE-zills) Recommend on Facebook Tweet Share ... also be up to date on their MMR vaccination. The MMR vaccine is very safe and effective. ...

Vaccination of school children with live mumps virus vaccine.

PubMed

Furesz, J; Nagler, F P

1970-05-30

Live, attenuated mumps virus vaccine (Mumpsvax) was administered to 146 school children 6 to 9 years of age. One child developed clinical mumps nine days after vaccination; epidemiological and serological data strongly suggest that this child had become infected before vaccination. Apart from this single instance there were no apparent clinical reactions that could be ascribed to the administration of the vaccine. Sixty-three of the 146 children with no clinical history of mumps had an initial serum neutralizing antibody titre of less than 1:2. Specific antibodies to mumps virus were detected in 93.5% of the sera of the susceptible children 28 days after vaccination, and the geometric mean antibody titre of these sera was low (1:6). Of the 80 initially seropositive children 21 (26.2%) showed a significant antibody response to the vaccine and this was influenced by the pre-existing antibody level. These data have further demonstrated the safety and efficacy of the live mumps vaccine in children.

Vaccination of School Children With Live Mumps Virus Vaccine

PubMed Central

Furesz, J.; Nagler, F. P.

1970-01-01

Live, attenuated mumps virus vaccine (Mumpsvax) was administered to 146 school children 6 to 9 years of age. One child developed clinical mumps nine days after vaccination; epidemiological and serological data strongly suggest that this child had become infected before vaccination. Apart from this single instance there were no apparent clinical reactions that could be ascribed to the administration of the vaccine. Sixty-three of the 146 children with no clinical history of mumps had an initial serum neutralizing antibody titre of less than 1:2. Specific antibodies to mumps virus were detected in 93.5% of the sera of the susceptible children 28 days after vaccination, and the geometric mean antibody titre of these sera was low (1:6). Of the 80 initially seropositive children 21 (26.2%) showed a significant antibody response to the vaccine and this was influenced by the pre-existing antibody level. These data have further demonstrated the safety and efficacy of the live mumps vaccine in children. PMID:5420994

Vaccines against Botulism.

PubMed

Sundeen, Grace; Barbieri, Joseph T

2017-09-02

Botulinum neurotoxins (BoNT) cause the flaccid paralysis of botulism by inhibiting the release of acetylcholine from motor neurons. There are seven serotypes of BoNT (A-G), with limited therapies, and no FDA approved vaccine for botulism. An investigational formalin-inactivated penta-serotype-BoNT/A-E toxoid vaccine was used to vaccinate people who are at high risk of contracting botulism. However, this formalin-inactivated penta-serotype-BoNT/A-E toxoid vaccine was losing potency and was discontinued. This article reviews the different vaccines being developed to replace the discontinued toxoid vaccine. These vaccines include DNA-based, viral vector-based, and recombinant protein-based vaccines. DNA-based vaccines include plasmids or viral vectors containing the gene encoding one of the BoNT heavy chain receptor binding domains (HC). Viral vectors reviewed are adenovirus, influenza virus, rabies virus, Semliki Forest virus, and Venezuelan Equine Encephalitis virus. Among the potential recombinant protein vaccines reviewed are HC, light chain-heavy chain translocation domain, and chemically or genetically inactivated holotoxin.

Vaccines against Botulism

PubMed Central

Sundeen, Grace; Barbieri, Joseph T.

2017-01-01

Botulinum neurotoxins (BoNT) cause the flaccid paralysis of botulism by inhibiting the release of acetylcholine from motor neurons. There are seven serotypes of BoNT (A-G), with limited therapies, and no FDA approved vaccine for botulism. An investigational formalin-inactivated penta-serotype-BoNT/A-E toxoid vaccine was used to vaccinate people who are at high risk of contracting botulism. However, this formalin-inactivated penta-serotype-BoNT/A-E toxoid vaccine was losing potency and was discontinued. This article reviews the different vaccines being developed to replace the discontinued toxoid vaccine. These vaccines include DNA-based, viral vector-based, and recombinant protein-based vaccines. DNA-based vaccines include plasmids or viral vectors containing the gene encoding one of the BoNT heavy chain receptor binding domains (HC). Viral vectors reviewed are adenovirus, influenza virus, rabies virus, Semliki Forest virus, and Venezuelan Equine Encephalitis virus. Among the potential recombinant protein vaccines reviewed are HC, light chain-heavy chain translocation domain, and chemically or genetically inactivated holotoxin. PMID:28869493

Measles vaccination before the measles-mumps-rubella vaccine.

PubMed

Hendriks, Jan; Blume, Stuart

2013-08-01

At the beginning of the 1960s, it was clear that a vaccine against measles would soon be available. Although measles was (and remains) a killer disease in the developing world, in the United States and Western Europe this was no longer so. Many parents and many medical practitioners considered measles an inevitable stage of a child's development. Debating the desirability of measles immunization, public health experts reasoned differently. In the United States, introduction of the vaccine fit well with Kennedy's and Johnson's administrations' political commitments. European policymakers proceeded cautiously, concerned about the acceptability of existing vaccination programs. In Sweden and the Netherlands, recent experience in controlling polio led researchers to prefer an inactivated virus vaccine. Although in the early 1970s attempts to develop a sufficiently potent inactivated vaccine were abandoned, we have argued that the debates and initiatives of the time during the vaccine's early history merit reflection in today's era of standardization and global markets.

Polio Vaccine

MedlinePlus

... IBS) Home Family Health Infants and Toddlers Polio Vaccine Polio Vaccine Share Print What is polio? Poliomyelitis (polio) is ... each year. Fortunately, the use of the polio vaccine has made the disease very rare in most ...

Paradox of vaccination: is vaccination really effective against avian flu epidemics?

PubMed

Iwami, Shingo; Suzuki, Takafumi; Takeuchi, Yasuhiro

2009-01-01

Although vaccination can be a useful tool for control of avian influenza epidemics, it might engender emergence of a vaccine-resistant strain. Field and experimental studies show that some avian influenza strains acquire resistance ability against vaccination. We investigated, in the context of the emergence of a vaccine-resistant strain, whether a vaccination program can prevent the spread of infectious disease. We also investigated how losses from immunization by vaccination imposed by the resistant strain affect the spread of the disease. We designed and analyzed a deterministic compartment model illustrating transmission of vaccine-sensitive and vaccine-resistant strains during a vaccination program. We investigated how the loss of protection effectiveness impacts the program. Results show that a vaccination to prevent the spread of disease can instead spread the disease when the resistant strain is less virulent than the sensitive strain. If the loss is high, the program does not prevent the spread of the resistant strain despite a large prevalence rate of the program. The epidemic's final size can be larger than that before the vaccination program. We propose how to use poor vaccines, which have a large loss, to maximize program effects and describe various program risks, which can be estimated using available epidemiological data. We presented clear and simple concepts to elucidate vaccination program guidelines to avoid negative program effects. Using our theory, monitoring the virulence of the resistant strain and investigating the loss caused by the resistant strain better development of vaccination strategies is possible.

Varicella (Chickenpox) Vaccine

MedlinePlus

ProQuad® (as a combination product containing Measles Vaccine, Mumps Vaccine, Rubella Vaccine, Varicella Vaccine) ... Has a parent, brother, or sister with a history of immune system problems. Is taking salicylates (such ...

Engineered human vaccines

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

Sandhu, J.S.

1994-01-01

The limitations of human vaccines in use at present and the design requirements for a new generation of human vaccines are discussed. The progress in engineering of human vaccines for bacteria, viruses, parasites, and cancer is reviewed, and the data from human studies with the engineered vaccines are discussed, especially for cancer and AIDS vaccines. The final section of the review deals with the possible future developments in the field of engineered human vaccines and the requirement for effective new human adjuvants.

Measles, immune suppression and vaccination: direct and indirect nonspecific vaccine benefits.

PubMed

Mina, Michael J

2017-06-01

The measles virus is among the most transmissible viruses known to infect humans. Prior to measles vaccination programs, measles infected over 95% of all children and was responsible for over 4 million deaths each year. Measles vaccination programs have been among the greatest public health achievements reducing, eliminating endemic measles in the whole of the Americas and across much of the globe. Where measles vaccines are introduced, unexpectedly large reductions in all-cause childhood mortality have been observed. These gains appear to derive in part from direct heterologous benefits of measles vaccines that enhance innate and adaptive immune responses. Additionally, by preventing measles infections, vaccination prevents measles-associated short- and long-term immunomodulating effects. Before vaccination, these invisible hallmarks of measles infections increased vulnerability to non-measles infections in nearly all children for weeks, months, or years following acute infections. By depleting measles incidence, vaccination has had important indirect benefits to reduce non-measles mortality. Delineating the relative importance of these two modes of survival benefits following measles vaccine introduction is of critical public health importance. While both support continued unwavering global commitments to measles vaccination programs until measles eradication is complete, direct heterologous benefits of measles vaccination further support continued commitment to measles vaccination programs indefinitely. We discuss what is known about direct and indirect nonspecific measles vaccine benefits, and their implications for continued measles vaccination programs. © 2017 The British Infection Association. Published by Elsevier Ltd. All rights reserved.

Student experimenter and sponsor display SE83-9 "Chix in Space" incubator

NASA Image and Video Library

1988-08-13

S88-44514 (13 Aug 1988) --- Student experimenter John C. Vellinger, left, explains components of an incubator used in his experiment to be carried onboard the Discovery for NASA's STS-29 mission next year. Mark S. Deusser, representing the sponsoring organization, holds up the incubator for inspection by members of the STS-29 crew who will monitor in-space operation of the experiment, titled "Chicken Embryo Development in Space." Astronaut Robert C. Springer is partially visible in lower right foreground. The student's sponsor is Kentucky Fried Chicken.

Student experimenter and sponsor display SE83-9 'Chix in Space' incubator

NASA Technical Reports Server (NTRS)

1988-01-01

Student experimenter John C. Vellinger (left) explains components of an incubator for his Student Experiment (SE) 83-9 Chicken Embryo Development in Space or 'Chix in Space' to be carried onboard STS-29 Discovery, Orbiter Vehicle (OV) 103. Mark S. Deusser, representing the sponsoring organization, holds up the incubator for inspection by STS-29 crewmembers who will monitor in-space operation of the experiment. Mission Specialist (MS) Robert C. Springer is partially visible in the lower right foreground. The student's sponsor is Kentucky Fried Chicken (KFC).

Timeliness Vaccination of Measles Containing Vaccine and Barriers to Vaccination among Migrant Children in East China

PubMed Central

Hu, Yu; Li, Qian; Luo, Shuying; Lou, Linqiao; Qi, Xiaohua; Xie, Shuyun

2013-01-01

Background The reported coverage rates of first and second doses of measles containing vaccine (MCV) are almost 95% in China, while measles cases are constantly being reported. This study evaluated the vaccine coverage, timeliness, and barriers to immunization of MCV1 and MCV2 in children aged from 8–48 months. Methods We assessed 718 children aged 8–48 months, of which 499 children aged 18–48 months in September 2011. Face to face interviews were administered with children’s mothers to estimate MCV1 and MCV2 coverage rate, its timeliness and barriers to vaccine uptake. Results The coverage rates were 76.9% for MCV1 and 44.7% for MCV2 in average. Only 47.5% of surveyed children received the MCV1 timely, which postpone vaccination by up to one month beyond the stipulated age of 8 months. Even if coverage thus improves with time, postponed vaccination adds to the pool of unprotected children in the population. Being unaware of the necessity for vaccination and its schedule, misunderstanding of side-effect of vaccine, and child being sick during the recommended vaccination period were significant preventive factors for both MCV1 and MCV2 vaccination. Having multiple children, mother’s education level, household income and children with working mothers were significantly associated with delayed or missing MCV1 immunization. Conclusions To avoid future outbreaks, it is crucial to attain high coverage levels by timely vaccination, thus, accurate information should be delivered and a systematic approach should be targeted to high-risk groups. PMID:24013709

Timeliness vaccination of measles containing vaccine and barriers to vaccination among migrant children in East China.

PubMed

Hu, Yu; Li, Qian; Luo, Shuying; Lou, Linqiao; Qi, Xiaohua; Xie, Shuyun

2013-01-01

The reported coverage rates of first and second doses of measles containing vaccine (MCV) are almost 95% in China, while measles cases are constantly being reported. This study evaluated the vaccine coverage, timeliness, and barriers to immunization of MCV1 and MCV2 in children aged from 8-48 months. We assessed 718 children aged 8-48 months, of which 499 children aged 18-48 months in September 2011. Face to face interviews were administered with children's mothers to estimate MCV1 and MCV2 coverage rate, its timeliness and barriers to vaccine uptake. The coverage rates were 76.9% for MCV1 and 44.7% for MCV2 in average. Only 47.5% of surveyed children received the MCV1 timely, which postpone vaccination by up to one month beyond the stipulated age of 8 months. Even if coverage thus improves with time, postponed vaccination adds to the pool of unprotected children in the population. Being unaware of the necessity for vaccination and its schedule, misunderstanding of side-effect of vaccine, and child being sick during the recommended vaccination period were significant preventive factors for both MCV1 and MCV2 vaccination. Having multiple children, mother's education level, household income and children with working mothers were significantly associated with delayed or missing MCV1 immunization. To avoid future outbreaks, it is crucial to attain high coverage levels by timely vaccination, thus, accurate information should be delivered and a systematic approach should be targeted to high-risk groups.

IND2, a pyrimido[1”,2”:1,5]pyrazolo[3,4-b]quinoline derivative, circumvents multi-drug resistance and causes apoptosis in colon cancer cells

PubMed Central

Karthikeyan, Chandrabose; Lee, Crystal; Moore, Joshua; Mittal, Roopali; Suswam, Esther A.; Abbott, Kodye L; Pondugula, Satyanarayana R.; Manne, Upender; Narayanan, Narayanan K.; Trivedi, Piyush; Tiwari, Amit K.

2014-01-01

Naturally occurring condensed quinolines have anticancer properties. In efforts to find active analogues, we designed and synthesized eight polycyclic heterocycles with a pyrimido[1”,2”:1,5]pyrazolo[3,4-b]quinoline framework (IND series). The compounds were evaluated for activity against colon (HCT-116 and S1-MI-80), prostate (PC3 and DU-145), breast (MCF-7 and MDAMB-231), ovarian (ov2008 and A2780), and hepatocellular (HepG2) cancer cells and against non-cancerous Madin Darby canine kidney (MDCK), mouse embryonic fibroblast (NIH/3T3), and human embryonic kidney cells (HEK293). IND-2, a 4-chloro-2-methyl pyrimido[1”,2”:1,5]pyrazolo[3,4-b]quinoline, exhibited more than tenfold selectivity and potent cytotoxic activity against colon cancer cells relative to the other cancer and non-cancer cells. With five additional colon cancer cell lines (HT-29, HCT-15, LS-180, LS-174, and LoVo), IND-2 had similar cytotoxicity and selectivity, and submicromolar concentrations caused changes in the morphology of HCT-116 and HCT-15 cells. IND-2 did not activate the transactivating function of the pregnane X receptor (PXR), indicating that it does not induce PXR-regulated ABCB1 or ABCG2 transporters. Indeed, IND-2 was not a substrate of ABCB1 or ABCG2, and it induced cytotoxicity in HEK293 cells overexpressing ABCB1 or ABCG2 to the same extent as in normal HEK293 cells. IND-2 was cytotoxic to resistant colon carcinoma S1-MI-80 cells, approximately three- and fivefold more than SN-38 and topotecan, respectively. In HCT-116 colon cancer cells, IND-2 produced concentration-dependent changes in mitochondrial membrane potential, leading to apoptosis, and sub-micromolar concentrations caused chromosomal DNA fragmentation. These findings suggest that, by increasing apoptosis, IND-2 has potential therapeutic efficacy for colorectal cancer. PMID:25537531

Use of a current varicella vaccine as a live polyvalent vaccine vector.

PubMed

Murakami, Kouki; Mori, Yasuko

2016-01-04

Varicella-zoster virus (VZV) is the causative agent of varicella and zoster. The varicella vaccine was developed to control VZV infection in children. The currently available Oka vaccine strain is the only live varicella vaccine approved by the World Health Organization. We previously cloned the complete genome of the Oka vaccine strain into a bacterial artificial chromosome vector and then successfully reconstituted the virus. We then used this system to generate a recombinant Oka vaccine virus expressing mumps virus gene(s). The new recombinant vaccine may be an effective polyvalent live vaccine that provides protection against both varicella and mumps viruses. In this review, we discussed about possibility of polyvalent live vaccine(s) using varicella vaccine based on our recent studies. Copyright © 2014 Elsevier Ltd. All rights reserved.

Newcastle disease virus vectored vaccines as bivalent or antigen delivery vaccines

PubMed Central

2017-01-01

Recent advances in reverse genetics techniques make it possible to manipulate the genome of RNA viruses such as Newcastle disease virus (NDV). Several NDV vaccine strains have been used as vaccine vectors in poultry, mammals, and humans to express antigens of different pathogens. The safety, immunogenicity, and protective efficacy of these NDV-vectored vaccines have been evaluated in pre-clinical and clinical studies. The vaccines are safe in mammals, humans, and poultry. Bivalent NDV-vectored vaccines against pathogens of economic importance to the poultry industry have been developed. These bivalent vaccines confer solid protective immunity against NDV and other foreign antigens. In most cases, NDV-vectored vaccines induce strong local and systemic immune responses against the target foreign antigen. This review summarizes the development of NDV-vectored vaccines and their potential use as a base for designing other effective vaccines for veterinary and human use. PMID:28775971

Primary vaccine failure to routine vaccines: Why and what to do?

PubMed

Wiedermann, Ursula; Garner-Spitzer, Erika; Wagner, Angelika

2016-01-01

There are 2 major factors responsible for vaccine failures, the first is vaccine-related such as failures in vaccine attenuation, vaccination regimes or administration. The other is host-related, of which host genetics, immune status, age, health or nutritional status can be associated with primary or secondary vaccine failures. The first describes the inability to respond to primary vaccination, the latter is characterized by a loss of protection after initial effectiveness. Our studies concentrate on the evaluation of immunological characteristics responsible for primary vaccine failures in different (risk) populations for which the underlying mechanisms are currently unknown. Here we summarise current knowledge and findings from our studies. About 2-10% of healthy individuals fail to mount antibody levels to routine vaccines. Comparing the immune responses to different vaccines in non-responder and high-responder vaccinees revealed that hypo-responsiveness is antigen/vaccine-specific at the humoral but not at the cellular level. We found that T-regulatory as well as B-regulatory cells and the production of IL-10 are involved in non/hypo-responsiveness. Non-responsiveness increases with age and in particular vaccination to a novel vaccine in persons > 65 years is associated with a high low/non-responder rate, indicating that vaccine schedules and doses (at least for primary vaccination) should be adapted according to age. In light of the growing number of allergic but also obese people, our current studies concentrate on these risk groups to reveal whether different vaccination approaches are necessary for optimal protection compared to healthy individuals. These studies are in line with the significant paradigm shift taking place in many fields of medical research and care, and will extend the concept of personalised medicine into the field of vaccinology.

Reducing the dose of smallpox vaccine reduces vaccine-associated morbidity without reducing vaccination success rates or immune responses.

PubMed

Couch, Robert B; Winokur, Patricia; Edwards, Kathryn M; Black, Steven; Atmar, Robert L; Stapleton, Jack T; Kissner, Jennifer M; Shinefield, Henry; Denny, Thomas N; Bybel, Michael J; Newman, Frances K; Yan, Lihan

2007-03-15

When the decision was made to prepare for a deliberate release of smallpox, the United States had approximately 15 million doses of Wyeth Dryvax vaccine, which was known to induce significant morbidity when used undiluted; Sanofi Pasteur, Inc., later identified approximately 85 million additional doses in storage. Eleven vaccine-dose groups, each with 30 vaccinia-naive subjects, were given diluted Dryvax vaccine or 1 of 2 lots of Sanofi Pasteur smallpox vaccine and were evaluated for vaccination success rates, morbidity, and immune responses. Estimated doses of 10(6.6)-10(8.2) pfu of virus/mL induced major reactions (or "takes") in 93%-100% of subjects in each dose group. No differences in vaccination take rates, lesion size, erythema, and induration or in serum neutralizing-antibody response were detected between the groups. However, systemic reactogenicity and missed activities were significantly lower for the vaccine groups given doses of 10(6.6)-10(7.2) pfu/mL than for those given doses of 10(7.6)-10(8.2) pfu/mL. These findings support the use of a higher dilution of Wyeth Dryvax vaccine and Sanofi Pasteur smallpox vaccine, given that the resulting morbidity should be significantly lower without loss of vaccine effectiveness. A plan for use of higher dilutions would create an enormous stockpile of vaccine.

Immunology Update: New Vaccines.

PubMed

Starr, S Paul

2016-11-01

A new 9-valent human papillomavirus (HPV) vaccine is effective against more cancer-causing HPV types than previous vaccines. HPV vaccine series started with previous vaccines can be completed with the 9-valent vaccine. Two new influenza vaccines are available for adults 65 years and older: a high-dose vaccine and an enhanced adjuvant vaccine. These elicit stronger antibody responses than standard-dose vaccines. Current guidelines specify no preference for the new versus standard-dose vaccines. Two new group B meningococcal vaccines are intended for use during outbreaks and for patients with asplenia, complement deficiencies, frequent occupational meningococcus exposure, or for patients who desire protection from type B meningococcus. These are not substitutes for the quadrivalent vaccine already in use. For pneumococcus, new recommendations state that 13-valent pneumococcal conjugate vaccine (PCV13) should be administered to patients 65 years and older, followed at least 1 year later by the polyvalent pneumococcal polysaccharide vaccine (PPSV23). For patients ages 19 to 64 years with immunocompromise and not previously vaccinated against pneumococcus, administration of these two vaccines should be separated by at least 8 weeks. Rotavirus vaccine is standard for infants at age 2 months. Also, there is a new cholera vaccine approved for use in the United States. Written permission from the American Academy of Family Physicians is required for reproduction of this material in whole or in part in any form or medium.

Local measles vaccination gaps in Germany and the role of vaccination providers.

PubMed

Eichner, Linda; Wjst, Stephanie; Brockmann, Stefan O; Wolfers, Kerstin; Eichner, Martin

2017-08-14

Measles elimination in Europe is an urgent public health goal, yet despite the efforts of its member states, vaccination gaps and outbreaks occur. This study explores local vaccination heterogeneity in kindergartens and municipalities of a German county. Data on children from mandatory school enrolment examinations in 2014/15 in Reutlingen county were used. Children with unknown vaccination status were either removed from the analysis (best case) or assumed to be unvaccinated (worst case). Vaccination data were translated into expected outbreak probabilities. Physicians and kindergartens with statistically outstanding numbers of under-vaccinated children were identified. A total of 170 (7.1%) of 2388 children did not provide a vaccination certificate; 88.3% (worst case) or 95.1% (best case) were vaccinated at least once against measles. Based on the worst case vaccination coverage, <10% of municipalities and <20% of kindergartens were sufficiently vaccinated to be protected against outbreaks. Excluding children without a vaccination certificate (best case) leads to over-optimistic views: the overall outbreak probability in case of a measles introduction lies between 39.5% (best case) and 73.0% (worst case). Four paediatricians were identified who accounted for 41 of 109 unvaccinated children and for 47 of 138 incomplete vaccinations; GPs showed significantly higher rates of missing vaccination certificates and unvaccinated or under-vaccinated children than paediatricians. Missing vaccination certificates pose a severe problem regarding the interpretability of vaccination data. Although the coverage for at least one measles vaccination is higher in the studied county than in most South German counties and higher than the European average, many severe and potentially dangerous vaccination gaps occur locally. If other federal German states and EU countries show similar vaccination variability, measles elimination may not succeed in Europe.

Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials.

PubMed

Vesikari, Timo; Esposito, Susanna; Prymula, Roman; Ypma, Ellen; Kohl, Igor; Toneatto, Daniela; Dull, Peter; Kimura, Alan

2013-03-09

Meningococcal serogroup B disease disproportionately affects infants. We assessed lot-to-lot consistency, safety and immunogenicity, and the effect of concomitant vaccination on responses to routine vaccines of an investigational multicomponent vaccine (4CMenB) in this population. We did primary and booster phase 3 studies between March 31, 2008, and Aug 16, 2010, in 70 sites in Europe. We used two series of sponsor-supplied, computer-generated randomisation envelopes to allocate healthy 2 month-old infants to receive routine vaccinations (diphtheria-tetanus-acellular pertussis, inactivated poliovirus, hepatitis B plus Haemophilus influenzae type b, and seven-valent pneumococcal vaccine) at 2, 4, and 6 months of age alone, or concomitantly with 4CMenB or serogroup C conjugate vaccine (MenC) in: 1) an open-label, lot-to-lot immunogenicity and safety substudy of three 4CMenB lots compared with routine vaccines alone (1:1:1:1, block size eight); or 2) an observer-blind, lot-to-lot safety substudy of three 4CMenB lots compared with MenC (1:1:1:3, block size six). At 12 months, 4CMenB-primed children from either substudy were randomised (1:1, block size two) to receive 4CMenB booster, with or without measles-mumps-rubella-varicella (MMRV) vaccine. Immunogenicity was assessed by serum bactericidal assay with human complement (hSBA) against serogroup B test strains, and on randomly selected subsets of serum samples for routine vaccines; laboratory personnel were masked to assignment. The first coprimary outcome was lot-to-lot consistency (hSBA geometric mean ratio of all lots between 0·5 and 2·0), and the second was an immune response (hSBA titre ≥5) for each of the three strains. The primary outcome for the booster study was immune response to booster dose. Immunogenicity data for 4CMenB were for the modified intention-to-treat population, including all infants from the open-label substudy who provided serum samples. The safety population included all participants

Seasonal influenza vaccines.

PubMed

Fiore, Anthony E; Bridges, Carolyn B; Cox, Nancy J

2009-01-01

Influenza vaccines are the mainstay of efforts to reduce the substantial health burden from seasonal influenza. Inactivated influenza vaccines have been available since the 1940s and are administered via intramuscular injection. Inactivated vaccines can be given to anyone six months of age or older. Live attenuated, cold-adapted influenza vaccines (LAIV) were developed in the 1960s but were not licensed in the United States until 2003, and are administered via nasal spray. Both vaccines are trivalent preparations grown in eggs and do not contain adjuvants. LAIV is licensed for use in the United States for healthy nonpregnant persons 2-49 years of age.Influenza vaccination induces antibodies primarily against the major surface glycoproteins hemagglutinin (HA) and neuraminidase (NA); antibodies directed against the HA are most important for protection against illness. The immune response peaks at 2-4 weeks after one dose in primed individuals. In previously unvaccinated children <9 years of age, two doses of influenza vaccine are recommended, as some children in this age group have limited or no prior infections from circulating types and subtypes of seasonal influenza. These children require both an initial priming dose and a subsequent booster dose of vaccine to mount a protective antibody response.The most common adverse events associated with inactivated vaccines are sore arm and redness at the injection site; systemic symptoms such as fever or malaise are less commonly reported. Guillian-Barré Syndrome (GBS) was identified among approximately 1 per 100,000 recipients of the 1976 swine influenza vaccine. The risk of influenza vaccine-associated GBS from seasonal influenza vaccine is thought to be at most approximately 1-2 cases per 1 million vaccinees, based on a few studies that have found an association; other studies have found no association.The most common adverse events associated with LAIV are nasal congestion, headache, myalgias or fever. Studies of the

Evaluation of vaccine competition using HVT vector vaccines

USDA-ARS?s Scientific Manuscript database

Turkey herpesvirus (HVT) has been widely used as a vaccine for Marek’s disease (MD) since the 1970s. Because HVT is a safe vaccine that is poorly sensitive to interference from maternally derived antibodies, it has seen rising use as a vector for vaccines developed for protection against other comm...

Awareness among adults of vaccine-preventable diseases and recommended vaccinations, United States, 2015.

PubMed

Lu, Peng-Jun; O'Halloran, Alissa; Kennedy, Erin D; Williams, Walter W; Kim, David; Fiebelkorn, Amy Parker; Donahue, Sara; Bridges, Carolyn B

2017-05-25

Adults are recommended to receive select vaccinations based on their age, underlying medical conditions, lifestyle, and other considerations. Factors associated with awareness of vaccine-preventable diseases and recommended vaccines among adults in the United States have not been explored. Data from a 2015 internet panel survey of a nationally representative sample of U.S. adults aged ≥19years were analyzed to assess awareness of selected vaccine-preventable diseases and recommended vaccines for adults. A multivariable logistic regression model with a predictive marginal approach was used to identify factors independently associated with awareness of selected vaccine-preventable infections/diseases and corresponding vaccines. Among the surveyed population, from 24.6 to 72.1% reported vaccination for recommended vaccines. Awareness of vaccine-preventable diseases among adults aged ≥19years ranged from 63.4% to 94.0% (63.4% reported awareness of HPV, 71.5% reported awareness of tetanus, 72.0% reported awareness of pertussis, 75.4% reported awareness of HZ, 75.8% reported awareness of hepatitis B, 83.1% reported awareness of pneumonia, and 94.0% reported awareness of influenza). Awareness of the corresponding vaccines among adults aged ≥19years ranged from 59.3% to 94.1% (59.3% HZ vaccine, 59.6% HPV vaccine, 64.3% hepatitis B vaccine, 66.2% pneumococcal vaccine, 86.3% tetanus vaccines, and 94.1% influenza vaccine). In multivariable analysis, being female and being a college graduate were significantly associated with a higher level of awareness for majority of vaccine-preventable diseases, and being female, being a college graduate, and working as a health care provider were significantly associated with a higher level of awareness for majority of corresponding vaccines. Although adults in this survey reported high levels of awareness for most vaccines recommended for adults, self-reported vaccination coverage was not optimal. Combining interventions known to

Adolescent Attitudes toward Influenza Vaccination and Vaccine Uptake in a School-Based Influenza Vaccination Intervention: A Mediation Analysis

ERIC Educational Resources Information Center

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

2011-01-01

Background: School-based vaccination programs may provide an effective strategy to immunize adolescents against influenza. This study examined whether adolescent attitudes toward influenza vaccination mediated the relationship between receipt of a school-based influenza vaccination intervention and vaccine uptake. Methods: Participants were…

Industry sponsored anti-smoking ads and adolescent reactance: test of a boomerang effect.

PubMed

Henriksen, L; Dauphinee, A L; Wang, Y; Fortmann, S P

2006-02-01

To examine whether adolescents' exposure to youth smoking prevention ads sponsored by tobacco companies promotes intentions to smoke, curiosity about smoking, and positive attitudes toward the tobacco industry. A randomised controlled experiment compared adolescents' responses to five smoking prevention ads sponsored by a tobacco company (Philip Morris or Lorillard), or to five smoking prevention ads sponsored by a non-profit organisation (the American Legacy Foundation), or to five ads about preventing drunk driving. A large public high school in California's central valley. A convenience sample of 9th and 10th graders (n = 832) ages 14-17 years. Perceptions of ad effectiveness, intention to smoke, and attitudes toward tobacco companies measured immediately after exposure. As predicted, adolescents rated Philip Morris and Lorillard ads less favourably than the other youth smoking prevention ads. Adolescents' intention to smoke did not differ as a function of ad exposure. However, exposure to Philip Morris and Lorillard ads engendered more favourable attitudes toward tobacco companies. This study demonstrates that industry sponsored anti-smoking ads do more to promote corporate image than to prevent youth smoking. By cultivating public opinion that is more sympathetic toward tobacco companies, the effect of such advertising is likely to be more harmful than helpful to youth.

Methodology and lessons-learned from the efficacy clinical trial of the pentavalent rotavirus vaccine in Bangladesh.

PubMed

Zaman, K; Yunus, M; El Arifeen, Shams; Azim, Tasnim; Faruque, A S G; Huq, Ehsanul; Hossain, Ilias; Luby, Stephen P; Victor, John C; Dallas, Michael J; Lewis, Kristen D C; Rivers, Stephen B; Steele, A Duncan; Neuzil, Kathleen M; Ciarlet, Max; Sack, David A

2012-04-27

An efficacy clinical trial with pentavalent rotavirus vaccine (PRV), RotaTeq(®), was conducted at Matlab field site of ICDDR,B, Bangladesh from March 2007 to March 2009. The methodology, including operation logistics, and lessons-learned are described in this report. Vaccination was organized at 41 fixed-site clinics twice/month. A total of 1136 infants were randomized 1:1 to receive 3 doses of PRV/placebo at approximately 6-, 10-, and 14-weeks of age with routine vaccines of the Expanded Programme on Immunization (EPI) schedule. Twelve field-workers routinely visited study participants for safety and efficacy follow-up. The study was conducted following good clinical practices and maintaining cold-chain requirements. There were no temperature deviations of clinical vaccine supplies. Data entry was done using the source documents to a central database developed by the sponsor which was linked to web. Among enrolled infants, 1128 (99.3%) received 3 doses of PRV/placebo and efficacy follow-up was conducted for a median of 554 days. For the evaluation of immunogenicity, blood samples were collected from 150 participants predose 1 and from 147 (98%) of the same participants post dose 3. Stool samples were collected from 778 (99.9%) acute gastroenteritis episodes among children who reported to diarrhoea treatment centres. Thirty-nine serious adverse events, including 6 deaths, occurred among study participants. The efficacy of PRV against severe rotavirus gastroenteritis was 42.7% through the entire follow-up period; serum anti-rotavirus IgA response was 78.1%. Inclement weather, difficult transportation, and movement of study participants were some of the challenges identified. This is the first vaccine trial in rural Bangladesh with online data entry. The study was well accepted in the community and was completed successfully. Copyright © 2011 Elsevier Ltd. All rights reserved.

Vaccination and allergy.

PubMed

Rottem, Menachem; Shoenfeld, Yehuda

2004-06-01

Vaccines have had a major effect on controlling the spread of infectious diseases, but use of certain vaccines was linked to potential allergic and autoimmune side effects in healthy and often in certain high-risk populations. In this review the authors summarize the current knowledge of such risks. Immediate systemic allergic reactions after vaccination with commonly used vaccines are extremely rare. Use of certain vaccines was linked to potential allergic side effects in healthy and often in certain high-risk populations. The authors review the data on the risk associated with important vaccines including influenza, smallpox, pneumococcus, Japanese encephalitis, Bacille Calmette-Guerin, pertussis, and measles, mumps, and rubella. Two main components were identified as a source for allergic reactions in vaccines: gelatin and egg protein. There is growing interest in the potential interactions between infant vaccination and risk for development of atopic disease. In addition, there is concern that genetic risk for atopy influences capacity to respond to vaccination during infancy. There is no evidence that vaccines such as Bacille Calmette-Guerin; pertussis; influenza; measles, mumps, and rubella; or smallpox have an effect on the risk of the development of atopy later in life. Immunotherapy provides an efficacious and safe method for the treatment of allergic conditions by immunomodulation of the immune system. The possibility of vaccination triggering or unmasking autoimmunity in genetically susceptible individuals cannot be ruled out, but for the general population the risk-to-benefit ratio is overwhelmingly in favor of vaccinations. Childhood vaccination remains an essential part of child health programs and should not be withheld, even from children predisposed to allergy. Vaccinations are safe, but special attention should be taken in high-risk individuals with anaphylactic reactions to foods, and in patients with autoimmune diseases.

Current ebola vaccines.

PubMed

Hoenen, Thomas; Groseth, Allison; Feldmann, Heinz

2012-07-01

Ebolaviruses cause severe viral hemorrhagic fever in humans and non-human primates (NHPs), with case fatality rates of up to 90%. Currently, neither a specific treatment nor a vaccine licensed for use in humans is available. However, a number of vaccine candidates have been developed in the last decade that are highly protective in NHPs, the gold standard animal model for ebola hemorrhagic fever. This review analyzes a number of scenarios for the use of ebolavirus vaccines, discusses the requirements for ebolavirus vaccines in these scenarios and describes current ebolavirus vaccines. Among these vaccines are recombinant adenoviruses, recombinant vesicular stomatitis viruses (VSVs), recombinant human parainfluenza viruses and virus-like particles. Interestingly, one of these vaccine platforms, based on recombinant VSVs, has also demonstrated post-exposure protection in NHPs. The most pressing remaining challenge is now to move these vaccine candidates forward into human trials and toward licensure. In order to achieve this, it will be necessary to establish the mechanisms and correlates of protection for these vaccines, and to continue to demonstrate their safety, particularly in potentially immunocompromised populations. However, already now there is sufficient evidence that, from a scientific perspective, a vaccine protective against ebolaviruses is possible.

Vaccine Policy Issues

DTIC Science & Technology

2005-05-19

evidence “favors rejection” of the idea that either the measles- mumps-rubella vaccine or thimerosal-containing vaccines cause autism (IOM...Immunization Safety Review: Vaccines and Autism , Washington, D.C., National Academies Press, 2004). 46ACIP’s rotavirus vaccine fact sheet is at [http...that the vaccines or preservatives or packaging might cause autism and other neurodevelopmental disorders. One focus has been on thimerosal, a mercury

Chinese vaccine products go global: vaccine development and quality control.

PubMed

Xu, Miao; Liang, Zhenglun; Xu, Yinghua; Wang, Junzhi

2015-05-01

Through the continuous efforts of several generations, China has become one of the few countries in the world that is capable of independently addressing all the requirements by the Expanded Program on Immunization. Regulatory science is applied to continuously improve the vaccine regulatory system. Passing the prequalification by WHO has allowed Chinese vaccine products to go global. Chinese vaccine products not only secure disease prevention and control domestically but also serve the needs for international public health. This article describes the history of Chinese vaccine development, the current situation of Chinese vaccine industry and its contribution to the prevention and control of infectious diseases. We also share our experience of national quality control and vaccine regulation during the past decades. China's experience in vaccine development and quality control can benefit other countries and regions worldwide, including the developing countries.

Midwives' influenza vaccine uptake and their views on vaccination of pregnant women.

PubMed

Ishola, D A; Permalloo, N; Cordery, R J; Anderson, S R

2013-12-01

Pregnant women in England are now offered seasonal influenza vaccine. Midwives could be influential in promoting this, but specific information on their views on the policy and their role in its implementation is lacking. London midwives were surveyed for their views on the new policy and their own vaccine uptake, using an anonymously self-completed semi-structured online survey via a convenience sampling approach. In total, 266 midwives responded. Sixty-nine percent agreed with the policy of vaccinating all pregnant women. Seventy-six percent agreed that midwives should routinely advise pregnant women on vaccination, but only 25% felt adequately prepared for this role. Just 28% wished to be vaccinators, due to concerns about increased workload and inadequate training. Forty-three percent received seasonal influenza vaccine themselves. Major reasons for non-uptake were doubts about vaccine necessity (34%), safety (25%) and effectiveness (10%); and poor arrangements for vaccination (11%). Suggested strategies for improving their own uptake included better access to evidence of effectiveness (67%) and improved work-based vaccination (45%). London midwives support influenza vaccination of pregnant women, but are more willing to give advice on, than to administer, the vaccine. Midwives' own influenza vaccine uptake could improve with more information and easier access to vaccination in their workplace.

The inflammatory & neurodegenerative (I&ND) hypothesis of depression: leads for future research and new drug developments in depression.

PubMed

Maes, Michael; Yirmyia, Raz; Noraberg, Jens; Brene, Stefan; Hibbeln, Joe; Perini, Giulia; Kubera, Marta; Bob, Petr; Lerer, Bernard; Maj, Mario

2009-03-01

Despite extensive research, the current theories on serotonergic dysfunctions and cortisol hypersecretion do not provide sufficient explanations for the nature of depression. Rational treatments aimed at causal factors of depression are not available yet. With the currently available antidepressant drugs, which mainly target serotonin, less than two thirds of depressed patients achieve remission. There is now evidence that inflammatory and neurodegenerative (I&ND) processes play an important role in depression and that enhanced neurodegeneration in depression may-at least partly-be caused by inflammatory processes. Multiple inflammatory-cytokines, oxygen radical damage, tryptophan catabolites-and neurodegenerative biomarkers have been established in patients with depression and these findings are corroborated by animal models of depression. A number of vulnerability factors may predispose towards depression by enhancing inflammatory reactions, e.g. lower peptidase activities (dipeptidyl-peptidase IV, DPP IV), lower omega-3 polyunsaturated levels and an increased gut permeability (leaky gut). The cytokine hypothesis considers that external, e.g. psychosocial stressors, and internal stressors, e.g. organic inflammatory disorders or conditions, such as the postpartum period, may trigger depression via inflammatory processes. Most if not all antidepressants have specific anti-inflammatory effects, while restoration of decreased neurogenesis, which may be induced by inflammatory processes, may be related to the therapeutic efficacy of antidepressant treatments. Future research to disentangle the complex etiology of depression calls for a powerful paradigm shift, i.e. by means of a high throughput-high quality screening, including functional genetics and genotyping microarrays; established and novel animal and ex vivo-in vitro models for depression, such as new transgenic mouse models and endophenotype-based animal models, specific cell lines, in vivo and ex vivo

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.

The frequency of company-sponsored alcohol brand-related sites on Facebook™-2012.

PubMed

Nhean, Siphannay; Nyborn, Justin; Hinchey, Danielle; Valerio, Heather; Kinzel, Kathryn; Siegel, Michael; Jernigan, David H

2014-06-01

This research provides an estimate of the frequency of company-sponsored alcohol brand-related sites on Facebook™. We conducted a systematic overview of the extent of alcohol brand-related sites on Facebook™ in 2012. We conducted a 2012 Facebook™ search for sites specifically related to 898 alcohol brands across 16 different alcoholic beverage types. Descriptive statistics were produced using Microsoft SQL Server. We identified 1,017 company-sponsored alcohol-brand related sites on Facebook™. Our study advances previous literature by providing a systematic overview of the extent of alcohol brand sites on Facebook™.

Prior DNA vaccination does not interfere with the live-attenuated measles vaccine.

PubMed

Premenko-Lanier, Mary; Rota, Paul; Rhodes, Gary; Bellini, William; McChesney, Michael

2004-01-26

The currently used live-attenuated measles vaccine is very effective although maternal antibody prevents its administration prior to 6 months of age. We are investigating the ability of a DNA vaccine encoding the measles viral hemagglutinin, fusion and nucleoprotein to protect newborn infants from measles. Here, we show that a measles DNA vaccine protects juvenile macaques from pathogenic measles virus challenge and that macaques primed and boosted with this DNA vaccine have anemnestic antibody and cell-mediated responses after vaccination with a live-attenuated canine distemper-measles vaccine. Therefore, this DNA vaccine administered to newborn infants may not hinder the subsequent use of live-attenuated measles vaccine.

Typhoid fever vaccination strategies.

PubMed

Date, Kashmira A; Bentsi-Enchill, Adwoa; Marks, Florian; Fox, Kimberley

2015-06-19

Typhoid vaccination is an important component of typhoid fever prevention and control, and is recommended for public health programmatic use in both endemic and outbreak settings. We reviewed experiences with various vaccination strategies using the currently available typhoid vaccines (injectable Vi polysaccharide vaccine [ViPS], oral Ty21a vaccine, and injectable typhoid conjugate vaccine [TCV]). We assessed the rationale, acceptability, effectiveness, impact and implementation lessons of these strategies to inform effective typhoid vaccination strategies for the future. Vaccination strategies were categorized by vaccine disease control strategy (preemptive use for endemic disease or to prevent an outbreak, and reactive use for outbreak control) and vaccine delivery strategy (community-based routine, community-based campaign and school-based). Almost all public health typhoid vaccination programs used ViPS vaccine and have been in countries of Asia, with one example in the Pacific and one experience using the Ty21a vaccine in South America. All vaccination strategies were found to be acceptable, feasible and effective in the settings evaluated; evidence of impact, where available, was strongest in endemic settings and in the short- to medium-term. Vaccination was cost-effective in high-incidence but not low-incidence settings. Experience in disaster and outbreak settings remains limited. TCVs have recently become available and none are WHO-prequalified yet; no program experience with TCVs was found in published literature. Despite the demonstrated success of several typhoid vaccination strategies, typhoid vaccines remain underused. Implementation lessons should be applied to design optimal vaccination strategies using TCVs which have several anticipated advantages, such as potential for use in infant immunization programs and longer duration of protection, over the ViPS and Ty21a vaccines for typhoid prevention and control. Copyright © 2015. Published by

Vaccine process technology.

PubMed

Josefsberg, Jessica O; Buckland, Barry

2012-06-01

The evolution of vaccines (e.g., live attenuated, recombinant) and vaccine production methods (e.g., in ovo, cell culture) are intimately tied to each other. As vaccine technology has advanced, the methods to produce the vaccine have advanced and new vaccine opportunities have been created. These technologies will continue to evolve as we strive for safer and more immunogenic vaccines and as our understanding of biology improves. The evolution of vaccine process technology has occurred in parallel to the remarkable growth in the development of therapeutic proteins as products; therefore, recent vaccine innovations can leverage the progress made in the broader biotechnology industry. Numerous important legacy vaccines are still in use today despite their traditional manufacturing processes, with further development focusing on improving stability (e.g., novel excipients) and updating formulation (e.g., combination vaccines) and delivery methods (e.g., skin patches). Modern vaccine development is currently exploiting a wide array of novel technologies to create safer and more efficacious vaccines including: viral vectors produced in animal cells, virus-like particles produced in yeast or insect cells, polysaccharide conjugation to carrier proteins, DNA plasmids produced in E. coli, and therapeutic cancer vaccines created by in vitro activation of patient leukocytes. Purification advances (e.g., membrane adsorption, precipitation) are increasing efficiency, while innovative analytical methods (e.g., microsphere-based multiplex assays, RNA microarrays) are improving process understanding. Novel adjuvants such as monophosphoryl lipid A, which acts on antigen presenting cell toll-like receptors, are expanding the previously conservative list of widely accepted vaccine adjuvants. As in other areas of biotechnology, process characterization by sophisticated analysis is critical not only to improve yields, but also to determine the final product quality. From a regulatory

[Measles vaccination].

PubMed

Floret, Daniel

2010-12-20

France is facing since 2008 a re-emerging measles outbreak affecting a high proportion of adults currently not or not correctly vaccinated. The non application since 30 years of the immunization program on measles mumps and rubella is the cause of this situation, despite the efficacy and the good tolerance of this vaccine has been demonstrated. The present epidemic is expected to go on, as long as the millions of measles susceptible people have not been either affected or vaccinated. A 95% protection rate is needed to interrupt the circulation of the virus. So, the objective of the French Plan for elimination of measles and congenital rubella is to reach at least a 95% vaccination coverage for the first dose and 80% for the second dose. The immunization recommendations should be strictly respected: first dose of MMR vaccine at 12 months and second dose within the second year of life. In this context, catch up immunization of children, adolescents and young adults (up to 30 year) not or not correctly vaccinated is particularly important, as well as the post exposure prophylactic measures, including vaccination.

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

A Guide to Orientation Materials for Refugees and their Sponsors. A Selected, Annotated Bibliography Supplement.

ERIC Educational Resources Information Center

Center for Applied Linguistics, Washington, DC. Language and Orientation Resource Center.

An annotated bibliography of materials for the orientation of refugees and their sponsors is a supplement to "A Guide to Orientation Materials for Indochinese Refugees and their Sponsors," and includes 40 entries for materials pertinent to many other, non-Indochinese refugee groups. The materials are grouped alphabetically by the…

77 FR 31722 - New Animal Drugs; Change of Sponsor; Estradiol; Estradiol Benzoate and Testosterone Propionate...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-30

... 558 [Docket No. FDA-2012-N-0002] New Animal Drugs; Change of Sponsor; Estradiol; Estradiol Benzoate.... ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 17 new animal drug applications (NADAs) and abbreviated new...

The Administration of Sponsored Programs. Handbook for Developing and Managing Research Activities and Other Projects.

ERIC Educational Resources Information Center

Beasley, Kenneth L.; And Others

Designed as a standard reference and training resource for administrators and project managers, this handbook discusses how to plan, organize, and manage sponsored projects in any organizational setting. It provides detailed, how-to-do-it information and many resources for: negotiating grants, awards, and contracts; organizing a sponsored projects…

Human Vaccines & Immunotherapeutics: News

PubMed Central

Riedmann, Eva M

2013-01-01

Vaccinating boys against HPV to reduce cancer rates across the sexes New melanoma vaccine contains natural product from marine sponges Impact of Hib conjugate vaccines in developing countries Electronic Health Records to keep track of immunization status Pregnant women urged to get whooping cough vaccination New nano-coating developed to preserve vaccines Alternative approach to creating a universal flu vaccine New modular vaccine design: MAPS technology PMID:24051387

14 CFR 60.9 - Additional responsibilities of the sponsor.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 2 2013-01-01 2013-01-01 false Additional responsibilities of the sponsor. 60.9 Section 60.9 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE § 60.9...

14 CFR 60.9 - Additional responsibilities of the sponsor.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 2 2012-01-01 2012-01-01 false Additional responsibilities of the sponsor. 60.9 Section 60.9 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE § 60.9...

14 CFR 60.9 - Additional responsibilities of the sponsor.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 2 2014-01-01 2014-01-01 false Additional responsibilities of the sponsor. 60.9 Section 60.9 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE § 60.9...

14 CFR 60.9 - Additional responsibilities of the sponsor.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 2 2011-01-01 2011-01-01 false Additional responsibilities of the sponsor. 60.9 Section 60.9 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE § 60.9...

14 CFR 60.9 - Additional responsibilities of the sponsor.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Additional responsibilities of the sponsor. 60.9 Section 60.9 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE § 60.9...

Employer-Sponsored Career Development Programs. Information Series No. 231.

ERIC Educational Resources Information Center

Lancaster, Anita Sklare; Berne, Richard R.

This monograph presents an overview of employer-sponsored career development programs. It is divided into four sections. The "Adult Development" and "Adult Career Development" sections review pertinent theories and research (basic concepts, task model, transition model, theme model, adult career stages, career anchors approach, career development…

Current Ebola vaccines

PubMed Central

Hoenen, Thomas; Groseth, Allison; Feldmann, Heinz

2012-01-01

Introduction Ebolaviruses cause severe viral hemorrhagic fever in humans and non-human primates, with case fatality rates of up to 90%. Currently, neither a specific treatment nor a vaccine licensed for use in humans is available. However, a number of vaccine candidates have been developed in the last decade that are highly protective in non-human primates, the gold standard animal model for Ebola hemorrhagic fever. Areas covered This review analyzes a number of scenarios for the use of ebolavirus vaccines, discusses the requirements for ebolavirus vaccines in these scenarios, and describes current ebolavirus vaccines. Among these vaccines are recombinant Adenoviruses, recombinant Vesicular Stomatitis viruses, recombinant Human Parainfluenza viruses and virus-like particles. Interestingly, one of these vaccine platforms, based on recombinant Vesicular Stomatitis viruses, has also demonstrated post-exposure protection in non-human primates. Expert opinion The most pressing remaining challenge is now to move these vaccine candidates forward into human trials and towards licensure. In order to achieve this, it will be necessary to establish the mechanisms and correlates of protection for these vaccines, and to continue to demonstrate their safety, particularly in potentially immunocompromised populations. However, already now there is sufficient evidence that, from a scientific perspective, a vaccine protective against ebolaviruses is possible. PMID:22559078

[Human papillomavirus vaccines].

PubMed

Brun, J-L

2008-02-01

To assess the efficacy, the tolerance, the duration of protection and the limitations of papillomavirus vaccines and to determine the potential indications for prophylactic vaccination. Medline, Biosis and Pascal contents were searched to July 2007. Of 546 abstracts, 30 studies were selected. Prophylactic vaccines are composed of L1 virus-like particles. They are well-tolerated and effective in preventing HPV 16/18 infections and related cervical diseases in young women who are naive to HPV 16/18 after five years of follow-up. In addition, the quadrivalent vaccine prevents HPV 6/11 infections and their consequences. The bivalent vaccine may also prevent HPV 31/45 infections by cross-protection. Young girls before sexual debut are the main target for prophylactic vaccines. Indeed, they demonstrate an excellent immune response after injection and the prevalence of HPV infection increases dramatically after the first sexual intercourse. However, vaccines are ineffective in healthy HPV 16/18 carriers or on existing lesions. Prophylactic vaccines are not effective in women infected by other oncogenic HPV. Therapeutic vaccine effects against cervical dysplasia are currently being assessed. Prophylactic vaccination against HPV is effective, well-tolerated, and should be associated with screening to optimize the prevention of cervical cancer.

Vaccine administration decision making: the case of yellow fever vaccine.

PubMed

Lown, Beth A; Chen, Lin H; Wilson, Mary E; Sisson, Emily; Gershman, Mark; Yanni, Emad; Jentes, Emily S; Hochberg, Natasha S; Hamer, Davidson H; Barnett, Elizabeth D

2012-09-01

Providers must counsel travelers to yellow fever (YF)-endemic areas, although risk estimates of disease and vaccine serious adverse events (SAEs) may be imprecise. The impact of risk information and patients' requests for participation in vaccine decisions on providers' recommendations is unknown. Vaccine providers were surveyed regarding decisions for 4 patient scenarios before and after being presented information about risk of YF disease vs vaccine SAEs. Participants' theoretical attitudes were compared with actual responses to scenarios in which patients wanted to share vaccine decisions. Analyses were done by using χ(2) tests with significance level of .05. Forty-six percent of respondents made appropriate initial YF vaccine administration decisions for a pregnant woman, 73% for an immunosuppressed man, and 49% for an 8-month-old infant. After receiving scenario-specific information, 20%, 54%, and 23% of respondents respectively who initially responded incorrectly changed to a more appropriate decision. Thirty-one percent of participants made consistently appropriate decisions. Among participants who made ≥1 incorrect decision, 35.7% made no decision changes after receiving information. In the scenario in which either a decision to withhold or to administer vaccine was acceptable, 19% of respondents refused a patient's request for vaccine. Targeted information is necessary but insufficient to change the process of vaccine administration decision making. Providers need additional education to enable them to apply evidence, overcome cognitive decision-making errors, and involve patients in vaccine decisions.

78 FR 67216 - Norfolk Southern Railway Company-Abandonment Exemption-in Lake County, Ind.

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-08

... Junction Avenue in the City of Schererville, Ind.) and milepost MQ 283.10 (near the line's crossing of E... 14, 2014, or 10 days after service of a decision granting the petition for exemption, whichever occurs sooner. Each OFA must be accompanied by a $1,600 filing fee. See 49 CFR 1002.2(f)(25). All...

Knowledge of HPV infection and vaccination among vaccinated and unvaccinated teenaged girls.

PubMed

Sopracordevole, Francesco; Cigolot, Federica; Mancioli, Francesca; Agarossi, Alberto; Boselli, Fausto; Ciavattini, Andrea

2013-07-01

To assess the knowledge of teenaged girls on human papillomavirus (HPV) infection and vaccination 12 months after the start of a vaccine administration and information campaign. Between May 15 and June 15, 2009, an anonymous questionnaire was given to 629 girls attending a secondary school in a northeastern Italian city (286 were vaccinated against HPV, 343 were unvaccinated) to investigate their knowledge on HPV infection, transmission, prevention, vaccination, and post-vaccination behaviors. The responses were evaluated with respect to the vaccination status of the participants. Vaccinated teenaged girls had no more knowledge than unvaccinated ones about the route of HPV transmission, and the relationship between HPV and AIDS. Vaccinated girls had less knowledge than unvaccinated girls about preventing transmission by condom (P=0.003) and about the correlation between HPV and penile cancer (P=0.034) and warts (P=0.001). Furthermore, compared with unvaccinated girls, more vaccinated girls believed that contraceptive pills might prevent HPV-related disease (P=0.001). Vaccinated girls better understood the importance of performing regular Pap smears after vaccination (P=0.021). Knowledge on HPV infection and vaccination remains suboptimal, especially among vaccinated teenaged girls, despite a broad information campaign. Misconceptions about the utility of secondary prevention may increase risky sexual behaviors. Copyright © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

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.

[History of vaccination: from empiricism towards recombinant vaccines].

PubMed

Guérin, N

2007-01-01

Two hundreds years after the discovery of the smallpox vaccine, immunization remains one of the most powerful tools of preventive medicine. Immunization was born with Jenner, then Pasteur and expanded during the 19th and 20th century. It started with the empirical observation of cross-immunity between two diseases, cowpox and smallpox. It became a real science, with pathogen isolation, culture and attenuation or inactivation, to prepare a vaccine. Together with clinical and biological efficacy studies and adverse events assessments, it constructed the concept of "vaccinology". Protein conjugation of polyosidic vaccines has made possible early immunisation of infants. Nowadays, recombinant, reassortant, or virus-like particles technologies open the road for new vaccines. Ongoing research opens the way for the development of new vaccines that will help to control transmittable diseases for which we are lacking antimicrobial agents.

41. March 18, 1939 Oakland, California Launching party with sponsor ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

41. March 18, 1939 Oakland, California Launching party with sponsor Miss Harriet Biota Mason (holding flowers) at the Moore Dry Dock Company. - U.S. Coast Guard Cutter FIR, Puget Sound Area, Seattle, King County, WA

Young multiethnic women's attitudes toward the HPV vaccine and HPV vaccination.

PubMed

Wong, Li Ping

2008-11-01

To investigate the acceptability of the HPV vaccine among a multiethnic sample of young women in Malaysia. A qualitative study of 40 young women aged between 13 and 27 years recruited into 7 focus groups to discuss their knowledge of HPV infection, and their attitudes toward and acceptance of the HPV vaccine. The women were divided into Malay, Chinese, and Indian groups to allow for comparison among ethnicities. Poor knowledge about HPV did not influence the HPV vaccine's acceptability. Although participants were in favor of the vaccine, the majority preferred to delay vaccination because it is newly introduced, they did not perceive themselves to be at risk of HPV infection, or because of cost factors. Concerns were raised regarding the vaccine's safety, the potential to be perceived as promiscuous and sexually active, and whether the vaccine was halal. Promotion of the HPV vaccine should take account of social and cultural acceptability. The findings will help develop strategies for effective vaccination initiatives in a multiethnic and multireligious Asian society.

Warning letters to sponsor-investigators at academic health centres - the regulatory "canaries in a coal mine".

PubMed

O'Reilly, Erin K; Blair Holbein, M E; Berglund, Jelena P; Parrish, Amanda B; Roth, Mary-Tara; Burnett, Bruce K

2013-12-01

This study highlights Warning Letter (WL) findings issued to sponsor-investigators (S-Is) by the Food and Drug Administration (FDA). The online index of WLs issued from October 1, 2007 through September 30, 2012 was reviewed [1]. Through a manual screening process, letters were evaluated if specifically issued to 'clinical investigators', 'sponsors' or 'sponsor-investigators'. A particular focus was given to S-Is at Academic Health Centres (AHCs). Each letter was scored for the presence of violations in 40 general regulatory categories. A review of FDA WLs issued over a five-year period (FDA Fiscal Years 2008-2012) revealed that WLs to S-Is represent half of the WLs issued to all sponsors (16 of 32 letters). A review of these letters indicates that S-Is are not aware of, or simply do not meet, their regulatory responsibilities as either investigators or sponsors. In comparing total sponsor letters to those of S-Is, the most cited violation was the same: a lack of monitoring. A review of publicly available inspection data indicates that these 16 letters merely represent the tip of the iceberg. This review of the WL database reveals the potential for serious regulatory violations among S-Is at AHCs. Recent translational funding initiatives may serve to increase the number of S-Is, especially among Academic Health Centres (AHCs) [2]; thus, AHCs must become aware of this S-I role and work to support investigators who assume both roles in the course of their research.

Vaccines Against Malaria

PubMed Central

Ouattara, Amed; Laurens, Matthew B.

2015-01-01

Despite global efforts to control malaria, the illness remains a significant public health threat. Currently, there is no licensed vaccine against malaria, but an efficacious vaccine would represent an important public health tool for successful malaria elimination. Malaria vaccine development continues to be hindered by a poor understanding of antimalarial immunity, a lack of an immune correlate of protection, and the genetic diversity of malaria parasites. Current vaccine development efforts largely target Plasmodium falciparum parasites in the pre-erythrocytic and erythrocytic stages, with some research on transmission-blocking vaccines against asexual stages and vaccines against pregnancy-associated malaria. The leading pre-erythrocytic vaccine candidate is RTS,S, and early results of ongoing Phase 3 testing show overall efficacy of 46% against clinical malaria. The next steps for malaria vaccine development will focus on the design of a product that is efficacious against the highly diverse strains of malaria and the identification of a correlate of protection against disease. PMID:25452593

Rural parents' vaccination-related attitudes and intention to vaccinate middle and high school children against influenza following educational influenza vaccination intervention

PubMed Central

Painter, Julia E.; Pazol, Karen; Gargano, Lisa M.; Orenstein, Walter; Hughes, James M.; DiClemente, Ralph J.

2011-01-01

Objective: This study examined changes in parental influenza vaccination attitudes and intentions after participating in school-based educational influenza vaccination intervention. Methods: Participants were drawn from three counties participating in a school-based influenza vaccination intervention in rural Georgia (baseline N=324; follow-up N=327). Data were collected pre- and post-intervention from phone surveys with parents’ with children attending middle- and high-school. Attitudes, beliefs, vaccination history, and intention to vaccinate were assessed.  Results:  Parents who participated in the intervention conditions reported significantly higher influenza vaccination rates in their adolescents, relative to a control group, as well as increased vaccination rates post-intervention participation relative to their baseline rates. Intervention participants reported greater intention to have their adolescent vaccinated in the coming year compared to control parents.  Significant differences were observed post intervention in perceived barriers and benefits of vaccination. Conclusions: These findings suggest that a school-delivered educational influenza vaccination intervention targeting parents and teens may influence influenza vaccination in rural communities. Future influenza vaccination efforts geared toward the parents of rural middle- and high-school students may benefit from addressing barriers and benefits of influenza vaccination. PMID:22048112

Parental attitudes towards vaccinating sons with human papillomavirus vaccine.

PubMed

Mortensen, Gitte Lee

2010-12-01

Male human papillomavirus (HPV) infections are frequent and lead to an increased risk of HPV-related disease in their female sexual partners. In males, HPV can cause head/neck, penile and anal cancer, as well as genital warts. In this study we assessed parental attitudes to HPV vaccination of their sons. Telephone interviews were conducted in a random, nationally representative sample of 450 Danish parents with sons aged 12-15 years. We gave them information about the main direct benefits of male vaccination and then asked them about their views on HPV vaccination of their sons aged 12-15 years. HPV vaccination of sons was accepted by 80% of respondents; 45% were willing to cover the cost themselves. Parents primarily wanted to protect their sons from cancer and genital warts. 20% rejected or had doubts about HPV vaccination of their sons. Their concerns were mainly due to lack of knowledge about the vaccine, fear of side effects and lack of recommendations from health care authorities. These high acceptance rates are similar to those reported for vaccination of girls prior to its inclusion in the Danish immunisation programme. General practitioners and national health services play a crucial role in providing parents with the information required to make an informed decision about HPV vaccination of sons as well as daughters.

HIV Vaccines

MedlinePlus