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1

Vaccines and biologics.  

PubMed

Patients with autoimmune rheumatic diseases are more susceptible to infectious complications during the course of their disease. The introduction of biologics has been a major achievement in treating these diseases, but an increased risk of infection associated with these therapies has become evident. Some infections can be prevented by vaccination and it is clearly worthwhile considering which immunisations would be sensible and practicable for these patients. To date no formal specific recommendations for patients on biologics have been published. A search was made of Medline (via PubMed) from 1970 to January 2014 to provide results. This review aims to provide a systematic analysis of the data about vaccines and biologics and considers recommendations for vaccination in adult patients with autoimmune rheumatic diseases treated with biologics. PMID:24845388

Ferreira, Isabel; Isenberg, David

2014-08-01

2

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

Federal Register 2010, 2011, 2012, 2013

...committee will meet in open session to hear an overview of the research program in the Laboratory of Enteric and Sexually Transmitted Diseases, Division of Bacterial, Parasitic and Allergenic Products, Office of Vaccines Research and Review,...

2011-07-22

3

76 FR 52668 - Vaccines and Related Biological Products Advisory Committee; Amendment of Notice  

Federal Register 2010, 2011, 2012, 2013

...committee will meet in open session to hear updates of the research programs in the Laboratory of Enteric and Sexually Transmitted Diseases, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review,...

2011-08-23

4

Systems biology in vaccine design.  

PubMed

Vaccines are the most effective tools to prevent infectious diseases and to minimize their impact on humans or animals. Despite the successful development of vaccines that are able to elicit potent and protective immune responses, the majority of vaccines have been so far developed empirically and mechanistic events leading to protective immune responses are often poorly understood. This hampers the development of new prophylactic as well as therapeutic vaccines for infectious diseases and cancer. Biological correlates of immune-mediated protection are currently based on standard readout such as antibody titres and ELISPOT assays. The development of successful vaccines for difficult settings, such as infectious agents leading to chronic infection (HIV, HCV...) or cancer, calls for novel 'readout systems' or 'correlates' of immune-mediated protection that would reliably predict immune responses to novel vaccines in vivo. Systems biology offers a new approach to vaccine design that is based upon understanding the molecular network mobilized by vaccination. Systems vaccinology approaches investigate more global correlates of successful vaccination, beyond the specific immune response to the antigens administered, providing new methods for measuring early vaccine efficacy and ultimately generating hypotheses for understanding the mechanisms that underlie successful immunogenicity. Using functional genomics, specific molecular signatures of individual vaccine can be identified and used as predictors of vaccination efficiency. The immune response to vaccination involves the coordinated induction of master transcription factors that leads to the development of a broad, polyfunctional and persistent immune response integrating all effector cells of the immune systems. PMID:22189033

Six, Adrien; Bellier, Bertrand; Thomas-Vaslin, Véronique; Klatzmann, David

2012-03-01

5

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

Federal Register 2010, 2011, 2012, 2013

...Biological Products Advisory Committee. General Function of the Committee: To provide advice and recommendations...Administration, 1401 Rockville Pike Rockville, MD 20852, (301) 827- 0314, or FDA Advisory Committee Information Line,...

2012-01-25

6

75 FR 59729 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...Biological Products Advisory Committee. General Function of the Committee: To provide advice and recommendations...Administration, 1401 Rockville, Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line,...

2010-09-28

7

77 FR 63839 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...Biological Products Advisory Committee. General Function of the Committee: To provide advice and recommendations...Administration, 1401 Rockville Pike, Rockville, MD 20852, 301- 827-0314, or FDA Advisory Committee Information Line,...

2012-10-17

8

78 FR 5465 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...Biological Products Advisory Committee. General Function of the Committee: To provide advice and recommendations...Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827- 0314, or FDA Advisory Committee Information Line,...

2013-01-25

9

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

Federal Register 2010, 2011, 2012, 2013

...Biological Products Advisory Committee. General Function of the Committee: To provide advice and recommendations...Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line,...

2011-09-07

10

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

Federal Register 2010, 2011, 2012, 2013

...Biological Products Advisory Committee. General Function of the Committee: To provide advice and recommendations...Administration, 1401 Rockville Pike (HFM-71), Rockville...301-827-0314, or FDA Advisory Committee Information Line,...

2013-10-02

11

76 FR 13646 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...Biological Products Advisory Committee. General Function of the Committee: To provide advice and recommendations...Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line,...

2011-03-14

12

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

Federal Register 2010, 2011, 2012, 2013

...Biological Products Advisory Committee. General Function of the Committee: To provide advice and recommendations...Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line,...

2013-04-05

13

76 FR 3639 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...Biological Products Advisory Committee. General Function of the Committee: To provide advice and recommendations...Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827- 0314, or FDA Advisory Committee Information Line,...

2011-01-20

14

75 FR 2876 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...Biological Products Advisory Committee. General Function of the Committee: To provide advice and recommendations...Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line,...

2010-01-19

15

77 FR 42319 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...Biological Products Advisory Committee. General Function of the Committee: To provide advice and recommendations...Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line,...

2012-07-18

16

76 FR 79203 - Prospective Grant of Exclusive License: Veterinary Biological Products for Swine Influenza Vaccines  

Federal Register 2010, 2011, 2012, 2013

...12/838,292, filed Jul 16, 2010; entitled ``Influenza DNA Vaccination and Methods of Use Thereof'', by Rao et al (NIAID...reassortment and adaption to humans. This technology describes DNA vaccines against influenza serotypes H5N1, H1N1, H3N2,...

2011-12-21

17

Plant Production of Veterinary Vaccines and Therapeutics  

Microsoft Academic Search

Plant-derived biologicals for use in animal health are becoming an increasingly important target for research into alternative,\\u000a improved methods for disease control. Although there are no commercial products on the market yet, the development and testing\\u000a of oral, plant-based vaccines is now beyond the proof-of-principle stage. Vaccines, such as those developed for porcine transmissible\\u000a gastroenteritis virus, have the potential to

R. W. Hammond; L. G. Nemchinov

18

Systems biology approach predicts immunogenicity of the yellow fever vaccine in humans  

Microsoft Academic Search

A major challenge in vaccinology is to prospectively determine vaccine efficacy. Here we have used a systems biology approach to identify early gene 'signatures' that predicted immune responses in humans vaccinated with yellow fever vaccine YF-17D. Vaccination induced genes that regulate virus innate sensing and type I interferon production. Computational analyses identified a gene signature, including complement protein C1qB and

Troy D Querec; Rama S Akondy; Eva K Lee; Weiping Cao; Helder I Nakaya; Dirk Teuwen; Ali Pirani; Kim Gernert; Jiusheng Deng; Bruz Marzolf; Kathleen Kennedy; Haiyan Wu; Soumaya Bennouna; Herold Oluoch; Joseph Miller; Ricardo Z Vencio; Mark Mulligan; Alan Aderem; Rafi Ahmed; Bali Pulendran

2008-01-01

19

Pilot Production of 'M. pneumoniae' Experimental Vaccines.  

National Technical Information Service (NTIS)

The work reported here represents the production of 36 batch runs of experimental M. pneumoniae vaccine. Within this group, 9 batches have been packaged representing 4 separate lots of vaccine which have recently been utilized in field trial studies. With...

T. R. Carski, N. F. Robillard

1971-01-01

20

The Optimal Composition of Influenza Vaccines Subject to Random Production Yields  

E-print Network

1 The Optimal Composition of Influenza Vaccines Subject to Random Production Yields Soo-Haeng Cho1@anderson.ucla.edu December 30, 2007 Abstract The Vaccine and Related Biologic Products Advisory Committee meets at least once a year to decide the composition of the influenza vaccine in the U.S. Past evidence suggests

21

Cross neutralization of dangerous snake venoms from Africa and the Middle East using the VACSERA polyvalent antivenom. Egyptian Organization for Biological Products & Vaccines.  

PubMed

This study was performed to assess the ability of polyvalent snake venom anti-serum, produced by the Egyptian Organization for Biological Products & Vaccines (VACSERA), to neutralize several toxic activities of snake venoms, not only of those included in the antivenom mixture, but also some additional venoms of snakes from Egyptian, African, and Middle Eastern habitats. In general, the results revealed that polyvalent snake venom anti-serum from VACSERA is highly effective in neutralizing Egyptian snake venoms, especially Naja haje, Naja nigricolles, Naja pallida, Cerastes cerastes, Cerastes cerastes cerastes, Cerastes vipera, Pseudocerastes persicus fieldi, and Walterinnisia egyptia. The antivenom was also effective against Naja haje, Walterinnisia egyptia, and Bites aritans from Saudi Arabia. High activity was obtained against venoms from Naja haje, Naja nigricolles, and Naja pallida of Sudan, as well as the African Naja melanoleuca, Naja mossambica, Naja naja oxiana, Bites gabonica, and Vipera lebetina. Only moderate effectiveness was obtained with Echis coloratus and Echis carinatus, and the polyvalent antiserum was ineffective against the venom of Naja nivea. PMID:12503876

Seddik, Salwa S; Wanas, Soheir; Helmy, Madiha H; Hashem, Mohamed

2002-12-01

22

Vaccine production, distribution, access and uptake  

PubMed Central

Making human vaccines available on a global scale requires the use of complex production methods, meticulous quality control and reliable distribution channels that ensure the products are potent and effective at their point of use. The technologies involved in manufacturing different types of vaccines may strongly influence vaccine cost, ease of industrial scale-up, stability and ultimately world-wide availability. Manufacturing complexity is compounded by the need for different formulations for different countries and age groups. Reliable vaccine production in appropriate quantities and at affordable prices is the cornerstone of developing global vaccination policies. However, ensuring optimal access and uptake also requires strong partnerships between private manufacturers, regulatory authorities and national and international public health services. For vaccines whose supplies are limited, either due to rapidly emerging diseases or longer-term mismatch of supply and demand, prioritizing target groups can increase vaccine impact. Focusing on influenza vaccines as an example that well illustrates many of the relevant points, this article considers current production, distribution, access and other factors that ultimately impact on vaccine uptake and population-level effectiveness. PMID:21664680

Smith, Jon; Lipsitch, Marc; Almond, Jeffrey W.

2011-01-01

23

Optimization of vaccine production for animal health  

Microsoft Academic Search

Vaccines on the basis of mammalian cell cultures are of major importance for human and animal health. Therefore efforts are undertaken for the improved production of more effective vaccines. Of course, the main purpose of all these approaches is to save lives and improve the quality of life for human beings. However, there is also some remarkable effort in the

W. Noe; R. Bux; W. Berthold; W. Werz

1994-01-01

24

78 FR 65904 - Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products  

Federal Register 2010, 2011, 2012, 2013

...to biological products, including vaccines and plasma-derived products and their recombinant analogs...section 506C to biological products, ``including plasma products derived from human plasma protein and their recombinant analogs''...

2013-11-04

25

The search for a promising cell factory system for production of edible vaccine.  

PubMed

Despite worldwide vaccination against devastating diseases for decades, millions of children in remote and impoverished regions of the globe die every year from vaccine-preventable infectious diseases. The reasons for incomplete coverage of vaccination programs are based in part on the relatively high costs of conventional vaccinations, including mass production, refrigeration, transportation, and training as well as funding personnel for their administration. Plant-based edible vaccines (PEVs) have been introduced as a revolutionary cost-effective vaccination modality. However, they suffer from major deficiencies that have restricted their application to bench-scale. This article discusses the deficiencies of PEVs and also provides concise overview on the health-promoting, biological and biotechnological features of spirulina (Arthrospira). In short, we envision that spirulina could be considered as a potential alternative biofactory system to the plants toward the production of edible vaccines in high-yield with low-costs that other hosts cannot yet offer. PMID:25424962

Barzegari, Abolfazl; Saeedi, Nazli; Zarredar, Habib; Barar, Jaleh; Omidi, Yadollah

2014-08-01

26

Immune Signatures and Systems Biology of Vaccines  

Microsoft Academic Search

\\u000a Vaccines represent a strategic successful tool to prevent or contain diseases with high morbidity or mortality. However, despite\\u000a the extensive and wide use, we still have a limited knowledge on mechanisms underlying the effective elicitation of protective\\u000a immune responses by vaccines, which represents the final outcome of a effective cooperation between the innate and adaptive\\u000a arms of the immunity.\\u000a \\u000a \\u000a Immunity

F. M. Buonaguro; M. L. Tornesello; L. Buonaguro

27

FDA 101: Regulating Biological Products  

MedlinePLUS

... mail Consumer Updates RSS Feed FDA 101: Regulating Biological Products Search the Consumer Updates Section Consumer Update ... friendly PDF (196 KB) On this page: What biological products does FDA regulate? How do biologics differ ...

28

SmithKline Beecham Biologicals Worldwide Vaccines  

NSDL National Science Digital Library

This new site from SmithKline Beecham, a "virtual gateway into the world of vaccinology," offers a host of resources on vaccination and vaccine preventable diseases. These resources are organized in three principle sections: Disease, Bio News, and Links. The first and largest section contains various reference resources for ten different diseases or disease groups, which are listed in four columns: disease, virus, epidemiology, and prevention. Although a public site, much of this information is aimed at physicians, health professionals, or other informed users. The Bio News section offers a selection of recent and archived scientific published data from peer-reviewed journals, a select list of links for breaking health news, and recent SmithKline Beecham vaccine press releases. A collection of related annotated links, sorted by country, rounds out the site. An additional site for registered medical professionals only is also available, and these users may log on via the public site. Please note that the site authors indicate that "This site is not intended for US audiences."

29

Cattle Vaccines  

E-print Network

Vaccines deliver antigens that stimulate the body's production of antibodies in response to disease. Cattle can be vaccinated with noninfectious or infectious vaccines. The types of vaccine products, proper handling of vaccines, and vaccination...

Faries Jr., Floron C.

2005-11-11

30

Avipoxviruses: infection biology and their use as vaccine vectors  

PubMed Central

Avipoxviruses (APVs) belong to the Chordopoxvirinae subfamily of the Poxviridae family. APVs are distributed worldwide and cause disease in domestic, pet and wild birds of many species. APVs are transmitted by aerosols and biting insects, particularly mosquitoes and arthropods and are usually named after the bird species from which they were originally isolated. The virus species Fowlpox virus (FWPV) causes disease in poultry and associated mortality is usually low, but in flocks under stress (other diseases, high production) mortality can reach up to 50%. APVs are also major players in viral vaccine vector development for diseases in human and veterinary medicine. Abortive infection in mammalian cells (no production of progeny viruses) and their ability to accommodate multiple gene inserts are some of the characteristics that make APVs promising vaccine vectors. Although abortive infection in mammalian cells conceivably represents a major vaccine bio-safety advantage, molecular mechanisms restricting APVs to certain hosts are not yet fully understood. This review summarizes the current knowledge relating to APVs, including classification, morphogenesis, host-virus interactions, diagnostics and disease, and also highlights the use of APVs as recombinant vaccine vectors. PMID:21291547

2011-01-01

31

Influenza Vaccines: From Surveillance Through Production to Protection  

PubMed Central

Influenza is an important contributor to population and individual morbidity and mortality. The current influenza pandemic with novel H1N1 has highlighted the need for health care professionals to better understand the processes involved in creating influenza vaccines, both for pandemic as well as for seasonal influenza. This review presents an overview of influenza-related topics to help meet this need and includes a discussion of the burden of disease, virology, epidemiology, viral surveillance, and vaccine strain selection. We then present an overview of influenza vaccine—related topics, including vaccine production, vaccine efficacy and effectiveness, influenza vaccine misperceptions, and populations that are recommended to receive vaccination. English-language articles in PubMed published between January 1, 1970, and October 7, 2009, were searched using key words human influenza, influenza vaccines, influenza A, and influenza B. PMID:20118381

Tosh, Pritish K.; Jacobson, Robert M.; Poland, Gregory A.

2010-01-01

32

Production of a falcon herpesvirus vaccine.  

PubMed

Ten common kestrels (Falco tinnunculus) were used for this falcon herpes vaccine experiment. Four kestrels were subcutaneously given 1 ml of an attenuated falcon herpesvirus that had originally been isolated from the liver of an American prairie falcon (Falco mexicanus). This virus was then passaged 100 times on chicken embryo fibroblast cells (CEF-cells). Another 4 kestrels were given subcutaneously an inactivated falcon herpesvirus vaccine derived from the same American field strain. This vaccine was concentrated, inactivated by heat and betapropiolactone and emulsified in complete Freund's adjuvans. Two further kestrels served as controls and were not vaccinated. Twenty-one days after vaccination, all 10 kestrels were challenged with passage 3 of the American falcon herpesvirus. The 2 control kestrels died 6 days after challenge and 3 of those given the inactivated herpes vaccine died 9 days after challenge, with typical lesions of herpesvirus inclusion body hepatitis. Before the vaccination experiment, all 10 kestrels were free of serum neutralising antibodies to the falcon herpesvirus. Twenty-one days after vaccination, all 4 kestrels vaccinated with the attenuated vaccine, and one vaccinated with the killed vaccine, had seroconverted, having shown no symptoms to the challenge with a low passage virulent American herpesvirus strain. Following the challenge their antibody titres to falcon herpesvirus increased. No herpesvirus was isolated from any of the cloacal swabs taken during this experiment, indicating that there is no danger for any other birds from the attenuated herpesvirus vaccine. This experiment clearly shows that an attenuated falcon herpesvirus vaccine can protect kestrels from fatal inclusion body hepatitis. PMID:10507183

Wernery, U; Wernery, R; Kinne, J

1999-09-01

33

The Differential Impact of Coadministered Vaccines, Geographic Region, Vaccine Product and Other Covariates on Pneumococcal Conjugate Vaccine Immunogenicity  

PubMed Central

Background: Antipneumococcal capsular polysaccharide antibody concentrations are used as predictors of vaccine efficacy against vaccine serotype (ST) pneumococcal disease among infants. While pneumococcal conjugate vaccines (PCV) are recommended globally, factors associated with optimal PCV immune response are not well described. We aimed to systematically assess local setting factors, beyond dosing schedule, which may affect PCV antibody levels. Methods: We conducted a literature review of PCV immunogenicity, abstracting data from published reports, unpublished sources, and conference abstracts from 1994 to 2010 (and ad hoc 2011 reports). Studies included in this analysis evaluated ? 2 primary doses of PCV before 6 months of age in non–high-risk populations, used 7-valent or higher PCV products (excluding Aventis-Pasteur and Merck products) and provided information on geometric mean concentration (GMC) for STs 1, 5, 6B, 14, 19F or 23F. Using random effects meta-regression, we assessed the impact of geographic region, coadministered vaccines and PCV product on postprimary GMC, adjusting for dosing schedule and ELISA laboratory method. Results: Of 12,980 citations reviewed, we identified 103 vaccine study arms for this analysis. Children in studies from Asia, Africa and Latin America had significantly higher GMC responses compared with those in studies from Europe and North America. Coadministration with acellular pertussis DTP compared with whole-cell DTP had no effect on PCV immunogenicity except for ST14, where GMCs were higher when coadministered with acellular pertussis DTP. Vaccine product, number of PCV doses, dosing interval, age at first dose and ELISA laboratory method also affected the GMC. Conclusions: PCV immunogenicity is associated with geographic region and vaccine product; however, the associations and magnitude varied by ST. Consideration of these factors is essential when comparing PCV immunogenicity results between groups and should be included in the evidence base when selecting optimal PCV vaccine schedules in specific settings. PMID:24336055

2014-01-01

34

75 FR 55776 - Request for Comments on Vaccine Production and Additional Planning for Future Possible Pandemic...  

Federal Register 2010, 2011, 2012, 2013

...Administration Request for Comments on Vaccine Production and Additional Planning for...the public and relevant industries on vaccine production and additional planning for...of the following methods: E-mail: Vaccine.Comments@trade.gov. Fax:...

2010-09-14

35

Foods as Production and Delivery Vehicles for Human Vaccines  

E-print Network

the use of genetically modified plants. It has been demonstrated that plant-derived antigensReview Foods as Production and Delivery Vehicles for Human Vaccines Schuyler S. Korban, PhD, Sergei.E.B.), University of Illinois, Urbana, Illinois Key words: food crops, transgenic plants, plant-based vaccines, oral

Korban, Schuyler S.

36

Vaccine R & D at CSIRO's Division of Tropical Animal Production.  

PubMed

The extensive research on animal vaccines being undertaken by the CSIRO Division of Tropical Animal Production in Brisbane is summarised in this paper. Much of the research is being developed in conjunction with commercial partners. Vaccines are being developed for the cattle tick, Babesia, Anaplasma, sheep blowfly, buffalo fly and bovine ephemeral fever. PMID:1367735

Leitch, A

1991-12-01

37

Journal of Theoretical Biology 253 (2008) 118130 A model for influenza with vaccination and antiviral treatment  

E-print Network

Journal of Theoretical Biology 253 (2008) 118­130 A model for influenza with vaccination Compartmental models for influenza that include control by vaccination and antiviral treatment are formulated are compared with those of recent stochastic simulation influenza models. Predictions of the deterministic

Arino, Julien

38

Biological safety concepts of genetically modified live bacterial vaccines  

Microsoft Academic Search

Live vaccines possess the advantage of having access to induce cell-mediated and antibody-mediated immunity; thus in certain cases they are able to prevent infection, and not only disease. Furthermore, live vaccines, particularly bacterial live vaccines, are relatively cheap to produce and easy to apply. Hence they are suitable to immunize large communities or herds. The induction of both cell-mediated immunity

Joachim Frey

2007-01-01

39

Smallpox and biological warfare: the case for abandoning vaccination of military personnel.  

PubMed Central

Smallpox was officially declared eradicated from the world in 1980. Earlier, in 1972, over 50 nations signed the Biological Weapons Convention renouncing this entire category of weapons. Despite this international agreement, both the United States and the Soviet Union continue to vaccinate their military troops against smallpox, thus implying that each fears the other might still use it in biological warfare. Vaccination is not a harmless procedure, and vaccinia infections continue to be reported in troops and their contacts. Negotiating an end to the vaccination of troops would be a final step in ending the fear of smallpox. PMID:2944401

Capps, L; Vermund, S H; Johnsen, C

1986-01-01

40

Production of EV71 vaccine candidates  

PubMed Central

Enterovirus 71 (EV71) is now recognized as an emerging neurotropic virus in Asia and with Coxsackie virus (CV) it is the other major causative agent of hand-foot-mouth diseases (HFMD). Effective medications and/or prophylactic vaccines against HFMD are urgently needed. From a scientific (the feasibility of bioprocess, immunological responses and potency in animal challenge model) and business development (cost of goods) points of view, we in this review address and discuss the pros and cons of different EV71 vaccine candidates that have been produced and evaluated in animal models. Epitope-based synthetic peptide vaccine candidates containing residues 211–225 of VP1 formulated with Freund’s adjuvant (CFA/IFA) elicited low EV71 virus neutralizing antibody responses, but were protective in the suckling mouse challenge model. Among recombinant EV71 subunits (rVP1, rVP2 and rVP3) expressed in E. coli, purified and formulated with CFA/IFA, only VP1 elicited mouse antibody responses with measurable EV71-specific virus neutralization titers. Immunization of mice with either a DNA plasmid containing VP1 gene or VP1 expressed in Salmonella typhimurium also generated neutralizing antibody responses and protected animals against a live EV71 challenge. Recombinant EV71 virus-like particles (rVLP) produced from baculovirus formulated either with CFA/IFA or alum elicited good virus neutralization titers in both mice and non-human primates, and were found to be protective in the suckling mouse EV71 challenge model. Synthetic peptides or recombinant EV71 subunit vaccines (rVP1 and rVLP) formulated in alum were found to be poorly immunogenic in rabbits. Only formalin-inactivated (FI) EV71 virions formulated in alum elicited cross-neutralizing antibodies against different EV71 genotypes in mice, rabbits and non-human primates but induced weak neutralizing responses against CAV16. From a regulatory, economic and market acceptability standpoint, FI-EV71 virion vaccines are the most promising candidates and are currently being evaluated in human clinical trials. We further describe and analyze some new bioprocesses technologies that have great potential applications in EV71 vaccine development. This review also demonstrates the opportunities and challenges that the Asian vaccine industry faces today. PMID:22992566

Chong, Pele; Hsieh, Shih-Yang; Liu, Chia-Chyi; Chou, Ai-Hsiang; Chang, Jui-Yuan; Wu, Suh-Chin; Liu, Shih-Jen; Chow, Yen-Hung; Su, Ih-Jen; Klein, Michel

2012-01-01

41

Designing vaccines based on biology of human dendritic cell subsets  

PubMed Central

The effective vaccines developed against a variety of infectious agents, including polio, measles and Hepatitis B, represent major achievements in medicine. These vaccines, usually composed of microbial antigens, are often associated with an adjuvant that activates dendritic cells (DCs). Many infectious diseases are still in need of an effective vaccine including HIV, malaria, hepatitis C and tuberculosis. In some cases, the induction of cellular rather than humoral responses may be more important as the goal is to control and eliminate the existing infection rather than to prevent it. Our increased understanding of the mechanisms of antigen presentation, particularly with the description of DC subsets with distinct functions, as well as their plasticity in responding to extrinsic signals, represent opportunities to develop novel vaccines. In addition, we foresee that this increased knowledge will permit us to design vaccines that will reprogram the immune system to intervene therapeutically in cancer, allergy and autoimmunity. PMID:21029958

Palucka, Karolina; Banchereau, Jacques; Mellman, Ira

2010-01-01

42

Ontology-supported research on vaccine efficacy, safety and integrative biological networks.  

PubMed

While vaccine efficacy and safety research has dramatically progressed with the methods of in silico prediction and data mining, many challenges still exist. A formal ontology is a human- and computer-interpretable set of terms and relations that represent entities in a specific domain and how these terms relate to each other. Several community-based ontologies (including Vaccine Ontology, Ontology of Adverse Events and Ontology of Vaccine Adverse Events) have been developed to support vaccine and adverse event representation, classification, data integration, literature mining of host-vaccine interaction networks, and analysis of vaccine adverse events. The author further proposes minimal vaccine information standards and their ontology representations, ontology-based linked open vaccine data and meta-analysis, an integrative One Network ('OneNet') Theory of Life, and ontology-based approaches to study and apply the OneNet theory. In the Big Data era, these proposed strategies provide a novel framework for advanced data integration and analysis of fundamental biological networks including vaccine immune mechanisms. PMID:24909153

He, Yongqun

2014-07-01

43

Bioprocess optimization for cell culture based influenza vaccine production.  

PubMed

Uncertainties and shortcomings associated with the current influenza vaccine production processes demand attention and exploration of new vaccine manufacture technologies. Based on a newly developed mammalian cell culture-based production process we investigated selected process parameters and describe three factors that are shown to impact productivity, process robustness and development time. They are time of infection, harvest time and virus input, or multiplicity of infection (MOI). By defining the time of infection as 4-5 days post cell seeding and harvest time as 2-3 days post-infection and comparing their effect on virus production, MOI is subsequently identified as the most impactful process parameter for live attenuated influenza vaccine (LAIV) manufacture. Infection at very low MOI (between 10(-4) and 10(-6) FFU/cell) resulted in high titer virus production (up to 30-fold productivity improvement) compared to higher MOI infections (10(-3) to 10(-2) FFU/cell). Application of these findings has allowed us to develop a platform process that can reduce the development time to approximately three weeks for an influenza vaccine manufacture process for new strains. PMID:21335031

Aggarwal, Kunal; Jing, Frank; Maranga, Luis; Liu, Jonathan

2011-04-12

44

Enhancing the role of veterinary vaccines reducing zoonotic diseases of humans: Linking systems biology with vaccine development  

SciTech Connect

The aim of research on infectious diseases is their prevention, and brucellosis and salmonellosis as such are classic examples of worldwide zoonoses for application of a systems biology approach for enhanced rational vaccine development. When used optimally, vaccines prevent disease manifestations, reduce transmission of disease, decrease the need for pharmaceutical intervention, and improve the health and welfare of animals, as well as indirectly protecting against zoonotic diseases of people. Advances in the last decade or so using comprehensive systems biology approaches linking genomics, proteomics, bioinformatics, and biotechnology with immunology, pathogenesis and vaccine formulation and delivery are expected to enable enhanced approaches to vaccine development. The goal of this paper is to evaluate the role of computational systems biology analysis of host:pathogen interactions (the interactome) as a tool for enhanced rational design of vaccines. Systems biology is bringing a new, more robust approach to veterinary vaccine design based upon a deeper understanding of the host pathogen interactions and its impact on the host's molecular network of the immune system. A computational systems biology method was utilized to create interactome models of the host responses to Brucella melitensis (BMEL), Mycobacterium avium paratuberculosis (MAP), Salmonella enterica Typhimurium (STM), and a Salmonella mutant (isogenic *sipA, sopABDE2) and linked to the basis for rational development of vaccines for brucellosis and salmonellosis as reviewed by Adams et al. and Ficht et al. [1,2]. A bovine ligated ileal loop biological model was established to capture the host gene expression response at multiple time points post infection. New methods based on Dynamic Bayesian Network (DBN) machine learning were employed to conduct a comparative pathogenicity analysis of 219 signaling and metabolic pathways and 1620 gene ontology (GO) categories that defined the host's biosignatures to each infectious condition. Through this DBN computational approach, the method identified significantly perturbed pathways and GO category groups of genes that define the pathogenicity signatures of the infectious agent. Our preliminary results provide deeper understanding of the overall complexity of host innate immune response as well as the identification of host gene perturbations that defines a unique host temporal biosignature response to each pathogen. The application of advanced computational methods for developing interactome models based on DBNs has proven to be instrumental in elucidating novel host responses and improved functional biological insight into the host defensive mechanisms. Evaluating the unique differences in pathway and GO perturbations across pathogen conditions allowed the identification of plausible host pathogen interaction mechanisms. Accordingly, a systems biology approach to study molecular pathway gene expression profiles of host cellular responses to microbial pathogens holds great promise as a methodology to identify, model and predict the overall dynamics of the host pathogen interactome. Thus, we propose that such an approach has immediate application to the rational design of brucellosis and salmonellosis vaccines.

Adams, Leslie G.; Khare, Sangeeta; Lawhon, Sara D.; Rossetti, Carlos A.; Lewin, Harris A.; Lipton, Mary S.; Turse, Joshua E.; Wylie, Dennis C.; Bai, Yu; Drake, Kenneth L.

2011-09-22

45

Biological consequences of multiple vaccine and pyridostigmine pretreatment in the guinea pig.  

PubMed

An investigation of the possible interactions between combinations of vaccines and pyridostigmine bromide (PB) has been undertaken in the guinea pig. This study is part of a research programme funded by the UK Government to determine any effects of the pretreatment regimes given to UK Forces during the Persian Gulf conflict of 1990-1991. The study was designed to simulate PB administration and to model multiple vaccination protocols that were experienced by UK Forces, modelling a "worst case" situation in which all ten vaccines and PB were administered within a short period of time. Seven of the vaccines were health and hygiene (H+H) vaccines given to protect against endemic diseases and two vaccines to protect against the biological warfare agents anthrax and plague. In addition, pertussis vaccine was administered as an adjuvant to reduce the time to achieve immunity against anthrax. Four groups of eight animals were treated with 1/20th, 1/10th or 1/5th human doses of vaccines or vehicles, respectively. The PB or saline was delivered by implanted 28 day mini-osmotic pumps to achieve a mean red blood cell acetylcholinesterase (AChE) inhibition of around 30%. Body weight, temperature, immunological response, biochemical indices and spontaneous activity were monitored for 72 days. Although immunological responses to bacterial vaccines were observed, there were no remarkable findings in the parameters measured other than minor changes in body weight (4.9% decrease at the 1/5th human dose of vaccines) and temperature increases in response to vaccination. Animals in all groups remained generally healthy and active without visible adverse signs throughout the study. Reproduced with the permission of Her Majesty's Stationery Office. Published by John Wiley & Sons, Ltd. PMID:11180281

Griffiths, G D; Hornby, R J; Stevens, D J; Scott, L A; Upshall, D G

2001-01-01

46

Biological safety concepts of genetically modified live bacterial vaccines.  

PubMed

Live vaccines possess the advantage of having access to induce cell-mediated and antibody-mediated immunity; thus in certain cases they are able to prevent infection, and not only disease. Furthermore, live vaccines, particularly bacterial live vaccines, are relatively cheap to produce and easy to apply. Hence they are suitable to immunize large communities or herds. The induction of both cell-mediated immunity as well as antibody-mediated immunity, which is particularly beneficial in inducing mucosal immune responses, is obtained by the vaccine-strain's ability to colonize and multiply in the host without causing disease. For this reason, live vaccines require attenuation of virulence of the bacterium to which immunity must be induced. Traditionally attenuation was achieved simply by multiple passages of the microorganism on growth medium, in animals, eggs or cell cultures or by chemical or physical mutagenesis, which resulted in random mutations that lead to attenuation. In contrast, novel molecular methods enable the development of genetically modified organisms (GMOs) targeted to specific genes that are particularly suited to induce attenuation or to reduce undesirable effects in the tissue in which the vaccine strains can multiply and survive. Since live vaccine strains (attenuated by natural selection or genetic engineering) are potentially released into the environment by the vaccinees, safety issues concerning the medical as well as environmental aspects must be considered. These involve (i) changes in cell, tissue and host tropism, (ii) virulence of the carrier through the incorporation of foreign genes, (iii) reversion to virulence by acquisition of complementation genes, (iv) exchange of genetic information with other vaccine or wild-type strains of the carrier organism and (v) spread of undesired genes such as antibiotic resistance genes. Before live vaccines are applied, the safety issues must be thoroughly evaluated case-by-case. Safety assessment includes knowledge of the precise function and genetic location of the genes to be mutated, their genetic stability, potential reversion mechanisms, possible recombination events with dormant genes, gene transfer to other organisms as well as gene acquisition from other organisms by phage transduction, transposition or plasmid transfer and cis- or trans-complementation. For this, GMOs that are constructed with modern techniques of genetic engineering display a significant advantage over random mutagenesis derived live organisms. The selection of suitable GMO candidate strains can be made under in vitro conditions using basic knowledge on molecular mechanisms of pathogenicity of the corresponding bacterial species rather than by in vivo testing of large numbers of random mutants. This leads to a more targeted safety testing on volunteers and to a reduction in the use of animal experimentation. PMID:17239999

Frey, Joachim

2007-07-26

47

9 CFR 113.3 - Sampling of biological products.  

Code of Federal Regulations, 2013 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...samples of Rabies Vaccine, Modified Live Virus; (v) Sixteen samples of all other...Equine Encephalomyelitis Vaccine, Killed Virus; (vii) Twenty-two...

2013-01-01

48

9 CFR 113.3 - Sampling of biological products.  

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...samples of Rabies Vaccine, Modified Live Virus; (v) Sixteen samples of all other...Equine Encephalomyelitis Vaccine, Killed Virus; (vii) Twenty-two...

2014-01-01

49

9 CFR 113.3 - Sampling of biological products.  

Code of Federal Regulations, 2011 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...samples of Rabies Vaccine, Modified Live Virus; (v) Sixteen samples of all other...Equine Encephalomyelitis Vaccine, Killed Virus; (vii) Twenty-two...

2011-01-01

50

9 CFR 113.3 - Sampling of biological products.  

Code of Federal Regulations, 2012 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...samples of Rabies Vaccine, Modified Live Virus; (v) Sixteen samples of all other...Equine Encephalomyelitis Vaccine, Killed Virus; (vii) Twenty-two...

2012-01-01

51

Scale-down of the inactivated polio vaccine production process.  

PubMed

The anticipated increase in the demand for inactivated polio vaccines resulting from the success in the polio eradication program requires an increase in production capacity and cost price reduction of the current inactivated polio vaccine production processes. Improvement of existing production processes is necessary as the initial process development has been done decades ago. An up-to-date lab-scale version encompassing the legacy inactivated polio vaccine production process was set-up. This lab-scale version should be representative of the large scale, meaning a scale-down model, to allow experiments for process optimization that can be readily applied. Initially the separate unit operations were scaled-down at setpoint. Subsequently, the unit operations were applied successively in a comparative manner to large-scale manufacturing. This allows the assessment of the effects of changes in one unit operation to the consecutive units at small-scale. Challenges in translating large-scale operations to lab-scale are discussed, and the concessions that needed to be made are described. The current scale-down model for cell and virus culture (2.3-L) presents a feasible model with its production scale counterpart (750-L) when operated at setpoint. Also, the current scale-down models for the DSP unit operations clarification, concentration, size exclusion chromatography, ion exchange chromatography, and inactivation are in agreement with the manufacturing scale. The small-scale units can be used separately, as well as sequentially, to study variations and critical product quality attributes in the production process. Finally, it is shown that the scale-down unit operations can be used consecutively to prepare trivalent vaccine at lab-scale with comparable characteristics to the product produced at manufacturing scale. PMID:23192424

Thomassen, Yvonne E; van 't Oever, Aart G; Vinke, Marian; Spiekstra, Arjen; Wijffels, René H; van der Pol, Leo A; Bakker, Wilfried A M

2013-05-01

52

Modeling Shrimp Biomass and Viral Infection for Production of Biological Countermeasures  

E-print Network

Modeling Shrimp Biomass and Viral Infection for Production of Biological Countermeasures H. T of large quantities of therapeutic and/or preventative countermeasures. We couple equations for biomass machinery in an existing biomass for the production of a vaccine or antibody by infection using a virus

53

Long?Lasting T Cell Responses to Biological Warfare Vaccines in Human Vaccinees  

Microsoft Academic Search

Background. Medical countermeasures against biological warfare include the use of vaccines for anthrax and plague, which require repeated dosing and adjuvant to achieve adequate protection from threats such as inhalational anthrax and pneumonic plague. Despite the widespread use of these measures in preparation for recent military deployments, little is known about the cell-mediated immune response that is induced by these

Jennifer S. Allen; Ania Skowera; G. James Rubin; Simon Wessely; Mark Peakman

2006-01-01

54

Production of a genetically engineered inhibin vaccine  

Microsoft Academic Search

The goal of this research was to synthesize a chimeric ovalbumin\\/inhibin antigen using recombinant techniques. Antigenic epitopes of the translated product from an ovalbumin cDNA were mapped using computer modeling techniques. The corresponding nucleotide sequences of ovalbumin epitopes were examined for unique restriction sites to allow insertion of a synthetic bovine inhibin ? gene fragment which encoded the first 26

T. W. Geary; J. J. Reeves

1996-01-01

55

Possible autoimmune reactions following smallpox vaccination: the biologic false positive test for syphilis.  

PubMed

Due to the threat of bioterrorism, large-scale clinical trials of a new cell culture smallpox vaccine were conducted. Biologically false positive (BFR) serological reactions to viruses (hepatitis B and C, HIV) and syphilis were evaluated. BPR rapid reagin tests (RPR) to syphilis occurred in 19% and false positive tests for antibody to hepatitis B in 3.3% of 90 healthy adults undergoing primary vaccination. Most subjects (94%) were RPR-positive on Day 15 after vaccination and all seroreverted within 2 months thereafter. One subject with myocarditis was RPR-negative. One RPR-positive and 1 RPR-negative subject had elevated CK-MB enzymes without other evidence for myocarditis. PMID:19022322

Monath, Thomas P; Frey, Sharon E

2009-03-01

56

[Viral safety of biological medicinal products].  

PubMed

Viral safety of blood donations, plasma products, viral vaccines and gene therapy medicinal products, biotechnical-derived products and tissue and cell therapy products is a particular challenge. These products are manufactured using a variety of human or animal-derived starting materials and reagents; therefore, extensive testing of donors and of cell banks established for production is required. Furthermore, the viral safety of reagents, such as bovine sera, porcine trypsin and human transferrin or albumin needs to be considered. Whenever possible, manufacturing steps for inactivation or removal of viruses should be introduced; however, sometimes it is not possible to introduce such steps for tissues or cell-based medicinal products as the activity and viability of cells will be compromised. It might be possible to implement steps for inactivation or removal of potential contaminating enveloped viruses only for production of small and stable non-enveloped viral gene vectors. PMID:25123140

Stühler, A; Blümel, J

2014-10-01

57

Development of an attenuated strain of chikungunya virus for use in vaccine production.  

PubMed

An attenuated chikungunya (CHIK) virus clone was developed for production of a live vaccine for human use. CHIK strain 15561 was subjected to 18 plaque-to-plaque passages in MRC-5 cultures before CHIK 181/clone 25 was selected as vaccine seed based on homogeneous small plaque size, suckling mouse avirulence, reduced monkey viraemia and genetic stability. Oligonucleotide mapping demonstrated differences between parent and clone. Vaccine (pilot-lot production) elicited neutralizing antibody and protected mice and rhesus monkeys against challenge. After challenge, viraemias were absent in vaccinated monkeys. Vaccine was then produced and tested in accordance with governmental regulatory requirements of human use. PMID:3020820

Levitt, N H; Ramsburg, H H; Hasty, S E; Repik, P M; Cole, F E; Lupton, H W

1986-09-01

58

Pediatricians Knowledge, Views, and Perspectives on Smallpox and Smallpox Vaccine  

Microsoft Academic Search

Increasing concerns regarding smallpox as a biologic weapon have led to massive production of vaccinia vaccine and targeted vaccination campaigns. A regional mail survey was conducted among pediatricians to assess their knowledge and perceptions on smallpox and smallpox vaccine. Fifty-nine percent of the responders were unable to differentiate chickenpox from smallpox, and the majority would not accept vaccination in the

M. Cecilia Di Pentima; Stephen C. Eppes; Joel D. Klein

2006-01-01

59

Biological Challenges and Technological Opportunities for Respiratory Syncytial Virus Vaccine Development  

PubMed Central

Summary Respiratory syncytial virus (RSV) is an important cause of respiratory disease causing high rates of hospitalizations in infants, significant morbidity in children and adults, and excess mortality in the elderly. Major barriers to vaccine development include early age of RSV infection, capacity of RSV to evade innate immunity, failure of RSV-induced adaptive immunity to prevent reinfection, history of RSV vaccine-enhanced disease, and lack of an animal model fully permissive to human RSV infection. These biological challenges, safety concerns, and practical issues have significantly prolonged the RSV vaccine development process. One great advantage compared to other difficult viral vaccine targets is that passively administered neutralizing monoclonal antibody is known to protect infants from severe RSV disease. Therefore, the immunological goals for vaccine development are to induce effective neutralizing antibody to prevent infection and to avoid inducing T-cell response patterns associated with enhanced disease. Live-attenuated RSV and replication-competent chimeric viruses are in advanced clinical trials. Gene-based strategies, which can control the specificity and phenotypic properties of RSV-specific T-cell responses utilizing replication-defective vectors and which may improve on immunity from natural infection, are progressing through preclinical testing. Atomic level structural information on RSV envelope glycoproteins in complex with neutralizing antibodies is guiding design of new vaccine antigens that may be able to elicit RSV-specific antibody responses without induction of RSV-specific T-cell responses. These new technologies may allow development of vaccines that can protect against RSV-mediated disease in infants and establish a new immunological paradigm in the host to achieve more durable protection against reinfection. PMID:21198670

Graham, Barney S.

2011-01-01

60

Pre-Vaccination Nasopharyngeal Pneumococcal Carriage in a Nigerian Population: Epidemiology and Population Biology  

PubMed Central

Background Introduction of pneumococcal vaccines in Nigeria is a priority as part of the Accelerated Vaccine Introduction Initiative (AVI) of the Global Alliance for Vaccines and Immunisation (GAVI). However, country data on the burden of pneumococcal disease (IPD) is limited and coverage by available conjugate vaccines is unknown. This study was carried out to describe the pre vaccination epidemiology and population biology of pneumococcal carriage in Nigeria. Methods This was a cross sectional survey. Nasopharyngeal swabs (NPS) were obtained from a population sample in 14 contiguous peri-urban Nigerian communities. Data on demographic characteristics and risk factor for carriage were obtained from all study participants. Pneumococci isolated from NPS were characterised by serotyping, antimicrobial susceptibility and Multi Locus Sequencing Typing (MLST). Results The prevalence of pneumococcal carriage was 52.5%. Carriage was higher in children compared to adults (67.4% vs. 26%), highest (?90%) in infants aged <9 months and reduced significantly with increasing age (P<0.001). Serotypes 19F (18.6%) and 6A (14.4%) were most predominant. Potential vaccine coverage was 43.8%, 45.0% and 62% for PCV-7, PCV-10 and PCV-13 respectively. There were 16 novel alleles, 72 different sequence types (STs) from the isolates and 3 Sequence Types (280, 310 and 5543) were associated with isolates of more than one serotype indicative of serotype switching. Antimicrobial resistance was high for cotrimoxazole (93%) and tetracycline (84%), a third of isolates had intermediate resistance to penicillin. Young age was the only risk factor significantly associated with carriage. Conclusions Pneumococcal carriage and serotype diversity is highly prevalent in Nigeria especially in infants. Based on the coverage of serotypes in this study, PCV-13 is the obvious choice to reduce disease burden and prevalence of drug resistant pneumococci. However, its use will require careful monitoring. Our findings provide sound baseline data for impact assessment following vaccine introduction in Nigeria. PMID:22291984

Adetifa, Ifedayo M. O.; Antonio, Martin; Okoromah, Christy A. N.; Ebruke, Chinelo; Inem, Victor; Nsekpong, David; Bojang, Abdoulie; Adegbola, Richard A.

2012-01-01

61

[Book review] Developments in biological standardization (Vol. 49): Fish Biologics: Seriodiagnostics and Vaccines, edited by W. Hennessen and D. P. Andersen  

USGS Publications Warehouse

Review of: Developments in Biologicals, Vol. 49. Fish Biologics: Serodiagnostics and Vaccines. International Symposium, Leetown, W.Va., April 1981. Editor(s): Hennessen, W. (Bern); Andersen, D.P. (Leetown, W.Va.); Society/Societies: International Association of Biological Standardization, XII + 496 p., 90 fig., 110 tab., soft cover, 1981. ISBN: 978-3-8055-3471-0.

Anderson, D. P.

1981-01-01

62

Varicella (Chickenpox) Vaccine  

MedlinePLUS

... product containing Measles Vaccine, Mumps Vaccine, Rubella Vaccine, Varicella Vaccine) ... about 1 person in 20) than MMR and varicella vaccines given separately. Moderate Problems:Seizure (jerking or staring) ...

63

Production of adenovirus vectors and their use as a delivery system for influenza vaccines  

PubMed Central

IMPORTANCE OF THE FIELD With the emergence of highly pathogenic avian influenza H5N1 viruses that have crossed species barriers and are responsible for lethal infections in humans in many countries, there is an urgent need for the development of effective vaccines which can be produced in large quantities at a short notice and confer broad protection against these H5N1 variants. In order to meet the potential global vaccine demand in a pandemic scenario, new vaccine-production strategies must be explored in addition to the currently used egg-based technology for seasonal influenza. AREAS COVERED IN THIS REVIEW Adenovirus (Ad) based influenza vaccines represent an attractive alternative/supplement to the currently licensed egg-based influenza vaccines. Ad-based vaccines are relatively inexpensive to manufacture, and their production process does not require either chicken eggs or labor intensive and time-consuming processes necessitating enhanced biosafety facilities. Most importantly, in a pandemic situation, this vaccine strategy could offer a stockpiling option to reduce the response time before a strain-matched vaccine could be developed. WHAT THE READER WILL GAIN This review discusses Ad-vector technology and the current progress in the development of Ad-based influenza vaccines. TAKE HOME MESSAGE Ad vector-based influenza vaccines for pandemic preparedness are under development to meet the global vaccine demand. PMID:20822477

Vemula, Sai V.; Mittal, Suresh K.

2010-01-01

64

Methods to select suitable fetal bovine serum for use in quality control assays for the detection of adventitious viruses from biological products  

Microsoft Academic Search

Production of biological products, especially vaccines, usually requires materials derived from animals, and there are always risks that animal pathogens derived from these materials could contaminate the final products. Detection of adventitious agents is performed by quality control tests. In these biological assays, animal derived materials are also used and another problem arises, as fetal bovine serum (FBS) is used

Takashi Kozasa; Hiroshi Aoki; Nao Nakajima; Akio Fukusho; Masatoshi Ishimaru; Shigeyuki Nakamura

2011-01-01

65

Therapeutic HIV Vaccines What is a vaccine?  

E-print Network

Therapeutic HIV Vaccines What is a vaccine? A vaccine is a medical product designed to stimulate there are currently no vaccines to prevent or treat HIV, researchers are developing and testing potential HIV vaccines. HIV vaccines designed to prevent HIV infection in HIV negative people are called preventive vaccines

Levin, Judith G.

66

Comparing Isotope Dilution Methods to Label Free Quantitation Methods For The Analysis of Vaccine Standards and Products  

PubMed Central

Determining protein content in biologics is an important part of the production process. An example of interest to public health is the influenza vaccine, where the amount of the major antigenic protein hemagglutinin and the amount of egg proteins from the expression system are regulated. Mass spectrometry has advantages of higher specificity, speed and permits other proteins to be analyzed simultaneously. Here, we present the use of a MRM method for quantitation of hemagglutinin and other vaccine proteins developed in our laboratory and compare this approach to a label free method (MSE) for simultaneous identification and absolute quantitation of virus and egg proteins. Influenza vaccine samples were tryptically digested using a protocol developed in our laboratory to ensure consistent and reproducible results. Traditional IDMS measurements were made on ThermoFisher Scientific TSQ quantum triple quadrupole platform. Label free methods (LC-MSE) were performed on a Waters qTOF Premier platform and the PLGS software. Both instruments were coupled to an Identical Agilent 1200 LC platform to insure an accurate comparison. The results of the study illustrated that IDMS remains the gold standard for absolute protein quantitation via mass spectrometry. MSE performed with comparable precision and accuracy in cases where the sample was less complex (monovalent pandemic vaccines vs. seasonal trivalent vaccines). In addition the choice of peptides made by the MSE algorithm and the choice of influenza proteins used in the database also affected the precision and accuracy of the MSE absolute quantitation results.

Winne, Emily; Santana, Wanda I.; Williams, Tracie L.; Barr, John R.; Bundy, Jonathan

2013-01-01

67

Do biological medicinal products pose a risk to the environment?: a current view on ecopharmacovigilance.  

PubMed

The occurrence of active pharmaceutical substances in the environment is of growing concern. The vast majority of the compounds in question are of low molecular weight, intended for oral use and designed to tolerate, for example, the digestive enzymes in the upper alimentary tract, the harsh milieus found in the acidic stomach, or the microbe rich intestine. Accordingly, these xenobiotic compounds may, due to their inherent biological activity, constitute a risk to the environment. Biological medicinal products, for example recombinant human insulin or monoclonal antibodies, however, are different. They are primarily made up of oligomers or polymers of amino acids, sugars or nucleotides and are thus readily metabolized. They are therefore generally not considered to pose any risk to the environment. Certain classes of biological medicinal products, however, are associated with specific safety issues. Genetically modified organisms as vectors in vaccines or in gene therapy products have attracted much attention in this regard. Issues include the degree of attenuation of the live recombinant vaccine, replication restrictions of the vaccine vector, alteration of the host and tissue tropism of the vector, the possibility of reversion to virulence, and risk to the ecosystem. In this review we discuss the fate and the potential environmental impact of biological medicinal products following clinical use from an ecopharmacovigilance point of view, and review relevant policy documents and regulatory statements. PMID:19810773

Kühler, Thomas C; Andersson, Mikael; Carlin, Gunnar; Johnsson, Ann; Akerblom, Lennart

2009-01-01

68

A cell-based backup to speed up pandemic influenza vaccine production.  

PubMed

Influenza vaccines are currently produced through egg-based methods, with one drawback being that this system is slow to respond to the surging global demand during an influenza pandemic. Alternative influenza vaccine production strategies, such as using a cell-based strategy, should be considered in pandemic situations. PMID:22257962

Lee, Min-Shi; Hu, Alan Yung-Chih

2012-03-01

69

Polyclonal hypergammaglobulinemia and autoantibody production induced by vaccination in farmed Atlantic salmon.  

PubMed

The introduction of oil-adjuvanted vaccines in salmon aquaculture made large-scale production feasible by reducing the impact of infections. Vaccines given intraperitoneally (ip) contain oil adjuvant such as mineral oil. However, in rodents, a single ip injection of adjuvant hydrocarbon oil induces lupus-like systemic autoimmune syndrome. We have recently reported that autoimmune disease in farmed salmon, characterized by production of various autoantibodies, immune complex glomerulonephritis, liver thrombosis, and spinal deformity, are previously unrecognized side effects of vaccination. In the present study, we examined whether vaccination-induced autoantibody production in farmed Atlantic salmon is a mere result of polyclonal B-cell activation. Sera were collected from 205 vaccinated and unvaccinated Atlantic salmon (experimental, 7 farms) and wild salmon. Total IgM levels and autoantibodies to salmon blood cell (SBC) extract in sera were measured by ELISA and the relationship between hypergammaglobulinemia and autoantibody production was analyzed. Comparison of endpoint titers vs levels/units using a single dilution of sera in detection of autoantibodies to SBC showed near perfect correlation, justifying the use of the latter for screening. Both total IgM and anti-SBC antibodies are increased in vaccinated salmon compared with unvaccinated controls, however, they do not always correlate well when compared between groups or between individuals, suggesting the involvement of antigen-specific mechanisms in the production of anti-SBC autoantibodies. The primary considerations of successful vaccine for aquaculture are cost-effectiveness and safety. Vaccination-induced autoimmunity in farmed Atlantic salmon may have consequences on future vaccine development and salmon farming strategy. Evaluation for polyclonal hypergamamglobulinemia and autoimmunity should be included as an important trait when vaccine efficacy and safety are evaluated in future. PMID:21316456

Satoh, Minoru; Bjerkås, Inge; Haugarvoll, Erlend; Chan, Edward K L; Szabo, Nancy J; Jirillo, Emilio; Poppe, Trygve T; Sveier, Harald; Tørud, Brit; Koppang, Erling O

2011-01-01

70

Chemistry and biology of selected natural products  

Microsoft Academic Search

Natural products often offer excitement, stimulation, challenges and op- portunities for chemists, biologists and medical investigators. The study of their chemistry, biology and medicine provides, more often than not, rewards imagined and unimagined, and is still a major frontier in organic chemistry. In this article we summa- rize some of our recent work in this area and project ahead to

K. C. Nicolaou; E. A. Theodorakis; C. F. Claiborne

1996-01-01

71

Harnessing the Biological Activity of Natural Products  

Cancer.gov

Researchers have been intrigued by the potent and beneficial biological activity shown by some natural products and are testing ways to incorporate them into standard and experimental cancer treatment regimens, both to enhance the anticancer effects of therapy and reduce side effects.

72

[Biological and nutritional value of food products].  

PubMed

The paper deals with a detailed analysis into the methods of study and of the validity of terminology adopted in denoting the usefulness of food products, proceeding from their chemical composition. The author proposes to distinctly subdivide the notions of the alimentary, biological and energy producing values, but unite them under a general term reflecting the totality of the useful qualities of the products that covers the estimation therein of a broad range of nutrients, which should be referred to as "nutritional value". The terms of biological and energy producing values are special designations. The first of them reflects the quality of proteinic components in the product which have to do both with the digestability of the protein and with the degree to which its amino acids compositions is balanced. Then it should be borne in mind that the indices of biological value may undergo substantial changes, both under the effect of rigid methods of technological treatment, that brings about a change in the structure of the protein molecules proper, and consequent upon their interaction with other nutrients, as well as during their long-term storage. An important advantage that offers the determination of the biological value indices is an analytical segregation from among numerous biological properties the ones which are related to the features specific for the structure precisely of the proteinic constituents of the food. The determination of this index allows it to differentiate the useful qualities of the protein from a great number of other factors that can significantly change the assimilation of the products by the organism, including the presence therein of extraneous substances. The term energy-producing value of the products characterizes the part of the energy that can be liberated from the nutrients in the course of biological oxidation and used in securing physiological functions of the organism. As a basis for expressing the alimentary (nutritional) value of the products a method of the integral score, reflecting the degree to which the chemical composition of the study product corresponds to the formula of balanced nutrition worked outhe author is suggested. The energy variant of the integral score presents definate advantages, for with it the author estimates the percentage of satisfied requirements of an adult person in nutrients with the consumption of products in an amount that corresponds to a definate portion of energy, 300 kcal, for example (which comprises roughly 10 per cent of an average diurnal requirement in energy). The energy variant of the score makes it possible to determine the "degree of completness" of the product's calories with essentian nutritional factors. PMID:1154700

Pokrovski?, A A

1975-01-01

73

Preventive HIV Vaccines What is a vaccine?  

E-print Network

Preventive HIV Vaccines What is a vaccine? A vaccine is a medical product designed to stimulate infection or make you sick. What is the difference between a preventive HIV vaccine and a therapeutic HIV vaccine? Therapeutic HIV vaccines are designed to control HIV infection in people who are already HIV

Levin, Judith G.

74

Vaccine process technology.  

PubMed

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 perspective, Quality by Design (QbD) and Process Analytical Technology (PAT) are important initiatives that can be applied effectively to many types of vaccine processes. Universal demand for vaccines requires that a manufacturer plan to supply tens and sometimes hundreds of millions of doses per year at low cost. To enable broader use, there is intense interest in improving temperature stability to allow for excursions from a rigid cold chain supply, especially at the point of vaccination. Finally, there is progress in novel routes of delivery to move away from the traditional intramuscular injection by syringe approach. PMID:22407777

Josefsberg, Jessica O; Buckland, Barry

2012-06-01

75

Safety and immunogenicity of co-administered MF59-adjuvanted 2009 pandemic and plain 2009-10 seasonal influenza vaccines in rheumatoid arthritis patients on biologicals.  

PubMed

Rheumatoid arthritis (RA) patients under immunosuppressive therapy are particularly susceptible to infections, mainly of the respiratory tract, thus vaccination may represent a strategy to reduce their incidence in this vulnerable population. In the 2009-10 influenza season, the safety and immunogenicity of co-administered non-adjuvanted seasonal and MF59-adjuvanted pandemic influenza vaccines were evaluated in this study in 30 RA patients under therapy with anti-tumour necrosis factor (TNF)-? agents or Abatacept and in 13 healthy controls (HC). Patients and HC underwent clinical and laboratory evaluation before (T0), 1 (T1) and 6 months (T2) after vaccinations. No severe adverse reactions, but a significant increase in total mild side effects in patients versus?HC were observed. Both influenza vaccines fulfilled the three criteria of the Committee for Proprietary Medicinal Products (CPMP). Seroconversion rate for any viral strain in patients and HC was, respectively, 68 versus 45 for H1-A/Brisbane/59/07, 72 versus 81 for H3-A/Brisbane/10/07, 68 versus 54 for B/Brisbane/60/08 and 81 versus 54 for A/California/7/2009. A slight increase in activated interferon (IFN)-?-, TNF-?- or interleukin (IL)-17A-secreting T cells at T1 compared to T0, followed by a reduction at T2 in both patients and HC, was registered. In conclusion, simultaneous administration of adjuvanted pandemic and non-adjuvanted seasonal influenza vaccines is safe and highly immunogenic. The largely overlapping results between patients and HC, in terms of antibody response and cytokine-producing T cells, may represent further evidence for vaccine safety and immunogenicity in RA patients on biologicals. PMID:24666311

Milanetti, F; Germano, V; Nisini, R; Donatelli, I; Di Martino, A; Facchini, M; Ferlito, C; Cappella, A; Crialesi, D; Caporuscio, S; Biselli, R; Rossi, F; Salemi, S; D'Amelio, R

2014-07-01

76

Vaccination Mathematics  

E-print Network

Vaccination Strategies for Epidemic Models Douglas B. Meade Department of Mathematics University://www.math.sc.edu/~meade/ 27 May 1999 #12; May 1999 IMA Mathematical Biology Seminar 0 Vaccination Strategies for Epidemic and natural death -- no death from infection -- no vaccination Ref: Shulgin, Stone, and Agur, Bull Math Bio

Meade, Douglas B.

77

Soybean Seeds: A Practical Host for the Production of Functional Subunit Vaccines  

PubMed Central

Soybean seeds possess several inherent qualities that make them an ideal host for the production of biopharmaceuticals when compared with other plant-based and non-plant-based recombinant expression systems (e.g., low cost of production, high protein to biomass ratio, long-term stability of seed proteins under ambient conditions, etc.). To demonstrate the practicality and feasibility of this platform for the production of subunit vaccines, we chose to express and characterize a nontoxic form of S. aureus enterotoxin B (mSEB) as a model vaccine candidate. We show that soy-mSEB was produced at a high vaccine to biomass ratio and represented ~76 theoretical doses of human vaccine per single soybean seed. We localized the model vaccine candidate both intracellularly and extracellularly and found no difference in mSEB protein stability or accumulation relative to subcellular environment. We also show that the model vaccine was biochemically and immunologically similar to native and recombinant forms of the protein produced in a bacterial expression system. Immunization of mice with seed extracts containing mSEB mounted a significant immune response within 14 days of the first injection. Taken together, our results highlight the practicality of soybean seeds as a potential platform for the production of functional subunit vaccines. PMID:24822195

Hudson, Laura C.; Bost, Kenneth L.; Piller, Kenneth J.

2014-01-01

78

Establishment of pandemic influenza vaccine production capacity at Bio Farma, Indonesia.  

PubMed

In Indonesia, avian influenza A(H5N1) virus started to spread in humans in June 2005, with an alarming case-fatality rate of more than 80%. Considering that global influenza vaccine production capacity would barely have covered 10% of the world's pandemic vaccine needs, and that countries with no production facilities or prearranged contracts would be without access to a vaccine, the Government of Indonesia embarked on a programme to increase its readiness for a future influenza pandemic. This included the domestic production of influenza vaccine, which was entrusted to Bio Farma. This health security strategy consists of developing trivalent influenza vaccine production capacity in order to be able to convert immediately to monovalent production of up to 20 million pandemic doses for the Indonesian market upon receipt of the seed strain from the World Health Organization (WHO). For this purpose, a dedicated production facility is being constructed within the Bio Farma premises in Bandung. As an initial stage of influenza vaccine development, imported seasonal influenza bulk has been formulated and filled in the Bio Farma facility. Following three consecutive batches and successful clinical trials, the product was licensed by the Indonesian National Regulatory Authority and distributed commercially for the Hajj programme in 2009. With continued support from its technology transfer partners, Bio Farma is now advancing with the development of upstream processes to produce its own bulk for seasonal and pandemic use. PMID:21684423

Suhardono, Mahendra; Ugiyadi, Dori; Nurnaeni, Ida; Emelia, Imelda

2011-07-01

79

Plasmid DNA Vaccine vector design: impact on efficacy, safety and upstream production  

PubMed Central

Critical molecular and cellular biological factors impacting design of licensable DNA vaccine vectors that combine high yield and integrity during bacterial production with increased expression in mammalian cells are reviewed. Food and Drug Administration (FDA), World Health Organization (WHO) and European Medical Agencies (EMEA) regulatory guidance’s are discussed, as they relate to vector design and plasmid fermentation. While all new vectors will require extensive preclinical testing to validate safety and performance prior to clinical use, regulatory testing burden for follow-on products can be reduced by combining carefully designed synthetic genes with existing validated vector backbones. A flowchart for creation of new synthetic genes, combining rationale design with bioinformatics, is presented. The biology of plasmid replication is reviewed, and process engineering strategies that reduce metabolic burden discussed. Utilizing recently developed low metabolic burden seed stock and fermentation strategies, optimized vectors can now be manufactured in high yields exceeding 2 g/L, with specific plasmid yields of 5% total dry cell weight. PMID:19233255

Williams, James A; Carnes, Aaron E; Hodgson, Clague P

2009-01-01

80

Immunization against Genital Herpes with a Vaccine Virus That has Defects in Productive and Latent Infection  

NASA Astrophysics Data System (ADS)

An effective vaccine for genital herpes has been difficult to achieve because of the limited efficacy of subunit vaccines and the safety concerns about live viruses. As an alternative approach, mutant herpes simplex virus strains that are replication-defective can induce protective immunity. To increase the level of safety and to prove that replication was not needed for immunization, we constructed a mutant herpes simplex virus 2 strain containing two deletion mutations, each of which eliminated viral replication. The double-mutant virus induces protective immunity that can reduce acute viral shedding and latent infection in a mouse genital model, but importantly, the double-mutant virus shows a phenotypic defect in latent infection. This herpes vaccine strain, which is immunogenic but has defects in both productive and latent infection, provides a paradigm for the design of vaccines and vaccine vectors for other sexually transmitted diseases, such as AIDS.

da Costa, Xavier J.; Jones, Cheryl A.; Knipe, David M.

1999-06-01

81

The Avian EB66(R) Cell Line, Application to Vaccines, and Therapeutic Protein Production.  

PubMed

Embryonated chicken eggs and primary chicken embryo fibroblasts (CEFs) have been used for decades as a means of manufacturing human and veterinary vaccines. However, these egg and CEF-based production systems are associated with many serious limitations in terms of their regulatory acceptability, production capacity, and supply chain risks. The development of a safer, cheaper, and more efficient cell substrate for vaccine production would represent a significant business advantage for vaccine manufacturers. Building on the exceptional properties of avian embryonic stem cells, Vivalis has created a new cell substrate, the Duck EB66® cell line. This article describes how this cell substrate was derived, the manufacture and qualification of a master cell bank, and the evaluation of the cell substrate for the manufacture of vaccines and human therapeutic proteins. PMID:21502045

Brown, Stephen W; Mehtali, Majid

2010-01-01

82

Screening vaccine formulations for biological activity using fresh human whole blood.  

PubMed

Understanding the relevant biological activity of any pharmaceutical formulation destined for human use is crucial. For vaccine-based formulations, activity must reflect the expected immune response, while for non-vaccine therapeutic agents, such as monoclonal antibodies, a lack of immune response to the formulation is desired. During early formulation development, various biochemical and biophysical characteristics can be monitored in a high-throughput screening (HTS) format. However, it remains impractical and arguably unethical to screen samples in this way for immunological functionality in animal models. Furthermore, data for immunological functionality lag formulation design by months, making it cumbersome to relate back to formulations in real-time. It is also likely that animal testing may not accurately reflect the response in humans. For a more effective formulation screen, a human whole blood (hWB) approach can be used to assess immunological functionality. The functional activity relates directly to the human immune response to a complete formulation (adjuvant/antigen) and includes adjuvant response, antigen response, adjuvant-modulated antigen response, stability, and potentially safety. The following commentary discusses the hWB approach as a valuable new tool to de-risk manufacture, formulation design, and clinical progression. PMID:24401565

Brookes, Roger H; Hakimi, Jalil; Ha, Yukyung; Aboutorabian, Sepideh; Ausar, Salvador F; Hasija, Manvi; Smith, Steven G; Todryk, Stephen M; Dockrell, Hazel M; Rahman, Nausheen

2014-04-01

83

Gulf war syndrome: could it be triggered by biological warfare-vaccines using pertussis as an adjuvant?  

Microsoft Academic Search

Several recent epidemiological studies have shown that vaccinations against biological warfare using pertussis as an adjuvant were associated with the Gulf war syndrome. If such epidemiological findings are confirmed, we propose that the use of pertussis as an adjuvant could trigger neurodegeneration through induction of interleukin-1? secretion in the brain. In turn, neuronal lesions may be sustained by stress or

J.-N. Tournier; A. Jouan; J. Mathieu; E. Drouet

2002-01-01

84

Influenza vaccine production for Brazil: a classic example of successful North-South bilateral technology transfer.  

PubMed

Technology transfer is a promising approach to increase vaccine production at an affordable price in developing countries. In the case of influenza, it is imperative that developing countries acquire the technology to produce pandemic vaccines through the transfer of know-how, as this will be the only way for the majority of these countries to face the huge demand for vaccine created by influenza pandemics. Access to domestically produced influenza vaccine in such health crises is thus an important national defence strategy. However, technology transfer is not a simple undertaking. It requires a committed provider who is willing to transfer a complete production process, and not just the formulation and fill-finish parts of the process. It requires a recipient with established experience in vaccine production for human use and the ability to conduct research into new developments. In addition, the country of the recipient should preferably have sufficient financial resources to support the undertaking, and an internal market for the new vaccine. Technology transfer should create a solid partnership that results in the joint development of new competency, improvements to the product, and to further innovation. The Instituto Butantan-sanofi pasteur partnership can be seen as a model for successful technology transfer and has led to the technological independence of the Instituto Butantan in the use a strategic public health tool. PMID:21684420

Miyaki, Cosue; Meros, Mauricio; Precioso, Alexander R; Raw, Isaias

2011-07-01

85

Physicochemical and biological characterization of 1E10 Anti-Idiotype vaccine  

PubMed Central

Background 1E10 monoclonal antibody is a murine anti-idiotypic antibody that mimics N-glycolyl-GM3 gangliosides. This antibody has been tested as an anti-idiotypic cancer vaccine, adjuvated in Al(OH)3, in several clinical trials for melanoma, breast, and lung cancer. During early clinical development this mAb was obtained in vivo from mice ascites fluid. Currently, the production process of 1E10 is being transferred from the in vivo to a bioreactor-based method. Results Here, we present a comprehensive molecular and immunological characterization of 1E10 produced by the two different production processes in order to determine the impact of the manufacturing process in vaccine performance. We observed differences in glycosylation pattern, charge heterogeneity and structural stability between in vivo-produced 1E10 and bioreactor-obtained 1E10. Interestingly, these modifications had no significant impact on the immune responses elicited in two different animal models. Conclusions Changes in 1E10 primary structure like glycosylation; asparagine deamidation and oxidation affected 1E10 structural stability but did not affect the immune response elicited in mice and chickens when compared to 1E10 produced in mice. PMID:22108317

2011-01-01

86

Two initial vaccinations with the Bm86-based Gavacplus vaccine against Rhipicephalus (Boophilus) microplus induce similar reproductive suppression to three initial vaccinations under production conditions  

PubMed Central

Background The cattle tick, Rhipicephalus (Boophilus) microplus, affects livestock production in many regions of the world. Up to now, the widespread use of chemical acaricides has led to the selection of acaricide-resistant ticks and to environmental contamination. Gavacplus is a subunit vaccine based on the recombinant Bm86 tick antigen expressed in yeast, capable to control infestations of R. microplus under controlled and production conditions. The vaccine constitutes the core element of broad control programs against this ectoparasite, in which acquired immunity in cattle to Bm86 is combined with a rational use of acaricides. At present, the conventional vaccine scheme consists of three doses that should be administered at weeks 0, 4 and 7, followed by a booster every six months. Results In this study we assayed a reduction in the number of the initial doses of Gavacplus, evaluated the time course and the level of bovine anti-Bm86 antibodies elicited, and analyzed the vaccine effect on ticks engorging on immunized cattle under production conditions. Following three different immunization schemes, the bovines developed a strong and specific immune response characterized by elevated anti-Bm86 IgG titers. A reduction in the weight of engorging female ticks, in the weight of the eggs laid and also in R. microplus viable eggs percentage was obtained by using only two doses of Gavacplus administered at weeks 0 and 4, followed by a booster six months later. This reduction did not differ from the results obtained on ticks engorging on cattle immunized at weeks 0, 4 and 7. It was also demonstrated that anti-Bm86 antibody titers over 1:640, measured in bovines immunized at weeks 0 and 4, were sufficient to affect weight and reproductive potential of female ticks as compared with ticks engorging on unvaccinated animals. In addition, no statistically significant differences were detected in the average weight of eggs laid by ticks engorged on immunized cattle that showed anti-Bm86 specific titers in the range of 1:640 to 1:81920. Conclusion The administration of two initial doses of Gavacplus containing 100 ?g of Bm86 antigen to non-immunized cattle under production conditions is sufficient to affect the weight and the reproductive capacity of R. microplus engorging females. According to these results, cattle herds' manipulation and vaccine costs could be potentially reduced with a positive impact on the implementation of integrated control programs against R. microplus. PMID:20846415

2010-01-01

87

Impact of Severe Weather Conditions on Biological Products  

MedlinePLUS

... e inundaciones Impact of Severe Weather Conditions on Biological Products CBER is providing interested persons with information concerning the storage and use of temperature-sensitive biological products that have been involved in a temporary ...

88

Production and purification of plasmid DNA vaccines: is there scope for further innovation?  

PubMed

The demand for plasmid DNA (pDNA) has vastly increased over the past decade in response to significant advances that have been made in its application for gene therapy and vaccine development. Plasmid DNA-based vaccines are experiencing a resurgence due to success with prime-boost immunization strategies. The challenge has always been poor productivity and delivery of pDNA. Plasmid DNA-based vaccines have traditionally required milligram scale of GMP-grade product for vaccination due to the relatively low efficacy and duration of gene expression. However, efforts to increase pDNA vaccine effectiveness are evolving in genetic manipulations of bacterial host, improvements in product recovery and innovative delivery methods. This review summarizes recent advances in large-scale pDNA vaccine manufacturing, ranging from upstream processing, downstream processing and formulation, as such information is usually not available to the scientific community. The article will highlight technology gaps and offer insight on further scope of innovation. PMID:25308708

Xenopoulos, Alex; Pattnaik, Priyabrata

2014-12-01

89

Mass production and standardization of Clostridium oedematiens vaccine against black disease (infectious necrotic hepatitis) of sheep.  

PubMed

The object of this study was to prepare a potent vaccine against black disease of sheep. Attempts were made to prepare and formulate the ingredients in order to obtain high yield of toxin. A 600 litre batch of mass production of Clostridium oedematiens (Cl. novyi) vaccine was prepared with ingredients consisting of 4% peptone, 0.25% NaCl, 0.5% liver extract, 0.1% L-cysteine, 1% maltose, 0.02% sodium dithionite and 0.25% ferrous sulphate solution. The prepared vaccine was diluted to concentrations of 20, 40, 60 and 80 per cent of antigens. Potassium alum was added as an adjuvant. The potency test of the prepared vaccine was determined in a group of forty rabbits according to the British Pharmacopoeia (Veterinary). Maximum titre was obtained at 80 per cent with the level of 33 units per ml of alpha antitoxin in rabbits pooled serum. 20, 16 and 8 units per ml of alpha antitoxin were obtained respectively for 60, 40 and 20 per cent of diluted antigen in rabbits pooled serum. Sheep have been vaccinated in black disease areas with this vaccine. Reports obtained from the field indicate that black disease in sheep could be effectively controlled by this vaccine in Iran. PMID:3792643

Ardehali, M; Darakhshan, H; Moosawi, M

1986-01-01

90

Regulatory science accelerates the development of biotechnology drugs and vaccines by NIFDC  

PubMed Central

The Chinese National Institutes for Food and Drug Control (NIFDC) is the national laboratory responsible for the quality control of pharmaceutical products. In recent years, to ensure the quality of biological products and improve the research and development (R&D) of new biological drugs and vaccines, NIFDC conducted a series of regulatory science studies on key technologies for quality control and evaluation, and established a quality control and evaluation platform for biological drugs and vaccines. These studies accelerated the R&D of the biological drugs and vaccines in China and assured their safety and efficacy. In this paper, NIFDC's duties and achievements in the biological drug and vaccine field are summarized.

Liang, Zhenglun; Mao, Qunying; Wang, Yiping; Li, Changgui; Gao, Kai; Wang, Junzhi

2014-01-01

91

Advances in host and vector development for the production of plasmid DNA vaccines.  

PubMed

Recent developments in DNA vaccine research provide a new momentum for this rather young and potentially disruptive technology. Gene-based vaccines are capable of eliciting protective immunity in humans to persistent intracellular pathogens, such as HIV, malaria, and tuberculosis, for which the conventional vaccine technologies have failed so far. The recent identification and characterization of genes coding for tumor antigens has stimulated the development of DNA-based antigen-specific cancer vaccines. Although most academic researchers consider the production of reasonable amounts of plasmid DNA (pDNA) for immunological studies relatively easy to solve, problems often arise during this first phase of production. In this chapter we review the current state of the art of pDNA production at small (shake flasks) and mid-scales (lab-scale bioreactor fermentations) and address new trends in vector design and strain engineering. We will guide the reader through the different stages of process design starting from choosing the most appropriate plasmid backbone, choosing the right Escherichia coli (E. coli) strain for production, and cultivation media and scale-up issues. In addition, we will address some points concerning the safety and potency of the produced plasmids, with special focus on producing antibiotic resistance-free plasmids. The main goal of this chapter is to make immunologists aware of the fact that production of the pDNA vaccine has to be performed with as much as attention and care as the rest of their research. PMID:24619702

Mairhofer, Juergen; Lara, Alvaro R

2014-01-01

92

Staphylococcal enterotoxin B mutants (N23K and F44S): biological effects and vaccine potential in a mouse model  

Microsoft Academic Search

Superantigens produced by Staphylococcus aureus can cause food poisoning and toxic shock syndrome. The biological activities and vaccine potential of mutant staphylococcal enterotoxin B (SEB) proteins, N23K and F44S, were studied in a lipopolysaccharide-potentiated mouse model. Although 10 ?g of SEB per mouse is equivalent to 30 LD50, the same intraperitoneal dose of either mutant protein was nonlethal and did

Mary Alice Woody; Teresa Krakauer; Bradley G. Stiles

1997-01-01

93

Impact of fowlpox-vectored Mycoplasma gallisepticum vaccine Vectormune FP MG on layer hen egg production and egg quality parameters.  

PubMed

This study was conducted to determine the impact of vaccination with Vectormune FP MG on egg production and egg quality characteristics of Single Comb White Leghorn hens. Due to questions of the efficacy of this vaccine in preventing Mycoplasma gallisepticum-mediated pathology, the ability of this vaccine to protect against postproduction-peak egg losses associated with F-strain M. gallisepticum (FMG) vaccination was also investigated. Vaccination with Vectormune FP MG did not result in any significant change in egg production or egg quality parameters compared with control (unvaccinated) hens. Subsequent revaccination with FMG at 45 wk of age (woa) yielded no impact on egg production or egg quality parameters of Vectormune FP MG vaccinated hens, unlike prior results for postproduction-peak vaccination of M. gallisepticum-clean hens with FMG, which exhibited a drop in egg production of approximately 6%. No difference in egg size distribution was observed for any of the treatment groups before or after FMG revaccination. These results suggest that hens can be safely vaccinated with Vectormune FP MG as pullets and can be revaccinated with a live M. gallisepticum vaccine such as FMG at a later date with no deleterious effects on egg production or egg or eggshell quality parameters. PMID:24235227

Leigh, S A; Branton, S L; Evans, J D; Collier, S D

2013-12-01

94

Lot-to-lot consistency of live attenuated SA 14-14-2 Japanese encephalitis vaccine manufactured in a good manufacturing practice facility and non-inferiority with respect to an earlier product.  

PubMed

We conducted a four-arm, double-blind, randomized controlled trial among 818 Bangladeshi infants between 10 and 12 months of age to establish equivalence among three lots of live attenuated SA 14-14-2 JE vaccine manufactured by the China National Biotec Group's Chengdu Institute of Biological Products (CDIBP) in a new Good Manufacturing Practice (GMP) facility and to evaluate non-inferiority of the product with a lot of the same vaccine manufactured in CDIBP's original facility. The study took place in two sites in Bangladesh, rural Matlab and Mirpur in urban Dhaka. We collected pre-vaccination (Day 0) and post-vaccination Day 28 (-4 to +14 days) blood samples to assess neutralizing anti-JE virus antibody titers in serum by plaque reduction neutralization tests (PRNT). Seroprotection following vaccination was defined as a PRNT titer ?1:10 at Day 28 in participants non-immune at baseline. Follow-up for reactogenicity and safety was conducted through home visits at Day 7 and monitoring for serious adverse events through Day 28. Seroprotection rates ranged from 80.2% to 86.3% for all four lots of vaccine. Equivalence of the seroprotection rates between pairs of vaccine lots produced in the new GMP facility was satisfied at the pre-specified 10% margin of the 95% confidence interval (CI) for two of the three pairwise comparisons, but not for the third (-4.3% observed difference with 95% CI of -11.9 to 3.3%). Nevertheless, the aggregate seroprotection rate for all three vaccine lots manufactured in the GMP facility was calculated and found to be within the non-inferiority margin (within 10%) to the vaccine lot produced in the original facility. All four lots of vaccine were safe and well tolerated. These study results should facilitate the use of SA 14-14-2 JE vaccine as a routine component of immunization programs in Asian countries. PMID:25239483

Zaman, K; Naser, Abu Mohd; Power, Maureen; Yaich, Mansour; Zhang, Lei; Ginsburg, Amy Sarah; Luby, Stephen P; Rahman, Mahmudur; Hills, Susan; Bhardwaj, Mukesh; Flores, Jorge

2014-10-21

95

9 CFR 114.6 - Mixing biological products.  

Code of Federal Regulations, 2010 CFR

... Section 114.6 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PRODUCTION REQUIREMENTS FOR BIOLOGICAL...

2010-01-01

96

9 CFR 114.4 - Identification of biological products.  

Code of Federal Regulations, 2012 CFR

... Section 114.4 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PRODUCTION REQUIREMENTS FOR BIOLOGICAL...

2012-01-01

97

Determination of hydrazine in a meningococcal C conjugate vaccine intermediary product.  

PubMed

In Brazil, polysaccharide-protein conjugate vaccine against Neisseria meningitidis group C (MenCPS-TT) using hydrazine-activated-tetanus toxoid (TT) as a carrier protein has been developed. Because of the toxicity of hydrazine in humans, it is necessary to monitor this substance's process control step during the vaccine production. The electroanalytical methodology was developed and validated for the determination of hydrazine during the process control of MenCPS-TT vaccine production by differential pulse polarography. The reduction potential was -0.95 V in acetone and sulphuric acid solution. The method presented linear range between 30 and 150 microgL(-1)and recovery of 93.5+/-0.8%. PMID:20598406

Bastos, Renata Chagas; de Carvalho, Juliana Machado; da Silveira, Ivna Alana Freitas Brasileiro; do Couto Jacob, Silvana; Leandro, Katia Christina

2010-08-01

98

Human vaccines & immunotherapeutics: news.  

PubMed

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

Riedmann, Eva M

2013-09-01

99

Human Vaccines & Immunotherapeutics: News  

PubMed Central

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

Riedmann, Eva M

2013-01-01

100

Journal of Theoretical Biology 224 (2003) 269275 Estimation of effective vaccination rate  

E-print Network

: pertussis in New Zealand as a case study A. Korobeinikova, *,1 , P.K. Mainia,2 , W.J. Walkerb a Centre vaccination is unreliable. For example vaccination against pertussis has comparatively high level of primary rate and suggest an approach to estimate it. We consider pertussis in New Zealand as a case study

Maini, Philip K.

101

Antiradiation Vaccine: Technology Development Of Prophylaxis, Prevention And Treatment Of Biological Consequences And Complications After Neutron Irradiation.  

NASA Astrophysics Data System (ADS)

Introduction: Neutrons irradiation produce a unique biological effectiveness compare to different types of radiation because their ability to create a denser trail of ionized atoms in biological living tissues[Straume 1982; Latif et al.2010; Katz 1978; Bogatyrev 1982]. The efficacy of an Anti-Radiation Vaccine for the prophylaxis, prevention and therapy of acute radiation pathology was studied in a neutron exposure facility. The biological effects of fast neutrons include damage of central nervous system and cardiovascular system with development of Acute Cerebrovascular and Cardiovascular forms of acute radiation pathology. After irradiation by high doses of fast neutron, formation of neurotoxins, hematotoxins,cytotoxins forming from cell's or tissue structures. High doses of Neutron Irradiation generate general and specific toxicity, inflammation reactions. Current Acute Medical Management and Methods of Radiation Protection are not effective against moderate and high doses of neutron irradiation. Our experiments demonstrate that Antiradiation Vaccine is the most effective radioprotectant against high doses of neutron-radiation. Radiation Toxins(biological substances with radio-mimetic properties) isolated from central lymph of gamma-irradiated animals could be working substance with specific antigenic properties for vaccination against neutron irradiation. Methods: Antiradiation Vaccine preparation standard - mixture of a toxoid form of Radiation Toxins - include Cerebrovascular RT Neurotoxin, Cardiovascular RT Neurotoxin, Gastrointestinal RT Neurotoxin, Hematopoietic RT Hematotoxin. Radiation Toxins were isolated from the central lymph of gamma-irradiated animals with different forms of Acute Radiation Syndromes - Cerebrovascular, Cardiovascular, Gastrointestinal, Hematopoietic forms. Devices for Y-radiation were "Panorama","Puma". Neutron exposure was accomplished at the Department of Research Institute of Nuclear Physics, Dubna, Russia. The neutrons irradiation generated in a canal of Research Reactor BBP-M and BBP-M. Mixed neutron beam contained 95% of fast neutron irradiation and 5% of gamma-irradiation. Neutron energy - 1.98 - 2.30 Me V energy. Dose - 10.7 Gy., 0.22 Gy-min. Scheme of experiments: Rabbits from all groups were irradiated in a canal of Research Reactor together. Group A: control-5 rabbits; Group B:placebo-5 rabbits; Group C: radioprotectant Cystamine (50 mg-kg)-5 rabbits, 15 minutes before irradiation Group D:Radio-protectant Mexamine (10 mg-kg)-5 rabbits { 15 minutes before irradiation; Group E: Antiradiation Vaccine: subcutaneus administration or I-M - 2 ml of active substance , 20 days before irradiation. Results: Control Group A - 100% mortality within the next two hours after neutron irradiation with clinical symptoms of acute cerebrovascular syndrome. Group B - 100% mortality less than two hours following irradiation. Group C - 100% mortality within 8-10 hours after irradiation. Group D - 100% mortality within 8-11 hours after irradiation. In Groups A - D the development of extremely severe form of Acute Radiation Cerebrovascular Syndrome produced rapid death. Group E - 100% mortality within 240 hours ( 9|10 days) following neutron irradiation with animals exhibiting cardiovascular, cerebrovascular and gastrointestinal clinical symptoms. Discussion: A pre-irradiation vaccination with Antiradiation Vaccine is effective against mild and even high doses of neutron radiation. Vaccination with antiradiation Vaccine prolonged survival time of rabbits, exposed to a high dose LD100, of neutron radiation: from two hours (control) up to 11 days. We also postulate that radiation toxins,isolated from lymph of gamma-irradiated animals are likely similar to structure of radiation toxins circulated in blood and lymph of neutron irradiated animals. Toxico-kinetics and toxico-dynamics of radiation toxins of after neutron-irradiation were quite unique and distinguished from different types of radiation

Popov, Dmitri; Maliev, Slava; Jones, Jeffrey

102

Production of avian influenza virus vaccine using primary cell cultures generated from host organs.  

PubMed

The global availability of a therapeutically effective influenza virus vaccine during a pandemic remains a major challenge for the biopharmaceutical industry. Long production time, coupled with decreased supply of embryonated chicken eggs (ECE), significantly affects the conventional vaccine production. Transformed cell lines have attained regulatory approvals for vaccine production. Based on the fact that the avian influenza virus would infect the cells derived from its natural host, the viral growth characteristics were studied on chicken embryo-derived primary cell cultures. The viral propagation was determined on avian origin primary cell cultures, transformed mammalian cell lines, and in ECE. A comparison was made between these systems by utilizing various cell culture-based assays. In-vitro substrate susceptibility and viral infection characteristics were evaluated by performing hemagglutination assay (HA), 50 % tissue culture infectious dose (TCID??) and monitoring of cytopathic effects (CPE) caused by the virus. The primary cell culture developed from chicken embryos showed stable growth characteristics with no contamination. HA, TCID??, and CPE exhibited that these cell systems were permissive to viral infection, yielding 2-10 times higher viral titer as compared to mammalian cell lines. Though the viral output from the ECE was equivalent to the chicken cell culture, the time period for achieving it was decreased to half. Some of the prerequisites of inactivated influenza virus vaccine production include generation of higher vial titer, independence from exogenous sources, and decrease in the production time lines. Based on the tests, it can be concluded that chicken embryo primary cell culture addresses these issues and can serve as a potential alternative for influenza virus vaccine production. PMID:23515853

Babar, Mustafeez Mujtaba; Riaz, Muhammad Suleman; Zaidi, Najam-us-Sahar Sadaf; Afzal, Farhan; Farooq, Muhammad Sabir

2013-06-01

103

CCMR: Engineering Bacteria for Vaccine Production and Stabilization  

NSDL National Science Digital Library

The goal of this research is to evaluate the stability of outer membrane vesicles (OMV) as a function of temperature and buffer formulation for future drug delivery and vaccine applications. Study was focused on two different types of vesicles, one type containing a recombinant green fluorescent protein (GFP) and one wild-type (unaltered) control. Overall, twenty different treatment groups were evaluated. Vesicles were prepared in two buffers, a phosphate buffered saline (PBS) or a Tris buffer containing 3% sucrose (TS). The samples were stored at one of five temperatures: 37oC, 4oC, -20oC, -70oC, and lyophilized. The vesicles were characterized over a 12- day period using dynamic light scattering (DLS), zeta potential, and transmission electron microscopy (TEM).

Shepardson, Kelly

2007-08-29

104

[Testing of vaccines : The challenge of testing complex combination vaccines].  

PubMed

Vaccines are biologicals. This group of medicinal products is produced with a predefined variability based on the biological starting materials used. Vaccines are subject to official control authority batch release performed by the Paul-Ehrlich-Institut (PEI). To release batches to the market, experimental testing has to be conducted by an official medicines control laboratory as the PEI. It is the aim of this independent testing to demonstrate the conformity of quality criteria with conditions set in the marketing authorization for each lot produced. The testing is performed on the basis of vaccine specific batch release guideline and due to the difficult and time consuming testing procedures often run in parallel with manufacturers testing. If test results comply with the predefined criteria, the lot in question is released. This article describes the challenge of official control authority batch release testing of two complex combination vaccines. PMID:25204275

Merkle, A; Lechner, H; Oppling, V; Meyer, H

2014-10-01

105

Biology of Francisella tularensis Subspecies holarctica Live Vaccine Strain in the Tick Vector Dermacentor variabilis  

PubMed Central

Background The ?-proteobacterium Francisella tularensis is the etiologic agent of seasonal tick-transmitted tularemia epizootics in rodents and rabbits and of incidental infections in humans. The biology of F. tularensis in its tick vectors has not been fully described, particularly with respect to its quanta and duration of colonization, tissue dissemination, and transovarial transmission. A systematic study of the colonization of Dermacentor variabilis by the F. tularensis subsp. holarctica live vaccine strain (LVS) was undertaken to better understand whether D. variabilis may serve as an inter-epizootic reservoir for F. tularensis. Methodology/Principal Findings Colony-reared larva, nymph, and adult D. variabilis were artificially fed LVS via glass capillary tubes fitted over the tick mouthparts, and the level of colonization determined by microbial culture. Larvae and nymphs were initially colonized with 8.8±0.8×101 and 1.1±0.03×103 CFU/tick, respectively. Post-molting, a significant increase in colonization of both molted nymphs and adults occurred, and LVS persisted in 42% of molted adult ticks at 126 days post-capillary tube feeding. In adult ticks, LVS initially colonized the gut, disseminated to hemolymph and salivary glands by 21 days, and persisted up to 165 days. LVS was detected in the salivary secretions of adult ticks after four days post intra-hemocoelic inoculation, and LVS recovered from salivary gland was infectious to mice with an infectious dose 50% of 3 CFU. LVS in gravid female ticks colonized via the intra-hemocoelic route disseminated to the ovaries and then to the oocytes, but the pathogen was not recovered from the subsequently-hatched larvae. Conclusions/Significance This study demonstrates that D. variabilis can be efficiently colonized with F. tularensis using artificial methods. The persistence of F. tularensis in D. variabilis suggests that this tick species may be involved in the maintenance of enzootic foci of tularemia in the central United States. PMID:22530023

Mani, Rinosh J.; Reichard, Mason V.; Morton, Rebecca J.; Kocan, Katherine M.; Clinkenbeard, Kenneth D.

2012-01-01

106

Effect of a trivalent vaccine against Staphylococcus aureus mastitis lymphocyte subpopulations, antibody production, and neutrophil phagocytosis  

PubMed Central

Abstract The effect of a novel bovine mastitis trivalent vaccine, containing Staphylococcus aureus capsular polysaccharide type 5 (T5), 8 (T8), and 336 (T336), on lymphocyte subpopulations, antibody production, and neutrophil phagocytosis was evaluated. Twenty pregnant heifers were immunized with either the trivalent alone, trivalent emulsified in Freund’s incomplete adjuvant (FICA), trivalent in aluminum hydroxide, or adjuvant only (FICA). Immunization was done 30 d before the expected calving date followed by 2 boosts in a 2-week interval. Compared to FICA, serum antigen-specific immunoglobulin (Ig)G1 and IgG2 were significantly increased in all the vaccinated groups before parturition and sustained until 3 wk postpartum. In comparison with the trivalent alone, formulation with either adjuvant enhanced production of IgG2, but not IgG1. Immune sera, which contained the highest amount of antibodies, slightly increased neutrophil phagocytosis to the 3 serotypes of killed S. aureus, but most of the differences were not significant due to large variation between the cows. The percentage of CD4+ lymphocyte was significantly higher in vaccinated groups than that of FICA 4 wk after the primary immunization. In comparison with FICA, cows inoculated with trivalent vaccine and adjuvants had an increased percentage of CD8+ lymphocytes at 2 time points, 2 wk before and after calving. Our results indicated that the whole cell trivalent vaccine, with or without adjuvants, is able to elicit antibody responses specific to the 3 capsular polysaccharide antigens. The increase of T8-specific IgG2 was more noticeable when the vaccine was emulsified with adjuvants. PMID:15745217

2005-01-01

107

Biological treatment of shrimp production wastewater.  

PubMed

Over the last few decades, there has been an increase in consumer demand for shrimp, which has resulted in its worldwide aquaculture production. In the United States, the stringent enforcement of environmental regulations encourages shrimp farmers to develop new technologies, such as recirculating raceway systems. This is a zero-water exchange system capable of producing high-density shrimp yields. The system also produces wastewater characterized by high levels of ammonia, nitrate, nitrite, and organic carbon, which make waste management costs prohibitive. Shrimp farmers have a great need for a waste management method that is effective and economical. One such method is the sequencing batch reactor (SBR). A SBR is a variation of the activated sludge biological treatment process. This process uses multiple steps in the same reactor to take the place of multiple reactors in a conventional treatment system. The SBR accomplishes equalization, aeration, and clarification in a timed sequence in a single reactor system. This is achieved through reactor operation in sequences, which includes fill, react, settle, decant, and idle. A laboratory scale SBR was successfully operated using shrimp aquaculture wastewater. The wastewater contained high concentrations of carbon and nitrogen. By operating the reactors sequentially, namely, aerobic and anoxic modes, nitrification and denitrification were achieved as well as removal of carbon. Ammonia in the waste was nitrified within 4 days. The denitrification of nitrate was achieved by the anoxic process, and 100% removal of nitrate was observed within 15 days of reactor operation. PMID:19396482

Boopathy, Raj

2009-07-01

108

Challenges in mucosal vaccines for the control of infectious diseases.  

PubMed

The mucosal surface is the largest route through which pathogens enter the human body. To control the outbreak of mucosal infectious diseases, we must use our knowledge of the mucosal immune system to create vaccines that elicit protective mucosal and systemic immunity. Mucosal vaccines have advantages over traditional injectable vaccines in that they not only induce effective mucosal immune responses, but they also do not cause physical or psychological discomfort. Mucosal vaccines currently licensed for human use include oral vaccines against Vibrio cholerae, Salmonella typhi, poliovirus and rotavirus, and nasal vaccines against influenza virus. To further improve the existing vaccines, it will be necessary to develop novel vaccine production, storage and delivery systems through innovative strategies derived from interdisciplinary scientific research. Our accumulated knowledge of the innate and acquired arms of the mucosal immune system and the recent scientific and technical advancements in the fields of molecular biology, plant biology, bio-engineering and chemical engineering, genome biology and systems biology have created a unique research and development platform for the development of the next generation of mucosal vaccines. This review summarizes the current perspectives and future directions of mucosal vaccine development with emphasis on oral and nasal vaccines for the control of infectious diseases. PMID:24914172

Azegami, Tatsuhiko; Yuki, Yoshikazu; Kiyono, Hiroshi

2014-09-01

109

An Automated HIV-1 Env-Pseudotyped Virus Production for Global HIV Vaccine Trials  

PubMed Central

Background Infections with HIV still represent a major human health problem worldwide and a vaccine is the only long-term option to fight efficiently against this virus. Standardized assessments of HIV-specific immune responses in vaccine trials are essential for prioritizing vaccine candidates in preclinical and clinical stages of development. With respect to neutralizing antibodies, assays with HIV-1 Env-pseudotyped viruses are a high priority. To cover the increasing demands of HIV pseudoviruses, a complete cell culture and transfection automation system has been developed. Methodology/Principal Findings The automation system for HIV pseudovirus production comprises a modified Tecan-based Cellerity system. It covers an area of 5×3 meters and includes a robot platform, a cell counting machine, a CO2 incubator for cell cultivation and a media refrigerator. The processes for cell handling, transfection and pseudovirus production have been implemented according to manual standard operating procedures and are controlled and scheduled autonomously by the system. The system is housed in a biosafety level II cabinet that guarantees protection of personnel, environment and the product. HIV pseudovirus stocks in a scale from 140 ml to 1000 ml have been produced on the automated system. Parallel manual production of HIV pseudoviruses and comparisons (bridging assays) confirmed that the automated produced pseudoviruses were of equivalent quality as those produced manually. In addition, the automated method was fully validated according to Good Clinical Laboratory Practice (GCLP) guidelines, including the validation parameters accuracy, precision, robustness and specificity. Conclusions An automated HIV pseudovirus production system has been successfully established. It allows the high quality production of HIV pseudoviruses under GCLP conditions. In its present form, the installed module enables the production of 1000 ml of virus-containing cell culture supernatant per week. Thus, this novel automation facilitates standardized large-scale productions of HIV pseudoviruses for ongoing and upcoming HIV vaccine trials. PMID:23300558

Fuss, Martina; Mazzotta, Angela S.; Sarzotti-Kelsoe, Marcella; Ozaki, Daniel A.; Montefiori, David C.; von Briesen, Hagen; Zimmermann, Heiko; Meyerhans, Andreas

2012-01-01

110

Biology and technology for photochemical fuel production.  

PubMed

Sunlight is the ultimate energy source for the vast majority of life on Earth, and organisms have evolved elegant machinery for energy capture and utilization. Solar energy, whether converted to wind, rain, biomass or fossil fuels, is also the primary energy source for human-engineered energy transduction systems. This tutorial review draws parallels between biological and technological energy systems. Aspects of biology that might be advantageously incorporated into emerging technologies are highlighted, as well as ways in which technology might improve upon the principles found in biological systems. Emphasis is placed upon artificial photosynthesis, as well as the use of protonmotive force in biology. PMID:19088962

Hambourger, Michael; Moore, Gary F; Kramer, David M; Gust, Devens; Moore, Ana L; Moore, Thomas A

2009-01-01

111

Application of vaccination protocols to manage beef cattle productivity and mitigate production risk  

E-print Network

questions. At the cow/calf level, producers must decide whether or not to vaccinate their calves. Vaccination leads to reduced disease incidence and severity in the feedyard, thus being beneficial to the feeder. However, if the feedlot does not respond...

Horne, Willy J.

2010-01-16

112

Distinct B-cell populations contribute to vaccine antigen-specific antibody production in a transgenic mouse model.  

PubMed

The generation of memory B cells by vaccination plays a critical role in maintaining antigen-specific antibodies and producing antibody responses upon re-exposure to a pathogen. B-cell populations contributing to antibody production and protection by vaccination remain poorly defined. We used influenza virus-like particle (VLP) vaccine in a transgenic mouse model that would identify germinal centre-derived memory B cells with the expression of yellow fluorescent protein (YFP(+) cells). Immunization with influenza VLP vaccine did not induce significant increases in YFP(+) cells although vaccine antigen-specific antibodies in sera were found to confer protection against a lethal dose of influenza A virus (A/PR8). In addition, CD43(+)  B220(-) populations with low YFP(+) cells mainly contributed to the production of vaccine antigen-specific IgG isotype-switched antibodies whereas CD43(-)  B220(+) populations with high YFP(+) cells were able to produce vaccine antigen-specific IgM antibodies. Challenge infection of immunized transgenic mice with live influenza A virus resulted in significant increases in YFP(+) cells in the B220(-) populations of spleen and bone marrow cells. These results suggest that CD43(+)  B220(-) B cells generated by vaccination are important for producing influenza vaccine antigen-specific antibodies and conferring protection. PMID:24645831

O, Eunju; Ko, Eun-Ju; Kim, Min-Chul; Lee, Young-Tae; Song, Jae-Min; Kwon, Young-Man; Compans, Richard W; Kang, Sang-Moo

2014-08-01

113

Defossiling Fuel: How Synthetic Biology Can Transform Biofuel Production  

E-print Network

Defossiling Fuel: How Synthetic Biology Can Transform Biofuel Production David F. Savage , Jeffrey through natural intermediates to final molecule is long, and biofuel production is perhaps the ultimate engineering, economic, political, and environmental realities. Are biofuels sustainable? Consider U

114

Biological control and sustainable food production  

Microsoft Academic Search

The use of biological control for the management of pest insects pre-dates the modern pesticide era. The first major successes in biological control occurred with exotic pests controlled by natural enemy species collected from the country or area of origin of the pest (classical control). Augmentative control has been successfully applied against a range of open-field and greenhouse pests, and

J. S. Bale; Lenteren van J. C; F. Bigler

2008-01-01

115

Old and New: Recent Innovations in Vaccine Biology and Skin T Cells  

PubMed Central

Memory is the hallmark of the adaptive immune system, and the observation that infectious diseases often lead to lifelong immunity in individuals who survive a first infection became the genesis for the development of vaccines. Immunization, which is the iatrogenic engineering of a protective memory immune response to a pathogen, became a standard part of medical care in the twentieth century, and has had an almost incalculable positive effect on human health and wellness. Vaccines to many, but by no means all, infectious diseases have been developed and are in common use. Smallpox vaccine, arguably the most effective vaccine in human history, was (and still is) delivered through disrupted epidermis in a process called scarification. Virtually all vaccines today are delivered by means of a hypodermic needle and syringe into muscle, in a process that bypasses the epidermis and dermis and their attendant innate and adaptive immune attributes. This article discusses vaccines in the context of the newly appreciated paradigm of tissue-resident memory T cells, and specifically discusses the role of these cells in skin and other epithelial interfaces with the environment in the maintenance of protective immunity. PMID:22237702

Kupper, Thomas S.

2013-01-01

116

DNA vaccines  

NASA Astrophysics Data System (ADS)

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.

Gregersen, Jens-Peter

2001-12-01

117

Limited efficacy of inactivated influenza vaccine in elderly individuals is associated with decreased production of vaccine-specific antibodies  

PubMed Central

During seasonal influenza epidemics, disease burden is shouldered predominantly by the very young and the elderly. Elderly individuals are particularly affected, in part because vaccine efficacy wanes with age. This has been linked to a reduced ability to induce a robust serum antibody response. Here, we show that this is due to reduced quantities of vaccine-specific antibodies, rather than a lack of antibody avidity or affinity. We measured levels of vaccine-specific plasmablasts by ELISPOT 1 week after immunization of young and elderly adults with inactivated seasonal influenza vaccine. Plasmablast-derived polyclonal antibodies (PPAbs) were generated from bulk-cultured B cells, while recombinant monoclonal antibodies (re-mAbs) were produced from single plasmablasts. The frequency of vaccine-specific plasmablasts and the concentration of PPAbs were lower in the elderly than in young adults, whereas the yields of secreted IgG per plasmablast were not different. Differences were not detected in the overall vaccine-specific avidity or affinity of PPAbs and re-mAbs between the 2 age groups. In contrast, reactivity of the antibodies induced by the inactivated seasonal influenza vaccine toward the 2009 pandemic H1N1 virus, which was not present in the vaccine, was higher in the elderly than in the young. These results indicate that the inferior antibody response to influenza vaccination in the elderly is primarily due to reduced quantities of vaccine-specific antibodies. They also suggest that exposure history affects the cross-reactivity of vaccination-induced antibodies. PMID:21785218

Sasaki, Sanae; Sullivan, Meghan; Narvaez, Carlos F.; Holmes, Tyson H.; Furman, David; Zheng, Nai-Ying; Nishtala, Madhuri; Wrammert, Jens; Smith, Kenneth; James, Judith A.; Dekker, Cornelia L.; Davis, Mark M.; Wilson, Patrick C.; Greenberg, Harry B.; He, Xiao-Song

2011-01-01

118

Improved Production Process for Native Outer Membrane Vesicle Vaccine against Neisseria meningitidis  

PubMed Central

An improved detergent-free process has been developed to produce vaccine based on native outer membrane vesicles (NOMV) against Neisseria meningitidis serogroup B. Performance was evaluated with the NonaMen vaccine concept, which provides broad coverage based on nine distinct PorA antigens. Scalable aseptic equipment was implemented, replacing undesirable steps like ultracentrifugation, inactivation with phenol, and the use of preservatives. The resulting process is more consistent and gives a higher yield than published reference processes, enabling NOMV production at commercial scale. Product quality met preliminary specifications for 9 consecutive batches, and an ongoing study confirmed real-time stability up to 12 months after production. As the NOMV had low endotoxic activity and induced high bactericidal titres in mice, they are expected to be safe and effective in humans. The production process is not limited to NonaMen and may be applicable for other N. meningitidis serogroups and other gram-negative pathogens. The current results therefore facilitate the late-stage development and clinical evaluation of NOMV vaccines. PMID:23741478

van de Waterbeemd, Bas; Zomer, Gijsbert; Kaaijk, Patricia; Ruiterkamp, Nicole; Wijffels, Rene H.; van den Dobbelsteen, Germie P. J. M.; van der Pol, Leo A.

2013-01-01

119

Tetanus, Diphtheria, Pertussis (Tdap) Vaccine  

MedlinePLUS

Adacel® (as a combination product containing Diphtheria, Tetanus Toxoids, Acellular Pertussis Vaccine) ... Boostrix® (as a combination product containing Diphtheria, Tetanus Toxoids, Acellular Pertussis Vaccine)

120

The potential of Physcomitrella patens as a platform for the production of plant-based vaccines.  

PubMed

The moss Physcomitrella patens has a number of advantages for the production of biopharmaceuticals, including: i) availability of standardized conditions for cultivation in bioreactors; ii) not being part of the food chain; iii) high biosafety; iv) availability of highly efficient transformation methods; v) a haploid, fully sequenced genome providing genetic stability and uniform expression; vi) efficient gene targeting at the nuclear level allows for the generation of mutants with specific post-translational modifications (e.g., glycosylation patterns); and vii) oral formulations are a viable approach as no toxic effects are attributed to ingestion of this moss. In the light of this panorama, this opinion paper analyzes the possibilities of using P. patens for the production of oral vaccines and presents some specific cases where its use may represent significant progress in the field of plant-based vaccine development. The advantages represented by putative adjuvant effects of endogenous secondary metabolites and producing specific glycosylation patterns are highlighted. PMID:24405402

Rosales-Mendoza, Sergio; Orellana-Escobedo, Lucía; Romero-Maldonado, Andrea; Decker, Eva L; Reski, Ralf

2014-02-01

121

Vaccines for Pandemic Influenza  

PubMed Central

Recent outbreaks of highly pathogenic avian influenza in Asia and associated human infections have led to a heightened level of awareness and preparation for a possible influenza pandemic. Vaccination is the best option by which spread of a pandemic virus could be prevented and severity of disease reduced. Production of live attenuated and inactivated vaccine seed viruses against avian influenza viruses, which have the potential to cause pandemics, and their testing in preclinical studies and clinical trials will establish the principles and ensure manufacturing experience that will be critical in the event of the emergence of such a virus into the human population. Studies of such vaccines will also add to our understanding of the biology of avian influenza viruses and their behavior in mammalian hosts. PMID:16494720

Luke, Catherine J.

2006-01-01

122

Recombinant LipL32 stimulates interferon-gamma production in cattle vaccinated with a monovalent Leptospira borgpetersenii serovar Hardjo subtype Hardjobovis vaccine.  

PubMed

Leptospira borgpetersenii serovar Hardjo subtype Hardjobovis (Hardjobovis) is the main causative agent of bovine leptospirosis in Australia, New Zealand, North America and elsewhere. Bovine leptospirosis can result in spontaneous abortion, stillbirth and reduced milk output. The organism is shed in the urine of infected animals and contact with contaminated materials can result in zoonotic infections in humans. Protective immunity in cattle against Hardjobovis involves stimulation of a Th1 cell mediated immune response, which can be characterized by the production of IFN-? when blood from vaccinated animals is exposed to Hardjobovis antigens. However, the leptospiral components involved in stimulating this response have yet to be identified. In this study, 238 recombinant leptospiral proteins were evaluated for their ability to stimulate IFN-? production in blood of cattle vaccinated with a commercial monovalent Hardjobovis vaccine. The conserved lipoprotein LipL32 is the major outer membrane protein of pathogenic Leptospira spp. A pool of soluble recombinant proteins which included LipL32, as well as LipL32 alone, stimulated significant IFN-? production in blood of vaccinated cattle. A number of recombinant LipL32 fragments was generated, which identified the amino acids between 20 and 200 as containing the bovine T-cell reactive regions of LipL32. However, whether LipL32 plays a role in stimulating protective immunity in mammals has yet to be conclusively determined. PMID:24467929

Deveson Lucas, Deanna S; Lo, Miranda; Bulach, Dieter M; Quinsey, Noelene S; Murray, Gerald L; Allen, Andy; Adler, Ben

2014-03-14

123

Molecular farming for antigen (vaccine) production in plants  

Microsoft Academic Search

Genomic and proteomic approaches to the study of fundamental cell mechanisms are rapidly contributing to broaden our knowledge\\u000a on metabolic pathways for the optimal exploitation of the cell as a factory. In the last few years this knowledge has led\\u000a to important advances in the large scale production of diagnostic and therapeutic proteins in heterologous hosts (bacteria,\\u000a yeasts, mammalian and

Chiara Lico; Selene Baschieri; Carla Marusic; Eugenio Benvenuto

124

Influenza virus surveillance, vaccine strain selection, and manufacture.  

PubMed

As outlined in other chapters, the influenza virus, existing laboratory diagnostic abilities, and disease epidemiology have several peculiarities that impact on the timing and processes for the annual production of influenza vaccines. The chapter provides an overview on the key biological and other factors that influence vaccine production. They are the reason for an "annual circle race" beginning with global influenza surveillance during the influenza season in a given year to the eventual supply of vaccines 12 months later in time before the next seasonal outbreak and so on. As influenza vaccines are needed for the Northern and Southern Hemisphere outbreaks in fall and spring, respectively, global surveillance and vaccine production has become a year round business. Its highlights are the WHO recommendations on vaccine strains in February and September and the eventual delivery of vaccine doses in time before the coming influenza season. In between continues vaccine strain and epidemiological surveillance, preparation of new high growth reassortments, vaccine seed strain preparation and development of standardizing reagents, vaccine bulk production, fill-finishing and vaccine release, and in some regions, clinical trials for regulatory approval. PMID:22528158

Stöhr, Klaus; Bucher, Doris; Colgate, Tony; Wood, John

2012-01-01

125

Efficacy of three candidate Rift Valley fever vaccines in sheep.  

PubMed

Rift Valley fever virus (RVFV) is a mosquito-transmitted Bunyavirus that causes high morbidity and mortality among ruminants and humans. The virus is endemic to the African continent and the Arabian Peninsula and continues to spread into new areas. The explosive nature of RVF outbreaks requires that vaccines provide swift protection after a single vaccination. We recently developed several candidate vaccines and here report their efficacy in lambs within three weeks after a single vaccination. The first vaccine comprises the purified ectodomain of the Gn structural glycoprotein formulated in a water-in-oil adjuvant. The second vaccine is based on a Newcastle disease virus-based vector that produces both RVFV structural glycoproteins Gn and Gc. The third vaccine comprises a recently developed nonspreading RVFV. The latter two vaccines were administered without adjuvant. The inactivated whole virus-based vaccine produced by Onderstepoort Biological Products was used as a positive control. Five out of six mock-vaccinated lambs developed high viremia and fever and one lamb succumbed to the challenge infection. A single vaccination with each vaccine resulted in a neutralizing antibody response within three weeks after vaccination and protected lambs from viremia, pyrexia and mortality. PMID:22449427

Kortekaas, J; Antonis, A F G; Kant, J; Vloet, R P M; Vogel, A; Oreshkova, N; de Boer, S M; Bosch, B J; Moormann, R J M

2012-05-14

126

Biologically active peptides and enzymatic approaches to their production  

Microsoft Academic Search

This review briefly surveys various classes of biologically active and flavor peptides that have been isolated and characterized in recent years, and analyzes emerging trends and advances in biotechnological methods for their production.

Iqbal Gill; Rosina López-Fandiño; Xavier Jorba; Evgeny N. Vulfson

1996-01-01

127

Cell-free production of trimeric influenza hemagglutinin head domain proteins as vaccine antigens.  

PubMed

In order to effectively combat pandemic influenza threats, there is a need for more rapid and robust vaccine production methods. In this article, we demonstrate E. coli-based cell-free protein synthesis (CFPS) as a method to rapidly produce domains from the protein hemagglutinin (HA), which is present on the surface of the influenza virus. The portion of the HA coding sequence for the "head" domain from the 2009 pandemic H1N1 strain was first optimized for E. coli expression. The protein domain was then produced in CFPS reactions and purified in soluble form first as a monomer and then as a trimer by a C-terminal addition of the T4 bacteriophage foldon domain. Production of soluble trimeric HA head domain was enhanced by introducing stabilizing amino acid mutations to the construct in order to avoid aggregation. Trimerization was verified using size exclusion HPLC, and the stabilized HA head domain trimer was more effectively recognized by antibodies from pandemic H1N1 influenza vaccine recipients than was the monomer and also bound to sialic acids more strongly, indicating that the trimers are correctly formed and could be potentially effective as vaccines. PMID:22729608

Welsh, John P; Lu, Yuan; He, Xiao-Song; Greenberg, Harry B; Swartz, James R

2012-12-01

128

Translation of an experimental oral vaccine formulation into a commercial product.  

PubMed

An effective experimental vaccine may fail to become a therapeutic reality for a number of scientific, regulatory or commercial reasons. In this review, we share some of our personal experiences as University-based researchers and provide an account of some of the problems that we have encountered during preliminary scale-up and assessment of an oral influenza vaccine formulation. Many of the problems we have faced have been non-scientific and related to identifying project-funding sources, finding suitable contract manufacturing companies that are GMP compliant, and protecting intellectual property generated from the scientific studies. The review is intended as a practical guide that will allow other researchers to adopt effective strategies to permit the translation of an effective experimental formulation to a viable commercial product. PMID:16406571

Carter, K C; Ferro, V A; Alexander, J; Mullen, A B

2006-02-01

129

Vaccine shortages and suspect online pharmacy sellers.  

PubMed

Vaccines represent half the products on the FDA Biologics Product Shortages list. As a result, providers and patients may purchase them online, a process rife with patient safety risks. We examined vaccine online availability by assessing up to 5 identified online sellers. We determined if sites were accredited by the National Association of Boards of Pharmacy (NABP) VIPPS program, listed as US or international, employed social media linking to suspect online pharmacies, and if they were on the NABP Not Recommended list. All vaccines were advertised by online pharmacies and through data aggregation and social media sites, none were VIPPS-accredited, and most were on the NABP Not Recommended list. We found some online sellers advertising vaccines as over-the-counter. We extended our analysis to WHO Essential Medicines List vaccines and found all are also available online from suspect, non-VIPPS accredited sellers. Stakeholders should be aware of these online patient safety dangers. PMID:22094281

Liang, Bryan A; Mackey, Tim K

2012-01-01

130

Biological Hydrogen Production Using Synthetic Wastewater Biotin and glutamic acid are not required for biological hydrogen production.  

E-print Network

source due to: ·Global warming and rapid depletion of fossil fuel reserves · Less energy intensive be made when fortifying industrial wastewater by eliminating or reducing these three nutrients. ·Future Biological Hydrogen Production? Defined as hydrogen produced by a biological process. Viable alternative fuel

Barthelat, Francois

131

Gastrointestinal comorbidity, autistic regression and Measles-containing vaccines: positive re-challenge and biological gradient  

Microsoft Academic Search

Background: A temporal association between exposure to measles-containing vaccine (MCV) and autistic-like developmental regression in a sub- set of children with enterocolitis has been reported. Measles virus (MV) was detected in ileal biopsies from these children at higher prevalence than in developmentally normal pediatric controls. This study tested the hypothesis of a dose-response effect of MCV exposure on intestinal pathology,

Andrew J. Wakefield; Carol Stott

132

Biological production of ethanol from coal  

SciTech Connect

Previously studies have shown the importance of both medium composition and concentration and medium pH on ethanol production of Clostridium ljungdahlii in fermenting CO, CO{sub 2} and H{sub 2} in synthesis gas. Four additional batch experiments involving medium composition and concentration were carried out in modified basal medium without yeast extract at pH 4.0. These experiments indicate that basal medium with only small amounts of B-vitamins can yield significant cell growth while yielding ethanol as the major product. Product ratios as high as 11.0 g ethanol per g acetate were obtained with half strength B-vitamins. Further experiments indicates that Ca-pantothenate may be necessary for the growth of C. ljungdahlii and that growth and ethanol production can occur simultaneously.

Not Available

1991-01-01

133

Biological production of ethanol from coal  

SciTech Connect

Research is continuing in an attempt to increase both the ethanol concentration and product ratio using C. ljungdahlii. The purpose of this report is to present data utilizing a medium prepared especially for C. ljungdahlii. Medium development studies are presented, as well as reactor studies with the new medium in batch reactors. CSTRs and CSTRs with cell recycle. The use of this new medium has resulted in significant improvements in cell concentration, ethanol concentration and product ratio.

Not Available

1992-01-01

134

Biological production of ethanol fom coal  

SciTech Connect

Research is continuing in an attempt to increase both the ethanol concentration and product ratio using C. ljungdahlii. The purpose of this report is to present data (acetate to ethanol) utilizing a medium prepared especially for C. ljungdahlii. Medium development studies are presented, as well as reactor studies with the new medium in batch reactors. Continuous stirred tank reactor (CSTR) with cell recycle. The use of this new medium has resulted in significant improvements in cell concentration, ethanol concentration and product ratio.

Not Available

1992-05-01

135

9 CFR 113.51 - Requirements for primary cells used for production of biologics.  

Code of Federal Regulations, 2010 CFR

...2010-01-01 false Requirements for primary cells used for production of biologics. 113...Requirements § 113.51 Requirements for primary cells used for production of biologics. Primary cells used to prepare biological products...

2010-01-01

136

Production and Characterization of Neutralizing Monoclonal Antibodies Against Haemagglutinin Protein of peste des petits ruminants (PPR) Vaccine Virus  

Microsoft Academic Search

Saravanan, S., Singh, R.P., Balamurugan, V., Saravanan, P., Sen, A., Sahay, B., Sarkar, J. and Singh, R.K. 2007. Production and characterization of neutralizing monoclonal antibodies against haemagglutinin protein of peste des petits ruminants (PPR) vaccine virus. J. Appl. Anim. Res., 32: 207–210.A set of nine Peste des petits ruminants (PPR) virus specific hybridoma clones were produced against PPR vaccine virus

S. Saravanan; R. P. Singh; V. Balamurugan; P. Saravanan; A. Sen; B. Sahay; J. Sarkar

2007-01-01

137

Norovirus P Particle, a Novel Platform for Vaccine Development and Antibody Production?  

PubMed Central

The norovirus P particle is an octahedral nanoparticle formed by 24 copies of the protrusion (P) domain of the norovirus capsid protein. This P particle is easily produced in Escherichia coli, extremely stable, and highly immunogenic. There are three surface loops per P domain, making a total of 72 loops per particle, and these are potential sites for foreign antigen presentation for immune enhancement. To prove this concept, a small peptide (His tag, 7 amino acids [aa]) and a large antigen (rotavirus VP8, 159 aa) were inserted into one of the loops. Neither insertion affects P particle formation, while both antigens were presented well on the P particle surface. The immune-enhancement effect of the P particle was demonstrated by significantly increased antibody titers induced by the P particle-presented antigens compared to the titers induced by free antigens. In addition, the measured neutralization antibody titers and levels of protection against rotavirus shedding in mice immunized with the VP8 chimeric P particles were significantly higher than those of mice immunized with the free VP8 antigen. Sera from P particle-VP8 chimera-vaccinated animals also blocked norovirus virus-like particle (VLP) binding to the histo-blood group antigen (HBGA) receptors. From these data, the P particle appears to be an excellent vaccine platform for antigen presentation. The readily available three surface loops and the great capacity for foreign antigen insertion make this platform attractive for wide application in vaccine development and antibody production. The P particle-VP8 chimeras may serve as a dual vaccine against both rotavirus and norovirus. PMID:21068235

Tan, Ming; Huang, Pengwei; Xia, Ming; Fang, Ping-An; Zhong, Weiming; McNeal, Monica; Wei, Chao; Jiang, Wen; Jiang, Xi

2011-01-01

138

Antiradiation UV Vaccine: UV Radiation, Biological effects, lesions and medical management - immune-therapy and immune-protection.  

NASA Astrophysics Data System (ADS)

Key Words: Ultraviolet radiation,Standard Erythema Dose(SED), Minimal Erythema Dose(MED), Sun Burns, Solar Dermatitis, Sun Burned Disease, DNA Damage,Cell Damage, Antiradiation UV Vaccine, Immune-Prophylaxis of Sun Burned Diseases, Immune-Prophylaxis of Sun Burns, Immune-Therapy of Sun-Burned Disease and Sun Burns,Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC), Toxic Epidermal Necrolysis(TEN). Introduction: High doses of UV generated by solar source and artificial sources create an exposure of mammals and other species which can lead to ultraviolet(UV)radiation- associated disease (including erythema, epilation, keratitis, etc.). UV radiation belongs to the non-ionizing part of the electromagnetic spectrum and ranges between 100 nm and 400 nm with 100 nm having been chosen arbitrarily as the boundary between non-ionizing and ionizing radiation, however EMR is a spectrum and UV can produce molecular ionization. UV radiation is conventionally categorized into 3 areas: UV-A (>315-400 nm),UV-B (>280-315 nm)and UV-C (>100-280 nm) [IARC,Working Group Reports,2005] An important consequence of stratospheric ozone depletion is the increased transmission of solar ultraviolet (UV)radiation to the Earth's lower atmosphere and surface. Stratospheric ozone levels have been falling, in certain areas, for the past several decades, so current surface ultraviolet-B (UV-B) radiation levels are thought to be close to their modern day maximum. [S.Madronich et al.1998] Overexposure of ultraviolet radiation a major cause of skin cancer including basal cell carcinoma (BCC), squamous cell carcinoma (SCC) { collectively referred to as “non-melanoma" skin cancer (NMSC) and melanoma as well, with skin cancers being the most common cancer in North America. [Armstrong et al. 1993, Gallagher et al. 2005] Methods and Experimental Design: Our experiments and testing of a novel UV “Antiradiation Vaccine” have employed a wide variety of laboratory animals which include : Chinchilla rabbits, 11-12 months old, live weight 3.5-3.7 (n=11), Balb mice, 2-3 months old, live weight 20-22 g (n=33), Wistar rats, 3-4 months old, live weight 180-220 g(n=33). The studies were approved by the Animal Care and Use Committee for ethical animal research equivalent, at each institution. Seven rabbits, ten mice, eleven Wistar rats were vaccinated with a UV antiradiation vaccine. A second group of animals was used as biological control which received vaccine but no UV Radiation and a third group of animals was used as control without any interventions. Before and after UV Radiation, Vaccination with the UV antiradiation vaccine were provided 17 days prior to UV exposure. The animals were irradiated by a DRT-1 UV generator lamp. The dose of irradiation for laboratory, experimental animals was 10-12 * Standard Erythema Dose (SED) at L=283,7 Laboratory animals were placed in to the box with ventilation. Results: Ultraviolet irradiation of the skin was performed with high doses and causes an inflammation or erythema in all experimental animals. However the grade of skin damage and inflammation was significantly different between animals protected by vaccination and non-protected, non-vaccinated animals. Animals UV-irradiated, but who did not receive the antiradiation vaccine suffered from extensive UV skin burns of second or third degree (grade 2-3). However, animals protected with the UV antiradiation vaccine demonstrated much mild forms of skin cellular injury - mainly erythema, first degree skin burns and a few small patches with second degree skin burns (grade 1-2). Discussion: The severity of skin damage depended on area of exposed skin, time and dose of UV irradiation. Skin injury could be divided into 4 major grades: 1. Faint erythema with dry desquamation. 2. Moderate to severe erythema. 3. Severe erythema with blistering, moist desquamation. 4. Toxic epidermal necrolysis. Mild doses of UV radiation and ionizing radiation can induce cell death by apoptosis and moderate and high doses of UV and ionizing radiation induce cell death by necro

Popov, Dmitri; Jones, Jeffrey; Maliev, Slava

139

A risk-assessment model to rate the occurrence and relevance of adventitious agents in the production of influenza vaccines.  

PubMed

Influenza vaccine production has traditionally relied on the use of embryonated chicken eggs for virus isolation and propagation, but recently, cell-culture-derived manufacturing methods have been introduced. During influenza vaccine production, by either conventional or cell culture methods, there is a risk of incidental contamination by adventitious agents. Thus, a risk-assessment model has been developed to qualitatively assess the potential risk of vaccine process contamination by viral pathogens. The model takes into account the basic growth characteristics of each virus, its ability to grow in different cell substrates and resistance to processing steps during vaccine manufacture. The risk-assessment model has been applied to various pathogens to determine potential risk and relevance in different manufacturing scenarios, using different cell substrates for virus propagation, including Madin-Darby canine kidney (MDCK) cells. Avian viruses, introduced via use of embryonated eggs for virus isolation, were found to present the greatest risk, irrespective of the substrate used for influenza virus propagation. The use of MDCK cells to propagate vaccine virus from egg-isolated influenza virus strains does not introduce a new or greater adventitious virus risk, compared with egg-based vaccine production. Indeed, the adventitious virus risk is potentially reduced as fewer viruses are able to grow in MDCK cells. PMID:18468737

Gregersen, Jens-Peter

2008-06-19

140

Minimization of excess sludge production for biological wastewater treatment  

Microsoft Academic Search

Excess sludge treatment and disposal currently represents a rising challenge for wastewater treatment plants (WWTPs) due to economic, environmental and regulation factors. There is therefore considerable impetus to explore and develop strategies and technologies for reducing excess sludge production in biological wastewater treatment processes. This paper reviews current strategies for reducing sludge production based on these mechanisms: lysis-cryptic growth, uncoupling

Yuansong Wei; Renze T. Van Houten; Arjan R. Borger; Dick H. Eikelboom; Yaobo Fan

2003-01-01

141

Biological production of ethanol from coal  

SciTech Connect

The fermentation pH has been observed to be the key parameter affecting the ratio of ethanol to acetate produced by Clostridium ljungdahlii. The effects of controlled pH on cell growth and product formation by C. ljungdahlii were measured. It was found that cell concentration and acetate concentration increased with pH, while the ethanol concentration was highest at the lower pH. The molar product ratio of ethanol to acetate was 0.74 at pH 4.0, 0.39 at pH 4.5 and 0.12 at pH 5.0. Future experiments will concentrate on studying other important parameters such as agitation rate and nutrients concentrations with controlled pH as a preclude to continuous reactor studies.

Not Available

1990-01-01

142

Physical Transport of Nutrients and the Maintenance of Biological Production  

Microsoft Academic Search

\\u000a The oceanic distributions of nutrients and patterns of biological production are controlled by the interplay of biogeochemical\\u000a and physical processes, and external sources. Biological and chemical processes lead to the transformation of nutrients between\\u000a inorganic and organic forms, and also between dissolved and particulate forms. Physical processes redistribute nutrients within\\u000a the water column through transport and mixing. The combined role

Richard G. Williams; Michael J. Follows

143

Microbial production of virus-like particle vaccine protein at gram-per-litre levels.  

PubMed

This study demonstrates the feasibility of large-scale production of murine polyomavirus VP1 protein in recombinant Escherichia coli as pentamers which are able to subsequently self-assemble in vitro into virus-like particles (VLPs). High-cell-density pH-stat fed-batch cultivation was employed to produce glutathione-S-transferase (GST)-VP1 fusion protein in soluble form. The expression of recombinant VP1 was induced with IPTG at different cell optical densities (OD at 600 nm of 20, 60 or 100). GST-VP1 production was highest when the culture was induced at a cell density of OD 60, with volumetric yield reaching 4.38 gL?¹ in 31h, which we believe is the highest volumetric productivity for viral capsid protein reported to date. The induction cell density is shown to have a significant effect on the overall volumetric yield of recombinant VP1 and on final cell density, but not on VLP quality. VP1 yield was enhanced 15-fold by scaling-up from shake flask to pH-stat fed-batch cultivation in a bioreactor. Although numerous studies have expressed structural viral protein in E. coli, we believe this is the first report of translation to bioreactors yielding gram-per-litre levels. This VLP production technology overcomes major drawbacks associated with eukaryotic cell-based vaccine production technologies, and propounds the scope for large-scale commercially viable E. coli based VLP production by significantly reducing vaccine production time and cost. PMID:20797415

Liew, Mervyn W O; Rajendran, Aravindan; Middelberg, Anton P J

2010-10-15

144

Antibody response to purified chick embryo cell vaccine in equines for production of equine rabies immune globulin.  

PubMed

Rabies is endemic in India. The post exposure treatment of class three bite cases, as recommended by the World Health Organization, must involve the use of rabies immunoglobulin as soon as possible and up to the seventh day of start of anti rabies vaccination. The annual requirement in India as projected by the Ministry of Health, Government of India is about 1500 liters of purified anti rabies serum (ERIG). Central Research Institute (CRI), Kasauli, being the sole producer of ERIG in India, an effort was made to increase the production of ERIG by the use of tissue culture vaccine (Human) for primary immunization of equines. It also involved changing the vaccine from horse brain suspension to tissue culture vaccine by eliminating horse sacrifice for antigen preparation. A better immune response was obtained. PMID:14624792

Goel, S K; Sharma, S; Singh, U S

2003-12-01

145

Neurotrophic Natural Products: Chemistry and Biology  

PubMed Central

Neurodegenerative diseases and spinal cord injury affect approximately 50 million people worldwide, bringing the total healthcare cost to over 600 billion dollars per year. Nervous system growth factors, that is, neurotrophins, are a potential solution to these disorders, since they could promote nerve regeneration. An average of 500 publications per year attests to the significance of neurotrophins in biomedical sciences and underlines their potential for therapeutic applications. Nonetheless, the poor pharmacokinetic profile of neurotrophins severely restricts their clinical use. On the other hand, small molecules that modulate neurotrophic activity offer a promising therapeutic approach against neurological disorders. Nature has provided an impressive array of natural products that have potent neurotrophic activities. This Review highlights the current synthetic strategies toward these compounds and summarizes their ability to induce neuronal growth and rehabilitation. It is anticipated that neurotrophic natural products could be used not only as starting points in drug design but also as tools to study the next frontier in biomedical sciences: the brain activity map project. PMID:24353244

Xu, Jing; Lacoske, Michelle H.

2014-01-01

146

The Interstellar Production of Biologically Important Organics  

NASA Technical Reports Server (NTRS)

One of the primary tasks of the Astrochemistry Laboratory at Ames Research Center is to use laboratory simulations to study the chemical processes that occur in dense interstellar clouds. Since new stars are formed in these clouds, their materials may be responsible for the delivery of organics to new habitable planets and may play important roles in the origin of life. These clouds are extremely cold (less than 50 kelvin), and most of the volatiles in these clouds are condensed onto dust grains as thin ice mantles. These ices are exposed to cosmic rays and ultraviolet (UV) photons that break chemical bonds and result in the production of complex molecules when the ices are warmed (as they would be when incorporated into a star-forming region). Using cryovacuum systems and UV lamps, this study simulates the conditions of these clouds and studies the resulting chemistry. Some of the areas of progress made in 1999 are described below. It shows some of the types of molecules that may be formed in the interstellar medium. Laboratory simulations have already confirmed that many of these compounds are made under these conditions.

Sandford, Scott A.; Bernstein, Max P.; Dworkin, Jason; Allamandola, Louis J.

2000-01-01

147

Biological and genetic properties of SA??-14-2, a live-attenuated Japanese encephalitis vaccine that is currently available for humans.  

PubMed

Japanese encephalitis virus (JEV), a mosquito-borne flavivirus, is a major cause of acute encephalitis, a disease of significance for global public health. In the absence of antiviral therapy to treat JEV infection, vaccination is the most effective method of preventing the disease. In JE-endemic areas, the most widely used vaccine to date is SA(14)-14-2, a live-attenuated virus derived from its virulent parent SA(14). In this study, we describe the biological properties of SA(14)-14-2, both in vitro and in vivo, and report the genetic characteristics of its genomic RNA. In BHK-21 (hamster kidney) cells, SA(14)-14-2 displayed a slight delay in plaque formation and growth kinetics when compared to a virulent JEV strain, CNU/LP2, with no decrease in maximum virus production. The delay in viral growth was also observed in two other cell lines, SH-SY5Y (human neuroblastoma) and C6/36 (mosquito larva), which are potentially relevant to JEV pathogenesis and transmission. In 3-week-old ICR mice, SA(14)-14-2 did not cause any symptoms or death after either intracerebral or peripheral inoculation with a maximum dose of up to 1.5×10(3) plaque-forming units (PFU) per mouse. The SA(14)-14-2 genome consisted of 10977 nucleotides, one nucleotide longer than all the previously reported genomes of SA(14)-14-2, SA(14) and two other SA(14)-derived attenuated viruses. This difference was due to an insertion of one G nucleotide at position 10701 in the 3 noncoding region. Also, we noted a significant number of nucleotide and/or amino acid substitutions throughout the genome of SA(14)-14-2, except for the prM protein-coding region, that differed from SA(14) and/or the other two attenuated viruses. Our results, together with others', provide a foundation not only for the study of JEV virulence but also for the development of new and improved vaccines for JEV. PMID:22923123

Song, Byung-Hak; Yun, Gil-Nam; Kim, Jin-Kyoung; Yun, Sang-Im; Lee, Young-Min

2012-08-01

148

Comparison of initial feasibility of host cell lines for viral vaccine production.  

PubMed

In order to reduce the time required for the development and production of viral vaccines, host cell lines should be available as expression systems for production of viral vaccines against groups of viral pathogens. A selection of cell lines was compared for their initial feasibility as expression system for the replication of polioviruses, influenza A viruses and respiratory syncytial virus (wild type strain A2). Six adherent cell lines (Vero, HEK-293, MRC-5, CHO-K1, BHK-21 c13, MDCK) and six single cell suspension cell lines (CAP, AGE1.CR.HS, sCHO-K1, BHK-21 c13 2p, MDCK SFS) were studied for their ability to propagate viruses. First, maximum cell densities were determined. Second, virus receptor expression and polarization of the cell lines regarding receptor distribution of eight different viruses were monitored using flow cytometry and immunocytochemistry. Organization of the actin cytoskeleton was studied by transfection of the cells with Lifeact™, a construct coding for actin-EGFP. Finally, the ability to produce virus progeny of the viruses studied was assayed for each cell line. The results suggest that single cell suspension cell lines grown on serum free medium are the best candidates to serve as host cell lines for virus replication. PMID:23684847

Vlecken, Danielle H W; Pelgrim, Ralf P M; Ruminski, Slawomir; Bakker, Wilfried A M; van der Pol, Leo A

2013-10-01

149

Mercury Poisoning Linked to Skin Products  

MedlinePLUS

... Tobacco Products Vaccines, Blood & Biologics Articulos en Espanol Mercury Poisoning Linked to Skin Products Search the Consumer ... these products on Flickr. Signs and Symptoms of Mercury Poisoning irritability shyness tremors changes in vision or ...

150

The aluminum content of biological products containing aluminum adjuvants: determination by atomic absorption spectrometry.  

PubMed

Aluminum compounds are used as adjuvants in certain types of vaccines, toxoids and allergenic extracts for human use. The most common Al compounds used in biological products to enhance the immune response are aluminum potassium sulphate (alum), aluminum hydroxide and aluminum phosphate. This study describes an atomic absorption spectrometric method for the determination of the Al content of Al adsorbed toxoid preparations and allergenic extracts at levels of less than 0.85 mg of Al per half millilitre human dose. Aliquots of the samples which contained Al suspensions were acid digested with nitric and sulphuric acid and analysed in the nitrous oxide-acetylene flame of an atomic absorption spectrometer. The 396.2 nm Al line was used for analysis. The Al content of the National Bureau of Standards (NBS) Standard Reference Material No. 1075a aluminum 2- ethylhexanoate was determined to within 1% of the NBS certificate value by this method. Atomic absorption results for the Al content of tetanus toxoids containing aluminum potassium sulphate and aluminum phosphate were compared with polarographic and inductively coupled argon plasma (ICP) emission spectrometry results. Reproducibility and recovery data for Al are tabulated for a variety of biological products containing aluminum phosphate, aluminum potassium sulphate and aluminum hydroxide adjuvants. In addition, ICP has been used to characterize the Al and P compositions of the precipitates and supernatant solutions which resulted from centrifuging toxoid suspensions that contained the three different Al adjuvants. PMID:6736048

May, J C; Progar, J J; Chin, R

1984-01-01

151

Irradiation of advanced health care products - Tissues and biologics  

NASA Astrophysics Data System (ADS)

Radiation sterilization of tissues and biologics has become more common in recent years. As a result it has become critical to understand how to adapt the typical test methods and validation approaches to a tissue or biological product scenario. Also data evaluation sometimes becomes more critical than with traditional medical devices because for many tissues and biologics a low radiation dose is required. It is the intent behind this paper to provide information on adapting bioburden tests used in radiation validations such that the data can be most effectively used on tissues and biologics. In addition challenges with data evaluation are discussed, particularly the use of less-than values for bioburden results in radiation validation studies.

Winters, Martell

2014-12-01

152

Do Baby Products Prevent SIDS?  

MedlinePLUS

... Vaccines, Blood & Biologics Articulos en Espanol Do Baby Products Prevent SIDS? FDA Says No Search the Consumer ... to prevent manufacturers of over-the-counter sleep products for babies from claiming that their use will ...

153

Biological Interventions for Enhancing Saffron Productivity in Kashmir  

Microsoft Academic Search

The heterogeneity found in the natural saffron population for morphological, developmental and yield component traits are primarily due to the genetic and environmental factors. Development of high yielding genotypes using the existing gene pool of saffron applying the biological tools shows potential for improving the productivity of this crop. A survey undertaken to study the extent of variation revealed wide

F. A. Nehvi; S. A. Wani; S. A. Dar; M. I. Makhdoomi; B. A. Allie; Z. A. Mir

154

Hydrogen production by biological processes: a survey of literature  

Microsoft Academic Search

Hydrogen is the fuel of the future mainly due to its high conversion efficiency, recyclability and nonpolluting nature. Biological hydrogen production processes are found to be more environment friendly and less energy intensive as compared to thermochemical and electrochemical processes. They are mostly controlled by either photosynthetic or fermentative organisms. Till today, more emphasis has been given on the former

Debabrata Das; T. Nejat Veziro?lu

2001-01-01

155

BIOLOGIC SHIELDING AGAINST GAMMA-RAYS FROM FISSION-PRODUCTS  

Microsoft Academic Search

An effective attenuation-coefficient is determined in order to calcuiate ; the biologic shielding against gamma-rays of an originai fission product mixture. ; Its demonstration by diagrams is given as a function of the irradiation time of ; the uranium, of the cooling time after irradiation, of the wall thickness, and of ; the shielding material. (auth);

1962-01-01

156

Mechanism of Action for Anti-radiation Vaccine in Reducing the Biological Impact of High-dose Gamma Irradiation  

NASA Technical Reports Server (NTRS)

Ionizing radiation is a major health risk of long-term space travel, the biological consequences of which include genetic and oxidative damage. In this study, we propose an original mechanism by which high doses of ionizing radiation induce acute toxicity. We identified biological components that appear in the lymphatic vessels shortly after gamma irradiation. These radiation-induced toxins, which we have named specific radiation determinants (SRD), were generated in the irradiated tissues and then collected and circulated throughout the body via the lymph circulation and bloodstream. Depending on the type of SRD elicited, different syndromes of acute radiation sickness (ARS) were expressed. The SRDs were developed into a vaccine used to confer active immunity against acute radiation toxicity in immunologically naive animals. Animals that were pretreated with SRDs exhibited resistance to lethal doses of gamma radiation, as measured by increased survival times and survival rates. In comparison, untreated animals that were exposed to similar large doses of gamma radiation developed acute radiation sickness and died within days. This phenomenon was observed in a number of mammalian species. Initial analysis of the biochemical characteristics indicated that the SRDs were large molecular weight (200-250 kDa) molecules that were comprised of a mixture of protein, lipid, carbohydrate, and mineral. Further analysis is required to further identify the SRD molecules and the biological mechanism by which the mediate the toxicity associated with acute radiation sickness. By doing so, we may develop an effective specific immunoprophylaxis as a countermeasure against the acute effects of ionizing radiation.

Maliev, Vladislav; Popov, Dmitri; Jones, Jeffrey A.; Casey, Rachael C.

2007-01-01

157

Mechanism of Action for Anti-Radiation Vaccine in Reducing the Biological Impact of High-Dose Irradiation  

NASA Technical Reports Server (NTRS)

Ionizing radiation is a major health risk of long-term space travel, the biological consequences of which include genetic and oxidative damage. In this study, we propose an original mechanism by which high doses of ionizing radiation induce acute toxicity. We identified biological components that appear in the lymphatic vessels shortly after gamma irradiation. These radiation-induced toxins, which we have named specific radiation determinants (SRD), were generated in the irradiated tissues and then collected and circulated throughout the body via the lymph circulation and bloodstream. Depending on the type of SRD elicited, different syndromes of acute radiation sickness (ARS) were expressed. The SRDs were developed into a vaccine used to confer active immunity against acute radiation toxicity in immunologically naive animals. Animals that were pretreated with SRDs exhibited resistance to lethal doses of gamma radiation, as measured by increased survival times and survival rates. In comparison, untreated animals that were exposed to similar large doses of gamma radiation developed acute radiation sickness and died within days. This phenomenon was observed in a number of mammalian species. We partially analyzed the biochemical characteristics of the SRDs. The SRDs were large molecular weight (200-250 kDa) molecules that were comprised of a mixture of protein, lipid, carbohydrate, and mineral. Further analysis is required to further identify the SRD molecules and the biological mechanism by which the mediate the toxicity associated with acute radiation sickness. By doing so, we may develop an effective specific immunoprophylaxis as a countermeasure against the acute effects of ionizing radiation.

Maliev, Vladislav; Popov, Dmitri; Jones, Jeffrey A.; Casey, Rachael C.

2006-01-01

158

The Biology of Avian Eimeria with an Emphasis on their Control by Vaccination  

Microsoft Academic Search

Studies on the biology of the avian species of Eimeria are currently benefiting from the availability of a comprehensive sequence for the nuclear genome of Eimeria tenella. Allied to some recent advances in transgenic technologies and genetic approaches to identify protective antigens, some elements are now being assembled that should be helpful for the development of a new generation of

Martin W. Shirley; Adrian L. Smith; Fiona M. Tomley

2005-01-01

159

Recombinant Plants Provide a New Approach to the Production of Bacterial Polysaccharide for Vaccines  

PubMed Central

Bacterial polysaccharides have numerous clinical or industrial uses. Recombinant plants could offer the possibility of producing bacterial polysaccharides on a large scale and free of contaminating bacterial toxins and antigens. We investigated the feasibility of this proposal by cloning and expressing the gene for the type 3 synthase (cps3S) of Streptococcus pneumoniae in Nicotinia tabacum, using the pCambia2301 vector and Agrobacterium tumefaciens-mediated gene transfer. In planta the recombinant synthase polymerised plant-derived UDP-glucose and UDP-glucuronic acid to form type 3 polysaccharide. Expression of the cps3S gene was detected by RT-PCR and production of the pneumococcal polysaccharide was detected in tobacco leaf extracts by double immunodiffusion, Western blotting and high-voltage paper electrophoresis. Because it is used a component of anti-pneumococcal vaccines, the immunogenicity of the plant-derived type 3 polysaccharide was tested. Mice immunised with extracts from recombinant plants were protected from challenge with a lethal dose of pneumococci in a model of pneumonia and the immunised mice had significantly elevated levels of serum anti-pneumococcal polysaccharide antibodies. This study provides the proof of the principle that bacterial polysaccharide can be successfully synthesised in plants and that these recombinant polysaccharides could be used as vaccines to protect against life-threatening infections. PMID:24498433

Smith, Claire M.; Fry, Stephen C.; Gough, Kevin C.; Patel, Alexandra J. F.; Glenn, Sarah; Goldrick, Marie; Roberts, Ian S.; Andrew, Peter W.

2014-01-01

160

A serum-free Vero production platform for a chimeric virus vaccine candidate.  

PubMed

MedImmune Vaccines has engineered a live, attenuated chimeric virus that could prevent infections caused by parainfluenza virus type 3 (PIV3) and respiratory syncytial virus (RSV), causative agents of acute respiratory diseases in infants and young children. The work here details the development of a serum-free Vero cell culture production platform for this virus vaccine candidate. Efforts to identify critical process parameters and optimize culture conditions increased infectious virus titers by approximately 2 log(10) TCID(50)/ml over the original serum-free process. In particular, the addition of a chemically defined lipid concentrate to the pre-infection medium along with the shift to a lower post-infection cultivation temperature increased virus titers by almost 100-fold. This improved serum-free process achieved comparable virus titers to the serum-supplemented process, and demonstrated consistent results upon scale-up: Vero cultures in roller bottles, spinner flasks and bioreactors reproducibly generated maximum infectious virus titers of 8 log(10) TCID(50)/ml. PMID:19002888

Yuk, Inn H; Lin, Gina B; Ju, Hui; Sifi, Inesse; Lam, Yvonne; Cortez, Armida; Liebertz, Danny; Berry, J Michael; Schwartz, Richard M

2006-07-01

161

Production of cell culture (MDCK) derived live attenuated influenza vaccine (LAIV) in a fully disposable platform process.  

PubMed

The majority of influenza vaccines are manufactured using embryonated hens' eggs. The potential occurrence of a pandemic outbreak of avian influenza might reduce or even eliminate the supply of eggs, leaving the human population at risk. Also, the egg-based production technology is intrinsically cumbersome and not easily scalable to provide a rapid worldwide supply of vaccine. In this communication, the production of a cell culture (Madin-Darby canine kidney (MDCK)) derived live attenuated influenza vaccine (LAIV) in a fully disposable platform process using a novel Single Use Bioreactor (SUB) is presented. The cell culture and virus infection was maintained in a disposable stirred tank reactor with PID control of pH, DO, agitation, and temperature, similar to traditional glass or stainless steel bioreactors. The application of this technology was tested using MDCK cells grown on microcarriers in proprietary serum free medium and infection with 2006/2007 seasonal LAIV strains at 25-30 L scale. The MDCK cell growth was optimal at the agitation rate of 100 rpm. Optimization of this parameter allowed the cells to grow at a rate similar to that achieved in the conventional 3 L glass stirred tank bioreactors. Influenza vaccine virus strains, A/New Caledonia/20/99 (H1N1 strain), A/Wisconsin/67/05 (H3N2 strain), and B/Malaysia/2506/04 (B strain) were all successfully produced in SUB with peak virus titers > or =8.6 log(10) FFU/mL. This result demonstrated that more than 1 million doses of vaccine can be produced through one single run of a small bioreactor at the scale of 30 L and thus provided an alternative to the current vaccine production platform with fast turn-around and low upfront facility investment, features that are particularly useful for emerging and developing countries and clinical trial material production. PMID:20589670

George, Meena; Farooq, Masiha; Dang, Thi; Cortes, Bernadette; Liu, Jonathan; Maranga, Luis

2010-08-15

162

Microbial Production of Isoprenoids Enabled by Synthetic Biology  

PubMed Central

Microorganisms transform inexpensive carbon sources into highly functionalized compounds without toxic by-product generation or significant energy consumption. By redesigning the natural biosynthetic pathways in an industrially suited host, microbial cell factories can produce complex compounds for a variety of industries. Isoprenoids include many medically important compounds such as antioxidants and anticancer and antimalarial drugs, all of which have been produced microbially. While a biosynthetic pathway could be simply transferred to the production host, the titers would become economically feasible when it is rationally designed, built, and optimized through synthetic biology tools. These tools have been implemented by a number of research groups, with new tools pledging further improvements in yields and expansion to new medically relevant compounds. This review focuses on the microbial production of isoprenoids for the health industry and the advancements though synthetic biology. PMID:23577007

Immethun, Cheryl M.; Hoynes-O’Connor, Allison G.; Balassy, Andrea; Moon, Tae Seok

2013-01-01

163

Home Biology Medicine Technology Products News Definition Dictionary Movies Links Tags Search RSS nadler detonator georgia Whole Site Google Search  

E-print Network

Biology Dictionary Medicine Dictionary Biology Navigation Medical Navigation HOME >> BIOLOGY >> NEWS MHome Biology Medicine Technology Products News Definition Dictionary Movies Links Tags Search RSS nadler detonator georgia Whole Site Google Search Navigation Links Biology News Medicine News Biology

Bennett, Gisele

164

21 CFR 510.4 - Biologics; products subject to license control.  

Code of Federal Regulations, 2010 CFR

...2010-04-01 false Biologics; products subject to license control...DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS General...Provisions § 510.4 Biologics; products subject to license control...the Federal Food, Drug, and Cosmetic...

2010-04-01

165

Neisseria proteomics for antigen discovery and vaccine development.  

PubMed

Neisseria meningitidis (meningococcus) is a major causative organism of meningitis and sepsis and Neisseria gonorrhoeae (gonococcus) is the causative organism of the sexually transmitted disease gonorrhea. Infections caused by meningococci are vaccine-preventable, whereas gonococcal vaccine research and development has languished for decades and the correlates of protection are still largely unknown. In the past two decades, complementary 'omic' platforms have been developed to interrogate Neisseria genomes and gene products. Proteomic techniques applied to whole Neisseria bacteria, outer membranes and outer membrane vesicle vaccines have generated protein maps and also allowed the examination of environmental stresses on protein expression. In particular, immuno-proteomics has identified proteins whose expression is correlated with the development of human natural immunity to meningococcal infection and colonization and following vaccination. Neisseria proteomic techniques have produced a catalog of potential vaccine antigens and investigating the functional and biological properties of these proteins could finally provide 'universal' Neisseria vaccines. PMID:25017717

Christodoulides, Myron

2014-10-01

166

Evaluation of the immunogenicity and biological activity of the Citrobacter freundii Vi-CRM197 conjugate as a vaccine for Salmonella enterica serovar Typhi.  

PubMed

Typhoid fever remains a major health problem in developing countries. Young children are at high risk, and a vaccine effective for this age group is urgently needed. Purified capsular polysaccharide from Salmonella enterica serovar Typhi (Vi) is licensed as a vaccine, providing 50 to 70% protection in individuals older than 5 years. However, this vaccine is ineffective in infants. Vi conjugated to a carrier protein (i.e., an exoprotein A mutant from Pseudomonas aeruginosa [rEPA]) is highly immunogenic, provides long-term protection, and shows more than 90% protective efficacy in children 2 to 5 years old. Here, we describe an alternative glycoconjugate vaccine for S. Typhi, Vi-CRM(197), where Vi was obtained from Citrobacter freundii WR7011 and CRM(197), the mutant diphtheria toxin protein, was used as the carrier. We investigated the optimization of growth conditions for Vi production from C. freundii WR7011 and the immunogenicity of Vi-CRM(197) conjugates in mice. The optimal saccharide/protein ratio of the glycoconjugates was identified for the best antibody production. We also demonstrated the ability of this new vaccine to protect mice against challenge with Vi-positive Salmonella enterica serovar Typhimurium. PMID:21248155

Rondini, Simona; Micoli, Francesca; Lanzilao, Luisa; Hale, Christine; Saul, Allan J; Martin, Laura B

2011-03-01

167

Cytokine production and dysregulation in HIV pathogenesis: Lessons for development of therapeutics and vaccines  

PubMed Central

Numerous studies have characterized the cytokine modulation observed in human immunodeficiency virus (HIV) infected individuals, from initial infection through chronic disease. Progressive and non-progressive HIV infection models show the cytokine milieu differs in terms of production and responsiveness in these two groups, suggesting an understanding of the role cytokines play during infection is necessary for directing the immune response toward viral control. This review will cover cytokine induction and dysfunction during HIV pathogenesis, with a focus on the interplay between cytokines and transcription factors, T cell activation, and exhaustion. We highlight cytokines that have either vaccine adjuvant or therapeutic potential and discuss the need to identify key factors required for prevention of progression, clearance of infection, or protection from acquisition. PMID:22743036

Reuter, Morgan A.; Pombo, Carolina; Betts, Michael R.

2012-01-01

168

Immunobiology of Influenza Vaccines  

PubMed Central

Vaccination is the primary strategy for prevention and control of influenza. The surface hemagglutinin (HA) protein of the influenza virus contains two structural elements (head and stalk) that differ in their potential utility as vaccine targets. The head of the HA protein is the primary target of antibodies that confer protective immunity to influenza viruses. The underlying health status, age, and gene polymorphisms of vaccine recipients and, just as importantly, the extent of the antigenic match between the viruses in the vaccine and those that are circulating modulate influenza vaccine protection. Vaccine adjuvants and live attenuated influenza vaccine improve the breadth of immunity to seasonal and pandemic virus strains. Eliciting antibodies against the conserved HA stem region that cross-react with HAs within influenza virus types or subtypes would allow for the development of a universal influenza vaccine. The highly complex network of interactions generated after influenza infection and vaccination can be studied with the use of systems biology tools, such as DNA microarray chips. The use of systems vaccinology has allowed for the generation of gene expression signatures that represent key transcriptional differences between asymptomatic and symptomatic host responses to influenza infection. Additionally, the use of systems vaccinology tools have resulted in the identification of novel surrogate gene markers that are predictors of the magnitude of host responses to vaccines, which is critical to both vaccine development and public health. Identifying associations between variations in vaccine immune responses and gene polymorphisms is critical in the development of universal influenza vaccines. PMID:23381315

Fenton, Matthew J.

2013-01-01

169

Systems Biology of Recombinant Protein Production in Bacillus megaterium  

NASA Astrophysics Data System (ADS)

Over the last two decades the Gram-positive bacterium Bacillus megaterium was systematically developed to a useful alternative protein production host. Multiple vector systems for high yield intra- and extracellular protein production were constructed. Strong inducible promoters were combined with DNA sequences for optimised ribosome binding sites, various leader peptides for protein export and N- as well as C-terminal affinity tags for affinity chromatographic purification of the desired protein. High cell density cultivation and recombinant protein production were successfully tested. For further system biology based control and optimisation of the production process the genomes of two B. megaterium strains were completely elucidated, DNA arrays designed, proteome, fluxome and metabolome analyses performed and all data integrated using the bioinformatics platform MEGABAC. Now, solid theoretical and experimental bases for primary modeling attempts of the production process are available.

Biedendieck, Rebekka; Bunk, Boyke; Fürch, Tobias; Franco-Lara, Ezequiel; Jahn, Martina; Jahn, Dieter

170

Milk production change following clinical mastitis and reproductive performance compared among J5 vaccinated and control dairy cattle.  

PubMed

Naturally occurring cases of bovine clinical mastitis (CM) were studied among J5 vaccinates and controls on 3 commercial dairy farms. Milk production change and reproductive performance following CM were compared between the 2 groups. Among 306 controls and 251 vaccinates, there were 221 new cases of CM affecting 120 cows; 437 lactations never had a case of CM. Environmental pathogens made up 90% (159/176) of etiologic agents isolated. Change in daily milk production following CM was associated with J5 vaccination, days in milk (DIM) at onset of CM, and herd effect as well as each 2-way interaction between the 3 factors. The adjusted daily milk for 21 d following CM was 7.6 kg greater among J5 vaccinates than controls; however, this protective effect of vaccination waned with increasing DIM at onset of CM. A mixed linear model with autoregressive order 1 [AR(1)] correlation structure estimated the daily milk production of any cow (whether or not she had CM) on a given DIM. Cows with CM caused by nonagalactiae streptococci, Staphylococcus aureus, Escherichia coli, or Klebsiella lost significant daily milk production for the entire lactation relative to nonmastitic cows. Another mixed linear model for only coliform CM cases (E. coli, Klebsiella, and Enterobacter) within the first 50 DIM showed milk loss for 21 d following coliform CM to be significantly less for J5 vaccinates than for controls, by 6 to 15 kg per day. Cows were significantly less likely to become pregnant if they had CM caused by E. coli (42% pregnant) or Streptococcus spp. (38% pregnant), whereas 78% (342/437) of cows with no mastitis conceived. Days open (number of days from calving until pregnancy) averaged 131 d for cows with no CM and 162 d for cows that had at least one case of CM. Days until conception, days until last breeding, days open, times bred, and percentage of cows pregnant by 200 DIM were not changed with J5 vaccination. Nonetheless, an important benefit of the use of J5 bacterin appears to be reduction of the loss of daily milk production following CM, whether all cases or only those caused by coliform bacteria were considered. PMID:18832209

Wilson, D J; Grohn, Y T; Bennett, G J; González, R N; Schukken, Y H; Spatz, J

2008-10-01

171

Recommendations for rotavirus vaccine.  

PubMed

Rotavirus infection has been the leading cause of gastroenteritis among children in Taiwan. Studies have shown that 40% of hospitalization for acute gastroenteritis can be prevented through the use of vaccines, including a live, attenuated monovalent rotavirus vaccine and a pentavalent, human-bovine reassortant rotavirus vaccine. In 2009, the World Health Organization suggested that rotavirus vaccine should be included in all national immunization programs. This review summarizes issues and recommendations discussed during an expert meeting in Taiwan. The recommendations included: (1) rotavirus vaccine should be offered to all healthy infants (including those without contraindications, such as immunodeficiency) at an appropriate age; (2) either monovalent or pentavalent vaccine can be administered concurrently with routine injected vaccines; (3) the administration of rotavirus vaccine must be administered at least 2 weeks prior to oral polio vaccination; (4) the first vaccine dose for infants should be administered between age 6 weeks and age 14 weeks 6 days and the course should be completed by age 8 months 0 day; (5) pentavalent vaccines can be administered at 2 months, 4 months, and 6 months while monovalent vaccines can be taken at 2 months and 4 months; (6) a combined use of monovalent and pentavalent vaccine is justified only when the previous dose is unavailable or unknown; and (7) rotavirus vaccines may be given to premature infants, human immunodeficiency virus infected infants and infants who have received or are going to receive blood products. PMID:23746943

Lee, Ping-Ing; Chen, Po-Yen; Huang, Yhu-Chering; Lee, Chin-Yun; Lu, Chun-Yi; Chang, Mei-Hwei; Lin, Yung-Zen; Chiu, Nan-Chang; Ni, Yen-Hsuan; Chen, Chung-Ming; Chang, Luan-Yin; Tang, Ren-Bin; Huang, Li-Min; Huang, Yung-Feng; Hwang, Kao-Pin; Hwang, Betau; Lin, Tzou-Yien

2013-12-01

172

Production and stabilization of the trimeric influenza hemagglutinin stem domain for potentially broadly protective influenza vaccines  

PubMed Central

The rapid dissemination of the 2009 pandemic H1N1 influenza virus emphasizes the need for universal influenza vaccines that would broadly protect against multiple mutated strains. Recent efforts have focused on the highly conserved hemagglutinin (HA) stem domain, which must undergo a significant conformational change for effective viral infection. Although the production of isolated domains of multimeric ectodomain proteins has proven difficult, we report a method to rapidly produce the properly folded HA stem domain protein from influenza virus A/California/05/2009 (H1N1) by using Escherichia coli-based cell-free protein synthesis and a simple refolding protocol. The T4 bacteriophage fibritin foldon placed at the C terminus of the HA stem domain induces trimer formation. Placing emphasis on newly exposed protein surfaces, several hydrophobic residues were mutated, two polypeptide segments were deleted, and the number of disulfide bonds in each monomer was reduced from four to two. High pH and Brij 35 detergent emerged as the most beneficial factors for improving the refolding yield. To stabilize the trimer of the HA stem-foldon fusion, new intermolecular disulfide bonds were finally introduced between foldon monomers and between stem domain monomers. The correct immunogenic conformation of the stabilized HA stem domain trimer was confirmed by using antibodies CR6261, C179, and FI6 that block influenza infection by binding to the HA stem domain trimer. These results suggest great promise for a broadly protective vaccine and also demonstrate a unique approach for producing individual domains of complex multimeric proteins. PMID:24344259

Lu, Yuan; Welsh, John P.; Swartz, James R.

2014-01-01

173

Evidence for interferon production and its correlation with YF 17DD vaccine virus yields in primary chick embryo cells.  

PubMed

Early experiments have resulted in the establishment of an efficient methodology for the production of a yellow fever vaccine in chicken embryo fibroblasts (CEF) using the 17DD virus strain [Freire, M.S., Mann, G.F., Marchevsky, R.S., Yamamura, A.M., Almeida, L.F., Jabor, A.V., Malachias, J.M., Coutinho, E.S., Galler, R., 2005. Production of yellow fever 17DD vaccine virus in primary culture of chicken embryo fibroblasts: yields, thermo and genetic stability, attenuation and immunogenicity. Vaccine 23, 2501-2512]. To investigate the role of the interferon system in vaccine virus yields, CEF cultures seeded at high and low cell densities and infected with the yellow fever 17DD virus were used. The supernatants of these cultures were tested for the presence of interferon by an assay based on the reduction of cytopathic effect of a challenge virus (Sindbis), for the enzymatic activity of the interferon-induced 2',5'-oligoadenylate synthetase and for the expression of 2',5'-oligoadenylate synthetase mRNA. The presence of interferon and its influence in the replication of yellow fever 17DD virus in CEF cultures was clearly demonstrated. PMID:18621087

Caride, Elena; Borges, Maria Beatriz Junqueira; Marcovistz, Rugimar; Galler, Ricardo; Freire, Marcos da Silva

2008-10-01

174

Antibiotic-free production of a herpes simplex virus 2 DNA vaccine in a high yield cGMP process  

PubMed Central

Two DNA vaccine plasmids encoding Herpes simplex virus type 2 (HSV-2) glycoprotein D, NTC8485-O2-gD2 and NTC8485-O2-UgD2tr, were produced at large scale under current good manufacturing practice (cGMP) for use in a Phase I human clinical trial. These DNA vaccines incorporate the regulatory agency compliant, minimal, antibiotic-free (AF) NTC8485 mammalian expression vector. Plasmid yields of > 1 g/L were achieved using the HyperGRO™ fed-batch fermentation process, with successful scale up from 10 L process development scale to 320 L culture volume for cGMP production. The DNA vaccines were purified using a low residence time, high shear lysis process and AIRMIXTM technology, followed by chromatographic purification. This combination of optimized plasmid vector, high yield upstream production, and efficient downstream purification resulted in purified HSV-2 DNA vaccines with > 99% total supercoiled plasmid, ? 0.2% RNA, ? 0.1% host cell genomic DNA, and ? 0.1 endotoxin units per mg. PMID:23899469

Nelson, Jared; Rodriguez, Stephen; Finlayson, Neil; Williams, Jim; Carnes, Aaron

2013-01-01

175

Biological treatment of chicken feather waste for improved biogas production.  

PubMed

A two-stage system was developed which combines the biological degradation of keratin-rich waste with the production of biogas. Chicken feather waste was treated biologically with a recombinant Bacillus megaterium strain showing keratinase activity prior to biogas production. Chopped, autoclaved chicken feathers (4%, W/V) were completely degraded, resulting in a yellowish fermentation broth with a level of 0.51 mg/mL soluble proteins after 8 days of cultivation of the recombinant strain. During the subsequent anaerobic batch digestion experiments, methane production of 0.35 Nm3/kg dry feathers (i.e., 0.4 Nm3/kg volatile solids of feathers), corresponding to 80% of the theoretical value on proteins, was achieved from the feather hydrolyzates, independently of the pre-hydrolysis time period of 1, 2 or 8 days. Cultivation with a native keratinase producing strain, Bacillus licheniformis resulted in only 0.25 mg/mL soluble proteins in the feather hydrolyzate, which then was digested achieving a maximum accumulated methane production of 0.31 Nm3/kg dry feathers. Feather hydrolyzates treated with the wild type B. megaterium produced 0.21 Nm3 CH4/kg dry feathers as maximum yield. PMID:22432272

Forgács, Gergely; Alinezhad, Saeid; Mirabdollah, Amir; Feuk-Lagerstedt, Elisabeth; Horváth, Ilona Sárvári

2011-01-01

176

Vaccines against poverty  

PubMed Central

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

MacLennan, Calman A.; Saul, Allan

2014-01-01

177

Vaccination of channel catfish with extracellular products of Aeromonas hydrophila provides protection against infection by the pathogen.  

PubMed

Aeromonas hydrophila, a Gram-negative bacterium, is one of the economically-important pathogens in modern aquaculture. Among various traits, extracellular products (ECP) secreted by the bacterium are considered to be essential factors for virulence. Whether vaccination with the ECP could produce immune protection in catfish against the pathogen was determined in this study. The results showed that fish vaccinated with ECP had 100% of relative percent survival (RPS) when challenged with the pathogen two weeks post vaccination. The anti-ECP serum from vaccinated fish could aggregate cells of homogeneous bacteria as well as other virulent strains (isolates) of A. hydrophila but not an A. veronii isolate and a low virulent field isolate. The agglutination titers increased from two weeks to four weeks post immunization and sustained a high level at week seven when the RPS remained at 100%. The anti-ECP serum could also provide naïve fish with immediate protection against A. hydrophila as evidenced by passive immunization. Immunoblotting analysis showed that the anti-ECP serum contained antibodies that bound to specific targets, including protein and lipopolysaccharide-like molecules, in the ECP. Mass spectrometric analysis identified following putative proteins that may serve as important immunogens: chitinase, chitodextrinase, outer membrane protein85, putative metalloprotease, extracellular lipase, hemolysin and elastase. Findings revealed in this study suggest that, while ECP prepared in a conventional and convenient way could be a vaccine candidate, further characterization of antibody-mediated targets in the ECP would uncover quintessential antigens for the future development of highly efficacious vaccines. PMID:24321514

Zhang, Dunhua; Pridgeon, Julia W; Klesius, Phillip H

2014-01-01

178

Development of a robust, versatile, and scalable inoculum train for the production of a DNA vaccine.  

PubMed

For many microbial fermentation processes, the inoculum train can have a substantial impact on process performance in terms of productivity, profitability, and process control. In general, it is understood that a well-characterized and flexible inoculum train is essential for future scale-up and implementation of the process in a pilot plant or manufacturing setting. A fermentation process utilizing E. coli DH5 for the production of plasmid DNA carrying the HIV gag gene for use as a vaccine is currently under development in our laboratory. As part of the development effort, we evaluated inoculum train schemes that incorporate one, two, or three stages. In addition, we investigated the effect of inoculum viable-cell concentrations, either thawed or actively growing, over a wide range (from 2.5 x 10(4) to 1.0 x 10(8) viable cells/mL or approximately 0.001% to 4% of final working volume). The various inoculum trains were evaluated in terms of final plasmid yield, process time, reproducibility, robustness, and feasibility at large scale. The results of these studies show that final plasmid yield remained in the desired range, despite the number of stages or inoculation viable-cell concentrations comprising the inoculum train. On the basis of these observations and because it established a large database, the first part of these investigations supports an exceptional flexibility in the design of scalable inoculum trains for this DNA vaccine process. This work also highlighted that a slightly higher level of process reproducibility, as measured by the time for the culture to reach mid-exponential growth, was observed when using actively growing versus frozen cells. It also demonstrated the existence of a viable-cell concentration threshold for the one-stage process, since we observed that inoculation of the production stage with very low amounts of viable cells from a frozen source could lead to increased process sensitivity to external factors such as variation in the quality of the raw materials used in the medium formulation. However, our analysis indicates that, despite this slight disadvantage, a one-stage inoculum train was a viable option in many situations, especially if the inoculation viable-cell concentration was kept above 4.8 x 10(6) viable cells/mL. Because it leads to a reduction in process steps and eliminates some capital investments (i.e., inoculum fermenter), when feasible a one-stage process configuration will positively impact process economics. PMID:16080681

Okonkowski, J; Kizer-Bentley, L; Listner, K; Robinson, D; Chartrain, M

2005-01-01

179

FDA: CVaccines, Blood & Biologics  

NSDL National Science Digital Library

The mission of the Food and Drug Administration's (FDA) Vaccines, Blood & Biologics program is "to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies." Their mission is an important one, and consumers and scientists will want to bookmark this page and return to it on a regular basis. On the right-hand side of the page, visitors can sign up for their RSS feed, check out the "About" section, and read through their FAQ. In the center of the page, visitors can peruse the "Hot Topics", which at any given moment might include information on influenza vaccinations or product recalls or withdrawals. The site is rounded out by topical guide to the site along the left-hand side of the homepage.

2009-10-20

180

Vaccine manufacturing: challenges and solutions  

Microsoft Academic Search

The recent influenza vaccine shortages have provided a timely reminder of the tenuous nature of the world's vaccine supply and the potential for manufacturing issues to severely disrupt vital access to important vaccines. The application of new technologies to the discovery, assessment, development and production of vaccines has the potential to prevent such occurrences and enable the introduction of new

Ulrich Valley; Rino Rappuoli; Jeffrey B Ulmer

2006-01-01

181

Production of yellow fever 17DD vaccine virus in primary culture of chicken embryo fibroblasts: yields, thermo and genetic stability, attenuation and immunogenicity.  

PubMed

While a good vaccine against yellow fever (YF) virus has been available for decades, the basic technology for the production of YF vaccine in chicken embryos has remained substantially unchanged since the 1940s. Here we describe the highly efficient and economic production of the 17DD strain of YF virus in chicken embryo fibroblast (CEF) cell cultures with viral titers ranging from 6.3 to 6.7 log10PFU/mL. Thermostability of two different formulations (5 and 50-dose vials) of the CEF vaccine virus was found to be as high as the current vaccines retaining the minimal titer required for YF 17D vaccines. The production passage in CEF did not lead to the selection of genetic variants as shown by nucleotide sequence analyses of the CEF-derived vaccine lots or the sequence of viruses recovered from monkeys experimentally inoculated with the CEF virus. YF 17DD virus produced in CEF was also indistinguishable from its seed lot virus parent in terms of plaque size and immunogenicity in mice and monkeys. Comparison of the CEF virus and the seed lot virus made in chicken embryo in the internationally accepted monkey neurovirulence test (MNVT) revealed a higher clinical score for the former. The differences in central nervous system (CNS) histological scores for monkeys inoculated with the chicken embryo and experimental CEF vaccines were at the borderline level of statistical significance. These data warrant further studies on the monkey attenuation of other batches of CEF-derived vaccines. PMID:15752837

Freire, Marcos S; Mann, George F; Marchevsky, Renato S; Yamamura, Anna M Y; Almeida, Luiz F C; Jabor, Alfredo V; Malachias, José M N; Coutinho, Evandro S F; Galler, Ricardo

2005-03-31

182

Biology and management of psocids infesting stored products.  

PubMed

Previously regarded as minor nuisance pests, psocids belonging to the genus Liposcelis now pose a major problem for the effective protection of stored products worldwide. Here we examine the apparent biological and operational reasons behind this phenomenon and why conventional pest management seems to be failing. We investigate what is known about the biology, behavior, and population dynamics of major pest species to ascertain their strengths, and perhaps find weaknesses, as a basis for a rational pest management strategy. We outline the contribution of molecular techniques to clarifying species identification and understanding genetic diversity. We discuss progress in sampling and trapping and our comprehension of spatial distribution of these pests as a foundation for developing management strategies. The effectiveness of various chemical treatments and the availability and potential of nonchemical control methods are critically examined. Finally, we identify research gaps and suggest future directions for research. PMID:24160430

Nayak, Manoj K; Collins, Patrick J; Throne, James E; Wang, Jin-Jun

2014-01-01

183

Anticancer vaccines.  

PubMed

With the tools of molecular biology and a greater understanding of mechanisms to harness the immune system, effective tumor immunotherapy is becoming a reality. This new class of therapeutics offers a more targeted, and therefore precise, approach to the treatment of cancer. The recent conditional licensure of a xenogeneic DNA vaccine for advanced canine malignant melanoma strongly suggests that immunotherapy can play an extremely important role alongside the classic cancer treatment triad components of surgery, radiation therapy, and chemotherapy. PMID:17950885

Bergman, Philip J

2007-11-01

184

To Vaccinate, or Not to Vaccinate That is the Question  

NSDL National Science Digital Library

The case was prompted by a newspaper story about a couple who refused on religious grounds to have their son vaccinated even though vaccination is a requirement for admission to the public schools. It explores the issues surrounding the necessity and consequences of vaccination.  The case is suitable for both non-majors and allied health biology courses.

Shapiro, Caren D.

2001-01-01

185

Molecular biology in studies of oceanic primary production  

SciTech Connect

Remote sensing and the use of moored in situ instrumentation has greatly improved our ability to measure phytoplankton chlorophyll and photosynthesis on global scales with high temporal resolution. However, the interpretation of these measurements and their significance with respect to the biogeochemical cycling of carbon relies on their relationship with physiological and biochemical processes in phytoplankton. For example, the use of satellite images of surface chlorophyll to estimate primary production is often based on the functional relationship between photosynthesis and irradiance. A variety of environmental factors such as light, temperature, nutrient availability affect the photosynthesis/irradiance (P vs I) relationship in phytoplankton. We present three examples showing how molecular biology can be used to provide basic insight into the factors controlling primary productivity at three different levels of complexity: 1. Studies of light intensity regulation in unicellular alga show how molecular biology can help understand the processing of environmental cues leading to the regulation of photosynthetic gene expression. 2. Probing of the photosynthetic apparatus using molecular techniques can be used to test existing mechanistic models derived from the interpretation of physiological and biophysical measurements. 3. Exploratory work on the expression of specific proteins during nutrient-limited growth of phytoplankton may lead to the identification and production of molecular probes for field studies.

LaRoche, J.; Falkowski, P.G. (Brookhaven National Lab., Upton, NY (United States)); Geider, R. (Delaware Univ., Lewes, DE (United States). Coll. of Marine Studies)

1992-01-01

186

Molecular biology in studies of oceanic primary production  

SciTech Connect

Remote sensing and the use of moored in situ instrumentation has greatly improved our ability to measure phytoplankton chlorophyll and photosynthesis on global scales with high temporal resolution. However, the interpretation of these measurements and their significance with respect to the biogeochemical cycling of carbon relies on their relationship with physiological and biochemical processes in phytoplankton. For example, the use of satellite images of surface chlorophyll to estimate primary production is often based on the functional relationship between photosynthesis and irradiance. A variety of environmental factors such as light, temperature, nutrient availability affect the photosynthesis/irradiance (P vs I) relationship in phytoplankton. We present three examples showing how molecular biology can be used to provide basic insight into the factors controlling primary productivity at three different levels of complexity: 1. Studies of light intensity regulation in unicellular alga show how molecular biology can help understand the processing of environmental cues leading to the regulation of photosynthetic gene expression. 2. Probing of the photosynthetic apparatus using molecular techniques can be used to test existing mechanistic models derived from the interpretation of physiological and biophysical measurements. 3. Exploratory work on the expression of specific proteins during nutrient-limited growth of phytoplankton may lead to the identification and production of molecular probes for field studies.

LaRoche, J.; Falkowski, P.G. [Brookhaven National Lab., Upton, NY (United States); Geider, R. [Delaware Univ., Lewes, DE (United States). Coll. of Marine Studies

1992-07-01

187

9 CFR 113.52 - Requirements for cell lines used for production of biologics.  

Code of Federal Regulations, 2010 CFR

...2010-01-01 false Requirements for cell lines used for production of biologics...Requirements § 113.52 Requirements for cell lines used for production of biologics...or in a filed Outline of Production each cell line used to prepare a biological...

2010-01-01

188

Influenza vaccine  

MedlinePLUS

Vaccine - influenza; Immunization - influenza; Flu shot; Flu vaccine ... with Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP) United States, 2013-2014. Available at: ...

189

Impact of defective interfering particles on virus replication and antiviral host response in cell culture-based influenza vaccine production.  

PubMed

During the replication of influenza viruses, defective interfering particles (DIPs) can be generated. These are noninfectious deletion mutants that require coinfection with a wild-type virus but interfere with its helper virus replication. Consequently, coinfected cells mainly produce DIPs. Little is known about how such noninfectious virus particles affect the virus yield of cell culture-based influenza vaccine production. We compared infections of Madin-Darby canine kidney cells with two seed virus preparations of the influenza virus strain A/Puerto Rico/8/34 that contain different amounts of DIPs. A combination of conventional RT-PCR, RT-qPCR, and flow cytometry revealed that DI genomes indeed strongly accumulate in coinfected cells and impede the viral RNA synthesis. Additionally, cells infected at the higher DIP concentration showed a stronger antiviral response characterized by increased interferon-? expression and apoptosis induction. Furthermore, in the presence of DIPs, a significant fraction of cells did not show any productive accumulation of viral proteins at all. Together, these effects of DIPs significantly reduce the virus yield. Therefore, the accumulation of DIPs should be avoided during influenza vaccine production which can be achieved by quality controls of working seed viruses based on conventional RT-PCR. The strategy for the depletion of DIPs presented here can help to make cell culture-based vaccine production more reliable and robust. PMID:25132064

Frensing, Timo; Pflugmacher, Antje; Bachmann, Mandy; Peschel, Britta; Reichl, Udo

2014-11-01

190

Regulatory cytokine production stimulated by DNA vaccination against an altered form of glutamic acid decarboxylase 65 in nonobese diabetic mice.  

PubMed

Nonobese diabetic (NOD) mice develop a T-cell dependent autoimmune form of diabetes, in which glutamic acid decarboxylase 65 (GAD65) is an important islet target antigen. Intramuscular DNA vaccination with a plasmid encoding native GAD65 (a cytosolic antigen) did not significantly alter the incidence of diabetes, but vaccination against an altered form of GAD65 with a signal peptide (spGAD), which is secreted in vitro, was protective. The preventive effect was further enhanced by repeated injections of the spGAD plasmid. Following DNA injection into muscle GAD65 was expressed for several months, and this was not accompanied by an inflammatory response. Immunization against GAD65 was not associated with substantial alterations in cytokine production by splenic lymphocytes stimulated with immunogenic GAD65 peptides. In contrast, spGAD induced increased secretion of both interleukin 10 and interferon gamma and a striking decrease in the interferon gamma/interleukin 10 ratio in culture supernatants. Similarly, spGAD-immunized mice had higher serum interleukin 10 levels and lower serum interferon gamma levels than other groups, suggesting a systemic effect. In nondiabetic mice there was increased basal production of transforming growth factor beta(1), which was enhanced by antigenic stimulation. These alterations in regulatory cytokine production were apparent both early and late after the treatment was initiated. These findings suggest that DNA vaccination against spGAD protects NOD mice by increasing regulatory cytokine production. PMID:12682726

Glinka, Yelena; De Pooter, Renée; Croze, France; Prud'homme, Gérald J

2003-03-01

191

High-yield production of a stable Vero cell-based vaccine candidate against the highly pathogenic avian influenza virus H5N1  

SciTech Connect

Highlights: Black-Right-Pointing-Pointer Vero cell-based HPAI H5N1 vaccine with stable high yield. Black-Right-Pointing-Pointer Stable high yield derived from the YNVa H3N2 backbone. Black-Right-Pointing-Pointer H5N1/YNVa has a similar safety and immunogenicity to H5N1delta. -- Abstract: Highly pathogenic avian influenza (HPAI) viruses pose a global pandemic threat, for which rapid large-scale vaccine production technology is critical for prevention and control. Because chickens are highly susceptible to HPAI viruses, the supply of chicken embryos for vaccine production might be depleted during a virus outbreak. Therefore, developing HPAI virus vaccines using other technologies is critical. Meeting vaccine demand using the Vero cell-based fermentation process has been hindered by low stability and yield. In this study, a Vero cell-based HPAI H5N1 vaccine candidate (H5N1/YNVa) with stable high yield was achieved by reassortment of the Vero-adapted (Va) high growth A/Yunnan/1/2005(H3N2) (YNVa) virus with the A/Anhui/1/2005(H5N1) attenuated influenza vaccine strain (H5N1delta) using the 6/2 method. The reassorted H5N1/YNVa vaccine maintained a high hemagglutination (HA) titer of 1024. Furthermore, H5N1/YNVa displayed low pathogenicity and uniform immunogenicity compared to that of the parent virus.

Zhou, Fangye; Zhou, Jian; Ma, Lei; Song, Shaohui; Zhang, Xinwen; Li, Weidong; Jiang, Shude [No. 5, Department of Bioproducts, Institute of Medical Biology, Chinese Academy of Medical Science and Pecking Union Medical College, Jiaoling Avenue 935, Kunming, Yunnan Province 650102, People's Republic of China (China)] [No. 5, Department of Bioproducts, Institute of Medical Biology, Chinese Academy of Medical Science and Pecking Union Medical College, Jiaoling Avenue 935, Kunming, Yunnan Province 650102, People's Republic of China (China); Wang, Yue, E-mail: euy-tokyo@umin.ac.jp [National Institute for Viral Disease Control and Prevention, China Center for Disease Control and Prevention, Yingxin Lane 100, Xicheng District, Beijing 100052, People's Republic of China (China)] [National Institute for Viral Disease Control and Prevention, China Center for Disease Control and Prevention, Yingxin Lane 100, Xicheng District, Beijing 100052, People's Republic of China (China); Liao, Guoyang, E-mail: liaogy@21cn.com [No. 5, Department of Bioproducts, Institute of Medical Biology, Chinese Academy of Medical Science and Pecking Union Medical College, Jiaoling Avenue 935, Kunming, Yunnan Province 650102, People's Republic of China (China)] [No. 5, Department of Bioproducts, Institute of Medical Biology, Chinese Academy of Medical Science and Pecking Union Medical College, Jiaoling Avenue 935, Kunming, Yunnan Province 650102, People's Republic of China (China)

2012-05-18

192

Field efficacy of an inactivated bivalent influenza vaccine in a multi-site swine production system during an outbreak of systemic porcine circovirus associated disease  

PubMed Central

Swine influenza (SI) is a disease of significance for the swine industry, and vaccination is often recommended as a way to reduce its impact on production. The efficacy of SI vaccines is well established under experimental conditions, but information about field efficacy is scarce. The objective of this study was to evaluate the efficacy of a commercial inactivated bivalent (H1N1/H3N2) vaccine under conditions of natural exposure to a field SI variant. To accomplish our goal we used a randomized, blinded, field trial in 2 cohorts of finisher pigs in a multi-site swine production system located in southern Ontario. During the trial, this herd experienced an outbreak of porcine circovirus associated disease (PCVAD). The efficacy of the SI vaccine was assessed through its effect on average daily weight gain, and serological responses to SI over time. The effect of vaccination on pig growth was different in the 2 cohorts. Weight gain was higher in vaccinated pigs than in control pigs in Cohort 1, but was numerically higher for control pigs than for vaccinated pigs in Cohort 2. Vaccination against swine influenza, in a herd experiencing an outbreak of PCVAD, was of questionable value. PMID:20592840

Poljak, Zvonimir; Dewey, Catherine E.; Martin, S. Wayne; Christensen, Jette; Friendship, Robert M.

2010-01-01

193

Natural products as a resource for biologically active compounds  

SciTech Connect

The goal of this study was to investigate various sources of biologically active natural products in an effort to identify the active pesticidal compounds involved. The study is divided into several parts. Chapter 1 contains a discussion of several new compounds from plant and animal sources. Chapter 2 introduces a new NMR technique. In section 2.1 a new technique for better utilizing the lanthanide relaxation agent Gd(fod)/sub 3/ is presented which allows the predictable removal of resonances without line broadening. Section 2.2 discusses a variation of this technique for use in an aqueous solvent by applying this technique towards identifying the binding sites of metals of biological interest. Section 2.3 presents an unambiguous /sup 13/C NMR assignment of melibiose. Chapter 3 deals with work relating to the molting hormone of most arthropods, 20-hydroxyecdysone. Section 3.1 discusses the use of two-dimensional NMR (2D NMR) to assign the /sup 1/H NMR spectrum of this biologically important compound. Section 3.2 presents a new application for Droplet countercurrent chromatography (DCCC). Chapter 4 presents a basic improvement to the commercial DCCC instrument that is currently being applied to future commercial instruments. Chapter 5 discusses a curious observation of the effects that two previously known compounds, nagilactone C and (-)-epicatechin, have on lettuce and rice and suggest a possible new role for the ubiquitous flavanol (-)-epicatechin in plants.

Hanke, F.J.

1986-01-01

194

Current studies on physiological functions and biological production of lactosucrose.  

PubMed

Lactosucrose (O-?-D-galactopyranosyl-(1,4)-O-?-D-glucopyranosyl-(1,2)-?-D-fructofuranoside) is a trisaccharide formed from lactose and sucrose by enzymatic transglycosylation. This rare trisaccharide is a kind of indigestible carbohydrate, has good prebiotic effect, and promotes intestinal mineral absorption. It has been used as a functional ingredient in a range of food products which are approved as foods for specified health uses in Japan. Using lactose and sucrose as substrates, lactosucrose can be produced through transfructosylation by ?-fructofuranosidase from Arthrobacter sp. K-1 or a range of levansucrases, or through transgalactosylation by ?-galactosidase from Bacillus circulans. This article presented a review of recent studies on the physiological functions of lactosucrose and the biological production from lactose and sucrose by different enzymes. PMID:23828605

Mu, Wanmeng; Chen, Qiuming; Wang, Xiao; Zhang, Tao; Jiang, Bo

2013-08-01

195

Evaluation and redesign of manual material handling in a vaccine production centre's warehouse.  

PubMed

This study was conducted in a warehouse at a vaccine production centre where improvement to existing storage and working conditions were sought through the construction of a new refrigerated store section (2-8C°). Warehousing tasks were videotaped and ergonomics analysis tools were used to assess the risk of developing MSDs. Specifically, these tools were the Rapid Entire Body Assessment (REBA) and the NIOSH equation. The current plant layout was sketched and analyzed to find possible targets for improvement trough the application of general work space design and ergonomics principles. Seven of the eight postures evaluated with REBA had a total score between 8 and 10, meaning a high risk, and only one was at a medium risk level. Nine of the eleven manual material handling tasks analyzed with the NIOSH equation had a Lifting Index between 1.14 and 1.80 and two had a recommended weight limit of 0 kg, indicating a need for job redesign. Solutions included the redesign of shelves, the design of a two-step stair and a trolley with adjustable height; also, changes in work methods were proposed by introducing a two-workers lifting strategy and job rotation, and, finally, a restructuring of plant layout was completed. PMID:22317092

Torres, Yaniel; Viña, Silvio

2012-01-01

196

Understanding Vaccines: What They Are How They Work  

NSDL National Science Digital Library

This is a PDF booklet providing information on vaccines including how they prevent disease, how they are developed and researched, and what the future holds for vaccines in production. Benefits of vaccines, and specific vaccine types are discussed.

2003-07-01

197

A melanoma helper peptide vaccine increases Th1 cytokine production by leukocytes in peripheral blood and immunized lymph nodes  

PubMed Central

Background Cancers produce soluble and cell-associated molecules that can suppress or alter antitumor immunity. Preclinical studies suggest the disease burden may alter the cytokine profile of helper T cell responses to cancer antigens. We studied cytokine production by helper T cells responding to vaccination with 6 melanoma helper peptides (6MHP) in blood and lymph nodes. Methods Twenty-three patients with stage IIIB-IV melanoma received a 6MHP vaccine. Antigen-reactive T cells from blood and draining lymph nodes were cultured, exposed to antigen, and then supernatants (days 2 and 5) were assayed for Th1 and Th2 cytokines. Results from 4 time points were compared to pre-vaccine levels. Results Cytokine responses to vaccinating peptides were observed in 83% of patients. Th1 favoring responses were most common (17 of 19 responders). The most abundant cytokines produced were IFN-? and IL-5 in the PBMC’s. IL-2 responses predominated in cells obtained from draining lymph nodes in 2-day culture but not in 5-day cultures. Patients with clinically measurable disease produced similar levels of total cytokine and similar degree of Th1 polarization as patients with no evidence of disease (NED). Conclusions The MHC class II-associated peptides used in this study induced helper T cells with a Th1-biased cytokine response in both PBMC and sentinel immunized nodes. Most patients can mount a Th1 dominant response to these peptides. Future studies are needed to test newer vaccine adjuvants in combination with these peptides. Trial registration CDR0000378171, Clinicaltrials: NCT00089219. PMID:25126421

2014-01-01

198

9 CFR 113.303 - Bluetongue Vaccine.  

Code of Federal Regulations, 2011 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.303 Bluetongue Vaccine...Bluetongue Vaccine shall be prepared from virus-bearing cell culture fluids....

2011-01-01

199

9 CFR 113.303 - Bluetongue Vaccine.  

Code of Federal Regulations, 2012 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.303 Bluetongue Vaccine...Bluetongue Vaccine shall be prepared from virus-bearing cell culture fluids....

2012-01-01

200

9 CFR 113.327 - Bronchitis Vaccine.  

Code of Federal Regulations, 2012 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.327 Bronchitis Vaccine...Bronchitis Vaccine shall be prepared from virus-bearing cell culture fluids or...

2012-01-01

201

9 CFR 113.327 - Bronchitis Vaccine.  

Code of Federal Regulations, 2011 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.327 Bronchitis Vaccine...Bronchitis Vaccine shall be prepared from virus-bearing cell culture fluids or...

2011-01-01

202

9 CFR 113.313 - Measles Vaccine.  

Code of Federal Regulations, 2011 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.313 Measles Vaccine. Measles Vaccine shall be prepared from virus-bearing cell culture fluids. Only...

2011-01-01

203

9 CFR 113.303 - Bluetongue Vaccine.  

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.303 Bluetongue Vaccine...Bluetongue Vaccine shall be prepared from virus-bearing cell culture fluids....

2014-01-01

204

9 CFR 113.327 - Bronchitis Vaccine.  

Code of Federal Regulations, 2013 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.327 Bronchitis Vaccine...Bronchitis Vaccine shall be prepared from virus-bearing cell culture fluids or...

2013-01-01

205

9 CFR 113.313 - Measles Vaccine.  

Code of Federal Regulations, 2013 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.313 Measles Vaccine. Measles Vaccine shall be prepared from virus-bearing cell culture fluids. Only...

2013-01-01

206

9 CFR 113.303 - Bluetongue Vaccine.  

Code of Federal Regulations, 2010 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.303 Bluetongue Vaccine...Bluetongue Vaccine shall be prepared from virus-bearing cell culture fluids....

2010-01-01

207

9 CFR 113.313 - Measles Vaccine.  

Code of Federal Regulations, 2010 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.313 Measles Vaccine. Measles Vaccine shall be prepared from virus-bearing cell culture fluids. Only...

2010-01-01

208

9 CFR 113.313 - Measles Vaccine.  

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.313 Measles Vaccine. Measles Vaccine shall be prepared from virus-bearing cell culture fluids. Only...

2014-01-01

209

9 CFR 113.303 - Bluetongue Vaccine.  

Code of Federal Regulations, 2013 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.303 Bluetongue Vaccine...Bluetongue Vaccine shall be prepared from virus-bearing cell culture fluids....

2013-01-01

210

9 CFR 113.313 - Measles Vaccine.  

Code of Federal Regulations, 2012 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.313 Measles Vaccine. Measles Vaccine shall be prepared from virus-bearing cell culture fluids. Only...

2012-01-01

211

Gardasil(R) - The New HPV Vaccine: The Right Product, the Right Time? A Commentary  

PubMed Central

The federal and provincial governments have undertaken a universal immunization program to protect school-aged girls against cervical cancer using the new human papillomavirus vaccine Gardasil®. While the vaccine appears to be effective and safe, there are a number of important unanswered questions regarding it and the effects of the immunization program. Here we briefly review key literature about the vaccine and then use the Erickson criteria, which offer an evidence basis for decision-making regarding national immunization strategies, to evaluate whether the program is congruent with sound public health policy. Our analysis of the national decision to recommend and fund a vaccination program using Gardasil® raises significant questions about the basis for this program. PMID:21532767

Lexchin, Joel; Arya, Neil; Singh, Sonal

2010-01-01

212

Plant-based vaccines for animal health  

Microsoft Academic Search

Summary Plant-based vaccines are recombinant protein subunit vaccines. Ideally, the choice of plant species used to produce the selected antigen should allow for oral delivery in the form of an edible vaccine. These vaccines are well suited to combat diseases where there is a clear antigen candidate, and where the costs of production or delivery for any current vaccine are

S. J. Streatfield

2005-01-01

213

Rapid and Scalable Plant-based Production of a Cholera Toxin B Subunit Variant to Aid in Mass Vaccination against Cholera Outbreaks  

PubMed Central

Introduction Cholera toxin B subunit (CTB) is a component of an internationally licensed oral cholera vaccine. The protein induces neutralizing antibodies against the holotoxin, the virulence factor responsible for severe diarrhea. A field clinical trial has suggested that the addition of CTB to killed whole-cell bacteria provides superior short-term protection to whole-cell-only vaccines; however, challenges in CTB biomanufacturing (i.e., cost and scale) hamper its implementation to mass vaccination in developing countries. To provide a potential solution to this issue, we developed a rapid, robust, and scalable CTB production system in plants. Methodology/Principal Findings In a preliminary study of expressing original CTB in transgenic Nicotiana benthamiana, the protein was N-glycosylated with plant-specific glycans. Thus, an aglycosylated CTB variant (pCTB) was created and overexpressed via a plant virus vector. Upon additional transgene engineering for retention in the endoplasmic reticulum and optimization of a secretory signal, the yield of pCTB was dramatically improved, reaching >1 g per kg of fresh leaf material. The protein was efficiently purified by simple two-step chromatography. The GM1-ganglioside binding capacity and conformational stability of pCTB were virtually identical to the bacteria-derived original B subunit, as demonstrated in competitive enzyme-linked immunosorbent assay, surface plasmon resonance, and fluorescence-based thermal shift assay. Mammalian cell surface-binding was corroborated by immunofluorescence and flow cytometry. pCTB exhibited strong oral immunogenicity in mice, inducing significant levels of CTB-specific intestinal antibodies that persisted over 6 months. Moreover, these antibodies effectively neutralized the cholera holotoxin in vitro. Conclusions/Significance Taken together, these results demonstrated that pCTB has robust producibility in Nicotiana plants and retains most, if not all, of major biological activities of the original protein. This rapid and easily scalable system may enable the implementation of pCTB to mass vaccination against outbreaks, thereby providing better protection of high-risk populations in developing countries. PMID:23505583

Bennett, Lauren J.; Baldauf, Keegan J.; Kajiura, Hiroyuki; Fujiyama, Kazuhito; Matoba, Nobuyuki

2013-01-01

214

Production of inflammatory cytokines in response to diphtheria-pertussis-tetanus (DPT), haemophilus influenzae type b (Hib), and 7-valent pneumococcal (PCV7) vaccines.  

PubMed

Haemophilus influenzae type b (Hib) and 7-valent pneumococcal (PCV7) vaccines both became recommended in Japan in 2010. In this study, cytokine production was investigated in peripheral blood mononuclear cells (PBMCs) cultures stimulated with diphtheria and tetanus toxoids combined with acellular pertussis vaccine (DPT), Hib, and PCV7 separately or concurrent different combinations, all as final off-the-shelf vaccines without the individual vaccine components as controls. Higher IL-1? levels were produced when cultures were stimulated with PCV than with DPT or Hib, and the concurrent stimulation including PCV7 enhanced the production of IL-1?. Although Hib induced higher levels of IL-6, no significant difference was observed in IL-6 production with the concurrent stimulation. The concurrent stimulation with Hib/PCV7 and DPT/Hib/PCV7 produced higher levels of TNF-? and human G-CSF. Cytokine profiles were examined in serum samples obtained from 61 vaccine recipients with febrile reactions and 18 recipients without febrile illness within 24 h of vaccination. No significant difference was observed in cytokine levels of IL-1?, IL-4, IL-6, IL-10, IL-12, IFN-?, MIP-1, TNF-?, and prostaglandin E2 (PGE2) in sera between the two groups. However, significantly higher levels of human G-CSF were observed in recipients with febrile illness than in those without febrile reactions. Further investigations of the significance of elevated serum G-CSF levels are required in vaccine recipients with febrile illness. PMID:24589970

Kashiwagi, Yasuyo; Miyata, Akiko; Kumagai, Takuji; Maehara, Kouji; Suzuki, Eitarou; Nagai, Takao; Ozaki, Takao; Nishimura, Naoko; Okada, Kenji; Kawashima, Hisashi; Nakayama, Tetsuo

2014-03-01

215

Adventitious agents in viral vaccines: lessons learned from 4 case studies.  

PubMed

Since the earliest days of biological product manufacture, there have been a number of instances where laboratory studies provided evidence for the presence of adventitious agents in a marketed product. Lessons learned from such events can be used to strengthen regulatory preparedness for the future. We have therefore selected four instances where an adventitious agent, or a signal suggesting the presence of an agent, was found in a viral vaccine, and have developed a case study for each. The four cases are: a) SV40 in polio vaccines; b) bacteriophage in measles and polio vaccines; c) reverse transcriptase in measles and mumps vaccines; and d) porcine circovirus and porcine circovirus DNA sequences in rotavirus vaccines. The lessons learned from each event are discussed. Based in part on those experiences, certain scientific principles have been identified by WHO that should be considered in regulatory risk evaluation if an adventitious agent is found in a marketed vaccine in the future. PMID:25135887

Petricciani, John; Sheets, Rebecca; Griffiths, Elwyn; Knezevic, Ivana

2014-09-01

216

Biological production of monoethanolamine by engineered Pseudomonas putida S12.  

PubMed

Pseudomonas putida S12 was engineered for the production of monoethanolamine (MEA) from glucose via the decarboxylation of the central metabolite L-serine, which is catalyzed by the enzyme L-serine decarboxylase (SDC). The host was first evaluated for its tolerance towards MEA as well as its endogenous ability to degrade this alkanolamine. Growth inhibition was observed at MEA concentrations above 100 mM, but growth was never completely arrested even at 750 mM of MEA. P. putida S12 was able to catabolize MEA in the absence of ammonia, but deletion of the eutBC genes that encode ethanolamine ammonia-lyase (EAL) enzyme sufficed to eliminate this capacity. For the biological production of MEA, the sdc genes from Arabidopsis thaliana (full-length and a truncated version) and Volvox carteri were expressed in P. putida S12. From 20 mM of glucose, negligible amounts of MEA were produced by P. putida S12 ?eutBC expressing the sdc genes from A. thaliana and V. carteri. However, 0.07 mmol of MEA was obtained per g of cell dry weight of P. putida S12 ?eutBC expressing the truncated variant of the A. thaliana SDC. When the medium was supplemented with L-serine (30 mM), MEA production increased to 1.25 mmol MEA g?¹ CDW, demonstrating that L-serine availability was limiting MEA production. PMID:23876477

Foti, Mirjam; Médici, Rosario; Ruijssenaars, Harald J

2013-09-10

217

Suitability of Gray Water for Hydroponic Crop Production Following Biological and Physical Chemical and Biological Subsystems  

NASA Technical Reports Server (NTRS)

The water present in waste streams from a human habitat must be recycled in Controlled Ecological Life Support Systems (CELSS) to limit resupply needs and attain self-sufficiency. Plants play an important role in providing food, regenerating air, and producing purified water via transpiration. However, we have shown that the surfactants present in hygiene waste water have acute toxic effects on plant growth (Bubenheim et al. 1994; Greene et al., 1994). These phytotoxic affects can be mitigated by allowing the microbial population on the root surface to degrade the surfactant, however, a significant suppression (several days) in crop performance is experienced prior to reaching sub-toxic surfactant levels and plant recovery. An effective alternative is to stabilize the microbial population responsible for degradation of the surfactant on an aerobic bioreactor and process the waste water prior to utilization in the hydroponic solution (Wisniewski and Bubenheim, 1993). A sensitive bioassay indicates that the surfactant phytotoxicity is suppressed by more than 90% within 5 hours of introduction of the gray water to the bioreactor; processing for more than 12 hours degrades more than 99% of the phytotoxin. Vapor Compression Distillation (VCD) is a physical / chemical method for water purification which employees sequential distillation steps to separate water from solids and to volatilize contaminants. The solids from the waste water are concentrated in a brine and the pure product water (70 - 90% of the total waste water volume depending on operating conditions) retains non of the phytotoxic effects. Results of the bioassay were used to guide evaluations of the suitability of recovered gray water following biological and VCD processing for hydroponic lettuce production in controlled environments. Lettuce crops were grown for 28 days with 100% of the input water supplied with recovered water from the biological processor or VCD. When compared with the growth of plants in control hydroponic solution containing pure deionized water, no growth difference could be measured resulting from any of the recovered water treatments. Both biological treatment and VCD offer alternative technology approaches to recovering water from waste streams appropriate for input into a crop production system. A high level of crop performance (food, air, and water production) can be maintained with either processor; selection decisions can be based on other factors regarding system integration.

Bubenheim, David L.; Harper, Lynn D.; Wignarajah, Kanapathipillai; Greene, Catherine

1994-01-01

218

The Brazilian vaccine manufacturers' perspective and its current status.  

PubMed

This article aims to give an overview of the current situation and perspectives for the Brazilian vaccine manufacturers, who play strong roles for developing countries in this field. The research, development and production of immunobiologicals in Brazil, especially vaccines for human use, is mainly supported by governmental institutions linked to the Ministry of Health as part of a strategy that prioritizes the public sector for access to vaccines and other biologicals that are regarded essential for the population. As a result, 83% of the vaccines required in 2007 were provided by national vaccine producers and only 17% were imported, mainly to reference centers for special vaccines that were used for special patients. Moreover, the country has actively exported yellow fever vaccine since 2002 and meningitis AC vaccine since 2007, having covered more than 60 nations. The perspectives have positively increased due to the government's policy of making internal investments, not only to avoid the external dependence of products for public health, but also to strengthen the Brazilian industrial sector related to biotechnology. PMID:19423359

Homma, Akira

2009-06-01

219

Charting biologically relevant chemical space: A structural classification of natural products (SCONP)  

Microsoft Academic Search

The identification of small molecules that fall within the biologically relevant subfraction of vast chemical space is of utmost importance to chemical biology and medicinal chemistry research. The prerequirement of biological relevance to be met by such molecules is fulfilled by natural product-derived compound collections. We report a structural classification of natural products (SCONP) as organizing principle for charting the

Marcus A. Koch; Ansgar Schuffenhauer; Michael Scheck; Stefan Wetzel; Marco Casaulta; Alex Odermatt; Peter Ertl; Herbert Waldmann

2005-01-01

220

Product-specific validation of a serological potency test for release of Leptospira vaccines in the European Union.  

PubMed

Historically in the European Union, all Leptospira vaccines were released using the European Pharmacopoeia (Ph. Eur.) hamster potency assay. Recently, there has been a shift toward alternatives that offer either refinement of testing or replacement of animals for product release. This is being driven by animal welfare concerns but also by a drive to have more consistent, cheaper, and faster batch release tests. This publication discusses one such example of a multicomponent canine vaccine that includes three Leptospira serovars and has recently been registered in the European Union. The potency release test is a refinement because it uses rabbit serology rather than hamster challenge. This publication covers the principles of the test method, challenges faced during its development and registration, and discussion about benefits and limitations of this method. It concludes with a view of how the use of serology testing could fit into an overall strategy to move to fully in vitro testing by adopting a consistency approach. PMID:23849308

Stirling, Catrina; Novokova, Viera

2013-09-01

221

Valuing vaccination  

PubMed Central

Vaccination has led to remarkable health gains over the last century. However, large coverage gaps remain, which will require significant financial resources and political will to address. In recent years, a compelling line of inquiry has established the economic benefits of health, at both the individual and aggregate levels. Most existing economic evaluations of particular health interventions fail to account for this new research, leading to potentially sizable undervaluation of those interventions. In line with this new research, we set forth a framework for conceptualizing the full benefits of vaccination, including avoided medical care costs, outcome-related productivity gains, behavior-related productivity gains, community health externalities, community economic externalities, and the value of risk reduction and pure health gains. We also review literature highlighting the magnitude of these sources of benefit for different vaccinations. Finally, we outline the steps that need to be taken to implement a broad-approach economic evaluation and discuss the implications of this work for research, policy, and resource allocation for vaccine development and delivery. PMID:25136129

Barnighausen, Till; Bloom, David E.; Cafiero-Fonseca, Elizabeth T.; O'Brien, Jennifer Carroll

2014-01-01

222

Recombinant Influenza Vaccines  

PubMed Central

This review covers the problems encountered in the construction and production of new recombinant influenza vaccines. New approaches to the development of influenza vaccines are investigated; they include reverse genetics methods, production of virus-like particles, and DNA- and viral vector-based vaccines. Such approaches as the delivery of foreign genes by DNA- and viral vector-based vaccines can preserve the native structure of antigens. Adenoviral vectors are a promising gene-delivery platform for a variety of genetic vaccines. Adenoviruses can efficiently penetrate the human organism through mucosal epithelium, thus providing long-term antigen persistence and induction of the innate immune response. This review provides an overview of the practicability of the production of new recombinant influenza cross-protective vaccines on the basis of adenoviral vectors expressing hemagglutinin genes of different influenza strains. PMID:23346377

Sedova, E.S.; Shcherbinin, D.N.; Migunov, A.I.; Smirnov, Iu.A.; Logunov, D.Iu.; Shmarov, M.M.; Tsybalova, L.M.; Naroditskii, B.S.; Kiselev, O.I.; Gintsburg, A.L.

2012-01-01

223

Milk and Serum J5-Specific Antibody Responses, Milk Production Change, and Clinical Effects following Intramammary Escherichia coli Challenge for J5 Vaccinate and Control Cows?  

PubMed Central

Holstein dairy cows (four J5 vaccinates and four controls) selected for no recorded intramammary disease and low somatic cell count (SCC) during the previous lactation were challenged by intramammary infusion of Escherichia coli. Vaccination with J5 was at 8 weeks and again 4 weeks before the anticipated calving date. Cows were challenged at 8 to 16 days in milk (DIM). Shedding of E. coli in milk was significantly higher among controls than vaccinates (no shedding) from 6 h to 21 h postchallenge. From 21 h to 132 h postchallenge, SCC in challenged quarters of controls (5,429,000/ml) was significantly higher than that of vaccinates (490,000/ml). On the day after challenge, milk production in control cows was 8 kg less, while vaccinates gained 0.5 kg, a significant difference. In serum immediately prior to challenge, J5-specific immunoglobulin G1 (IgG1) was significantly higher, IgG2 was nearly significantly higher, and IgM was the same in J5 vaccinates relative to controls. Vaccinates had proportionally more IgG2 in serum postcalving and in the first 12 h following challenge and less IgG2 in milk 24 h after challenge than the controls, approaching statistical significance. The ratio of J5-specific IgG1 and IgG2 combined compared to IgM was significantly higher in vaccinates than in controls in prechallenge serum (ratios of 15.8 and 3.2, respectively) and milk (5.0 and 1.3, respectively). Cows with higher IgM titers in milk 12 h postchallenge produced significantly less milk. Vaccination with J5 was significantly associated with higher production of J5-specific IgG1 and IgG2 in early lactation, reduced SCC, faster clearance of E. coli from milk, and less milk production loss following intramammary challenge. PMID:17460115

Wilson, David J.; Mallard, Bonnie A.; Burton, Jeanne L.; Schukken, Ynte H.; Grohn, Yrjo T.

2007-01-01

224

9 CFR 102.5 - U.S. Veterinary Biological Product License.  

Code of Federal Regulations, 2010 CFR

9 Animals and Animal Products 1 2010-01-01 2010-01-01 false U.S. Veterinary Biological Product License. 102.5 Section 102.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT...

2010-01-01

225

9 CFR 112.9 - Biological products imported for research and evaluation.  

Code of Federal Regulations, 2010 CFR

... Animals and Animal Products ANIMAL AND PLANT...TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING § 112.9 Biological products imported for research...section. (a) The label shall identify...

2010-01-01

226

Influences of F-strain Mycoplasma gallisepticum vaccine on productive and reproductive performance of commercial parent broiler chicken breeders on a multi-age farm.  

PubMed

The influences of F-strain Mycoplasma gallisepticum (FMG) vaccine inoculation during the pullet period on the subsequent productive and reproductive performance of parent broiler chicken breeders on a multi-age farm were evaluated. Three thousand breeders were randomly divided into 2 treatment groups that were either vaccinated with FMG (FMG-vaccinated group) or not vaccinated with FMG (FMG-free group). Body weight and egg production were determined through approximately 50 wk of age. Egg weight and feed conversion was determined at 26, 32, 35, 38, and 43 wk of age. Egg quality parameters, including eggshell strength, egg-specific gravity, egg shape index, blood-meat spots, Haugh unit score, eggshell thickness, yolk:albumen ratio, percentage yolk, albumen and eggshell weights, and percentage fertility, hatchability, and second-quality chicks were determined at 26, 32, and 43 wk of age. Air sacs were examined and lesions were scored at 20, 32, and 50 wk of age. The number of mature ovarian follicles, histologies of ovary, and lengths, and histologies of the infundibulum, magnum, isthmus, uterus, and vagina were determined. In the present study, an increase in egg production of broiler breeder hens in the FMG-vaccinated group during peak of lay was compared with the FMG-free group. Feed conversion of hens in the FMG-vaccinated group was significantly less at 32, 35, 38, and 43 wk of age. Eggs from hens in the FMG-vaccinated group had a significantly higher Haugh units score at 26 wk of age and had a significantly higher eggshell thickness and lower incidence of blood-meat spots at 32 wk. Hatching eggs from hens in the FMG-vaccinated group had a significantly higher hatchability. The mean lesion score of air-sac lesion of birds in the FMG-vaccinated group was significantly less than FMG-vaccinated group. Uteruses of hens in the FMG-vaccinated group had a significantly longer length compared with the FMG-free group at 32 wk of age. The results indicate that inoculation of commercial parent broiler chicken breeders with the FMG vaccine before laying may prevent infection by field M. gallisepticum, and facilitate productive and reproductive performance. PMID:23687149

Liu, J J; Ding, L; Wei, J Z; Li, Y

2013-06-01

227

Emerging Vaccine Informatics  

PubMed Central

Vaccine informatics is an emerging research area that focuses on development and applications of bioinformatics methods that can be used to facilitate every aspect of the preclinical, clinical, and postlicensure vaccine enterprises. Many immunoinformatics algorithms and resources have been developed to predict T- and B-cell immune epitopes for epitope vaccine development and protective immunity analysis. Vaccine protein candidates are predictable in silico from genome sequences using reverse vaccinology. Systematic transcriptomics and proteomics gene expression analyses facilitate rational vaccine design and identification of gene responses that are correlates of protection in vivo. Mathematical simulations have been used to model host-pathogen interactions and improve vaccine production and vaccination protocols. Computational methods have also been used for development of immunization registries or immunization information systems, assessment of vaccine safety and efficacy, and immunization modeling. Computational literature mining and databases effectively process, mine, and store large amounts of vaccine literature and data. Vaccine Ontology (VO) has been initiated to integrate various vaccine data and support automated reasoning. PMID:21772787

He, Yongqun; Rappuoli, Rino; De Groot, Anne S.; Chen, Robert T.

2010-01-01

228

[Poliovirus vaccine].  

PubMed

To avoid the risk of vaccine-associated paralytic poliomyelitis (VAPP) and polio outbreaks due to circulating vaccine-derived polioviruses, an inactivated poliovirus vaccine (IPV) was introduced for routine immunization in a number of countries with a low risk of polio outbreaks. Currently, production and marketing of a standalone conventional IPV and two diphtheria-pertussis-tetanus-IPV (Sabin-derived IPV; sIPV) products have been submitted, and it is expected that the IPV products will be introduced in Japan in the autumn of 2012. At the same time, a decline in the OPV immunization rate became apparent in Japan due to serious public concerns about a remaining risk of VAPP and introduction of IPV in the near future. Therefore, the recent development of polio immunity gaps should be carefully monitored, and surveillance of suspected polio cases and laboratory diagnosis of polioviruses have to be intensified for the transition period from OPV to IPV in Japan. The development of sIPV is one of the most realistic options to introduce affordable IPV to developing countries. In this regard, further clinical studies on its efficacy, safety, and interchangeability of sIPV will be needed after the introduction of the sIPV products, which will be licensed in Japan for the first time in the world. PMID:23189825

Shimizu, Hiroyuki

2012-06-01

229

37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.  

Code of Federal Regulations, 2010 CFR

...patent term extension for a human drug, antibiotic drug or human biological product...patent term extension for a human drug, antibiotic drug or human biological product...750 that a patent for a human drug, antibiotic drug or human biological...

2010-07-01

230

37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.  

Code of Federal Regulations, 2011 CFR

...patent term extension for a human drug, antibiotic drug or human biological product...patent term extension for a human drug, antibiotic drug or human biological product...750 that a patent for a human drug, antibiotic drug or human biological...

2011-07-01

231

37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.  

Code of Federal Regulations, 2012 CFR

...patent term extension for a human drug, antibiotic drug or human biological product...patent term extension for a human drug, antibiotic drug or human biological product...750 that a patent for a human drug, antibiotic drug or human biological...

2012-07-01

232

37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.  

Code of Federal Regulations, 2013 CFR

...patent term extension for a human drug, antibiotic drug or human biological product...patent term extension for a human drug, antibiotic drug or human biological product...750 that a patent for a human drug, antibiotic drug or human biological...

2013-07-01

233

Biological hydrogen production in suspended and attached growth anaerobic reactor systems  

Microsoft Academic Search

Biological production of hydrogen gas has received increasing interest from the international community during the last decade. Most studies on biological fermentative hydrogen production from carbohydrates using mixed cultures have been conducted in conventional continuous stirred tank reactors (CSTR) under mesophilic conditions. Investigations on hydrogen production in reactor systems with attached microbial growth have recently come up as well as

Hariklia N. Gavala; Ioannis V. Skiadas; Birgitte K. Ahring

2006-01-01

234

Diphtheria, Tetanus, and Pertussis (DTaP) Vaccine  

MedlinePLUS

Certiva® (as a combination product containing Diphtheria, Tetanus Toxoids, Acellular Pertussis Vaccine) ... Daptacel® (as a combination product containing Diphtheria, Tetanus Toxoids, Acellular Pertussis Vaccine)

235

Sustainable production of biologically active molecules of marine based origin.  

PubMed

The marine environment offers both economic and scientific potential which are relatively untapped from a biotechnological point of view. These environments whilst harsh are ironically fragile and dependent on a harmonious life form balance. Exploitation of natural resources by exhaustive wild harvesting has obvious negative environmental consequences. From a European industry perspective marine organisms are a largely underutilised resource. This is not due to lack of interest but due to a lack of choice the industry faces for cost competitive, sustainable and environmentally conscientious product alternatives. Knowledge of the biotechnological potential of marine organisms together with the development of sustainable systems for their cultivation, processing and utilisation are essential. In 2010, the European Commission recognised this need and funded a collaborative RTD/SME project under the Framework 7-Knowledge Based Bio-Economy (KBBE) Theme 2 Programme 'Sustainable culture of marine microorganisms, algae and/or invertebrates for high value added products'. The scope of that project entitled 'Sustainable Production of Biologically Active Molecules of Marine Based Origin' (BAMMBO) is outlined. Although the Union is a global leader in many technologies, it faces increasing competition from traditional rivals and emerging economies alike and must therefore improve its innovation performance. For this reason innovation is placed at the heart of a European Horizon 2020 Strategy wherein the challenge is to connect economic performance to eco performance. This article provides a synopsis of the research activities of the BAMMBO project as they fit within the wider scope of sustainable environmentally conscientious marine resource exploitation for high-value biomolecules. PMID:23563183

Murray, Patrick M; Moane, Siobhan; Collins, Catherine; Beletskaya, Tanya; Thomas, Olivier P; Duarte, Alysson W F; Nobre, Fernando S; Owoyemi, Ifeloju O; Pagnocca, Fernando C; Sette, L D; McHugh, Edward; Causse, Eric; Pérez-López, Paula; Feijoo, Gumersindo; Moreira, Ma T; Rubiolo, Juan; Leirós, Marta; Botana, Luis M; Pinteus, Susete; Alves, Celso; Horta, André; Pedrosa, Rui; Jeffryes, Clayton; Agathos, Spiros N; Allewaert, Celine; Verween, Annick; Vyverman, Wim; Laptev, Ivan; Sineoky, Sergei; Bisio, Angela; Manconi, Renata; Ledda, Fabio; Marchi, Mario; Pronzato, Roberto; Walsh, Daniel J

2013-09-25

236

Evaluation of components of X-ray irradiated 7-valent pneumococcal conjugate vaccine and pneumococcal vaccine polyvalent and X-ray and gamma-ray irradiated acellular pertussis component of DTaP vaccine products  

NASA Astrophysics Data System (ADS)

Samples of pneumococcal vaccine polyvalent, 7-valent pneumococcal conjugate vaccine, and two different diphtheria and tetanus toxoids and acellular pertussis vaccines adsorbed were irradiated with X-rays and/or gamma-rays (Co-60). Mouse IgG and IgM antibody responses (ELISA) for types 9V, 14, 18C, and 19F pneumococcal polysaccharides and conjugates indicated that the polysaccharides were more tolerant of the radiation than the conjugates. The mouse antibody response for the detoxified pertussis toxin (PT) antigen, filamentous hemagglutinin antigen (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM) antigens for the appropriate vaccine type indicated that the antibody response was not significantly changed in the 25 kGy X-ray irradiated vaccines frozen in liquid nitrogen compared to the control vaccine.

May, J. C.; Rey, L.; Lee, Chi-Jen; Arciniega, Juan

2004-09-01

237

The use of BHK suspension cells for the production of foot and mouth disease vaccines  

Microsoft Academic Search

The isolation of Baby Hamster Kidney (BHK) 21 cells and their adaptation, characterisation and development for the commercial manufacture of foot and mouth disease vaccines over a twenty year period is reviewed, including the preparation of media, handling of cell substrates and control of the physical environment during manufacture. A description is given of the successful operation of the BHK

P. J. Radlett

238

Leptospirosis vaccines  

PubMed Central

Leptospirosis is a serious infection disease caused by pathogenic strains of the Leptospira spirochetes, which affects not only humans but also animals. It has long been expected to find an effective vaccine to prevent leptospirosis through immunization of high risk humans or animals. Although some leptospirosis vaccines have been obtained, the vaccination is relatively unsuccessful in clinical application despite decades of research and millions of dollars spent. In this review, the recent advancements of recombinant outer membrane protein (OMP) vaccines, lipopolysaccharide (LPS) vaccines, inactivated vaccines, attenuated vaccines and DNA vaccines against leptospirosis are reviewed. A comparison of these vaccines may lead to development of new potential methods to combat leptospirosis and facilitate the leptospirosis vaccine research. Moreover, a vaccine ontology database was built for the scientists working on the leptospirosis vaccines as a starting tool. PMID:18072968

Wang, Zhijun; Jin, Li; Wegrzyn, Alicja

2007-01-01

239

Vaccine Shortages  

MedlinePLUS

... produce the vaccine fast enough to meet the demand. The company decides to stop making the vaccine ... will last and what to do until new supplies arrive. Typically, the vaccine supply is not completely ...

240

HPV vaccine  

MedlinePLUS

Vaccine - HPV; Immunization - HPV; Gardasil; Cervarix; HPV2; HPV4; Vaccine to prevent cervical cancer ... of Obstetricians and Gynecologists. Committee Opinion No. 588: Human Papillomavirus Vaccination. Obstet Gynecol . 2014;123:712-8. American ...

241

Footrot vaccines and vaccination.  

PubMed

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 acquired immunity. PMID:24736003

Dhungyel, Om; Hunter, James; Whittington, Richard

2014-05-30

242

Effects of 2 commercially-available 9-way killed vaccines on milk production and rectal temperature in Holstein-Friesian dairy cows.  

PubMed Central

Veterinarians and farmers employing multivalent killed vaccines in lactating dairy cows have reported transient losses in milk production. Few studies have quantified this loss. In this report, effects of 2 commercially available 9-way vaccines on milk production and rectal temperature are examined. Repeated measures analyses of variance were used to compare changes in milk production and rectal temperature over time between treatment groups. There was a significant (P < 0.01) interaction among treatment and time when comparing vaccine- and placebo-treated animals. When pretreatment milk production (or days in milk) and pretreatment rectal temperature were considered, respectively, as covariates, a significant (P < 0.05) depression of milk production and a significant (P < 0.05) increase in rectal temperature were observed one day following injection. These effects were small and short-lived. The stage of lactation, level of milk production, and choice of product may be used as decision-making tools to decrease milk production losses in vaccine-candidate cows. PMID:11665428

Scott, H M; Atkins, G; Willows, B; McGregor, R

2001-01-01

243

Chickenpox vaccine  

MedlinePLUS

Immunization - chickenpox; Vaccine - VAR;Immunization - VAR; Varicella zoster vaccine ... for Disease Control and Prevention. Advisory Committee on Immunization Practices (ACIP) Recommended Immunization Schedules for Persons Aged ...

244

75 FR 47605 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...Notice of Meeting AGENCY: Food and Drug Administration...advisory committee of the Food and Drug Administration...Research (HFM-71), Food and Drug Administration...and Laboratory of Vector Borne Virus Diseases, Division of Viral...

2010-08-06

245

Protection against Fasciola gigantica using paramyosin antigen as a candidate for vaccine production.  

PubMed

Yet no vaccine to protect ruminants against liver fluke infection has been commercialized. In an attempt to develop a suitable vaccine against Fasciola gigantica (F. gigantica) infection in rabbits, using 97 kDa Pmy antigen. It was found that, the mean worm burdens and bile egg count after challenge were reduced significantly by 58.40 and 61.40%, respectively. On the other hand, immunization of rabbits with Pmy induced a significant expression of humoral antibodies (IgM, total IgG, IgG1, IgG2 and IgG4) and different cytokines (IL-6, IL-10, L-12 and TNF-alpha). Among Ig isotypes, IgG2 and IgG4 were most dominant Post-infection (PI) while, recording a low IgG1 level. The dominance of IgG2 and IgG4 suggested late T helper1 (Th1) involvement in rabbit's cellular response. While, the low IgG1 level suggested Th2 response to adult F. gigantica worm Pmy. Among all cytokines, IL-10 was the highest in rabbits immunized with Pmy PI suggesting also the enhancement of Th2 response. It was clear that the native F. gigantica Pmy is considered as a relevant candidate for vaccination against fascioliasis. Also, these data suggested the immunoprophylactic effect of the native F. gigantica Pmy which is mediated by a mixed Th1/Th2 response. PMID:24511686

Abou-Elhakam, H; Rabee, I; El Deeb, S; El Amir, A

2013-11-15

246

78 FR 12760 - Guidance for Industry on Labeling for Human Prescription Drug and Biological Products...  

Federal Register 2010, 2011, 2012, 2013

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Labeling for Human Prescription Drug and Biological Products--Implementing the PLR Content and Format Requirements.'' This guidance is intended to assist applicants in complying with the content and format requirements of labeling for human prescription drug and biological products. The......

2013-02-25

247

Attenuated and replication-competent vaccinia virus strains M65 and M101 with distinct biology and immunogenicity as potential vaccine candidates against pathogens.  

PubMed

Replication-competent poxvirus vectors with an attenuation phenotype and with a high immunogenic capacity of the foreign expressed antigen are being pursued as novel vaccine vectors against different pathogens. In this investigation, we have examined the replication and immunogenic characteristics of two vaccinia virus (VACV) mutants, M65 and M101. These mutants were generated after 65 and 101 serial passages of persistently infected Friend erythroleukemia (FEL) cells. In cultured cells of different origins, the mutants are replication competent and have growth kinetics similar to or slightly reduced in comparison with those of the parental Western Reserve (WR) virus strain. In normal and immune-suppressed infected mice, the mutants showed different levels of attenuation and pathogenicity in comparison with WR and modified vaccinia Ankara (MVA) strains. Wide genome analysis after deep sequencing revealed selected genomic deletions and mutations in a number of viral open reading frames (ORFs). Mice immunized in a DNA prime/mutant boost regimen with viral vectors expressing the LACK (Leishmania homologue for receptors of activated C kinase) antigen of Leishmania infantum showed protection or a delay in the onset of cutaneous leishmaniasis. Protection was similar to that triggered by MVA-LACK. In immunized mice, both polyfunctional CD4(+) and CD8(+) T cells with an effector memory phenotype were activated by the two mutants, but the DNA-LACK/M65-LACK protocol preferentially induced CD4(+) whereas DNA-LACK/M101-LACK preferentially induced CD8(+) T cell responses. Altogether, our findings showed the adaptive changes of the WR genome during long-term virus-host cell interaction and how the replication competency of M65 and M101 mutants confers distinct biological properties and immunogenicity in mice compared to those of the MVA strain. These mutants could have applicability for understanding VACV biology and as potential vaccine vectors against pathogens and tumors. PMID:23596295

Sánchez-Sampedro, Lucas; Gómez, Carmen Elena; Mejías-Pérez, Ernesto; Pérez-Jiménez, Eva; Oliveros, Juan Carlos; Esteban, Mariano

2013-06-01

248

VACCINE INFORMATION STATEMENT Hepatitis B Vaccine  

E-print Network

VACCINE INFORMATION STATEMENT Hepatitis B Vaccine What You Need to Know ManyVaccine; - beingstuckwithausedneedle. 2 Hepatitis B vaccine: Why get vaccinated? Hepatitis hepatitis B vaccine and when? Children and Adolescents · Babiesnormallyget3dosesofhepatitisBvaccine: 1st

Tennessee, University of

249

[Risk of smallpox, vaccination, bioterrorism].  

PubMed

The use of the smallpox virus as a biological weapon is very old. Confronted with a high probability of a current bioterrorist menace, counteracting strategies have been developed. One of the principle aims relies on the vaccination of teams dedicated to the management of persons infected and the stocking of vaccine for the whole population of a country. Following worldwide eradication of the disease, preventive vaccination was topped in 1978 in France for the primo-vaccination, and in 1984 for repeat vaccinations. The various strains used in the first generation vaccinations are weakened living vaccine, the natural host and origin of which is unknown. Second and third generations vaccines are under study; the principle objective is to obtain efficacy with a minimum of side effects. There are two types of adverse events, generally observed with the first generation vaccines: the first, extremely rare, can be life-threatening; the others, more frequent (10 to 15% of patients) are benign. In emergency situations, in the presence of smallpox, there should be no absolute contraindications to vaccination. In the bioterrorist context, massive vaccination campaigns of the population are unadvisable (because of the considerable risk of death and severe adverse events) in the absence of any real permit, in each case, definition of the vaccinal strategy to be adopted. PMID:15706726

Bossi, P; Garin, D; Combadière, B; Rouleau, E; Rigaudeau, S; LebrunVignes, B; Martinez, V; Autran, B; Bricaire, F

2005-01-29

250

9 CFR 114.18 - Reprocessing of biological products.  

...Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE...TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PRODUCTION REQUIREMENTS...shall be submitted to Animal and Plant Health Inspection Service...until notified by Animal and Plant Health Inspection Service...

2014-01-01

251

Protection against anthrax toxin by vaccination with a DNA plasmid encoding anthrax protective antigen  

Microsoft Academic Search

A DNA vaccine encoding the immunogenic and biologically active portion of anthrax protective antigen (PA) was constructed. Spleen cells from BALB\\/c mice immunized intramuscularly with this vaccine were stimulated to secrete IFN? and IL-4 when exposed to PA in vitro. Immunized mice also mounted a humoral immune response dominated by IgG1 anti-PA antibody production, the subclass previously shown to confer

Mi-Li Gu; Stephen H Leppla; Dennis M Klinman

1999-01-01

252

Pricing of new vaccines  

PubMed Central

New vaccine pricing is a complicated process that could have substantial long-standing scientific, medical and public health ramifications. Pricing can have a considerable impact on new vaccine adoption and, thereby, either culminate or thwart years of research and development and public health efforts. Typically, pricing strategy consists of the following eleven components: (1) Conduct a target population analysis; (2) Map potential competitors and alternatives; (3) Construct a vaccine target product profile (TPP) and compare it to projected or actual TPPs of competing vaccines; (4) Quantify the incremental value of the new vaccine's characteristics; (5) Determine vaccine positioning in the marketplace; (6) Estimate the vaccine price-demand curve; (7) Calculate vaccine costs (including those of manufacturing, distribution, and research and development); (8) Account for various legal, regulatory, third party payer and competitor factors; (9) Consider the overall product portfolio; (10) Set pricing objectives; (11) Select pricing and pricing structure. While the biomedical literature contains some studies that have addressed these components, there is still considerable room for more extensive evaluation of this important area. PMID:20861678

McGlone, Sarah M

2010-01-01

253

The efficacy of vaccination for the eradication of rage-virus mediated zombieism. Department of Mathematics and Statistics & Department of Biology  

E-print Network

The efficacy of vaccination for the eradication of rage-virus mediated zombieism. Troy Day mutates into a dangerous form that does just the opposite. Those infected display zombie-like symptoms for a vaccine, but here I use standard techniques from mathematical epidemiology to show that such vaccines

Day, Troy

254

Tetanus, Diphtheria (Td) Vaccine  

MedlinePLUS

Tenivac® (as a combination product containing Diphtheria, Tetanus Toxoids) ... Why get vaccinated?Tetanus and diphtheria are very serious diseases. They are rare in the United States today, but people who do become ...

255

International reference preparations for standardization of biological medicinal products.  

PubMed

International standards are prepared as materials assigned an arbitrary unitage for a biological activity by the Expert Committee on Biological Standardization of the World Health Organization. Working reference materials are calibrated against international standards giving a common unit of measurement between laboratories. The references are assessed by a collaborative study including all relevant assays rather than by a single reference method as in the SI (Le Système international d'unités) system and the unitage assigned is an arbitrary value derived from a consensus of all valid methods. The process has proved valuable in assaying the activity of therapeutic biological medicines and in standardizing certain types of diagnostics. Issues arise with maintaining the unit when the primary reference must be replaced and to some extent in assessing the commutability of the reference with real life analytes. PMID:25204274

Minor, P

2014-10-01

256

Stability evaluation of vaccines: WHO approach.  

PubMed

The stability of vaccines has a major impact on the success of immunization programmes worldwide. In line with this, clear definition of the stability characteristics of a vaccine is of critical importance. One of the concerns at country level is whether vaccines will remain potent on its way from the manufacturer, through the distribution channels, to the final users and vaccine recipients. In response to the requests for assistance in defining stability profile of vaccines, the Expert Committee on Biological Standardization (ECBS) in October 2006 agreed that new WHO guidelines be established on stability evaluation of vaccines (http://www.who.int/biologicals/publications/trs/areas/vaccines/stability/en/index.html). This document applies to all vaccines against infectious diseases. The aim of this guideline is to provide the scientific basis and guiding principles for evaluation of vaccine stability for the purpose of clinical trial approval, licensing, and post-licensure monitoring. As part of its initiative to promote use of vaccines of assured quality, WHO emphasizes the role of National Regulatory Authorities (NRAs) and National Control Laboratories (NCLs) in overall vaccine evaluation, including stability assessment. While recognizing that manufacturers are responsible for the quality of the vaccines they produce, compliance with vaccine quality specifications is part of regulatory oversight. This article provides basic information about WHO international standards as well as key definitions and principles for stability evaluation of vaccines that are elaborated in detail in the above mentioned guidance document. PMID:19729320

Knezevic, Ivana

2009-11-01

257

9 CFR 115.2 - Inspections of biological products.  

Code of Federal Regulations, 2013 CFR

...Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT...SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS INSPECTIONS § 115.2...distribution and sale actions to the Animal and Plant Health Inspection Service pursuant...

2013-01-01

258

Malaria vaccines in development.  

PubMed

The recent infusion of public and private funding for malaria vaccine development has greatly accelerated the pace at which candidate malaria vaccines are entering the clinic. Recent promising results from vaccine trials carried out in malaria-naive and -endemic populations have revealed important insights into what will be required of a successful vaccine. Significant challenges lie ahead, not the least of which is insuring access of a malaria vaccine to the populations that need it most. Creative strategies, strong partnerships with developing countries, industry-like approaches to product development, and political vision and leadership on the part of wealthy nations will be critical to the successful implementation of this important new tool to reduce the intolerable burden of malaria. PMID:16083325

Ballou, W Ripley

2005-08-01

259

Influenza Vaccines: Unmet Needs and Recent Developments  

PubMed Central

Influenza is a worldwide public health concern. Since the introduction of trivalent influenza vaccine in 1978, vaccination has been the primary means of prevention and control of influenza. Current influenza vaccines have moderate efficacy, good safety, and acceptable tolerability; however, they have unsatisfactory efficacy in older adults, are dependent on egg supply for production, and are time-consuming to manufacture. This review outlines the unmet medical needs of current influenza vaccines. Recent developments in influenza vaccines are also described. PMID:24475351

Noh, Ji Yun

2013-01-01

260

Current perspectives on conventional and novel vaccines against peste des petits ruminants.  

PubMed

Peste des petits ruminants (PPR) is an acute or subacute, highly contagious viral disease of small ruminants, characterized by fever, oculonasal discharges, stomatitis, diarrhoea and pneumonia. This disease is included in the OIE (Office International des Epizooties) list of notifiable terrestrial animal diseases. PPR was first described in the early 1940s in Côte d'Ivoire, and at present, PPR is mainly circulating in Western and Central Africa, the Arabian Peninsula and Southern Asia. Peste des petits ruminants virus (PPRV), the etiological agent of PPR, is classified into the genus Morbillivirus in the family Paramyxoviridae, as its biological and physicochemical features are closely related to the other morbilliviruses. The first homologous PPR vaccine was developed by an artificially attenuated PPRV, named as Nigeria 75/1, which has been widely used in the production of live attenuated vaccines to protect small ruminants. A new generation of PPR vaccine candidates can be genetically modified to differentiate infected from vaccinated animals (DIVA), which nevertheless is difficult to achieve by conventional vaccines. In this review, we systematically discussed a broad range of vaccines against PPR, including commercially available vaccines and potential vaccine candidates, and further DIVA strategies for immunization with the new generation vaccines. PMID:25224755

Liu, Fuxiao; Wu, Xiaodong; Liu, Wenhua; Li, Lin; Wang, Zhiliang

2014-12-01

261

9 CFR 113.326 - Avian Pox Vaccine.  

Code of Federal Regulations, 2012 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.326 Avian Pox Vaccine...Pigeon Pox Vaccine shall be prepared from virus-bearing cell culture fluids or...

2012-01-01

262

9 CFR 113.326 - Avian Pox Vaccine.  

Code of Federal Regulations, 2011 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.326 Avian Pox Vaccine...Pigeon Pox Vaccine shall be prepared from virus-bearing cell culture fluids or...

2011-01-01

263

9 CFR 113.302 - Distemper Vaccine-Mink.  

Code of Federal Regulations, 2013 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.302 Distemper Vaccine...Vaccine—Mink shall be prepared from virus-bearing cell culture fluids. Only...

2013-01-01

264

9 CFR 113.326 - Avian Pox Vaccine.  

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.326 Avian Pox Vaccine...Pigeon Pox Vaccine shall be prepared from virus-bearing cell culture fluids or...

2014-01-01

265

9 CFR 113.302 - Distemper Vaccine-Mink.  

Code of Federal Regulations, 2012 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.302 Distemper Vaccine...Vaccine—Mink shall be prepared from virus-bearing cell culture fluids. Only...

2012-01-01

266

9 CFR 113.326 - Avian Pox Vaccine.  

Code of Federal Regulations, 2013 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.326 Avian Pox Vaccine...Pigeon Pox Vaccine shall be prepared from virus-bearing cell culture fluids or...

2013-01-01

267

9 CFR 113.302 - Distemper Vaccine-Mink.  

Code of Federal Regulations, 2011 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.302 Distemper Vaccine...Vaccine—Mink shall be prepared from virus-bearing cell culture fluids. Only...

2011-01-01

268

9 CFR 113.302 - Distemper Vaccine-Mink.  

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.302 Distemper Vaccine...Vaccine—Mink shall be prepared from virus-bearing cell culture fluids. Only...

2014-01-01

269

9 CFR 113.326 - Avian Pox Vaccine.  

Code of Federal Regulations, 2010 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.326 Avian Pox Vaccine...Pigeon Pox Vaccine shall be prepared from virus-bearing cell culture fluids or...

2010-01-01

270

Insights on novel biologically active natural products: 7-isopentenyloxycoumarin.  

PubMed

7-Isopentenyloxycoumarin is a prenyloxyphenylpropanoid derivative found in low concentration in a restricted number of plant families (Apiaceae, Asteraceae, and Rutaceae). Synthetic schemes were recently developed enabling sufficient quantities of the title coumarin to be obtained in order to evidence its valuable biological effects, mainly as an anti-cancer agent. The aim of this review is to examine the phytochemical and pharmacological properties of this compound. PMID:20120120

Epifano, Francesco; Pelucchini, Caroline; Curini, Massimo; Genovese, Salvatore

2009-12-01

271

Biological production of liquid and gaseous fuels from synthesis gas  

Microsoft Academic Search

Liquid and gaseous fuels may be produced biologically from coal by the indirect conversion of coal synthesis gas. Methane\\u000a has been produced from synthesis gas using acetate and CO2\\/H2 as intermediates, utilizing a number of CO-utilizing and methanogenic bacteria. Also, a bacterium that is capable of producing\\u000a ethanol from synthesis gas through indirect liquefaction has been isolated fron natural inocula.

K. T. Klasson; B. B. Elmore; J. L. Vega; M. D. Ackerson; E. C. Clausen; J. L. Gaddy

1990-01-01

272

Control of disinfection by-products and biodégradable organic matter through biological treatment  

Microsoft Academic Search

SUMMARY The optimal use of ozonation as a pretreatment process prior to biological treatment of Ohio River water was investigated at both the bench (batch) and pilot-plant (continuons flow) scale. The study focused on disinfection by- products (DBPs) and DBP precursor compoonds and on the production of biologically stable water. Biotreatment was achieved using a bench-scale fixed-fifm reactor with sand

H. M. SHUKAIRY; R. J. MILTNER; R. S. SUMMERS

273

In vivo cross-protection to African horse sickness Serotypes 5 and 9 after vaccination with Serotypes 8 and 6.  

PubMed

The polyvalent African horsesickness (AHS) attenuated live virus (AHS-ALV) vaccine produced at Onderstepoort Biological Products incorporates 7 of the 9 known serotypes circulating in southern Africa. Serological cross-reaction has been shown in vitro to Serotypes 5 and 9 by Serotypes 8 and 6 respectively, but the degree of in vivo cross-protection between these serotypes in vaccinated horses has not previously been reported. Due to the increasing incidence of AHS Serotypes 5 and 9 in the field, over the last 3-4 seasons of AHS in South Africa, and the absence of Serotypes 5 and 9 in the AHS-ALV vaccine, it was necessary to conduct a vaccination-challenge study to determine in vivo cross-protection of vaccine-incorporated Serotypes 8 and 6 respectively. Groups of horses were vaccinated with either the polyvalent AHS-ALV vaccine or a monovalent Serotype 6 (vAHSV6) or 8 (vAHSV8) vaccine to determine the cross-protection of vaccinated horses following challenge with virulent AHS virus (AHSV) of either Serotype 5, 6, 8 or 9. Serial vaccination of naive horses with the polyvalent AHS-ALV vaccine generated a broad neutralizing antibody response to all vaccine strains as well as cross-neutralizing antibodies to Serotypes 5 and 9. Booster vaccination of horses with monovalent vaccine vAHSV6 or vAHSV8 induced an adequate protective immune response to challenge with homologous and heterologous virulent virus. In vivo cross-protection between AHSV6 and AHSV9 and AHSV8 and AHSV5 respectively, was demonstrated. PMID:20638456

von Teichman, Beate F; Dungu, Baptiste; Smit, Theresa K

2010-09-01

274

Biological Factors Affecting Seed Production in East African Highland Bananas  

Microsoft Academic Search

Seed production from hybridizations involving the East African Highland bananas (Mum spp., AAA group) is low due to high levels of sterility. This is a major impediment for the development of hybrids with disease and pest resistance and superior agronomic traits. The objective of this study was to examine the effect of inflorescence and stigma developmental stages on seed production

R. Ssebuliba; M. Magambo; D. Talengera; D. Makumbi; A. Tenkouano; P. Rubaihayo; M. Pillay

2006-01-01

275

Modified Vaccinia Virus Ankara (MVA) as Production Platform for Vaccines against Influenza and Other Viral Respiratory Diseases  

PubMed Central

Respiratory viruses infections caused by influenza viruses, human parainfluenza virus (hPIV), respiratory syncytial virus (RSV) and coronaviruses are an eminent threat for public health. Currently, there are no licensed vaccines available for hPIV, RSV and coronaviruses, and the available seasonal influenza vaccines have considerable limitations. With regard to pandemic preparedness, it is important that procedures are in place to respond rapidly and produce tailor made vaccines against these respiratory viruses on short notice. Moreover, especially for influenza there is great need for the development of a universal vaccine that induces broad protective immunity against influenza viruses of various subtypes. Modified Vaccinia Virus Ankara (MVA) is a replication-deficient viral vector that holds great promise as a vaccine platform. MVA can encode one or more foreign antigens and thus functions as a multivalent vaccine. The vector can be used at biosafety level 1, has intrinsic adjuvant capacities and induces humoral and cellular immune responses. However, there are some practical and regulatory issues that need to be addressed in order to develop MVA-based vaccines on short notice at the verge of a pandemic. In this review, we discuss promising novel influenza virus vaccine targets and the use of MVA for vaccine development against various respiratory viruses. PMID:25036462

Altenburg, Arwen F.; Kreijtz, Joost H. C. M.; de Vries, Rory D.; Song, Fei; Fux, Robert; Rimmelzwaan, Guus F.; Sutter, Gerd; Volz, Asisa

2014-01-01

276

Construction of Live Vaccines by Using Genetically Engineered Poxviruses: Biological Activity of Recombinant Vaccinia Virus Expressing Influenza Virus Hemagglutinin  

Microsoft Academic Search

Recombinant vaccinia viruses containing the cloned hemagglutinin (HA) gene from influenza virus were constructed. The biological activity of these poxvirus vectors was demonstrated both in vitro and in vivo. Expression of HA in cells infected with recombinant vaccinia was detected by using specific anti-HA antiserum and 125I-labeled protein A, showing that HA synthesized under the regulation of vaccinia virus was

Dennis Panicali; Stephen W. Davis; Randall L. Weinberg; Enzo Paoletti

1983-01-01

277

Geminiviral vectors based on bean yellow dwarf virus for production of vaccine antigens and monoclonal antibodies in plants  

PubMed Central

Expression of recombinant vaccine antigens and monoclonal antibodies using plant viral vectors has developed extensively during the past several years. The approach benefits from high yields of recombinant protein obtained within days after transient delivery of viral vectors to leaves of Nicotiana benthamiana, a tobacco relative. Modified viral genomes of both RNA and DNA viruses have been created. Geminiviruses such as bean yellow dwarf virus (BeYDV) have a small, single stranded DNA genome that replicates in the nucleus of an infected plant cell, using the cellular DNA synthesis apparatus and a virus-encoded replication initiator protein (Rep). BeYDV-derived expression vectors contain deletions of the viral genes encoding coat and movement proteins and insertion of an expression cassette for a protein of interest. Delivery of the geminiviral vector to leaf cells via Agrobacterium-mediated delivery produces very high levels of recombinant DNA that can act as a transcription template, yielding high levels of mRNA for the protein of interest. Several vaccine antigens, including Norwalk virus capsid protein and hepatitis B core antigen, were expressed using the BeYDV vector at levels up to 1 mg per g of leaf mass. BeYDV replicons can be stacked in the same vector molecule by linking them in tandem, which enables production of multi-subunit proteins like monoclonal antibody (mAb) heavy and light chains. The protective mAb 6D8 against Ebola virus was produced at 0.5 mg per g of leaf mass. Multi-replicon vectors could be conveniently used to produce protein complexes, e.g., virus-like particles that require two or more subunits. PMID:21358270

Chen, Qiang; He, Junyun; Phoolcharoen, Waranyoo

2011-01-01

278

Polio Vaccination  

MedlinePLUS

... the benefits of OPV use (i.e. intestinal immunity, secondary spread) outweighed the risk for vaccine-associated ... to its advantages over IPV in providing intestinal immunity and providing secondary spread of the vaccine to ...

279

Meningococcal Vaccines  

MedlinePLUS

... common after MCV4 than after MPSV4.A small percentage of people who receive the vaccine develop a ... Vaccine Information Statement. U.S. Department of Health and Human Services/Centers for Disease Control and Prevention National ...

280

Chemistry and Biology of Bengamides and Bengazoles, Bioactive Natural Products from Jaspis Sponges  

PubMed Central

Sponges corresponding to the Jaspidae family have proved to be a prolific source of bioactive natural products. Among these, the bengamides and the bengazoles stand out by virtue of their unprecedented molecular architectures and impressive biological profiles, including antitumor, antibiotic and anthelmintic properties. As a consequence, intense research activity has been devoted to these compounds from both chemical and biological standpoints. This review describes in detail the research into these classes of natural products and the benefits they offer in chemistry and biology. PMID:24646945

Garcia-Ruiz, Cristina; Sarabia, Francisco

2014-01-01

281

9 CFR 115.2 - Inspections of biological products.  

...HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS ...shall not excuse any person from compliance with the Virus-Serum-Toxin Act. (Approved by the Office of Management and...

2014-01-01

282

9 CFR 115.2 - Inspections of biological products.  

Code of Federal Regulations, 2011 CFR

...HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS ...shall not excuse any person from compliance with the Virus-Serum-Toxin Act. (Approved by the Office of Management and...

2011-01-01

283

Estimate of biological production in some stream invertebrates  

Microsoft Academic Search

Annual production of invertebrates was investigated in two streams, the Hinau and Horokiwi, in the North Island of New Zealand. Estimates were based on the instantaneous growth rate method, with adjustments made according to the number of generations produced per year. Production of primary consumers (herbivores and detritus feeders) was 7.6–72.1 g.m.y, and of secondary consumers (predators) 0.8–11.9 g.m.y. In

C. L. Hopkins

1976-01-01

284

Smallpox Vaccine  

MedlinePLUS

... outbreak of the disease. In most cases, the vaccine causes mild side effects, such as soreness around the vaccination site, fever, ... very small percentage of people will suffer serious side effects and may even die. Thus the vaccine is only necessary when there has been an ...

285

Immortalized chick embryo cell line adapted to serum-free growth conditions and capable of replicating human and reassortant H5N1 influenza strains for vaccine production.  

PubMed

The current process of influenza vaccine production can take 6-9 months and is dependent on the availability of embryonated eggs. Additionally, this process selects for receptor-binding variants with reduced antigenicity and requires significant downstream production for purification. We have established an immortalized chick embryo cell line, termed PBS-12SF, which is adapted to growth in serum free conditions, and is capable of replicating human and reassortant H5N1 influenza strains to high titers. In many cases, PBS-12SF cells produced higher growth titers of influenza virus than those of primary chick embryo kidney (CEK) cells, Madin-Darby Canine Kidney (MDCK) cells and African green monkey kidney cells (Vero). Additionally, in PBS-12SF cell cultures, influenza virus is released into the culture fluid without need for exogenous proteases, which can simplify downstream processing for vaccine production. PMID:21911025

Coussens, Paul M; Smith, Kristen A; Weber, Patty S D; Colvin, Christopher J

2011-11-01

286

9 CFR 113.318 - Pseudorabies Vaccine.  

Code of Federal Regulations, 2013 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.318 Pseudorabies...Pseudorabies Vaccine shall be prepared from virus-bearing cell culture fluids....

2013-01-01

287

9 CFR 113.318 - Pseudorabies Vaccine.  

Code of Federal Regulations, 2011 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.318 Pseudorabies...Pseudorabies Vaccine shall be prepared from virus-bearing cell culture fluids....

2011-01-01

288

9 CFR 113.318 - Pseudorabies Vaccine.  

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.318 Pseudorabies...Pseudorabies Vaccine shall be prepared from virus-bearing cell culture fluids....

2014-01-01

289

9 CFR 113.332 - Tenosynovitis Vaccine.  

Code of Federal Regulations, 2011 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.332 Tenosynovitis...Tenosynovitis Vaccine shall be prepared from virus-bearing cell culture fluids or...

2011-01-01

290

9 CFR 113.318 - Pseudorabies Vaccine.  

Code of Federal Regulations, 2012 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.318 Pseudorabies...Pseudorabies Vaccine shall be prepared from virus-bearing cell culture fluids....

2012-01-01

291

9 CFR 113.332 - Tenosynovitis Vaccine.  

Code of Federal Regulations, 2012 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.332 Tenosynovitis...Tenosynovitis Vaccine shall be prepared from virus-bearing cell culture fluids or...

2012-01-01

292

9 CFR 113.332 - Tenosynovitis Vaccine.  

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.332 Tenosynovitis...Tenosynovitis Vaccine shall be prepared from virus-bearing cell culture fluids or...

2014-01-01

293

9 CFR 113.332 - Tenosynovitis Vaccine.  

Code of Federal Regulations, 2013 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.332 Tenosynovitis...Tenosynovitis Vaccine shall be prepared from virus-bearing cell culture fluids or...

2013-01-01

294

The case for vaccines.  

PubMed

The case for vaccines is one which has been made through scientific advancement and public health implementation, resulting in one of the most significant historical achievements for mankind. This includes the elimination of endemic smallpox, polio, measles and rubella from the U.S. This exhilarating accomplishment was sobered with the threat of smallpox through biological attack following September 11, 2001. While the unthinkable return of that vaccine-preventable disease never materialized, other vaccine-preventable disease, such as pertussis, have markedly increased in many states because of never-established or waning immunity. Drivers of these current threats come both from the anti-vaccine movement, through legislative efforts to expand childhood immunization exemptions and the medical establishment itself through lack of immunization prioritization in adolescent and adult populations. Therefore, the case for vaccines needs to be made both externally and internally through sound science, sound logic and sound ethics. Most powerfully, however, the case for vaccines is told through stories of real people who have suffered or died from these preventable diseases. PMID:23444585

Hoffman, Wendell W

2013-01-01

295

Avian influenza vaccines and vaccination in birds.  

PubMed

Although the use of vaccines against avian influenza viruses in birds has been discouraged over the years, the unprecedented occurrence of outbreaks caused by avian influenza (AI) viruses in recent times has required review of this policy. A variety of products are now available on the market, ranging from inactivated conventional to live recombinant products. The general consensus on the use of vaccination is that if complying to GMP standards and properly administered, birds will be more resistant to field challenge and will exhibit reduced shedding levels in case of infection. However, viral circulation may still occur in a clinically healthy vaccinated population. This may result in an endemic situation and in the emergence of antigenic variants. In order to limit these risks, monitoring programmes enabling the detection of field exposure in vaccinated populations are recommended by international organisations and are essential to allow the continuation of international trade. Adequate management of a vaccination campaign, including monitoring, improved biosecurity and restriction is essential for the success of any control program for AI. PMID:19230164

Capua, Ilaria; Alexander, Dennis J

2008-09-12

296

VACCINE INFORMATION STATEMENT Hepatitis A Vaccine  

E-print Network

VACCINE INFORMATION STATEMENT Hepatitis A Vaccine What You Need to Know Many Vaccine Information 1,000 cases). Hepatitis A vaccine can prevent hepatitis A. 2 Who should get hepatitis A vaccine and when? WHO? Some people should be routinely vaccinated with hepatitis A vaccine: · All children between

Leistikow, Bruce N.

297

DISINFECTION BY-PRODUCT CONTROL THROUGH BIOLOGICAL FILTRATION  

EPA Science Inventory

Disinfection by-product (DBP) control through biofiltration is defined as the removal of DBP precursor mateterial (PM) by bacteria attached to the filte nedia. The PM consists of dissolved organic matter (DOM) and is utilized by the filter bacteria as a substrate for cell mainten...

298

Phytosterol Oxidation Products: Their Formation, Occurrence, and Biological Effects  

Microsoft Academic Search

Phytosterols or plant sterols are integral natural components of plant cell membranes that are abundant in vegetable oils, nuts, seeds, and grains; as well as added components in various functional foods. Due to their chemical structure, phytosterols are susceptible to oxidation under certain conditions giving rise to a family of compounds known as phytosterol oxidation products (POPs). The following review

Eileen Ryan; Florence O. McCarthy; Anita R. Maguire; Nora M. OBrien

2009-01-01

299

Chemistry & Biology Structure-Based Dissection of the Natural Product  

E-print Network

, Department of Pharmacy and Pharmacology, University of Bath, Bath BA2 7AY, United Kingdom. *Correspondence. INTRODUCTION Natural products and compounds directly derived from them continue to play a significant role in modern drug discovery and development (Newman and Cragg, 2007). The most effec- tive compounds targeting

van Aalten, Daan

300

VACCINE INFORMATION STATEMENT Influenza Vaccine  

E-print Network

. The viruses in the vaccine have been weakened so they can't make you sick. A different vaccine, the "flu shot disease that year. While flu vaccine cannot prevent all cases of flu, it is our best defense against are not feeling well. They might suggest waiting. But you should come back. #12;· You should get the flu shot

Oklahoma, University of

301

Nanoparticles for transcutaneous vaccination.  

PubMed

The living epidermis and dermis are rich in antigen presenting cells (APCs). Their activation can elicit a strong humoral and cellular immune response as well as mucosal immunity. Therefore, the skin is a very attractive site for vaccination, and an intradermal application of antigen may be much more effective than a subcutaneous or intramuscular injection. However, the stratum corneum (SC) is a most effective barrier against the invasion of topically applied vaccines. Products which have reached the stage of clinical testing, avoid this problem by injecting the nano-vaccine intradermally or by employing a barrier disrupting method and applying the vaccine to a relatively large skin area. Needle-free vaccination is desirable from a number of aspects: ease of application, improved patient acceptance and less risk of infection among them. Nanocarriers can be designed in a way that they can overcome the SC. Also incorporation into nanocarriers protects instable antigen from degradation, improves uptake and processing by APCs, and facilitates endosomal escape and nuclear delivery of DNA vaccines. In addition, sustained release systems may build a depot in the tissue gradually releasing antigen which may avoid booster doses. Therefore, nanoformulations of vaccines for transcutaneous immunization are currently a very dynamic field of research. Among the huge variety of nanocarrier systems that are investigated hopes lie on ultra-flexible liposomes, superfine rigid nanoparticles and nanocarriers, which are taken up by hair follicles. The potential and pitfalls associated with these three classes of carriers will be discussed. PMID:21854553

Hansen, Steffi; Lehr, Claus-Michael

2012-03-01

302

Nanoparticles for transcutaneous vaccination  

PubMed Central

Summary The living epidermis and dermis are rich in antigen presenting cells (APCs). Their activation can elicit a strong humoral and cellular immune response as well as mucosal immunity. Therefore, the skin is a very attractive site for vaccination, and an intradermal application of antigen may be much more effective than a subcutaneous or intramuscular injection. However, the stratum corneum (SC) is a most effective barrier against the invasion of topically applied vaccines. Products which have reached the stage of clinical testing, avoid this problem by injecting the nano?vaccine intradermally or by employing a barrier disrupting method and applying the vaccine to a relatively large skin area. Needle?free vaccination is desirable from a number of aspects: ease of application, improved patient acceptance and less risk of infection among them. Nanocarriers can be designed in a way that they can overcome the SC. Also incorporation into nanocarriers protects instable antigen from degradation, improves uptake and processing by APCs, and facilitates endosomal escape and nuclear delivery of DNA vaccines. In addition, sustained release systems may build a depot in the tissue gradually releasing antigen which may avoid booster doses. Therefore, nanoformulations of vaccines for transcutaneous immunization are currently a very dynamic field of research. Among the huge variety of nanocarrier systems that are investigated hopes lie on ultra?flexible liposomes, superfine rigid nanoparticles and nanocarriers, which are taken up by hair follicles. The potential and pitfalls associated with these three classes of carriers will be discussed. PMID:21854553

Hansen, Steffi; Lehr, Claus-Michael

2012-01-01

303

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

PubMed

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. PMID:22034757

Gérard, M

2011-09-01

304

BIOLOGICALLY ACTIVE NATURAL PRODUCTS OF THE GENUS CALLICARPA?  

PubMed Central

About 20 species from Callicarpa have reported ethnobotanical and ethnomedical uses, and several members of this genus are well known in the traditional medical systems of China and South Asia. Ethnomedical reports indicate their use in the treatment of hepatitis, rheumatism, fever, headache, indigestion, and other ailments. Several species of Callicarpa have been reported to be used against cancer (e.g., Callicarpa americana root to treat skin cancer and Callicarpa rubella bark to treat tumors of the large intestine). Extracts from about 14 species in this genus have been evaluated for biological activity, including antibacterial, antifungal, anti-insect growth, cytotoxic, and phytotoxic activities. In addition to amino acids, benzenoids, simple carbohydrates, and lipids, numerous diterpenes, flavonoids, phenylpropanoids, phytosterols, sesquiterpenes, and triterpenes have been detected in or isolated from the genus Callicarpa. The essential oils of Callicarpa americana have recently been reported to have antialgal and phytotoxic activities, and several isolates from this species (and C. japonica) were identified as contributing to the mosquito bite-deterrent activity that was first indicated by folkloric usage. Recent bioassay-guided investigations of C. americana extracts have resulted in the isolation of several active compounds, mainly of the clerodane diterpene structural type. PMID:19830264

JONES, WILLIAM P.; KINGHORN, A. DOUGLAS

2009-01-01

305

Making vaccines "on demand"  

PubMed Central

The integrated US Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) has made great strides in strategic preparedness and response capabilities. There have been numerous advances in planning, biothreat countermeasure development, licensure, manufacturing, stockpiling and deployment. Increased biodefense surveillance capability has dramatically improved, while new tools and increased awareness have fostered rapid identification of new potential public health pathogens. Unfortunately, structural delays in vaccine design, development, manufacture, clinical testing and licensure processes remain significant obstacles to an effective national biodefense rapid response capability. This is particularly true for the very real threat of “novel pathogens” such as the avian-origin influenzas H7N9 and H5N1, and new coronaviruses such as hCoV-EMC. Conventional approaches to vaccine development, production, clinical testing and licensure are incompatible with the prompt deployment needed for an effective public health response. An alternative approach, proposed here, is to apply computational vaccine design tools and rapid production technologies that now make it possible to engineer vaccines for novel emerging pathogen and WMD biowarfare agent countermeasures in record time. These new tools have the potential to significantly reduce the time needed to design string-of-epitope vaccines for previously unknown pathogens. The design process—from genome to gene sequence, ready to insert in a DNA plasmid—can now be accomplished in less than 24 h. While these vaccines are by no means “standard,” the need for innovation in the vaccine design and production process is great. Should such vaccines be developed, their 60-d start-to-finish timeline would represent a 2-fold faster response than the current standard. PMID:23877094

De Groot, Anne S; Einck, Leo; Moise, Leonard; Chambers, Michael; Ballantyne, John; Malone, Robert W; Ardito, Matthew; Martin, William

2013-01-01

306

Selection for milk production from a lactation biology viewpoint.  

PubMed

The success of selection for increased milk production in dairy cows is apparent. Certainly, many herds now have average production levels that would have only been associated with the best producers in the herd 30 yr ago. There are, of course, many reasons for this success. Among these are improvements in genetic selection methods and associated use of artificial insemination, better fulfillment of nutritional needs and diet formulation, and careful attention to mastitis control and milking management. Development of new management tools (i.e., bovine somatotropin, improved crops, estrus detection devices, estrus synchronization, monitoring of individual animal performance, and disease prevention) should not be forgotten. Although many aspects of a dairy operation determine overall performance and profitability, the focus of this paper is the udder. Information indicates that both the structure and function of the bovine mammary gland have been directly impacted by long-term selection for increased milk production but improved functionality may have been more important. This review also considered studies that attempt to develop techniques and measurements for possible selection of genetically superior animals including measurement of circulating hormones and direct assay of mammary tissue function. PMID:10821592

Akers, R M

2000-05-01

307

Using Monte Carlo simulation to assess the value of combination vaccines for pediatric immunization  

Microsoft Academic Search

Research by vaccine manufacturers has resulted in the development of new vaccines that protect against a number of diseases. This has created a dilemma for how to introduce such new vaccines into an already crowded Recommended Childhood Immunization Schedule and prompted the development of vaccine products that combine several individual vaccines into a single injection. Such combination vaccines permit new

Sheldon H. Jacobson; Edward C. Sewell; Bruce G. Weniger

2001-01-01

308

Validation study to evaluate the reproducibility of a candidate in vitro potency assay of newcastle disease vaccines and to establish the suitability of a candidate biological reference preparation.  

PubMed

A quantification assay for the Haemagglutinin-Neuraminidase (HN) protein of Newcastle Disease Virus (NDV) has been developed at CIDC-Lelystad as a candidate in vitro potency test for inactivated Newcastle disease (ND) vaccines. In studies performed at CIDC-Lelystad, a high correlation was demonstrated between the results of this candidate in vitro potency assay and the results of the serological potency assay (European Pharmacopoeia monograph 0870; test A). Furthermore, a high correlation between the serological data (Haemagglutination Inhibition-antibody titres) and clinical protection after challenge was demonstrated. Correlation between in vivo and in vitro potency assays was confirmed in a collaborative pre-validation study. In the pre-validation study three Official Medicines Control Laboratories (OMCLs) determined both the NDV-HN antigen content and the in vivo potency (vaccination-serology and vaccination-challenge) of 6 vaccine batches. The conclusion of the pre-validation study was that a large-scale collaborative study should be organised to validate the in vitro method and the suitability of the reference preparation. This report describes the outcome of this study. In brief, 14 laboratories (8 OMCLs and 6 vaccine manufacturers) determined the NDV-HN antigen content of 9 different vaccines in 3 independent tests. The vaccine batches were produced by 5 different manufacturers and represent a quantitative range of ND antigen content. One vaccine batch with insufficient potency and one poultry vaccine not containing NDV were included. Statistical evaluation of the results indicated that the antigen content could be determined with high precision. A good repeatability as well as reproducibility was found. Furthermore all laboratories found a similar ranking of the vaccines, based on the antigen content. Comparison of the antigen content and the in vivo potency of a series of vaccines with relatively low potencies indicated that a threshold relative antigen level of 7.0 antigen units per dose would discriminate between vaccine batches with sufficient and insufficient potency. An in vitro assay with this threshold level for antigen content did not result in any false positive results and only a limited number of false negative results in the BSP055 study. We conclude that the in vitro measurement of the antigen content of inactivated ND-vaccines with the proposed method is a reliable alternative potency assay that could be included as a new method in monograph 0870 on ND-vaccines. PMID:15659281

Claassen, I; Maas, R; Oei, H; Daas, A; Milne, C

2004-12-01

309

Biological Hydrogen Production Using Chloroform-treated Methanogenic Granules  

NASA Astrophysics Data System (ADS)

In fermentative hydrogen production, the low-hydrogen-producing bacteria retention rate limits the suspended growth reactor productivity because of the long hydraulic retention time (HRT) required to maintain adequate bacteria population. Traditional bacteria immobilization methods such as calcium alginate entrapment have many application limitations in hydrogen fermentation, including limited duration time, bacteria leakage, cost, and so on. The use of chloroform-treated anaerobic granular sludge as immobilized hydrogen-producing bacteria in an immobilized hydrogen culture may be able to overcome the limitations of traditional immobilization methods. This paper reports the findings on the performance of fed-batch cultures and continuous cultures inoculated with chloroform-treated granules. The chloroform-treated granules were able to be reused over four fed-batch cultures, with pH adjustment. The upflow reactor packed with chloroform-treated granules was studied, and the HRT of the upflow reactor was found to be as low as 4 h without any decrease in hydrogen production yield. Initial pH and glucose concentration of the culture medium significantly influenced the performance of the reactor. The optimum initial pH of the culture medium was neutral, and the optimum glucose concentration of the culture medium was below 20 g chemical oxygen demand/L at HRT 4 h. This study also investigated the possibility of integrating immobilized hydrogen fermentation using chloroform-treated granules with immobilized methane production using untreated granular sludge. The results showed that the integrated batch cultures produced 1.01 mol hydrogen and 2 mol methane per mol glucose. Treating the methanogenic granules with chloroform and then using the treated granules as immobilized hydrogen-producing sludge demonstrated advantages over other immobilization methods because the treated granules provide hydrogen-producing bacteria with a protective niche, a long duration of an active culture, and excellent settling velocity. This integrated two-stage design for immobilized hydrogen fermentation and methane production offers a promising approach for modifying current anaerobic wastewater treatment processes to harvest hydrogen from the existing systems.

Hu, Bo; Chen, Shulin

310

Sex and Vaccination  

NSDL National Science Digital Library

This case study focuses on the controversy surrounding the decision by Texas Governor Rick Perry to mandate the compulsory vaccination of girls in the Texas public school system against the human papillomavirus (HPV) prior to entering the sixth grade. The interrupted case method is particularly appropriate for this subject, with successive sections providing a general overview of the disease, the reasons for and against such a mandatory vaccination program, and a disclosure of what ultimately transpired in Texas. Designed for an ethics or public policy course, the case could easily be adapted to emphasize biological and medical topics.

Zavrel, Eric; Herreid, Clyde F.

2008-01-01

311

Biological production of hydroxylated aromatics: Optimization strategies for Pseudomonas putida S12  

Microsoft Academic Search

To replace environmentally unfriendly petrochemical production processes, the demand for bio-based production of organic chemicals is increasing. This thesis focuses on the biological production of hydroxylated aromatics from renewable substrates by engineered P. putida S12 including several cases of strain improvement.\\u000aChapter 2 describes the construction of a P. putida S12 strain that produces p-hydroxybenzoate\\u000avia the aromatic amino acid

A. Verhoef

2010-01-01

312

Biological Degradation of Common Pharmaceuticals and Personal Care Products in Soils with High Water Content  

Microsoft Academic Search

Biological degradation rates of six pharmaceuticals and personal care products were examined in soil from a land application\\u000a site and in adjacent soil with no prior history of effluent exposure. Microbial degradation rates were compared over 2 weeks\\u000a under standing water or saturated conditions and draining conditions after having been saturated for 3 days. Biological degradation\\u000a of 17?-estradiol exhibited rapid rates of

Deborah L. Carr; Audra N. Morse; John C. Zak; Todd A. Anderson

2011-01-01

313

CHEMICAL AND BIOLOGICAL CHARACTERIZATION OF PRODUCTS OF INCOMPLETE COMBUSTION FROM THE SIMULATED FIELD BURNING OF AGRICULTURAL PLASTIC  

EPA Science Inventory

The article describes chemical and biological analyses performed to characterize products of incomplete combustion emitted during the simulated open field burning of agricultural plastic. The study highlights the benefits of a combined chemical/biological approach to characteizin...

314

Oceanographic frontal structure and biological production at an ice edge  

NASA Astrophysics Data System (ADS)

Marginal ice edge zones (MIZ) are unique frontal systems with air-ice-sea interfaces. Phytoplankton blooms, which occur along the edge of the melting ice pack in spring, are strongly related to the air-ice-sea interactive processes. In spring 1982, during a cruise to the Bering Sea ice pack, hydrographic sections, including standard biological oceanographic parameters, were collected across the MIZ showing such enhanced phytoplankton bloom populations in the ice edge. During this period the ice edge retreated at speeds of 6 to 38 cm s -1. Associated with the retreating ice edge were a faster moving upper layer oceanic front that kept pace with the retreating ice edge, and a nearly stationary deeper front. In the presence of light, the phytoplankton blooms are shown to be associated with, and primarily controlled by enhanced density stratification and frontal structure due to ice melt during the spring ice retreat. The ice melt water forms stratification that helps to maintain the phytoplankton within the photic zone. The ice edge blooms can be differentiated from open water blooms by the stratification mechanism; in MIZ blooms stratification is due to low salinity melt water as opposed to temperature derived stratification in most open water blooms. In addition, in the series of cross sections collected, a unique biophysical interaction was observed when the MIZ front moving north with the spring retreat, came in contact with a fixed shelf front forming a 'dish' shaped hydrographic structure within which a major phytoplankton bloom was observed. We suggest that upwelling from the tidally driven shelf front supplied nutrients to the surface waters extending the life of the bloom. Wind-driven ice edge upwelling was also observed but was difficult to distinguish from the shelf front circulation. In this same set of ice edge cross sections, a cold water mass was observed at the surface in the MIZ. This water mass was subsequently overridden by warmer water forming a cold tongue structure above the pycnocline and seaward of the shelf front. We suggest that this cold tongue was transient in nature, and illustrative of one mechanism by which the T-S characteristics of high latitude shelf waters are formed and altered.

Niebauer, H. J.; Alexander, V.

315

Cloning and assessment of tumorigenicity and oncogenicity of a Madin-Darby canine kidney (MDCK) cell line for influenza vaccine production.  

PubMed

An Madin-Darby canine kidney (MDCK) cell line, 9B9-1E4, was cloned by limit dilution from a heterologous cell population and chosen as a potential production cell substrate for cell culture-based influenza vaccine manufacture. Since MDCK cells are transformed cells of canine origin, extensive characterization, including evaluation of tumorigenicity and oncogenicity, was performed to ensure the safety of this cell line for vaccine production. Injection of intact MDCK cells into adult and newborn athymic nude mice did not lead to progressive tumor formation in two separate tumorigenicity studies. In addition, neither MDCK cell lysate nor cellular DNA induced tumors in newborn rodents (athymic nude mice, hamsters and rats) in six oncogenicity studies. Observations from these studies demonstrate the low tumorigenic and oncogenic potential of the MDCK cell clone 9B9-1E4. These observations coupled with other characterization study results strongly suggest a high safety assurance level can be achieved through cell cloning and selection of low tumorigenic and oncogenic cells for influenza vaccine production. PMID:19944150

Liu, Jonathan; Mani, Sachin; Schwartz, Richard; Richman, Laura; Tabor, David E

2010-02-01

316

Experimental vaccines against potentially pandemic and highly pathogenic avian influenza viruses  

PubMed Central

Influenza A viruses continue to emerge and re-emerge, causing outbreaks, epidemics and occasionally pandemics. While the influenza vaccines licensed for public use are generally effective against seasonal influenza, issues arise with production, immunogenicity, and efficacy in the case of vaccines against pandemic and emerging influenza viruses, and highly pathogenic avian influenza virus in particular. Thus, there is need of improved influenza vaccines and vaccination strategies. This review discusses advances in alternative influenza vaccines, touching briefly on licensed vaccines and vaccine antigens; then reviewing recombinant subunit vaccines, virus-like particle vaccines and DNA vaccines, with the main focus on virus-vectored vaccine approaches. PMID:23440999

Mooney, Alaina J; Tompkins, S Mark

2013-01-01

317

Recent progress in synthetic biology for microbial production of C3-C10 alcohols  

PubMed Central

The growing need to address current energy and environmental problems has sparked an interest in developing improved biological methods to produce liquid fuels from renewable sources. While microbial ethanol production is well established, higher-chain alcohols possess chemical properties that are more similar to gasoline. Unfortunately, these alcohols (except 1-butanol) are not produced efficiently in natural microorganisms, and thus economical production in industrial volumes remains a challenge. Synthetic biology, however, offers additional tools to engineer synthetic pathways in user-friendly hosts to help increase titers and productivity of these advanced biofuels. This review concentrates on recent developments in synthetic biology to produce higher-chain alcohols as viable renewable replacements for traditional fuel. PMID:22701113

Lamsen, Edna N.; Atsumi, Shota

2012-01-01

318

Bovine respiratory disease: commercial vaccines currently available in Canada.  

PubMed Central

Bovine respiratory disease (BRD) remains a significant cost to both the beef and dairy industries. In the United States, an estimated 640 million dollars is lost annually due to BRD. Losses are largely a result of pneumonic pasteurellosis ("shipping fever"), enzootic pneumonia of calves, and atypical interstitial pneumonia. In Canada, over 80% of the biologics licensed for use in cattle are against agents associated with BRD. The objectives of this paper were (a) to summarize information available concerning commercial vaccines currently used in Canada for protection against BRD, and (b) to provide an easily accessible resource for veterinary practitioners and researchers. Information from the most recent Compendium of Veterinary Products has been tabulated for each vaccine by trade name, according to vaccine type, and the pathogens against which they are designed to protect. Additional information from published articles (peer-reviewed and other) has been provided and referenced. PMID:10642871

Bowland, S L; Shewen, P E

2000-01-01

319

Prospective cost-benefit analysis of a two-dimensional barcode for vaccine production, clinical documentation, and public health reporting and tracking.  

PubMed

In the United States recording accurate vaccine lot numbers in immunization records is required by the National Childhood Vaccine Injury Act and is necessary for public health surveillance and implementation of vaccine product recalls. However, this information is often missing or inaccurate in records. The Food and Drug Administration (FDA) requires a linear barcode of the National Drug Code (NDC) on vaccine product labels as a medication verification measure, but lot number and expiration date must still be recorded by hand. Beginning in 2011, FDA permitted manufacturers to replace linear barcodes with two-dimensional (2D) barcodes on unit-of-use product labels. A 2D barcode can contain the NDC, expiration date, and lot number in a symbol small enough to fit on a unit-of-use label. All three data elements could be scanned into a patient record. To assess 2D barcodes' potential impacts, a mixed-methods approach of time-motion data analysis, interview and survey data collection, and cost-benefit analysis was employed. Analysis of a time-motion study conducted at 33 practices suggests scanning 2D-barcoded vaccines could reduce immunization documentation time by 36-39 s per dose. Data from an internet survey of primary care providers and local health officials indicate that 60% of pediatric practices, 54% of family medicine practices, and 39% of health departments would use the 2D barcode, with more indicating they would do so if they used electronic health records. Inclusive of manufacturer and immunization provider costs and benefits, we forecast lower-bound net benefits to be $310-334 million between 2011 and 2023 with a benefit-to-cost ratio of 3.1:1-3.2:1. Although we were unable to monetize benefits for expected improved immunization coverage, surveillance, or reduced medication errors, based on our findings, we expect that using 2D barcodes will lower vaccine documentation costs, facilitate data capture, and enhance immunization data quality. PMID:23664988

O'Connor, Alan C; Kennedy, Erin D; Loomis, Ross J; Haque, Saira N; Layton, Christine M; Williams, Warren W; Amoozegar, Jacqueline B; Braun, Fern M; Honeycutt, Amanda A; Weinbaum, Cindy

2013-06-28

320

Studies on production and biological potential of prodigiosin by Serratia marcescens.  

PubMed

Efficacy of Serratia marcescens for pigment production and biological activity was investigated. Natural substrates like sweet potato, mahua flower extract (Madhuca latifolia L.), and sesam at different concentrations were taken. As a carbon source microorganism favored potato powder was followed by sesam and mannitol, and as nitrogen source casein hydrolysate was followed by yeast and malt extract. The effect of inorganic salts on pigment production was also studied. At final optimized composition of suitable carbon, nitrogen source, and trace materials and at suitable physiological conditions, prodigiosin production was 4.8 g L(-1). The isolated pigment showed antimicrobial activity against different pathogenic bacteria and fungi. Extracted pigment was characterized by spectroscopy, Fourier transform infrared (FTIR), and thin layer chromatography (TLC) which confirm production of biological compound prodigiosin. This study suggests that use of sweet potato powder and casein can be a potential alternative bioresource for commercial production of pigment prodigiosin. PMID:24781979

Suryawanshi, Rahul K; Patil, Chandrashekhar D; Borase, Hemant P; Salunke, Bipinchandra K; Patil, Satish V

2014-07-01

321

Plant-derived virus-like particles as vaccines  

PubMed Central

Virus-like particles (VLPs) are self-assembled structures derived from viral antigens that mimic the native architecture of viruses but lack the viral genome. VLPs have emerged as a premier vaccine platform due to their advantages in safety, immunogenicity, and manufacturing. The particulate nature and high-density presentation of viral structure proteins on their surface also render VLPs as attractive carriers for displaying foreign epitopes. Consequently, several VLP-based vaccines have been licensed for human use and achieved significant clinical and economical success. The major challenge, however, is to develop novel production platforms that can deliver VLP-based vaccines while significantly reducing production times and costs. Therefore, this review focuses on the essential role of plants as a novel, speedy and economical production platform for VLP-based vaccines. The advantages of plant expression systems are discussed in light of their distinctive posttranslational modifications, cost-effectiveness, production speed, and scalability. Recent achievements in the expression and assembly of VLPs and their chimeric derivatives in plant systems as well as their immunogenicity in animal models are presented. Results of human clinical trials demonstrating the safety and efficacy of plant-derived VLPs are also detailed. Moreover, the promising implications of the recent creation of “humanized” glycosylation plant lines as well as the very recent approval of the first plant-made biologics by the U. S. Food and Drug Administration (FDA) for plant production and commercialization of VLP-based vaccines are discussed. It is speculated that the combined potential of plant expression systems and VLP technology will lead to the emergence of successful vaccines and novel applications of VLPs in the near future. PMID:22995837

Chen, Qiang; Lai, Huafang

2013-01-01

322

BIOLOG  

EPA Science Inventory

BIOLOG contains more than 43,000 citations to literature on microbial degradation and toxicity of more than 6,000 chemicals. Records are organized by CAS Registry Number and by 6 categories (i.e., biodegradation/toxicity; oxygen condition (anaerobic/aerobic); culture type (pure e...

323

Production and characterization of amplified tumor-derived cRNA libraries to be used as vaccines against metastatic melanomas  

Microsoft Academic Search

BACKGROUND: Anti-tumor vaccines targeting the entire tumor antigen repertoire represent an attractive immunotherapeutic approach. In the context of a phase I\\/II clinical trial, we vaccinated metastatic melanoma patients with autologous amplified tumor mRNA. In order to provide the large quantities of mRNA needed for each patient, the Stratagene Creator™ SMART™ cDNA library construction method was modified and applied to produce

Jean-Philippe Carralot; Benjamin Weide; Oliver Schoor; Jochen Probst; Birgit Scheel; Regina Teufel; Ingmar Hoerr; Claus Garbe; Hans-Georg Rammensee; Steve Pascolo

2005-01-01

324

Vaccines for Pregnant Women  

MedlinePLUS

... Vaccines for Adults Share Compartir Vaccines for Pregnant Women On this Page Vaccine Safety Before, During and ... appropriate for you. Important Vaccines to Consider for Women Planning a Pregnancy Vaccines Before Pregnancy Rubella (German ...

325

Viral vectors for vaccine applications  

PubMed Central

Traditional approach of inactivated or live-attenuated vaccine immunization has resulted in impressive success in the reduction and control of infectious disease outbreaks. However, many pathogens remain less amenable to deal with the traditional vaccine strategies, and more appropriate vaccine strategy is in need. Recent discoveries that led to increased understanding of viral molecular biology and genetics has rendered the used of viruses as vaccine platforms and as potential anti-cancer agents. Due to their ability to effectively induce both humoral and cell-mediated immune responses, viral vectors are deemed as an attractive alternative to the traditional platforms to deliver vaccine antigens as well as to specifically target and kill tumor cells. With potential targets ranging from cancers to a vast number of infectious diseases, the benefits resulting from successful application of viral vectors to prevent and treat human diseases can be immense. PMID:23858400

Choi, Youngjoo

2013-01-01

326

Rotaviruses: from pathogenesis to vaccination  

PubMed Central

Rotaviruses cause life-threatening gastroenteritis in children worldwide; the enormous disease burden has focused efforts to develop vaccines and led to the discovery of novel mechanisms of gastrointestinal virus pathogenesis and host responses to infection. Two live-attenuated vaccines for gastroenteritis (Rotateq and Rotarix) have been licensed in many countries. This review summarizes the latest data on these vaccines, their effectiveness and challenges to global vaccination. Recent insights into rotavirus pathogenesis are also discussed, including information on extra-intestinal infection, viral antagonists of the interferon response and the first described viral enterotoxin. Rotavirus-induced diarrhea is now considered to be a disease that can be prevented through vaccination, although there are many challenges to achieving global effectiveness. Molecular biology studies of rotavirus replication and pathogenesis have identified unique viral targets that might be useful in developing therapies for immunocompromised children with chronic infections. PMID:19457420

Greenberg, Harry B.; Estes, Mary K.

2013-01-01

327

[Vaccination programmes].  

PubMed

Immunization is a highly cost-effective intervention that saves many lives. Its objective is to control and eliminate vaccine-preventable diseases (when the characteristics of the disease and the vaccine make it possible), resulting in improvements in the health of the population. In Spain, the first vaccination schedule was introduced in 1975 and currently coverages > 95% are achieved in children aged < 2 years of age. Before deciding to introduce a vaccination programme in a community or country, a series of aspects should be considered, including the disease burden in the population, the effectiveness and safety of the vaccine, the changes in the dynamics of the infection when the vaccine is introduced, the cost-effectiveness of the vaccine, the theoretical potential of elimination/eradication of the disease and the existence of other preventive or therapeutic measures. Once the programme has been introduced it should be subject to evaluation, considering aspects such as the coverage, effectiveness, safety and the impact on the population. This work defines different vaccination strategies for three diseases for which efficacious and safe vaccines are available: hepatitis A, influenza and varicella. PMID:20111812

Varela, M Carmen

2009-01-01

328

Virosomal influenza vaccine: a safe and effective influenza vaccine with high efficacy in elderly and subjects with low pre-vaccination antibody titers  

Microsoft Academic Search

In 14 clinical studies, various efficacy and safety aspects of a new virosomal influenza vaccine (Invivac®) were assessed in 2865 subjects. The virosomal influenza vaccine fully complies with the Committee for Proprietary Medicinal Products (CPMP) requirement for immunogenicity of influenza vaccines. In particular, in a subset of subjects with low pre-vaccination titers (thus those persons who actually need protection by

I. A de Bruijn; J Nauta; L Gerez; A. M Palache

2004-01-01

329

Progress in Development of Liver Fluke Vaccines  

Microsoft Academic Search

Infection of ruminants by Fasciola spp continues to cause large economic losses worldwide. Recent results from several laboratories have demonstrated that animals can be significantly protected against infection by vaccination with defined Fasciola antigens. Apart from reducing fluke burdens, some vaccines can elicit a concurrent reduction in parasite egg production. The expectation of a commercially feasible vaccine that might also

T. W Spithill; J. P Dalton

1998-01-01

330

Advances in antiviral vaccine development.  

PubMed

Antiviral vaccines have been the most successful biomedical intervention for preventing epidemic viral disease. Vaccination for smallpox in humans and rinderpest in cattle was the basis for disease eradication, and recent progress in polio eradication is promising. Although early vaccines were developed empirically by passage in live animals or eggs, more recent vaccines have been developed because of the advent of new technologies, particularly cell culture and molecular biology. Recent technological advances in gene delivery and expression, nanoparticles, protein manufacturing, and adjuvants have created the potential for new vaccine platforms that may provide solutions for vaccines against viral pathogens for which no interventions currently exist. In addition, the technological convergence of human monoclonal antibody isolation, structural biology, and high-throughput sequencing is providing new opportunities for atomic-level immunogen design. Selection of human monoclonal antibodies can identify immunodominant antigenic sites associated with neutralization and provide reagents for stabilizing and solving the structure of viral surface proteins. Understanding the structural basis for neutralization can guide selection of vaccine targets. Deep sequencing of the antibody repertoire and defining the ontogeny of the desired antibody responses can reveal the junctional recombination and somatic mutation requirements for B-cell recognition and affinity maturation. Collectively, this information will provide new strategic approaches for selecting vaccine antigens, formulations, and regimens. Moreover, it creates the potential for rational vaccine design and establishing a catalogue of vaccine technology platforms that would be effective against any given family or class of viral pathogens and improve our readiness to address new emerging viral threats. PMID:23947359

Graham, Barney S

2013-09-01

331

Estradiol Improves Genital Herpes Vaccine Efficacy in Mice  

PubMed Central

Herpes Simplex Virus type 2 causes genital herpes but is frequently transmitted asymptomatically; therefore, a prophylactic vaccine is desirable. A candidate vaccine in clinical trials has only shown efficacy in preventing disease in women. Using this subunit vaccine candidate, we were able to demonstrate infection prophylaxis, improved disease prevention and modulated antibody production by complimenting vaccination with estradiol in our murine model. Findings of estradiol-enhanced vaccine efficacy are the first of their kind using a vaccine of this type and have potential clinical relevance to the development of other vaccines and our understanding of gender differences in vaccine efficacy. PMID:19660586

Pennock, Jeffry W.; Stegall, Rachael; Bell, Brent; Vargas, Gracie; Motamedi, Massoud; Milligan, Gregg; Bourne, Nigel

2009-01-01

332

Navigation Links Biology News  

E-print Network

the promise of personalized medicine." A paper describing the research, "Nanofountain Probe ElectroporationNavigation Links Biology News Medicine News Biology Products Medicine Products Biology Definition Medicine Definition Biology Technology Medicine Technology Biology Dictionary Medicine Dictionary Biology

Espinosa, Horacio D.

333

New opportunities by synthetic biology for biopharmaceutical production in Pichia pastoris  

PubMed Central

Biopharmaceuticals are an integral part of modern medicine and pharmacy. Both, the development and the biotechnological production of biopharmaceuticals are highly cost-intensive and require suitable expression systems. In this review we discuss established and emerging tools for reengineering the methylotrophic yeast Pichia pastoris for biopharmaceutical production. Recent advancements of this industrial expression system through synthetic biology include synthetic promoters to avoid methanol induction and to fine-tune protein production. New platform strains and molecular cloning tools as well as in vivo glycoengineering to produce humanized glycoforms have made P. pastoris an important host for biopharmaceutical production. PMID:23522654

Vogl, Thomas; Hartner, Franz S; Glieder, Anton

2013-01-01

334

Biological hydrogen production in an anaerobic sequencing batch reactor: pH and cyclic duration effects  

Microsoft Academic Search

An anaerobic sequencing batch reactor (ASBR) was used to evaluate biological hydrogen production from carbohydrate-rich organic wastes. The goal of the proposed project was to investigate the effects of pH (4.9, 5.5, 6.1, and 6.7), and cyclic duration (4, 6, and 8h) on hydrogen production. With the ASBR operated at 16-h HRT, 25g COD\\/L, and 4-h cyclic duration, the results

Wen-Hsing Chen; Shihwu Sung; Shen-Yi Chen

2009-01-01

335

Memory T cell proliferative responses and IFN-? productivity sustain long-lasting efficacy of a Cap-based PCV2 vaccine upon PCV2 natural infection and associated disease  

PubMed Central

Porcine circovirus type 2 (PCV2) vaccination represents an important measure to cope with PCV2 infection; however, data regarding the modulation of the immune cell compartment are still limited, especially under field conditions. This study is aimed at investigating the features of the cellular immune response in conventional piglets induced by vaccination using a capsid (Cap) protein-based PCV2 vaccine compared to unvaccinated animals when exposed to PCV2 natural infection. Immune reactivity was evaluated by quantifying peripheral cell subsets involved in the anti-viral response and characterizing the interferon-gamma (IFN-?) secreting cell (SC) responsiveness both in vivo and upon in vitro whole PCV2 recall. The vaccination triggered an early and intense IFN-? secreting cell response and induced the activation of peripheral lymphocytes. The early increase of IFN-? SC frequencies resulted in a remarkable and transient tendency to increased IFN-? productivity in vaccinated pigs. In vaccinated animals, soon before the onset of infection occurred 15-16 weeks post-vaccination, the recalled PCV2-specific immune response was characterized by moderate PCV2-specific IFN-? secreting cell frequencies and augmented productivity together with reactive CD4+CD8+ memory T cells. Conversely, upon infection, unvaccinated animals showed very high frequencies of IFN-? secreting cells and a tendency to lower productivity, which paralleled with effector CD4–CD8+ cytotoxic cell responsiveness. The study shows that PCV2 vaccination induces a long-lasting immunity sustained by memory T cells and IFN-? secreting cells that potentially played a role in preventing the onset of infection; the extent and duration of this reactivity can be an important feature for evaluating the protective immunity induced by vaccination. PMID:24735253

2014-01-01

336

21 CFR 310.4 - Biologics; products subject to license control.  

Code of Federal Regulations, 2010 CFR

...CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS General...Public Health Service Act (42 U.S.C. 262 et...under section 505 of the act. (b) To obtain marketing...biological products for human use, as defined in...FR 56448, Oct. 20, 1999, as amended at 70...

2010-04-01

337

The great 2012 Arctic Ocean summer cyclone enhanced biological productivity on the shelves  

E-print Network

The great 2012 Arctic Ocean summer cyclone enhanced biological productivity on the shelves Jinlun ecosystem in the Pacific sector of the Arctic Ocean (PSA). Model results indicate that the cyclone., C. Ashjian, R. Campbell, V. Hill, Y. H. Spitz, and M. Steele (2013), The great 2012 Arctic Ocean

Zhang, Jinlun

338

ORFeome Cloning and Systems Biology: Standardized Mass Production of the Parts  

E-print Network

ORFeome Cloning and Systems Biology: Standardized Mass Production of the Parts From the Parts, as predicted from genome and transcriptome sequences. Here we discuss the use of a recombinational cloning, the "parts-lists," are available for several model organisms and for human. With such parts-lists in hand

339

Dry column chromatographic procedure for rapid concentration of biological activity in natural products fractionation.  

PubMed

A dry column chromatographic procedure is described. It allows for the rapid concentration of biologically active materials in natural products fractionation. The potential value of the technique is described, utilizing as an example the separation of an anticancer active fraction obtained from Euphorbia cyparissias. PMID:7264904

Hokanson, G C; Matyunas, N J

1981-03-01

340

Biological Treatment of Agro?Industrial Wastewater for the Production of Glucoamylase and Rhizopus Biomass  

Microsoft Academic Search

The present work concerns the biological treatment of a starch wastewater, coupled with the production of microbial biomass and glucoamylase. Every unit operation of the process was tested in a laboratory scale, in order to perform a feasibility analysis. Fermentation tests confirmed that a stirring rate of 300 rpm was the optimum (in the investigated range) as concerns biomass growth and

F. Beolchini; G. Del Re; G. Di Giacomo; L. Spera; F. Vegliò

2006-01-01

341

Physical-Biological Oceanographic Coupling Influencing Phytoplankton and Primary Production in the South China Sea  

Microsoft Academic Search

Two cruises were carried out in the summer and winter of 1998 to study coupled physical-chemical-biological processes in the South China Sea and their effects on phytoplankton stock and production. The results clearly show that the seasonal distributions of phytoplankton were closely related to the coupled processes driven by the East Asian Monsoon. Summer southwesterly monsoon induced upwelling along the

X. Ning; Fei Chai; Huijie Xue; Y. Cai; C. Liu; J. Shi

2004-01-01

342

Physical-biological oceanographic coupling influencing phytoplankton and primary production in the South China Sea  

Microsoft Academic Search

Two cruises were carried out in the summer and winter of 1998 to study coupled physical-chemical-biological processes in the South China Sea and their effects on phytoplankton stock and production. The results clearly show that the seasonal distributions of phytoplankton were closely related to the coupled processes driven by the East Asian Monsoon. Summer southwesterly monsoon induced upwelling along the

X. Ning; F. Chai; H. Xue; Y. Cai; C. Liu; J. Shi

2004-01-01

343

9 CFR 113.51 - Requirements for primary cells used for production of biologics.  

Code of Federal Regulations, 2013 CFR

...of harvested material or samples of each subculture of cells used to prepare the biological product shall be shown free of mycoplasma as prescribed in § 113.28. The sample for testing shall consist of at least 75 cm2 of actively growing cells or the...

2013-01-01

344

Discharge of pharmaceutical products (PPs) through a conventional biological sewage treatment plant: MECs vs PECs?  

Microsoft Academic Search

Pharmaceuticals for human use are consumed in significant quantities and their occurrence in aquatic systems has been reported by a number of authors. In the context of environmental risk assessment, there is an increasing interest in evaluating the discharge of pharmaceutical products to surface waters through sewage treatment plants (STP). This case study was carried out on a conventional biological

C. M. Coetsier; S. Spinelli; L. Lin; B. Roig; E. Touraud

2009-01-01

345

Evolution of iceberg melting, biological productivity, and the record of Icelandic volcanism in the  

E-print Network

Evolution of iceberg melting, biological productivity, and the record of Icelandic volcanism Pleistocene discharges of icebergs from northern redbed regions to the Irminger Sea lie in the low end) beginning at ~380 ka, possibly initiated by the influx of meltwater from broad-scale iceberg discharges

South Florida, University of

346

INTELLECTUAL PROPERTY RIGHTS AND TRADE: ANALYSIS OF BIOLOGICAL PRODUCTS, MEDICINALS AND BOTANICALS, AND PHARMACEUTICALS  

Microsoft Academic Search

We examine the impact of intellectual property rights (IPRs) on US exports of biological, medicinal, botanical, and pharmaceutical products. We find that: (1) strong IPRs enhance monopoly power of US exports in countries with weak imitative abilities; and (2) strong IPRs expand markets for US exports in countries with strong imitative abilities.

Pamela J. Smith

1999-01-01

347

Robotics in Crop Production Department of Agricultural and Biological Engineering, University of Illinois at  

E-print Network

Robotics in Crop Production Tony Grift Department of Agricultural and Biological Engineering such as harvesting of citrus fruits, grapes, and raisins. An important part of Automation is the use of robots. Robotics in agriculture is not a new concept; in controlled environments (green houses), it has a his- tory

348

DNA Vaccines  

Microsoft Academic Search

In just a few years, injection of plasmid DNA to elicit immune responses in vivo has developed from an interesting observation to a viable vaccine strategy. DNA vaccines have been shown to elicit both cellular and humoral immune responses and to be effective in a variety of preclinical bacterial, viral, and parasitic animal models. This review will discuss the current

Donna L. Montgomery; Jeffrey B. Ulmer; John J. Donnelly; Margaret A. Liu

1997-01-01

349

Post-marketing surveillance of live-attenuated Japanese encephalitis vaccine safety in China.  

PubMed

Japanese encephalitis (JE) is the most severe form of viral encephalitis in Asia and no specific treatment is available. Vaccination provides an effective intervention to prevent JE. In this paper, surveillance data for adverse events following immunization (AEFI) related to SA-14-14-2 live-attenuated Japanese encephalitis vaccine (Chengdu Institute of Biological Products) was presented. This information has been routinely generated by the Chinese national surveillance system for the period 2009-2012. There were 6024 AEFI cases (estimated reported rate 96.55 per million doses). Most common symptoms of adverse events were fever, redness, induration and skin rash. There were 70 serious AEFI cases (1.12 per million doses), including 9 cases of meningoencephalitis and 4 cases of death. The post-marketing surveillance data add the evidence that the Chengdu institute live attenutated vaccine has a reasonable safety profile. The relationship between encephalitis and SA-14-14-2 vaccination should be further studied. PMID:25173477

Wang, Yali; Dong, Duo; Cheng, Gang; Zuo, Shuyan; Liu, Dawei; Du, Xiaoxi

2014-10-01

350

[Special considerations for the regulation of biological medicinal products in individualised medicine. More than stratified medicine].  

PubMed

The term individualised medicine, also called personalised medicine, is commonly used as an equivalent to stratified medicine. However, this is erroneous since quite often it is forgotten that especially biological medicinal products have other aspects of individualization that go beyond mere stratification. The principles of stratified medicine have been applied for biological medicinal products for many years. A historical example is diphtheria antitoxin made from horse serum, while current examples are transfusion of red blood cells and the administration of factor VIII in haemophilia A. The stratifying aspects of these medicinal products are given by the following considerations: diphtheria antitoxin is only administered after a diagnosis of diphtheria and not in other forms of tonsillitis, red blood cells should only be transfused once blood group compatibility as been established and factor VIII replacement is only administered in haemophilia A as opposed to other acquired or hereditary disease of the coagulation system. The peculiarities of biological medicinal products, in particular the inherent variability of the drug, are especially important for autologous cellular medicinal products. In addition to the expected variability of the biological source material there is interindividual variability of patients as cell donors, which make definition of specifications and determination of criteria for pharmaceutical quality and potency tests difficult. Therapy with modified autologous cells, a common and important application of advanced therapy medicinal products, is exemplary for the special considerations that must be made when evaluating pharmaceutical quality, mode of action and toxicological properties of the biological medicine. The clinical investigation of advanced therapy medicinal products with the intent of demonstrating safety and efficacy is particularly challenging because of the complexity of therapy, which often involves invasive interventions. The development of biomarkers accelerates the process towards stratified or individualised therapies. Increased requirements for companion diagnostics are a possible consequence. Progress in analytical processes and in biotechnology make a higher degree of individualization likely, possibly to the degree that medicinal products will be individually manufactured for each patient. Current principles of medicinal product testing and market authorization may be applicable only with limitations, because the individual medicinal products are not uniform and are not repeatedly manufactured. The assessment of the process, performed on several different medicinal products manufactured by the same process could potentially serve as a basis for the assessment. For the evaluation of risk for the patient in clinical trials new concepts must be considered, which can be facilitated by interaction of regulatory authorities and developers. PMID:24170083

Müller-Berghaus, J; Volkers, P; Scherer, J; Cichutek, K

2013-11-01

351

Influenza Vaccines: A Moving Interdisciplinary Field  

PubMed Central

Vaccination is by far the most effective way of preventing morbidity and mortality due to infection of the upper respiratory tract by influenza virus. Current vaccines require yearly vaccine updates as the influenza virus can escape vaccine-induced humoral immunity due to the antigenic variability of its surface antigens. In case of a pandemic, new vaccines become available too late with current vaccine practices. New technologies that allow faster production of vaccine seed strains in combination with alternative production platforms and vaccine formulations may shorten the time gap between emergence of a new influenza virus and a vaccine becoming available. Adjuvants may allow antigen-sparing, allowing more people to be vaccinated with current vaccine production capacity. Adjuvants and universal vaccines can target immune responses to more conserved influenza epitopes, which eventually will result in broader protection for a longer time. In addition, further immunological studies are needed to gain insights in the immune features that contribute to protection from influenza-related disease and mortality, allowing redefinition of correlates of protection beyond virus neutralization in vitro. PMID:25302957

Schotsaert, Michael; Garcia-Sastre, Adolfo

2014-01-01

352

Central nervous system demyelinating diseases and recombinant hepatitis B vaccination: a critical systematic review of scientific production.  

PubMed

The etiology of multiple sclerosis has not yet been fully described. A potential link between the recombinant hepatitis B vaccine and an increased risk of onset or exacerbation of multiple sclerosis emerged in the mid-1990s, leading to several spontaneous reports and studies investigating this association. We conducted a critical systematic review aimed at assessing whether hepatitis B vaccination increases the risk of onset or relapse of multiple sclerosis and other central nervous system demyelinating diseases. MEDLINE and EMBASE were used as data sources, and the search covered the period between 1981 and 2011. Twelve references met the inclusion criteria. No significant increased risk of onset or relapse of the diseases considered was associated with hepatitis B vaccination, except in one study. Most studies included in this review displayed methodological limitations and heterogeneity among them, which rendered it impossible to draw robust conclusions about the safety of hepatitis B vaccination in healthy subjects and patients with multiple sclerosis. Therefore, on the basis of current data there is no need to modify the vaccination recommendations; however, there is a need to improve the quality of observational studies with emphasis on certain considerations that are discussed in this review. PMID:23086181

Martínez-Sernández, V; Figueiras, A

2013-08-01

353

Statistical and regulatory considerations in assessments of interchangeability of biological drug products.  

PubMed

When the patent of a brand-name, marketed drug expires, new, generic products are usually offered. Small-molecule generic and originator drug products are expected to be chemically identical. Their pharmaceutical similarity can be typically assessed by simple regulatory criteria such as the expectation that the 90% confidence interval for the ratio of geometric means of some pharmacokinetic parameters be between 0.80 and 1.25. When such criteria are satisfied, the drug products are generally considered to exhibit therapeutic equivalence. They are then usually interchanged freely within individual patients. Biological drugs are complex proteins, for instance, because of their large size, intricate structure, sensitivity to environmental conditions, difficult manufacturing procedures, and the possibility of immunogenicity. Generic and brand-name biologic products can be expected to show only similarity but not identity in their various features and clinical effects. Consequently, the determination of biosimilarity is also a complicated process which involves assessment of the totality of the evidence for the close similarity of the two products. Moreover, even when biosimilarity has been established, it may not be assumed that the two biosimilar products can be automatically substituted by pharmacists. This generally requires additional, careful considerations. Without declaring interchangeability, a new product could be prescribed, i.e. it is prescribable. However, two products can be automatically substituted only if they are interchangeable. Interchangeability is a statistical term and it means that products can be used in any order in the same patient without considering the treatment history. The concepts of interchangeability and prescribability have been widely discussed in the past but only in relation to small molecule generics. In this paper we apply these concepts to biosimilars and we discuss: definitions of prescribability and interchangeability and their statistical implementation; the relation between bioequivalence and interchangeability for small-molecule drug products; regulatory requirements and expectations of biosimilar products in various jurisdictions; possible statistical approaches to establish the similarity and interchangeability of biologic drug products; definition of other technical terms such as switchability and automatic substitution. The paper will be concluded with a discussion of the anticipated future use of interchangeability of biological drug products. PMID:24832831

Tóthfalusi, Lászlo; Endrényi, László; Chow, Shein-Chung

2014-05-01

354

Vaccination of cattle with bovine papillomavirus type 4 L2 elicits the production of virus-neutralizing antibodies.  

PubMed

Prophylactic vaccination of cattle with the N terminus (L2a, aa 11-200) of the minor capsid protein L2 completely prevented bovine papillomavirus type 4 (BPV-4) infection of the alimentary canal. To investigate the mechanisms underlying protection from viral infection, sera from vaccinated animals were analysed in neutralization assays both in the nude mouse xenograft system and in cattle. BPV-4 retained its infectivity when incubated with preimmune cattle sera, whereas, when incubated with immune sera from animals vaccinated with either whole L2 or its N terminus L2a, its infectivity was greatly reduced, indicating that the immune sera had neutralizing activity against the virus. This activity could be abrogated by absorbing the immune sera with L2 or L2a, thus indicating that virus neutralization was due to the presence in the immune sera of anti-L2 antibodies. PMID:8758002

Gaukroger, J M; Chandrachud, L M; O'Neil, B W; Grindlay, G J; Knowles, G; Campo, M S

1996-07-01

355

Comparative analysis of six European influenza vaccines  

Microsoft Academic Search

Three split-virion vaccines (Vaxigrip, Begrivac, and Influsplit\\/Fluarix) and three subunit vaccines containing only viral surface glycoproteins (Influvac, Agrippai, and Fluvirin) available for the 1994–95 season were analysed by biological, molecular, and biochemical methods. Although all vaccines are required by health authorities to contain 15 µg haemagglutinin per dose of each virus strain, there were significant differences in haemagglutination titres among

I. Chaloupka; A. Schuler; M. Marschall; H. Meier-Ewert

1996-01-01

356

Integrated catalytic wet air oxidation and biological treatment of wastewater from Vitamin B 6 production  

NASA Astrophysics Data System (ADS)

This study investigated the feasibility of coupling a catalytic wet air oxidation (CWAO), with CuO/Al 2O 3 as catalyst, and an anaerobic/aerobic biological process to treat wastewater from Vitamin B 6 production. Results showed that the CWAO enhanced the biodegradability (BOD 5/COD) from 0.10 to 0.80. The oxidized effluents with COD of 10,000 mg l -1 was subjected to subsequent continuous anaerobic/aerobic oxidation, and 99.3% of total COD removal was achieved. The quality of the effluent obtained met the discharge standards of water pollutants for pharmaceutical industry Chemical Synthesis Products Category (GB21904-2008), and thereby it implies that the integrated CWAO and anaerobic/aerobic biological treatment may offer a promising process to treat wastewater from Vitamin B 6 production.

Kang, Jianxiong; Zhan, Wei; Li, Daosheng; Wang, Xiaocong; Song, Jing; Liu, Dongqi

357

The opinion of the production sector on the role of vaccines in the control and eradication of livestock diseases in Argentina.  

PubMed

Research by a number of international organisations indicates that world demand for red meat protein is set to increase significantly in the coming years. However, faced with the risk of infectious animal diseases and zoonoses--factors that could limit the growth of this production sector--the fight against livestock diseases must continue, especially against those that affect food safety or pose a threat to human life. The use of vaccination to prevent infectious animal diseases is of key importance, not only because it helps to control and effectively eradicate infectious livestock diseases, but also because it makes it possible to introduce new technologies for intensive or semi-intensive production, to protect the environment, to care for animal welfare and to guarantee the safety of animal-derived foodstuffs. As part of their professional culture, livestock producers have come to fully appreciate the advantages of using vaccination to prevent disease rather than curative measures, which are more costly to implement and in some cases not very effective. The control of anthrax and rabies by means of effective vaccines was a factor in the widespread development of livestock in Argentina and other parts of Latin America. Recent results in the control and eradication of foot and mouth disease have made producers even more convinced of the merits of this technology. Animal disease prevention has proven to be highly conducive to the production of healthy foodstuffs. It is the responsibility of international organisations to draw up appropriate regulations to protect trade, supply safe and healthy products and prevent the application of unjustified non-tariff measures. PMID:17892168

Miguens, L

2007-08-01

358

Detection of avian retroviruses in vaccines by amplification on DF-1 cells with immunostaining and fluorescent product-enhanced reverse transcriptase endpoint methods.  

PubMed

In order to ensure the safety of vaccines produced on avian cells, rigorous testing for the absence of avian retroviruses must be performed. Current methods used to detect avian retroviruses often exhibit a high invalid-test/false-positive rate, rely on hard-to-secure reagents, and/or have readouts that are difficult to standardize. Herein, we describe the development and validation of two consistent and sensitive methods for the detection of avian retroviruses in vaccines: viral amplification on DF-1 cells followed by immunostaining for the detection of avian leukosis virus (ALV) and viral amplification on DF-1 cells followed by fluorescent product-enhanced reverse transcriptase (F-PERT) for the detection of all avian retroviruses. Both assays share an infectivity stage on DF-1 cells followed by a different endpoint readout depending on the retrovirus to be detected. Validation studies demonstrated a limit of detection of one 50% cell culture infectious dose (CCID(50))/ml for retrovirus in a 30-ml test inoculum volume for both methods, which was as sensitive as a classical method used in the vaccine industry, namely, viral amplification on primary chicken embryo fibroblasts followed by the complement fixation test for avian leukosis virus (COFAL). Furthermore, viral amplification on DF-1 cells followed by either immunostaining or F-PERT demonstrated a sensitivity that exceeds the regulatory requirements for detection of ALV strains. A head-to-head comparison of the two endpoint methods showed that viral amplification on DF-1 cells followed by F-PERT is a suitable method to be used as a stand-alone test to ensure that vaccine preparations are free from infectious avian retroviruses. PMID:23467603

Birmingham, Cheryl L; Dupont, Dominique; Riou, Patrice; Armanet, Corinne; Edamura, Kerrie Nichol; Martinho, Briolange; Serres, Aurelie; Jacouton, Severine; Detrez, Valerie; McNeil, Bryan; Schreiber, Martha; Gaillac, David; Bonnevay, Thierry; Gisonni-Lex, Lucy; Mallet, Laurent

2013-05-01

359

Detection of Avian Retroviruses in Vaccines by Amplification on DF-1 Cells with Immunostaining and Fluorescent Product-Enhanced Reverse Transcriptase Endpoint Methods  

PubMed Central

In order to ensure the safety of vaccines produced on avian cells, rigorous testing for the absence of avian retroviruses must be performed. Current methods used to detect avian retroviruses often exhibit a high invalid-test/false-positive rate, rely on hard-to-secure reagents, and/or have readouts that are difficult to standardize. Herein, we describe the development and validation of two consistent and sensitive methods for the detection of avian retroviruses in vaccines: viral amplification on DF-1 cells followed by immunostaining for the detection of avian leukosis virus (ALV) and viral amplification on DF-1 cells followed by fluorescent product-enhanced reverse transcriptase (F-PERT) for the detection of all avian retroviruses. Both assays share an infectivity stage on DF-1 cells followed by a different endpoint readout depending on the retrovirus to be detected. Validation studies demonstrated a limit of detection of one 50% cell culture infectious dose (CCID50)/ml for retrovirus in a 30-ml test inoculum volume for both methods, which was as sensitive as a classical method used in the vaccine industry, namely, viral amplification on primary chicken embryo fibroblasts followed by the complement fixation test for avian leukosis virus (COFAL). Furthermore, viral amplification on DF-1 cells followed by either immunostaining or F-PERT demonstrated a sensitivity that exceeds the regulatory requirements for detection of ALV strains. A head-to-head comparison of the two endpoint methods showed that viral amplification on DF-1 cells followed by F-PERT is a suitable method to be used as a stand-alone test to ensure that vaccine preparations are free from infectious avian retroviruses. PMID:23467603

Dupont, Dominique; Riou, Patrice; Armanet, Corinne; Edamura, Kerrie Nichol; Martinho, Briolange; Serres, Aurelie; Jacouton, Severine; Detrez, Valerie; McNeil, Bryan; Schreiber, Martha; Gaillac, David; Bonnevay, Thierry; Gisonni-Lex, Lucy; Mallet, Laurent

2013-01-01

360

Heterologous production of plant-derived isoprenoid products in microbes and the application of metabolic engineering and synthetic biology.  

PubMed

The value associated with plant-derived products has spurred efforts to engineer new production routes. One such option is heterologous biosynthesis which requires reconstitution of a biosynthetic pathway in a host that provides both innate and developed cellular advantages relative to the native producer. This review will summarize success to date in heterologously producing plant-derived isoprenoid products when using hosts such as E. coli and yeast. The article will also address the significant challenges that face such efforts, the approaches that have been used to overcome obstacles, and the tools of metabolic engineering and synthetic biology being applied both in the course of establishing heterologous biosynthesis and optimizing final production metrics. PMID:24631884

Li, Yi; Pfeifer, Blaine A

2014-06-01

361

Tdap and Td vaccines  

MedlinePLUS

Tdap immunization; Td immunization; Diphtheria vaccination; Tetanus vaccination; Pertussis vaccination ... for Disease Control and Prevention. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices ( ...

362

Net biological oxygen production in the ocean: Remote in situ measurements of O2 and N2 in surface waters  

E-print Network

Net biological oxygen production in the ocean: Remote in situ measurements of O2 and N2 in surface biological oxygen production in the euphotic zone of the ocean using remote in situ measurements of oxygen and nitrogen gas. Temperature, salinity, oxygen, and total dissolved gas pressure were measured every 2 hours

Emerson, Steven R.

363

[Specific aspects of vaccine manufacturing].  

PubMed

The industrial development of vaccine manufacturing expanded during the second half of the 20th century. Vaccines are medicines which target healthy people. The active principles of vaccines arise from live organisms and can be distinguished from standard pharmaceutical compounds by their extreme complexity. The properties of vaccines depend mainly of the manufacturing process and it common to state that "the process makes the product". The manufacturing is done in confined rooms because of the pathogenic characters of the organisms involved. Raw materials are subjected to rigorous controls to guarantee the integrity of products towards non-conventional agents like prion. The vaccine industry is characterized by the length of the manufacturing cycle. The complexity of the products implies heavy quality controls, which represent 75% of the total duration of the manufacture cycle. As a key element of public health, the vaccine production can be subjected to variations and adaptations, in particular in the context of outbreaks or bioterrorism. The vaccine industry must integrate the regulatory requirements, which are more and more pressing. The spectacular development of the quality assurance and quality control departments these last 15 years testifies to this evolution. PMID:19446672

Speck, D

2009-05-01

364

Charting biologically relevant chemical space: A structural classification of natural products (SCONP)  

PubMed Central

The identification of small molecules that fall within the biologically relevant subfraction of vast chemical space is of utmost importance to chemical biology and medicinal chemistry research. The prerequirement of biological relevance to be met by such molecules is fulfilled by natural product-derived compound collections. We report a structural classification of natural products (SCONP) as organizing principle for charting the known chemical space explored by nature. SCONP arranges the scaffolds of the natural products in a tree-like fashion and provides a viable analysis- and hypothesis-generating tool for the design of natural product-derived compound collections. The validity of the approach is demonstrated in the development of a previously undescribed class of selective and potent inhibitors of 11?-hydroxysteroid dehydrogenase type 1 with activity in cells guided by SCONP and protein structure similarity clustering. 11?-hydroxysteroid dehydrogenase type 1 is a target in the development of new therapies for the treatment of diabetes, the metabolic syndrome, and obesity. PMID:16301544

Koch, Marcus A.; Schuffenhauer, Ansgar; Scheck, Michael; Wetzel, Stefan; Casaulta, Marco; Odermatt, Alex; Ertl, Peter; Waldmann, Herbert

2005-01-01

365

Plants for delivery of edible vaccines  

Microsoft Academic Search

Over the past decade, scientific advances in molecular biology and immunology have improved understanding of many diseases and led to the development of novel strategies for vaccination. The development of plants expressing vaccine antigens is a particularly promising approach. Plant-derived antigenic proteins have delayed or prevented the onset of disease in animals and have proven to be safe and functional

Amanda M Walmsley; Charles J Arntzen

2000-01-01

366

Metabolic engineering of microorganisms for biofuels production: from bugs to synthetic biology to fuels  

SciTech Connect

The ability to generate microorganisms that can produce biofuels similar to petroleum-based transportation fuels would allow the use of existing engines and infrastructure and would save an enormous amount of capital required for replacing the current infrastructure to accommodate biofuels that have properties significantly different from petroleum-based fuels. Several groups have demonstrated the feasibility of manipulating microbes to produce molecules similar to petroleum-derived products, albeit at relatively low productivity (e.g. maximum butanol production is around 20 g/L). For cost-effective production of biofuels, the fuel-producing hosts and pathways must be engineered and optimized. Advances in metabolic engineering and synthetic biology will provide new tools for metabolic engineers to better understand how to rewire the cell in order to create the desired phenotypes for the production of economically viable biofuels.

Kuk Lee, Sung; Chou, Howard; Ham, Timothy S.; Soon Lee, Taek; Keasling, Jay D.

2009-12-02

367

FDA: Center for Biologics Evaluation and Research  

NSDL National Science Digital Library

The mission of the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) is "to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies." Their mission is an important one, and consumers and scientists will want to bookmark this page and return to it on a regular basis. On this page, visitors can sign up for their RSS feed and read through some key resources. Users can also browse resources on biologics depending on their needs: consumer, healthcare and industry level information is provided.

368

Informed consent should be obtained from patients to use products (skin substitutes) and dressings containing biological material  

PubMed Central

Background: Biological products (tissue engineered skin, allograft and xenograft, and biological dressings) are widely used in the treatment of burns, chronic wounds, and other forms of acute injury. However, the religious and ethical issues, including consent, arising from their use have never been addressed in the medical literature. Aims: This study was aimed to ascertain the views of religious leaders about the acceptability of biological products and to evaluate awareness among healthcare professionals about their constituents. Methods: The religious groups that make up about 75% of the United Kingdom population were identified and a questionnaire on 11 biological products was sent to its leaders. Another questionnaire concerning 17 products (11 biological and 6 synthetic dressings) was sent to 100 healthcare professionals working in seven specialist units in the UK. Results: All religious leaders (100% response rate) replied, some after consultation with international bodies. Among them, 77% said that patients should be informed of the constituents of the biological products and consent obtained. Some leaders expressed concerns about particular products including the transmission of viral and prion diseases, cruelty to animals, and material derived from neonates. None of the healthcare professionals (73% response rate) surveyed knew the constituents of all the products correctly. Conclusion: Ignoring religious sensitivities and neglecting consent in the usage of biological products could have very serious implications, including litigation. Hospitals and manufacturers should take immediate measures to enlighten healthcare professionals of the constituents of these products so that they can obtain informed consent from patients. PMID:15634745

Enoch, S; Shaaban, H; Dunn, K

2005-01-01

369

Risk in Vaccine Research and Development Quantified  

PubMed Central

To date, vaccination is the most cost-effective strategy to combat infectious diseases. Recently, a productivity gap affects the pharmaceutical industry. The productivity gap describes the situation whereby the invested resources within an industry do not match the expected product turn-over. While risk profiles (combining research and development timelines and transition rates) have been published for new chemical entities (NCE), little is documented on vaccine development. The objective is to calculate risk profiles for vaccines targeting human infectious diseases. A database was actively compiled to include all vaccine projects in development from 1998 to 2009 in the pre-clinical development phase, clinical trials phase I, II and III up to Market Registration. The average vaccine, taken from the preclinical phase, requires a development timeline of 10.71 years and has a market entry probability of 6%. Stratification by disease area reveals pandemic influenza vaccine targets as lucrative. Furthermore, vaccines targeting acute infectious diseases and prophylactic vaccines have shown to have a lower risk profile when compared to vaccines targeting chronic infections and therapeutic applications. In conclusion; these statistics apply to vaccines targeting human infectious diseases. Vaccines targeting cancer, allergy and autoimmune diseases require further analysis. Additionally, this paper does not address orphan vaccines targeting unmet medical needs, whether projects are in-licensed or self-originated and firm size and experience. Therefore, it remains to be investigated how these - and other - variables influence the vaccine risk profile. Although we find huge differences between the risk profiles for vaccine and NCE; vaccines outperform NCE when it comes to development timelines. PMID:23526951

Pronker, Esther S.; Weenen, Tamar C.; Commandeur, Harry; Claassen, Eric H. J. H. M.; Osterhaus, Albertus D. M. E.

2013-01-01

370

High-latitude controls of thermocline nutrients and low latitude biological productivity.  

PubMed

The ocean's biological pump strips nutrients out of the surface waters and exports them into the thermocline and deep waters. If there were no return path of nutrients from deep waters, the biological pump would eventually deplete the surface waters and thermocline of nutrients; surface biological productivity would plummet. Here we make use of the combined distributions of silicic acid and nitrate to trace the main nutrient return path from deep waters by upwelling in the Southern Ocean and subsequent entrainment into subantarctic mode water. We show that the subantarctic mode water, which spreads throughout the entire Southern Hemisphere and North Atlantic Ocean, is the main source of nutrients for the thermocline. We also find that an additional return path exists in the northwest corner of the Pacific Ocean, where enhanced vertical mixing, perhaps driven by tides, brings abyssal nutrients to the surface and supplies them to the thermocline of the North Pacific. Our analysis has important implications for our understanding of large-scale controls on the nature and magnitude of low-latitude biological productivity and its sensitivity to climate change. PMID:14702082

Sarmiento, J L; Gruber, N; Brzezinski, M A; Dunne, J P

2004-01-01

371

Pertussis Vaccine  

Cancer.gov

The National Institute of Child Health and Human Development (NICHD) is seeking statements of capability or interest from parties interested in collaborative research to further co-develop vaccines against pertussis.

372

Rabies Vaccine  

MedlinePLUS

... rabies infection in the United States. Skunks, raccoons, dogs, and cats can also transmit the disease.Human ... rabies-related deaths each year. Bites from unvaccinated dogs cause most of these cases. Rabies vaccine can ...

373

DNA vaccines  

Microsoft Academic Search

DNA vaccines use eukaryotic expression vectors to produce immunizing proteins in the vaccinated host. Popular methods of delivery are intramuscular and intradermal saline injections of DNA and gene gun bombardment of skin with DNA-coated gold beads. The method of DNA inoculation (gene gun versus intramuscular injection) and the form of the DNA-expressed antigen (cell-associated versus secreted) determine whether T-cell help

Harriet L. Robinson; Celia Aurora Tiglao Torres

1997-01-01

374

Early history of regulatory requirements for poultry biologics in the United States.  

PubMed

Congress passed the Virus-Serum-Toxin Act in 1913, giving the U.S. Department of Agriculture (USDA) authority to prevent the importation or interstate shipment of worthless, contaminated, dangerous, or harmful veterinary biological products. The passage of this act marked the beginning of regulatory requirements for veterinary biological products in the United States. In 1913, only a few biologics establishments produced products for the poultry industry. The first license issued by the USDA for a poultry product was in 1918 to the University of California, Berkeley, for fowlpox vaccine. The list of biological products for poultry grew slowly in the 1920s. However, this began to change with the licensing of laryngotracheitis vaccine in 1933; pigeonpox vaccine in 1939; several Newcastle disease vaccines (inactivated in 1946, Roakin strain in 1948, B1 strain in 1950, and La Sota strain in 1952); and the first bronchitis vaccine in 1953. With the development of these and other new products, the biologics industry began to move its emphasis on hog cholera serum and virus to one based on the production of numerous new vaccines and bacterial products. The USDA's approach to the regulation of biologics in the early 1950s was still geared to the production of hog cholera products; however, as a result of the intervention of a group of dedicated poultry scientists, who were concerned about the poor performance of Newcastle disease vaccines, this soon changed. This presentation describes the initiation and development of modern standards for poultry biologics that occurred as a result of this intervention. The development and improvement of standards and regulatory requirements to address mycoplasma, leukosis, and other extraneous virus contaminations in chicken embryo origin products are reviewed. The licensing of products to meet new and emerging disease problems in the poultry industry and the close interaction among research scientists, poultry industry, biologics manufacturers, and government regulatory officials that has been needed to ensure the availability of products that meet appropriate standards of purity, safety, potency, and efficacy are also addressed. PMID:21313831

Espeseth, David A; Lasher, Hiram

2010-12-01

375

[Search of novel bioactive natural products from plant sources--novel structures and biological activities--].  

PubMed

Over 30 years, our laboratory has been involved in the search of bioactive natural products from plant sources of several plant families, Rutaceae, Guttiferae, Avicenniaceae, and so on. In this review, novel structures of acridone alkaloids, carbazole alkaloids, coumarins, depsidones, and so on isolated in our laboratory will be showed. In addition, some results of assay of biological activities of the isolated compounds also will be described. PMID:19797871

Furukawa, Hiroshi

2009-10-01

376

Optimizing nutritional conditions for the liquid culture production of effective fungal biological control agents  

Microsoft Academic Search

  Spores of fungal pathogens of weeds and insects are unique in their ability to actively infect and kill their pest host.\\u000a While these capabilities are advantageous in terms of their use as a contact biological control agent, or biopesticide, they\\u000a also require special consideration during spore production. Directed approaches to medium optimization must consider not\\u000a only spore yield but also

M A Jackson

1997-01-01

377

Traditional and New Influenza Vaccines  

PubMed Central

SUMMARY The challenges in successful vaccination against influenza using conventional approaches lie in their variable efficacy in different age populations, the antigenic variability of the circulating virus, and the production and manufacturing limitations to ensure safe, timely, and adequate supply of vaccine. The conventional influenza vaccine platform is based on stimulating immunity against the major neutralizing antibody target, hemagglutinin (HA), by virus attenuation or inactivation. Improvements to this conventional system have focused primarily on improving production and immunogenicity. Cell culture, reverse genetics, and baculovirus expression technology allow for safe and scalable production, while adjuvants, dose variation, and alternate routes of delivery aim to improve vaccine immunogenicity. Fundamentally different approaches that are currently under development hope to signal new generations of influenza vaccines. Such approaches target nonvariable regions of antigenic proteins, with the idea of stimulating cross-protective antibodies and thus creating a “universal” influenza vaccine. While such approaches have obvious benefits, there are many hurdles yet to clear. Here, we discuss the process and challenges of the current influenza vaccine platform as well as new approaches that are being investigated based on the same antigenic target and newer technologies based on different antigenic targets. PMID:23824369

Wong, Sook-San

2013-01-01

378

Vaccines and Thimerosal  

MedlinePLUS

... Thimerosal in Vaccines Qs and As Studies on Mercury and Vaccines Thimerosal Since 2001, with the exception ... in routinely recommended childhood vaccines. Thimerosal is a mercury-containing preservative used in some vaccines and other ...

379

Therapeutic Vaccines for Gastrointestinal Cancers  

PubMed Central

Despite progress in the management of gastrointestinal malignancies, these diseases remain devastating maladies. Conventional treatment with chemotherapy and radiation is still only partially effective and highly toxic. In the era of increasing knowledge of the molecular biology of tumors and the interaction between the tumor and immune system, the development of targeted agents, including cancer vaccines, has emerged as a promising modality. In this paper, we discuss the principals of vaccine development, and we review most of the published trials on gastrointestinal cancer vaccines that have been conducted over the last decade. Many antigens and various treatment approaches have already been tested in colon, pancreatic, and other cancers. Some of these approaches have already shown some clinical benefit. In this paper, we discuss these different strategies and some of the future directions for targeting gastrointestinal malignancies with vaccines. PMID:22298988

Rahma, Osama E.

2011-01-01

380

Using Monte Carlo simulation to assess the value of combination vaccines for pediatric immunization  

Microsoft Academic Search

Research by vaccine manufacturers in the USA has resulted in the development of new vaccines that protect against a number of diseases. This has created a dilemma for how to introduce such new vaccines into an already crowded US Recommended Childhood Immunization Schedule and prompted the development of vaccine products that combine several individual vaccines into a single injection. Such

Sheldon H. Jacobson; Edward C. Sewell; Bruce G. Weniger

2001-01-01

381

The combination of marker gene swapping and fluorescence-activated cell sorting improves the efficiency of recombinant modified vaccinia virus Ankara vaccine production for human use.  

PubMed

Modified vaccinia virus Ankara (MVA) is employed as a human vaccine vector for the high expression of heterologous genes and the lack of replication in mammalian cells. This study demonstrates that cells infected by recombinant viruses can be obtained by fluorescence-activated cell sorting. Recombinant viruses are generated by a swapping event between a red fluorescent protein gene in the acceptor virus and a plasmid cassette coding for both a green fluorescent marker and a transgene. To prevent the carry-over of parental virus, due to superinfection of the cells harbouring recombinant viruses, the sorting is performed on cells infected at low m.o.i. in the presence of a reversible inhibitor of viral particle release. Terminal dilution cloning is then used to isolate both green and marker-free recombinant viruses, which can be identified by whole-plate fluoroimaging. The differential visualization of all the viral types involved allows a stepwise monitoring of all recombinations and leads to a straightforward and efficient flow cytometry-based cell sorting purification protocol. As an example of the efficacy of this sorting procedure, the construction of rMVA's coding for the rat nuclear protein HMGB1 and H5N1 influenza A virus hemagglutinin is reported. The entire recombinant MVA production process is carried out in serum-free media employing primary chicken embryo fibroblasts (CEF), which are certified for the preparation of human vaccines. This rMVA production method is faster, simpler and more reliable than any other available procedure for obtaining safe vaccine stocks for human use. PMID:19778556

Di Lullo, Giulia; Soprana, Elisa; Panigada, Maddalena; Palini, Alessio; Agresti, Alessandra; Comunian, Claudio; Milani, Adelaide; Capua, Ilaria; Erfle, Volker; Siccardi, Antonio G

2010-02-01

382

The establishment of sub-strain specific WHO Reference Reagents for BCG vaccine  

PubMed Central

As the latest addition to the sub-strain specific WHO Reference Reagents of BCG vaccine, an international collaborative study was completed to evaluate the suitability of a candidate BCG Moreau-RJ sub-strain as a WHO Reference Reagent of BCG vaccine. This follows the recent replacement of the WHO 1st International Reference Preparation for BCG vaccine, by three sub-strain specific WHO Reference Reagents of BCG vaccine (Danish 1331, Tokyo 172-1 and Russian BCG-I) in order to complete the coverage of most predominant sub-strains used for BCG vaccine production and distribution for use worldwide. The study used cultural viable count and modified ATP assays to quantify the preparation and multiplex PCR to confirm the identity of the sub-strain. The establishment of this WHO Reference Reagent of BCG vaccine of Moreau-RJ sub-strain was approved by the WHO Expert Committee on Biological Standardization meeting in October 2012. This preparation is available for distribution by NIBSC-MHRA, UK. The data from real-time stability monitoring demonstrated that these Reference Reagents of BCG vaccine are very stable in storage condition at ?20 °C. They serve as the valuable source of BCG Reference Reagents for use as comparators (1) for viability assays (such as cultural viable count and modified ATP assays); (2) for in vivo assays (such as the absence of virulent mycobacteria, dermal reactivity and protection assays) in the evaluation of candidate TB vaccines in non-clinical models; (3) for identity assays using molecular biology techniques. PMID:25312272

Dagg, Belinda; Hockley, Jason; Rigsby, Peter; Ho, Mei M.

2014-01-01

383

VACCINE INFORMATION STATEMENT Influenza Vaccine  

E-print Network

much sicker than others. These people include young children, people 65 and older, pregnant women vaccine contain a small amount of egg. · If you ever had Guillain-Barré Syndrome (a severe paralyzing

Oklahoma, University of

384

Human vaccines & immunotherapeutics: news.  

PubMed

Infant rotavirus vaccination provides for herd immunity Nonreplicating sporozoite vaccine protects humans against malaria Personalized brain cancer vaccine enters phase 2 trial Novel implantable therapeutic cancer vaccine to be tested in humans Clostridium difficile vaccine candidate successful in phase 1 CDC reports strong uptake of HPV vaccine in boys Whooping cough outbreak in Texas. PMID:24056006

Riedmann, Eva M

2013-10-01

385

Genome sequence of Corynebacterium pseudotuberculosis biovar equi strain 258 and prediction of antigenic targets to improve biotechnological vaccine production.  

PubMed

Corynebacterium pseudotuberculosis is the causative agent of several veterinary diseases in a broad range of economically important hosts, which can vary from caseous lymphadenitis in sheep and goats (biovar ovis) to ulcerative lymphangitis in cattle and horses (biovar equi). Existing vaccines against C. pseudotuberculosis are mainly intended for small ruminants and, even in these hosts, they still present remarkable limitations. In this study, we present the complete genome sequence of C. pseudotuberculosis biovar equi strain 258, isolated from a horse with ulcerative lymphangitis. The genome has a total size of 2,314,404 bp and contains 2088 predicted protein-coding regions. Using in silico analysis, eleven pathogenicity islands were detected in the genome sequence of C. pseudotuberculosis 258. The application of a reverse vaccinology strategy identified 49 putative antigenic proteins, which can be used as candidate vaccine targets in future works. PMID:23201561

Soares, Siomar C; Trost, Eva; Ramos, Rommel T J; Carneiro, Adriana R; Santos, Anderson R; Pinto, Anne C; Barbosa, Eudes; Aburjaile, Flávia; Ali, Amjad; Diniz, Carlos A A; Hassan, Syed S; Fiaux, Karina; Guimarães, Luis C; Bakhtiar, Syeda M; Pereira, Ulisses; Almeida, Sintia S; Abreu, Vinícius A C; Rocha, Flávia S; Dorella, Fernanda A; Miyoshi, Anderson; Silva, Artur; Azevedo, Vasco; Tauch, Andreas

2013-08-20

386

Countermeasures and vaccination against terrorism using smallpox: pre-event and post-event smallpox vaccination and its contraindications  

Microsoft Academic Search

Smallpox, when used as a biological weapon, presents a serious threat to civilian populations. Core components of the public\\u000a health management of a terrorism attack using smallpox are: vaccination (ring vaccination and mass vaccination), adverse event\\u000a monitoring, confirmed and suspected smallpox case management, contact management, identifying, tracing, monitoring contacts,\\u000a and quarantine. Above all, pre-event and post-event vaccination is an indispensable

Hajime Sato

387

Biology and the Battlefield  

Microsoft Academic Search

th -century Black Death) to the anthrax attacks of fall 2001. The military-biology relationship also has a humane side. Over the years, medical advances have saved countless soldiers and contributed to the overall well being of society. From the smallpox inoculation of Continental Army recruits in 1777— nearly 20 years before Edward Jenner's smallpox vaccination—to the development of modern vaccines,

Robert E. Armstrong; Jerry B. Warner

388

Production and characterization of amplified tumor-derived cRNA libraries to be used as vaccines against metastatic melanomas  

PubMed Central

Background Anti-tumor vaccines targeting the entire tumor antigen repertoire represent an attractive immunotherapeutic approach. In the context of a phase I/II clinical trial, we vaccinated metastatic melanoma patients with autologous amplified tumor mRNA. In order to provide the large quantities of mRNA needed for each patient, the Stratagene Creator™ SMART™ cDNA library construction method was modified and applied to produce libraries derived from the tumors of 15 patients. The quality of those mRNA library vaccines was evaluated through sequencing and microarray analysis. Results Random analysis of bacterial clones of the library showed a rate of 95% of recombinant plasmids among which a minimum of 51% of the clones contained a full-Open Reading Frame. In addition, despite a biased amplification toward small abundant transcripts compared to large rare fragments, we could document a relatively conserved gene expression profile between the total RNA of the tumor of origin and the corresponding in vitro transcribed complementary RNA (cRNA). Finally, listing the 30 most abundant transcripts of patient MEL02's library, a large number of tumor associated antigens (TAAs) either patient specific or shared by several melanomas were found. Conclusion Our results show that unlimited amounts of cRNA representing tumor's transcriptome could be obtained and that this cRNA was a reliable source of a large variety of tumor antigens. PMID:16115316

Carralot, Jean-Philippe; Weide, Benjamin; Schoor, Oliver; Probst, Jochen; Scheel, Birgit; Teufel, Regina; Hoerr, Ingmar; Garbe, Claus; Rammensee, Hans-Georg; Pascolo, Steve

2005-01-01

389

Systems vaccinology for cancer vaccine development.  

PubMed

Results of therapeutic vaccines for established chronic infections or cancers are still unsatisfactory. The only therapeutic cancer vaccine approved for clinical use is the sipuleucel-T, for the treatment of metastatic prostate cancer, which induces a limited 4-month improvement in the overall survival of vaccinated patients compared to controls. This represents a remarkable advancement in the cancer immunotherapy field, although the clinical outcome of cancer vaccines needs to be substantially improved. To this aim, a multipronged strategy is required, including the evaluation of mechanisms underlying the effective elicitation of immune responses by cancer vaccines. The recent development of new technologies and computational tools allows the comprehensive and quantitative analysis of the interactions between all of the components of innate and adaptive immunity over time. Here we review the potentiality of systems biology in providing novel insights in the mechanisms of action of vaccines to improve their design and effectiveness. PMID:24766452

Petrizzo, Annacarmen; Tagliamonte, Maria; Tornesello, Marialina; Buonaguro, Franco M; Buonaguro, Luigi

2014-06-01

390

Biological Pretreatment of Rubberwood with Ceriporiopsis subvermispora for Enzymatic Hydrolysis and Bioethanol Production  

PubMed Central

Rubberwood (Hevea brasiliensis), a potential raw material for bioethanol production due to its high cellulose content, was used as a novel feedstock for enzymatic hydrolysis and bioethanol production using biological pretreatment. To improve ethanol production, rubberwood was pretreated with white rot fungus Ceriporiopsis subvermispora to increase fermentation efficiency. The effects of particle size of rubberwood (1?mm, 0.5?mm, and 0.25?mm) and pretreatment time on the biological pretreatment were first determined by chemical analysis and X-ray diffraction and their best condition obtained with 1?mm particle size and 90 days pretreatment. Further morphological study on rubberwood with 1 mm particle size pretreated by fungus was performed by FT-IR spectra analysis and SEM observation and the result indicated the ability of this fungus for pretreatment. A study on enzymatic hydrolysis resulted in an increased sugar yield of 27.67% as compared with untreated rubberwood (2.88%). The maximum ethanol concentration and yield were 17.9?g/L and 53% yield, respectively, after 120 hours. The results obtained demonstrate that rubberwood pretreated by C. subvermispora can be used as an alternative material for the enzymatic hydrolysis and bioethanol production. PMID:24167813

Nazarpour, Forough; Abdullah, Dzulkefly Kuang; Abdullah, Norhafizah; Motedayen, Nazila; Zamiri, Reza

2013-01-01

391

Laser-initiated decomposition products of indocyanine green (ICG) and carbon black sensitized biological tissues  

NASA Astrophysics Data System (ADS)

Organic dyes have found increasing use a s sensitizers in laser surgical procedures, due to their high optical absorbances. Little is known, however, about the nature of the degradation products formed when these dyes are irradiated with a laser. Previous work in our laboratories has shown that irradiation of polymeric and biological tissues with CO2 and Nd:YAG lasers produces a host of volatile and semivolatile by-products, some of which are known to be potential carcinogens. This work focuses on the identification of the chemical by-products formed by diode laser and Nd:YAG laser irradiation of indocyanine green (ICG) and carbon black based ink sensitized tissues, including bone, tendon and sheep's teeth. Samples were mounted in a 0.5-L Pyrex sample chamber equipped with quartz optical windows, charcoal filtered air inlet and an outlet attached to an appropriate sample trap and a constant flow pump. By-products were analyzed by GC/MS and HPLC. Volatiles identified included benzene and formaldehyde. Semi-volatiles included traces of polycyclic aromatics, arising from the biological matrix and inks, as well as fragments of ICG and the carbon ink components. The significance of these results will be discussed, including the necessity of using appropriate evacuation devices when utilizing lasers for surgical procedures.

Kokosa, John M.; Przyjazny, Andrzej; Bartels, Kenneth E.; Motamedi, Massoud; Hayes, Donald J.; Wallace, David B.; Frederickson, Christopher J.

1997-05-01

392

Antibacterial Activity within Degradation Products of Biological Scaffolds Composed of Extracellular Matrix  

PubMed Central

Biological scaffolds composed of extracellular matrix (ECM) have been shown to be resistant to deliberate bacterial contamination in preclinical in vivo studies. The present study evaluated the degradation products resulting from the acid digestion of ECM scaffolds for antibacterial effects against clinical strains of Staphylococcus aureus and Escherichia coli. The ECM scaffolds were derived from porcine urinary bladder (UBM-ECM) and liver (L-ECM). These biological scaffolds were digested with acid at high temperatures, fractionated using ammonium sulfate precipitation, and tested for antibacterial activity in a standardized in vitro assay. Degradation products from both UBM-ECM and L-ECM demonstrated antibacterial activity against both S. aureus and E. coli. Specific ammonium sulfate fractions that showed antimicrobial activity varied for the 2 different ECM scaffold types. The results of this study suggest that several different low-molecular-weight peptides with antibacterial activity exist within ECM and that these peptides may help explain the resistance to bacterial infection provided by such biological scaffolds. PMID:17518662

BRENNAN, ELLEN P.; REING, JANET; CHEW, DOUGLAS; MYERS-IRVIN, JULIE M.; YOUNG, E.J.; BADYLAK, STEPHEN F.

2011-01-01

393

Antibacterial activity within degradation products of biological scaffolds composed of extracellular matrix.  

PubMed

Biological scaffolds composed of extracellular matrix (ECM) have been shown to be resistant to deliberate bacterial contamination in preclinical in vivo studies. The present study evaluated the degradation products resulting from the acid digestion of ECM scaffolds for antibacterial effects against clinical strains of Staphylococcus aureus and Escherichia coli. The ECM scaffolds were derived from porcine urinary bladder (UBM-ECM) and liver (L-ECM). These biological scaffolds were digested with acid at high temperatures, fractionated using ammonium sulfate precipitation, and tested for antibacterial activity in a standardized in vitro assay. Degradation products from both UBM-ECM and L-ECM demonstrated antibacterial activity against both S. aureus and E. coli. Specific ammonium sulfate fractions that showed antimicrobial activity varied for the 2 different ECM scaffold types. The results of this study suggest that several different low-molecular-weight peptides with antibacterial activity exist within ECM and that these peptides may help explain the resistance to bacterial infection provided by such biological scaffolds. PMID:17518662

Brennan, Ellen P; Reing, Janet; Chew, Douglas; Myers-Irvin, Julie M; Young, E J; Badylak, Stephen F

2006-10-01

394

Mass and energy balance constraints on the biological production of chemicals from coal  

SciTech Connect

Several organic chemicals, including methane and ethanol, may be produced by the bioprocessing of coal. This may be done either by direct microbial attack on the coal, or indirectly by the bioprocessing of solubilized coal. As in chemical liquefaction and gasification, the relative amounts of the various products that can be produced are severely constrained by mass and energy balance considerations. The main differences in biological processing are that water is a ubiquitous reactant, carbon dioxide a common product, and that some of the carbon and nitrogen in the coal may go to the synthesis of new biomass rather than products. The conventional biotechnological yield analysis applied to coal processing has several interesting consequences. The mass balance reduces to a balance of available electrons, and coal has a similar oxidation/reduction state to both carbohydrates and biomass. This makes high product yields feasible particularly under anaerobic conditions, although leaving open the question of whether the relevant hydrolase enzymes exist. Recommendations are made on products, and combinations of two products, that may be made with high yields and economic return. The energy balance provides little extra information. A general intracellular energy balance can be written in terms of the production and consumption of ATP, but much of the necessary information on the metabolic pathways is currently not available for coal processing microorganisms. 9 refs., 2 figs., 2 tabs.

Andrews, G.

1990-01-01

395

Construction of Live Vaccines Using Genetically Engineered Poxviruses: Biological Activity of Vaccinia Virus Recombinants Expressing the Hepatitis B Virus Surface Antigen and the Herpes Simplex Virus Glycoprotein D  

Microsoft Academic Search

Potential live vaccines using recombinant vaccinia viruses have been constructed for both hepatitis B and herpes simplex. These recombinant vaccinia viruses express cloned genes of the hepatitis B virus surface antigen (HBsAg) or the glycoprotein D from herpes simplex virus (HSV-gD). The HBsAg synthesized in vitro under the regulation of vaccinia virus is secreted from infected cells as a particle

Enzo Paoletti; Bernard R. Lipinskas; Carol Samsonoff; Susan Mercer; Dennis Panicali

1984-01-01

396

Method for assessing the impact of emission gasses on physiology and productivity in biological methanogenesis.  

PubMed

This contribution presents a method for quantification of the impact of emission gasses on the methane production with hydrogenotrophic methanogenic archaea. The developed method allows a robust quantification of the influence of real gasses on the volumetric productivity of methanogenic cultures by uncoupling physiological and mass transfer effects. This is achieved over reference experiments with pure H2 and CO2, simulating the mass transfer influence of the non-convertible side components by addition of N2 to the reactant stream. Furthermore, this method was used to examine the performance of Methanothermobacter marburgensis on different emission gasses. None of the present side components had a negative effect on the volumetric methane production rate. The presented method showed to be ready to use as a generic tool for feasibility studies and quantification of the physiological impact regarding the use of exhaust gasses as reactant gas for the biological methanogenesis. PMID:23582218

Seifert, A H; Rittmann, S; Bernacchi, S; Herwig, C

2013-05-01

397

Combination vaccines in the South African setting.  

PubMed

The number of vaccines available and included as part of the national immunization schedules, has increased significantly over the past few decades. This impacts on patient/parent compliance and creates a challenge for health care providers for implementation of schedules necessitating training and infrastructure improvements. Use of combination rather than component vaccines offers advantages for compliance by single dose administration of various antigens, reducing stock costing as well as reducing cost of additional health care visits. Combination vaccines are often significantly more expensive than individual constituent vaccines. Concerns regarding an increased incidence of adverse events with use of combination vaccines have not been confirmed and rates may seem high as the adverse events seem to mimic the sum total of adverse event rates for each individual antigen used but may in fact be lower. Manufacturers typically advise against interchanging use of vaccine products. Despite this, health authorities advocate use of an alternative vaccine where the original vaccine in not available, to ensure continuity of vaccination. A notable exception is the acellular pertussis vaccine. Partly, because no serological correlates of immunity exist, but also a general lack of convincing follow up studies has prompted the recommendation for manufacturer fidelity for at least the first 3 vaccine doses. According to the South African Medicines Formulary, a variety of vaccines are available in South Africa. Although a large number are available in the private sector, the only true combination vaccine included in the current state EPI, modified in 2009, is the DTaP-IPV/Hib vaccine (Diphtheria, Tetanus, acellular Pertussis, inactivated Poliomyelitis virus and Haemophilus influenzae type b). There are many reasons justifying the use of combination vaccines rather that the individual constituent formulations. Implementation of use in the South African setting at this point is still limited, but may offer an exciting avenue of expanding the antigen repertoire without impacting on side-effects, efficacy or complexity of scheduling. PMID:22939020

Visser, Adele; Hoosen, Anwar

2012-09-01

398

21 CFR 610.53 - Dating periods for licensed biological products.  

Code of Federal Regulations, 2010 CFR

...percent excess of potency. Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed...applicable 18 months. Diphtheria and Tetanus Toxoids, Adsorbed ......do ...months ......do 6 months. 8. Tetanus Immune Globulin (Human) 1 year...

2010-04-01

399

21 CFR 610.53 - Dating periods for licensed biological products.  

...percent excess of potency. Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed...applicable 18 months. Diphtheria and Tetanus Toxoids, Adsorbed ......do ...months ......do 6 months. 8. Tetanus Immune Globulin (Human) 1 year...

2014-04-01

400

21 CFR 610.53 - Dating periods for licensed biological products.  

Code of Federal Regulations, 2012 CFR

...percent excess of potency. Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed...applicable 18 months. Diphtheria and Tetanus Toxoids, Adsorbed ......do ...months ......do 6 months. 8. Tetanus Immune Globulin (Human) 1 year...

2012-04-01

401

21 CFR 610.53 - Dating periods for licensed biological products.  

Code of Federal Regulations, 2013 CFR

...percent excess of potency. Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed...applicable 18 months. Diphtheria and Tetanus Toxoids, Adsorbed ......do ...months ......do 6 months. 8. Tetanus Immune Globulin (Human) 1 year...

2013-04-01

402

21 CFR 610.53 - Dating periods for licensed biological products.  

Code of Federal Regulations, 2011 CFR

...percent excess of potency. Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed...applicable 18 months. Diphtheria and Tetanus Toxoids, Adsorbed ......do ...months ......do 6 months. 8. Tetanus Immune Globulin (Human) 1 year...

2011-04-01

403

Comparison of egg and high yielding MDCK cell-derived live attenuated influenza virus for commercial production of trivalent influenza vaccine: in vitro cell susceptibility and influenza virus replication kinetics in permissive and semi-permissive cells.  

PubMed

Currently MedImmune manufactures cold-adapted (ca) live, attenuated influenza vaccine (LAIV) from specific-pathogen free (SPF) chicken eggs. Difficulties in production scale-up and potential exposure of chicken flocks to avian influenza viruses especially in the event of a pandemic influenza outbreak have prompted evaluation and development of alternative non-egg based influenza vaccine manufacturing technologies. As part of MedImmune's effort to develop the live attenuated influenza vaccine (LAIV) using cell culture production technologies we have investigated the use of high yielding, cloned MDCK cells as a substrate for vaccine production by assessing host range and virus replication of influenza virus produced from both SPF egg and MDCK cell production technologies. In addition to cloned MDCK cells the indicator cell lines used to evaluate the impact of producing LAIV in cells on host range and replication included two human cell lines: human lung carcinoma (A549) cells and human muco-epidermoid bronchiolar carcinoma (NCI H292) cells. The influenza viruses used to infect the indicators cell lines represented both the egg and cell culture manufacturing processes and included virus strains that composed the 2006-2007 influenza seasonal trivalent vaccine (A/New Caledonia/20/99 (H1N1), A/Wisconsin/67/05 (H3N2) and B/Malaysia/2506/04). Results from this study demonstrate remarkable similarity between influenza viruses representing the current commercial egg produced and developmental MDCK cell produced vaccine production platforms. MedImmune's high yielding cloned MDCK cells used for the cell culture based vaccine production were highly permissive to both egg and cell produced ca attenuated influenza viruses. Both the A549 and NCI H292 cells regardless of production system were less permissive to influenza A and B viruses than the MDCK cells. Irrespective of the indicator cell line used the replication properties were similar between egg and the cell produced influenza viruses. Based on these study results we conclude that the MDCK cell produced and egg produced vaccine strains are highly comparable. PMID:20307595

Hussain, Althaf I; Cordeiro, Melissa; Sevilla, Elizabeth; Liu, Jonathan

2010-05-14

404

Antiviral cationic peptides as a strategy for innovation in global health therapeutics for dengue virus: high yield production of the biologically active recombinant plectasin peptide.  

PubMed

Dengue virus infects millions of people worldwide, and there is no vaccine or anti-dengue therapeutic available. Antimicrobial peptides have been shown to possess effective antiviral activity against various viruses. One of the main limitations of developing these peptides as potent antiviral drugs is the high cost of production. In this study, high yield production of biologically active plectasin peptide was inexpensively achieved by producing tandem plectasin peptides as inclusion bodies in E. coli. Antiviral activity of the recombinant peptide towards dengue serotype-2 NS2B-NS3 protease (DENV2 NS2B-NS3pro) was assessed as a target to inhibit dengue virus replication in Vero cells. Single units of recombinant plectasin were collected after applying consecutive steps of refolding, cleaving by Factor Xa, and nickel column purification to obtain recombinant proteins of high purity. The maximal nontoxic dose (MNTD) of the recombinant peptide against Vero cells was 20??M (100??g/mL). The reaction velocity of DENV2 NS2B-NS3pro decreased significantly after increasing concentrations of recombinant plectasin were applied to the reaction mixture. Plectasin peptide noncompetitively inhibited DENV2 NS2B-NS3pro at Ki value of 5.03 ± 0.98??M. The percentage of viral inhibition was more than 80% at the MNTD value of plectasin. In this study, biologically active recombinant plectasin which was able to inhibit dengue protease and viral replication in Vero cells was successfully produced in E. coli in a time- and cost- effective method. These findings are potentially important in the development of potent therapeutics against dengue infection. PMID:24044366

Rothan, Hussin A; Mohamed, Zulqarnain; Suhaeb, Abdulrazzaq M; Rahman, Noorsaadah Abd; Yusof, Rohana

2013-11-01

405

9 CFR 113.325 - Avian Encephalomyelitis Vaccine.  

Code of Federal Regulations, 2013 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.325 Avian Encephalomyelitis...Encephalomyelitis Vaccine shall be prepared from virus-bearing tissues or fluids from...

2013-01-01

406

9 CFR 113.311 - Bovine Virus Diarrhea Vaccine.  

Code of Federal Regulations, 2013 CFR

...2013-01-01 2013-01-01 false Bovine Virus Diarrhea Vaccine. 113.311 Section...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.311 Bovine...

2013-01-01

407

9 CFR 113.314 - Feline Calicivirus Vaccine.  

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.314 Feline Calicivirus...Calicivirus Vaccine shall be prepared from virus-bearing cell culture fluids. Only...

2014-01-01

408

9 CFR 113.206 - Wart Vaccine, Killed Virus.  

Code of Federal Regulations, 2010 CFR

...2010-01-01 false Wart Vaccine, Killed Virus. 113.206 Section 113.206 Animals...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Killed Virus Vaccines § 113.206 Wart...

2010-01-01

409

9 CFR 113.316 - Canine Parainfluenza Vaccine.  

Code of Federal Regulations, 2010 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.316 Canine Parainfluenza...Parainfluenza Vaccine shall be prepared from virus-bearing cell culture fluids....

2010-01-01

410

9 CFR 113.213 - Pseudorabies Vaccine, Killed Virus.  

Code of Federal Regulations, 2013 CFR

... false Pseudorabies Vaccine, Killed Virus. 113.213 Section 113.213 Animals...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Killed Virus Vaccines § 113.213...

2013-01-01

411

9 CFR 113.316 - Canine Parainfluenza Vaccine.  

Code of Federal Regulations, 2011 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.316 Canine Parainfluenza...Parainfluenza Vaccine shall be prepared from virus-bearing cell culture fluids....

2011-01-01

412

9 CFR 113.308 - Encephalomyelitis Vaccine, Venezuelan.  

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.308 Encephalomyelitis...Vaccine, Venezuelan, shall be prepared from virus-bearing cell culture fluids....

2014-01-01

413

9 CFR 113.206 - Wart Vaccine, Killed Virus.  

Code of Federal Regulations, 2012 CFR

...2012-01-01 false Wart Vaccine, Killed Virus. 113.206 Section 113.206 Animals...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Killed Virus Vaccines § 113.206 Wart...

2012-01-01

414

9 CFR 113.309 - Bovine Parainfluenza3 Vaccine.  

Code of Federal Regulations, 2010 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.309 Bovine Parainfluenza3...Parainfluenza3 Vaccine shall be produced from virus-bearing cell culture fluids. Only...

2010-01-01

415

9 CFR 113.310 - Bovine Rhinotracheitis Vaccine.  

Code of Federal Regulations, 2011 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.310 Bovine Rhinotracheitis...Rhinotracheitis Vaccine shall be prepared from virus-bearing cell culture fluids. Only...

2011-01-01

416

9 CFR 113.325 - Avian Encephalomyelitis Vaccine.  

Code of Federal Regulations, 2012 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.325 Avian Encephalomyelitis...Encephalomyelitis Vaccine shall be prepared from virus-bearing tissues or fluids from...

2012-01-01

417

9 CFR 113.310 - Bovine Rhinotracheitis Vaccine.  

Code of Federal Regulations, 2010 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.310 Bovine Rhinotracheitis...Rhinotracheitis Vaccine shall be prepared from virus-bearing cell culture fluids. Only...

2010-01-01

418

9 CFR 113.329 - Newcastle Disease Vaccine.  

Code of Federal Regulations, 2011 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.329 Newcastle Disease...Disease Vaccine shall be prepared from virus-bearing cell culture fluids or...

2011-01-01

419

9 CFR 113.325 - Avian Encephalomyelitis Vaccine.  

Code of Federal Regulations, 2011 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.325 Avian Encephalomyelitis...Encephalomyelitis Vaccine shall be prepared from virus-bearing tissues or fluids from...

2011-01-01

420

9 CFR 113.310 - Bovine Rhinotracheitis Vaccine.  

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.310 Bovine Rhinotracheitis...Rhinotracheitis Vaccine shall be prepared from virus-bearing cell culture fluids. Only...

2014-01-01

421

9 CFR 113.210 - Feline Calicivirus Vaccine, Killed Virus.  

... Feline Calicivirus Vaccine, Killed Virus. 113.210 Section 113.210 Animals...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Killed Virus Vaccines § 113.210 Feline...

2014-01-01

422

9 CFR 113.316 - Canine Parainfluenza Vaccine.  

Code of Federal Regulations, 2012 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.316 Canine Parainfluenza...Parainfluenza Vaccine shall be prepared from virus-bearing cell culture fluids....

2012-01-01

423

9 CFR 113.317 - Parvovirus Vaccine (Canine).  

Code of Federal Regulations, 2011 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.317 Parvovirus Vaccine...for use in dogs shall be prepared from virus-bearing cell culture fluids....

2011-01-01

424

9 CFR 113.329 - Newcastle Disease Vaccine.  

Code of Federal Regulations, 2013 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.329 Newcastle Disease...Disease Vaccine shall be prepared from virus-bearing cell culture fluids or...

2013-01-01

425

9 CFR 113.325 - Avian Encephalomyelitis Vaccine.  

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.325 Avian Encephalomyelitis...Encephalomyelitis Vaccine shall be prepared from virus-bearing tissues or fluids from...

2014-01-01

426

9 CFR 113.317 - Parvovirus Vaccine (Canine).  

Code of Federal Regulations, 2013 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.317 Parvovirus Vaccine...for use in dogs shall be prepared from virus-bearing cell culture fluids....

2013-01-01

427

9 CFR 113.206 - Wart Vaccine, Killed Virus.  

...2014-01-01 false Wart Vaccine, Killed Virus. 113.206 Section 113.206 Animals...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Killed Virus Vaccines § 113.206 Wart...

2014-01-01

428

9 CFR 113.329 - Newcastle Disease Vaccine.  

Code of Federal Regulations, 2012 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.329 Newcastle Disease...Disease Vaccine shall be prepared from virus-bearing cell culture fluids or...

2012-01-01

429

9 CFR 113.328 - Fowl Laryngotracheitis Vaccine.  

Code of Federal Regulations, 2013 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.328 Fowl Laryngotracheitis...Laryngotracheitis Vaccine shall be prepared from virus-bearing cell culture fluids or...

2013-01-01

430

9 CFR 113.308 - Encephalomyelitis Vaccine, Venezuelan.  

Code of Federal Regulations, 2010 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.308 Encephalomyelitis...Vaccine, Venezuelan, shall be prepared from virus-bearing cell culture fluids....

2010-01-01

431

9 CFR 113.213 - Pseudorabies Vaccine, Killed Virus.  

... false Pseudorabies Vaccine, Killed Virus. 113.213 Section 113.213 Animals...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Killed Virus Vaccines § 113.213...

2014-01-01

432

9 CFR 113.309 - Bovine Parainfluenza3 Vaccine.  

Code of Federal Regulations, 2011 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.309 Bovine Parainfluenza3...Parainfluenza3 Vaccine shall be produced from virus-bearing cell culture fluids. Only...

2011-01-01

433

9 CFR 113.308 - Encephalomyelitis Vaccine, Venezuelan.  

Code of Federal Regulations, 2011 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.308 Encephalomyelitis...Vaccine, Venezuelan, shall be prepared from virus-bearing cell culture fluids....

2011-01-01

434

9 CFR 113.311 - Bovine Virus Diarrhea Vaccine.  

Code of Federal Regulations, 2012 CFR

...2012-01-01 2012-01-01 false Bovine Virus Diarrhea Vaccine. 113.311 Section...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.311 Bovine...

2012-01-01

435

9 CFR 113.314 - Feline Calicivirus Vaccine.  

Code of Federal Regulations, 2010 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.314 Feline Calicivirus...Calicivirus Vaccine shall be prepared from virus-bearing cell culture fluids. Only...

2010-01-01

436

9 CFR 113.210 - Feline Calicivirus Vaccine, Killed Virus.  

Code of Federal Regulations, 2012 CFR

... Feline Calicivirus Vaccine, Killed Virus. 113.210 Section 113.210 Animals...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Killed Virus Vaccines § 113.210 Feline...

2012-01-01

437

9 CFR 113.208 - Avian Encephalomyelitis Vaccine, Killed Virus.  

Code of Federal Regulations, 2011 CFR

...Avian Encephalomyelitis Vaccine, Killed Virus. 113.208 Section 113.208 Animals...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Killed Virus Vaccines § 113.208 Avian...

2011-01-01

438

9 CFR 113.214 - Parvovirus Vaccine, Killed Virus (Canine).  

... false Parvovirus Vaccine, Killed Virus (Canine). 113.214 Section 113...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Killed Virus Vaccines § 113.214 Parvovirus...

2014-01-01

439

9 CFR 113.329 - Newcastle Disease Vaccine.  

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.329 Newcastle Disease...Disease Vaccine shall be prepared from virus-bearing cell culture fluids or...

2014-01-01

440

9 CFR 113.208 - Avian Encephalomyelitis Vaccine, Killed Virus.  

Code of Federal Regulations, 2012 CFR

...Avian Encephalomyelitis Vaccine, Killed Virus. 113.208 Section 113.208 Animals...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Killed Virus Vaccines § 113.208 Avian...

2012-01-01

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