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1

Biologic Vaccines  

PubMed Central

The threat of new disease pandemics has spurred the development of biologic vaccines, which promise tremendous improvements in global and local health. Several lend themselves to the prevention or treatment of chronic diseases. But the uncertainties of whom to vaccinate raise the question of whether the health care system can make these promising products viable. PMID:22478749

ADAMS, KATHERINE T.

2009-01-01

2

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

Federal Register 2010, 2011, 2012, 2013, 2014

...HEALTH AND HUMAN SERVICES Food and Drug Administration...Vaccines and Related Biological Products Advisory Committee...Amendment of Notice AGENCY: Food and Drug Administration...The Food and Drug Administration...Vaccines and Related Biological Products Advisory...

2011-08-23

3

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

Federal Register 2010, 2011, 2012, 2013, 2014

...HEALTH AND HUMAN SERVICES Food and Drug Administration...Vaccines and Related Biological Products Advisory Committee...Notice of Meeting AGENCY: Food and Drug Administration...advisory committee of the Food and Drug Administration...Vaccines and Related Biological Products Advisory...

2010-01-19

4

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

Federal Register 2010, 2011, 2012, 2013, 2014

...HEALTH AND HUMAN SERVICES Food and Drug Administration...Vaccines and Related Biological Products Advisory Committee...Notice of Meeting AGENCY: Food and Drug Administration...advisory committee of the Food and Drug Administration...Vaccines and Related Biological Products Advisory...

2010-09-28

5

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

Federal Register 2010, 2011, 2012, 2013, 2014

...HEALTH AND HUMAN SERVICES Food and Drug Administration...Vaccines and Related Biological Products Advisory Committee...Notice of Meeting AGENCY: Food and Drug Administration...advisory committee of the Food and Drug Administration...Vaccines and Related Biological Products Advisory...

2011-09-07

6

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

Federal Register 2010, 2011, 2012, 2013, 2014

...HEALTH AND HUMAN SERVICES Food and Drug Administration...Vaccines and Related Biological Products Advisory Committee...Notice of Meeting AGENCY: Food and Drug Administration...advisory committee of the Food and Drug Administration...Vaccines and Related Biological Products Advisory...

2012-10-17

7

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

Federal Register 2010, 2011, 2012, 2013, 2014

...HEALTH AND HUMAN SERVICES Food and Drug Administration...Vaccines and Related Biological Products Advisory Committee...Notice of Meeting AGENCY: Food and Drug Administration...advisory committee of the Food and Drug Administration...Vaccines and Related Biological Products Advisory...

2011-03-14

8

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

Federal Register 2010, 2011, 2012, 2013, 2014

...HEALTH AND HUMAN SERVICES Food and Drug Administration...Vaccines and Related Biological Products Advisory Committee...Notice of Meeting AGENCY: Food and Drug Administration...advisory committee of the Food and Drug Administration...Vaccines and Related Biological Products Advisory...

2011-07-22

9

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

Federal Register 2010, 2011, 2012, 2013, 2014

...HEALTH AND HUMAN SERVICES Food and Drug Administration...Vaccines and Related Biological Products Advisory Committee...Notice of Meeting AGENCY: Food and Drug Administration...advisory committee of the Food and Drug Administration...Vaccines and Related Biological Products Advisory...

2013-01-25

10

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

Federal Register 2010, 2011, 2012, 2013, 2014

...HEALTH AND HUMAN SERVICES Food and Drug Administration...Vaccines and Related Biological Products Advisory Committee...Notice of Meeting AGENCY: Food and Drug Administration...advisory committee of the Food and Drug Administration...Vaccines and Related Biological Products Advisory...

2013-04-05

11

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

Federal Register 2010, 2011, 2012, 2013, 2014

...HEALTH AND HUMAN SERVICES Food and Drug Administration...Vaccines and Related Biological Products Advisory Committee...Notice of Meeting AGENCY: Food and Drug Administration...advisory committee of the Food and Drug Administration...Vaccines and Related Biological Products Advisory...

2012-01-25

12

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

Federal Register 2010, 2011, 2012, 2013, 2014

...HEALTH AND HUMAN SERVICES Food and Drug Administration...Vaccines and Related Biological Products Advisory Committee...Notice of Meeting AGENCY: Food and Drug Administration...advisory committee of the Food and Drug Administration...Vaccines and Related Biological Products Advisory...

2010-08-06

13

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

Federal Register 2010, 2011, 2012, 2013, 2014

...HEALTH AND HUMAN SERVICES Food and Drug Administration...Vaccines and Related Biological Products Advisory Committee...Notice of Meeting AGENCY: Food and Drug Administration...advisory committee of the Food and Drug Administration...Vaccines and Related Biological Products Advisory...

2011-01-20

14

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

Federal Register 2010, 2011, 2012, 2013, 2014

...HEALTH AND HUMAN SERVICES Food and Drug Administration...Vaccines and Related Biological Products Advisory Committee...Notice of Meeting AGENCY: Food and Drug Administration...advisory committee of the Food and Drug Administration...Vaccines and Related Biological Products Advisory...

2013-10-02

15

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

Federal Register 2010, 2011, 2012, 2013, 2014

...HEALTH AND HUMAN SERVICES Food and Drug Administration...Vaccines and Related Biological Products Advisory Committee...Notice of Meeting AGENCY: Food and Drug Administration...advisory committee of the Food and Drug Administration...Vaccines and Related Biological Products Advisory...

2012-07-18

16

Evaluation of growth based rapid microbiological methods for sterility testing of vaccines and other biological products.  

PubMed

Most biological products, including vaccines, administered by the parenteral route are required to be tested for sterility at the final container and also at various stages during manufacture. The sterility testing method described in the Code of Federal Regulations (21 CFR 610.12) and the United States Pharmacopoeia (USP, Chapter <71>) is based on the observation of turbidity in liquid culture media due to growth of potential contaminants. We evaluated rapid microbiological methods (RMM) based on detection of growth 1) by adenosine triphosphate (ATP) bioluminescence technology (Rapid Milliflex(®) Detection System [RMDS]), and 2) by CO(2) monitoring technologies (BacT/Alert and the BACTEC systems), as alternate sterility methods. Microorganisms representing Gram negative, Gram positive, aerobic, anaerobic, spore forming, slow growing bacteria, yeast, and fungi were prepared in aliquots of Fluid A or a biological matrix (including inactivated influenza vaccines) to contain approximately 0.1, 1, 10 and 100 colony forming units (CFU) in an inoculum of 10 ml. These preparations were inoculated to the specific media required for the various methods: 1) fluid thioglycollate medium (FTM) and tryptic soy broth (TSB) of the compendial sterility method (both membrane filtration and direct inoculation); 2) tryptic soy agar (TSA), Sabouraud dextrose agar (SDA) and Schaedler blood agar (SBA) of the RMDS; 3) iAST and iNST media of the BacT/Alert system and 4) Standard 10 Aerobic/F and Standard Anaerobic/F media of the BACTEC system. RMDS was significantly more sensitive in detecting various microorganisms at 0.1CFU than the compendial methods (p<0.05), whereas the compendial membrane filtration method was significantly more sensitive than the BACTEC and BacT/Alert methods (p<0.05). RMDS detected all microorganisms significantly faster than the compendial method (p<0.05). BacT/Alert and BACTEC methods detected most microorganisms significantly faster than the compendial method (p<0.05), but took almost the same time to detect the slow growing microorganism P. acnes, compared to the compendial method. RMDS using SBA detected all test microorganisms in the presence of a matrix containing preservative 0.01% thimerosal, whereas the BacT/Alert and BACTEC systems did not consistently detect all the test microorganisms in the presence of 0.01% thimerosal. RMDS was compatible with inactivated influenza vaccines and aluminum phosphate or aluminum hydroxide adjuvants at up to 8 mg/ml without any interference in bioluminescence. RMDS was shown to be acceptable as an alternate sterility method taking 5 days as compared to the 14 days required of the compendial method. Isolation of microorganisms from the RMDS was accomplished by re-incubation of membranes with fresh SBA medium and microbial identification was confirmed using the MicroSEQ Identification System. BacT/Alert and BACTEC systems may be applicable as alternate methods to the compendial direct inoculation sterility method for products that do not contain preservatives or anti-microbial agents. PMID:21871516

Parveen, Seema; Kaur, Simleen; David, Selwyn A Wilson; Kenney, James L; McCormick, William M; Gupta, Rajesh K

2011-10-19

17

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

Federal Register 2010, 2011, 2012, 2013, 2014

...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

18

Rapid production of synthetic influenza vaccines.  

PubMed

The strain composition of influenza vaccines must be changed regularly to track influenza virus antigenic evolution. During outbreaks with pandemic potential, strain changes are urgent. The systems for accomplishing vaccine strain changes have required the shipment of viruses and other biological materials around the globe, with delays in vaccine availability, and have used legacy techniques of egg-based virus cultivation, resulting in vaccine mismatches. In collaboration with Synthetic Genomics Vaccines Inc. and the US Biomedical Advanced Research and Development Authority, Novartis has developed a synthetic approach to influenza vaccine virus generation. Synthetic influenza vaccine viruses and mammalian cell culture technology promise influenza vaccines that match circulating influenza strains more closely and are delivered in greater quantities, more rapidly than vaccines produced by conventional technologies. These new technologies could yield an improved influenza vaccine response system in which viral sequence data from many sources are posted on the Internet, are downloaded by vaccine manufacturers, and are used to rescue multiple, attenuated vaccine viruses directly on high yielding backbones. Elements of this system were deployed in the response to the 2013 H7N9 influenza outbreak in China. The result was the production, clinical testing, and stockpiling of an H7N9 vaccine before the second wave of the outbreak struck at the end of 2013. Future directions in synthetic influenza vaccine technology include the automation of influenza virus rescue from sequence data and the merger of synthetic and self-amplifying mRNA vaccine technologies. The result could be a more robust and effective influenza vaccine system. PMID:24996863

Dormitzer, Philip R

2015-01-01

19

Conjugate Meningococcal Vaccines Development: GSK Biologicals Experience  

PubMed Central

Meningococcal diseases are serious threats to global health, and new vaccines specifically tailored to meet the age-related needs of various geographical areas are required. This paper focuses on the meningococcal conjugate vaccines developed by GSK Biologicals. Two combined conjugate vaccines were developed to help protect infants and young children in countries where the incidence of meningococcal serogroup C or serogroup C and Y disease is important: Hib-MenC-TT vaccine, which offers protection against Haemophilus influenzae type b and Neisseria meningitidis serogroup C diseases, is approved in several countries; and Hib-MenCY-TT vaccine, which adds N. meningitidis serogroup Y antigen, is currently in the final stages of development. Additionally, a tetravalent conjugate vaccine (MenACWY-TT) designed to help protect against four meningococcal serogroups is presently being evaluated for global use in all age groups. All of these vaccines were shown to be highly immunogenic and to have clinically acceptable safety profiles. PMID:21991444

Miller, Jacqueline M.; Mesaros, Narcisa; Van Der Wielen, Marie; Baine, Yaela

2011-01-01

20

Systems Biology Approaches to New Vaccine Development  

PubMed Central

Summary The current “isolate, inactivate, inject” vaccine development strategy has served the field of vaccinology well, and such empirical vaccine candidate development has even led to the eradication of smallpox. However, such an approach suffers from limitations, and as an empirical approach, does not fully utilize our knowledge of immunology and genetics. A more complete understanding of the biological processes culminating in disease resistance is needed. The advent of high-dimensional assay technology and “systems biology” along with a vaccinomics approach [1;2] is spawning a new era in the science of vaccine development. Here we review recent developments in systems biology and strategies for applying this approach and its resulting data to expand our knowledge base and drive directed development of new vaccines. We also provide applied examples and point out new directions for the field in order to illustrate the power of systems biology. PMID:21570272

Oberg, Ann L.; Kennedy, Richard B.; Li, Peter; Ovsyannikova, Inna G.; Poland, Gregory A.

2011-01-01

21

Report on Biological Warfare Defense Vaccine Research & Development Programs  

NSDL National Science Digital Library

This 190-page .pdf document, dated July 2001 but released online September 7, 2001 by the US Department of Defense (DoD), gives the latest status of biological warfare defense vaccine development. The DoD assembled a panel of experts in the scientific, regulatory, and industrial aspects of vaccine production and in federal procurement to review the topic. They concluded that the scope and complexity of the DoD biological warfare defense vaccine requirements were too great for either the DoD or the pharmaceutical industry to accomplish alone. The first part of this online report is an executive summary from the DoD, followed by the Floyd D. Spence National Defense Authorization Act For Fiscal Year 2001, and finally the independent panel's full report, Department of Defense Acquisition of Vaccine Production, of December 2000. Sections of the dense, 167-page report include financial and personnel resource requirements, policies, findings, and recommendations.

2001-01-01

22

Food and Drug Administration (FDA) Vaccines, Blood & Biologics  

NSDL National Science Digital Library

On this site, visitors can learn about the regulations and standards for Vaccines, Blood & Biologics. The site is divided up into a number of broad areas, including Allergenics, Cellular and Gene Therapy Products, Tissue and TIssue Products, and Xenotransplantation. The right side of the page also presents handy current issues, including recalls and alerts, and approvals and clearances.

2013-07-04

23

Evaluation of some selected vaccines and other biological products irradiated by gamma rays, electron beams and X-rays  

NASA Astrophysics Data System (ADS)

Molecular sizing potency results are presented for irradiated samples of one lot of Haemophilus b conjugate vaccine, pneumococcal polysaccharide type 6B and typhoid vi polysaccharide vaccine. The samples were irradiated (25 kGy) by gamma rays, electron beams and X-rays. IgG and IgM antibody response in mice test results (ELISA) are given for the Hib conjugate vaccine irradiated at 0°C or frozen in liquid nitrogen.

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

2002-03-01

24

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

25

Field vaccination of cattle using a bivalent modified-live vaccine against bluetongue virus serotypes 2 and 9: effect on milk production  

Microsoft Academic Search

Summary To evaluate the effect of bluetongue (BT) vaccination on milk production in cattle, 30 cows at various stages of gestation were vaccinated using a bivalent bluetongue virus serotype 2 (BTV-2) and BTV-9 modified-live vaccine produced by Onderstepoort Biological Products in South Africa. A second group of 30 pregnant cows was used unvaccinated controls. Blood samples were taken from all

F. Monaco; N. De Luca; D. Morelli; M. Pisciella; S. Palmarini; M. Di Giandomenico; G. Savini

26

Synthetic biology devices and circuits for RNA-based 'smart vaccines': a propositional review.  

PubMed

Nucleic acid vaccines have been gaining attention as an alternative to the standard attenuated pathogen or protein based vaccine. However, an unrealized advantage of using such DNA or RNA based vaccination modalities is the ability to program within these nucleic acids regulatory devices that would provide an immunologist with the power to control the production of antigens and adjuvants in a desirable manner by administering small molecule drugs as chemical triggers. Advances in synthetic biology have resulted in the creation of highly predictable and modular genetic parts and devices that can be composed into synthetic gene circuits with complex behaviors. With the recent advent of modified RNA gene delivery methods and developments in the RNA replicon platform, we foresee a future in which mammalian synthetic biologists will create genetic circuits encoded exclusively on RNA. Here, we review the current repertoire of devices used in RNA synthetic biology and propose how programmable 'smart vaccines' will revolutionize the field of RNA vaccination. PMID:25566800

Andries, Oliwia; Kitada, Tasuku; Bodner, Katie; Sanders, Niek N; Weiss, Ron

2015-02-01

27

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

2014-01-01

28

Production of glycoprotein vaccines in Escherichia coli  

PubMed Central

Background Conjugate vaccines in which polysaccharide antigens are covalently linked to carrier proteins belong to the most effective and safest vaccines against bacterial pathogens. State-of-the art production of conjugate vaccines using chemical methods is a laborious, multi-step process. In vivo enzymatic coupling using the general glycosylation pathway of Campylobacter jejuni in recombinant Escherichia coli has been suggested as a simpler method for producing conjugate vaccines. In this study we describe the in vivo biosynthesis of two novel conjugate vaccine candidates against Shigella dysenteriae type 1, an important bacterial pathogen causing severe gastro-intestinal disease states mainly in developing countries. Results Two different periplasmic carrier proteins, AcrA from C. jejuni and a toxoid form of Pseudomonas aeruginosa exotoxin were glycosylated with Shigella O antigens in E. coli. Starting from shake flask cultivation in standard complex medium a lab-scale fed-batch process was developed for glycoconjugate production. It was found that efficiency of glycosylation but not carrier protein expression was highly susceptible to the physiological state at induction. After induction glycoconjugates generally appeared later than unglycosylated carrier protein, suggesting that glycosylation was the rate-limiting step for synthesis of conjugate vaccines in E. coli. Glycoconjugate synthesis, in particular expression of oligosaccharyltransferase PglB, strongly inhibited growth of E. coli cells after induction, making it necessary to separate biomass growth and recombinant protein expression phases. With a simple pulse and linear feed strategy and the use of semi-defined glycerol medium, volumetric glycoconjugate yield was increased 30 to 50-fold. Conclusions The presented data demonstrate that glycosylated proteins can be produced in recombinant E. coli at a larger scale. The described methodologies constitute an important step towards cost-effective in vivo production of conjugate vaccines, which in future may be used for combating severe infectious diseases, particularly in developing countries. PMID:20701771

2010-01-01

29

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

E-print Network

Journal of Theoretical Biology 224 (2003) 269­275 Estimation of effective vaccination rate vaccination is unreliable. For example vaccination against pertussis has comparatively high level of primary and secondary failures. To evaluate efficiency of vaccination we introduce the idea of effective vaccination

Maini, Philip K.

30

Transgenic plants as vaccine production systems  

Microsoft Academic Search

Transgenic plants that express foreign proteins with industrial or pharmaceutical value represent an economical alternative to fermentation-based production systems. Specific vaccines have been produced in plants as a result of the transient or stable expression of foreign genes. It has recently been shown that genes encoding antigens of bacterial and viral pathogens can be expressed in plants in a form

Hugh S. Mason; Charles J. Arntzen

1995-01-01

31

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 ...

32

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."

33

Adjuvant solution for pandemic influenza vaccine production  

PubMed Central

Extensive preparation is underway to mitigate the next pandemic influenza outbreak. New vaccine technologies intended to supplant egg-based production methods are being developed, with recombinant hemagglutinin (rHA) as the most advanced program for preventing seasonal and avian H5N1 Influenza. Increased efforts are being focused on adjuvants that can broaden vaccine immunogenicity against emerging viruses and maximize vaccine supply on a worldwide scale. Here, we test protection against avian flu by using H5N1-derived rHA and GLA-SE, a two-part adjuvant system containing glucopyranosyl lipid adjuvant (GLA), a formulated synthetic Toll-like receptor 4 agonist, and a stable emulsion (SE) of oil in water, which is similar to the best-in-class adjuvants being developed for pandemic flu. Notably, a single submicrogram dose of rH5 adjuvanted with GLA-SE protects mice and ferrets against a high titer challenge with H5N1 virus. GLA-SE, relative to emulsion alone, accelerated induction of the primary immune response and broadened its durability against heterosubtypic H5N1 virus challenge. Mechanistically, GLA-SE augments protection via induction of a Th1-mediated antibody response. Innate signaling pathways that amplify priming of Th1 CD4 T cells will likely improve vaccine performance against future outbreaks of lethal pandemic flu. PMID:23045649

Clegg, Christopher H.; Roque, Richard; Van Hoeven, Neal; Perrone, Lucy; Baldwin, Susan L.; Rininger, Joseph A.; Bowen, Richard A.; Reed, Steven G.

2012-01-01

34

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

35

Foods as Production and Delivery Vehicles for Human Vaccines  

E-print Network

genetically engineered plants for the production of immunogenic peptides also provides a new approach such that the plant is capable of producing the desired immunogenic protein subunit vaccines. · The productionReview Foods as Production and Delivery Vehicles for Human Vaccines Schuyler S. Korban, PhD, Sergei

Korban, Schuyler S.

36

Evolution of M. bovis BCG Vaccine: Is Niacin Production Still a Valid Biomarker?  

PubMed Central

BCG vaccine is usually considered to be safe though rarely serious complications have also been reported, often incriminating contamination of the seed strain with pathogenic Mycobacterium tuberculosis. In such circumstances, it becomes prudent to rule out the contamination of the vaccine seed. M. bovis BCG can be confirmed by the absence of nitrate reductase, negative niacin test, and resistance to pyrazinamide and cycloserine. Recently in India, some stocks were found to be niacin positive which led to a national controversy and closer of a vaccine production plant. This prompted us to write this review and the comparative biochemical and genotypic studies were carried out on the these contentious vaccine stocks at the Indian vaccine plant and other seeds and it was found that some BCG vaccine strains and even some strains of M. bovis with eugenic-growth characteristics mainly old laboratory strains may give a positive niacin reaction. Most probably, the repeated subcultures lead to undefined changes at the genetic level in these seed strains. These changing biological characteristics envisage reevaluation of biochemical characters of existing BCG vaccine seeds and framing of newer guidelines for manufacturing, production, safety, and effectiveness of BCG vaccine. PMID:25694828

Singh, Sarman; Singh, Pragati

2015-01-01

37

Automated production of plant-based vaccines and pharmaceuticals.  

PubMed

A fully automated "factory" was developed that uses tobacco plants to produce large quantities of vaccines and other therapeutic biologics within weeks. This first-of-a-kind factory takes advantage of a plant viral vector technology to produce specific proteins within the leaves of rapidly growing plant biomass. The factory's custom-designed robotic machines plant seeds, nurture the growing plants, introduce a viral vector that directs the plant to produce a target protein, and harvest the biomass once the target protein has accumulated in the plants-all in compliance with Food and Drug Administration (FDA) guidelines (e.g., current Good Manufacturing Practices). The factory was designed to be time, cost, and space efficient. The plants are grown in custom multiplant trays. Robots ride up and down a track, servicing the plants and delivering the trays from the lighted, irrigated growth modules to each processing station as needed. Using preprogrammed robots and processing equipment eliminates the need for human contact, preventing potential contamination of the process and economizing the operation. To quickly produce large quantities of protein-based medicines, we transformed a laboratory-based biological process and scaled it into an industrial process. This enables quick, safe, and cost-effective vaccine production that would be required in case of a pandemic. PMID:23015521

Wirz, Holger; Sauer-Budge, Alexis F; Briggs, John; Sharpe, Aaron; Shu, Sudong; Sharon, Andre

2012-12-01

38

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

39

Overview of measles and mumps vaccine: origin, present, and future of vaccine production.  

PubMed

Measles and mumps are common viral childhood diseases that can cause serious complications. Vaccination remains the most efficient way to control the spread of these viruses. The manufacturing capability for viral vaccines produced in embryonated hen eggs and conventional/classical cell substrates, such as chicken embryo fibroblast or primary dog kidney cell substrates, is no longer sufficient. This limitation can be overcome by utilizing other recognized cell substrates such as Madin Darby Canine Kidney (MDCK), Chinese Hamster Ovary (CHO), Vero (monkey origin) cells, MRC-5 (human diploid) or as an alternative, introducing new cell substrates of human or avian origin. A very important factor in vaccine production is the safety and immunogenicity of the final vaccine, where the proper choice of cell substrate used for virus propagation is made. All substrates used in vaccine production must be fully characterized to avoid the contamination of hidden unknown pathogens which is difficult to achieve in primary cell substrates. PMID:23600866

Betáková, T; Svetlíková, D; Gocník, M

2013-01-01

40

Regulation of biologic oncology products in the FDA?s Center for Biologics Evaluation and Research.  

PubMed

In the United States, cancer vaccines and immunotherapies, including cell and gene therapies and peptides and proteins used as therapeutic vaccines, are regulated by the Food and Drug Administration's Center for Biologics Evaluation and Research in the Office of Cellular, Tissue, and Gene Therapies (OCTGT). Center for Biologics Evaluation and Research has licensed two immunotherapy products for urologic indications: bacillus Calmette-Guérin for superficial bladder cancer and sipuleucel-T for advanced prostate cancer. OCTGT places a high priority on scientific and regulatory activities that promote the development of safe and effective cancer therapy products. OCTGT has published guidance documents and developed innovative tools that are designed to aid the rapid development of biologic products for patient use. The success of immunotherapeutic products for urologic malignancies stands as an example for ongoing and future therapeutic research and discovery. PMID:25441459

Bross, Peter F; Fan, Chaohong; George, Bindu; Shannon, Kevin; Joshi, Bharat H; Puri, Raj K

2014-10-30

41

Systems biology applied to vaccine and immunotherapy development  

PubMed Central

Immunotherapies, including vaccines, represent a potent tool to prevent or contain disease with high morbidity or mortality such as infections and cancer. However, despite their widespread use, we still have a limited understanding of the mechanisms underlying the induction of protective immune responses. Immunity is made of a multifaceted set of integrated responses involving a dynamic interaction of thousands of molecules; among those is a growing appreciation for the role the innate immunity (i.e. pathogen recognition receptors - PRRs) plays in determining the nature and duration (immune memory) of adaptive T and B cell immunity. The complex network of interactions between immune manipulation of the host (immunotherapy) on one side and innate and adaptive responses on the other might be fully understood only employing the global level of investigation provided by systems biology. In this framework, the advancement of high-throughput technologies, together with the extensive identification of new genes, proteins and other biomolecules in the "omics" era, facilitate large-scale biological measurements. Moreover, recent development of new computational tools enables the comprehensive and quantitative analysis of the interactions between all of the components of immunity over time. Here, we review recent progress in using systems biology to study and evaluate immunotherapy and vaccine strategies for infectious and neoplastic diseases. Multi-parametric data provide novel and often unsuspected mechanistic insights while enabling the identification of common immune signatures relevant to human investigation such as the prediction of immune responsiveness that could lead to the improvement of the design of future immunotherapy trials. Thus, the paradigm switch from "empirical" to "knowledge-based" conduct of medicine and immunotherapy in particular, leading to patient-tailored treatment. PMID:21933421

2011-01-01

42

A Synthetic Biology Approach for a Vaccine Platform against Known and Newly Emerging Serotypes of Bluetongue Virus  

PubMed Central

ABSTRACT Bluetongue is one of the major infectious diseases of ruminants and is caused by bluetongue virus (BTV), an arbovirus existing in nature in at least 26 distinct serotypes. Here, we describe the development of a vaccine platform for BTV. The advent of synthetic biology approaches and the development of reverse genetics systems has allowed the rapid and reliable design and production of pathogen genomes which can be subsequently manipulated for vaccine production. We describe BTV vaccines based on “synthetic” viruses in which the outer core proteins of different BTV serotypes are incorporated into a common tissue-culture-adapted backbone. As a means of validation for this approach, we selected two BTV-8 synthetic reassortants and demonstrated their ability to protect sheep against virulent BTV-8 challenge. In addition to further highlight the possibilities of genome manipulation for vaccine production, we also designed and rescued a synthetic BTV chimera containing a VP2 protein, including regions derived from both BTV-1 and BTV-8. Interestingly, while the parental viruses were neutralized only by homologous antisera, the chimeric proteins could be neutralized by both BTV-1 and BTV-8 antisera. These data suggest that neutralizing epitopes are present in different areas of the BTV VP2 and likely “bivalent” strains eliciting neutralizing antibodies for multiple strains can be obtained. IMPORTANCE Overall, this vaccine platform can significantly reduce the time taken from the identification of new BTV strains to the development and production of new vaccines, since the viral genomes of these viruses can be entirely synthesized in vitro. In addition, these vaccines can be brought quickly into the market because they alter the approach, but not the final product, of existing commercial products. PMID:25142610

Nunes, Sandro Filipe; Hamers, Claude; Ratinier, Maxime; Shaw, Andrew; Brunet, Sylvie; Hudelet, Pascal

2014-01-01

43

[Biological properties of a ribosomal vaccine from S. sonnei obtained by polyethylene glycol fractionation].  

PubMed

Shigella ribosomal vaccine was prepared by fractionation with polyethylene glycol (PEG), recently proposed as an alternative of the more expensive and labor-consuming technique of differential centrifugation. In the present investigation the biological activity of ribosomal preparations isolated by these two methods was compared. Ribosomal vaccine obtained by PEG fractionation proved to be nontoxic for mice (LD50 greater than 2 mg) and produced no local and systemic reactions in monkeys when introduced subcutaneously in a dose of 600 micrograms. Ribosomes isolated by the two methods did not differ in the antigenic potency of their O-specific component responsible for inducing antibody formation in guinea pigs and monkeys. The protective potency of Shigella ribosomal vaccines prepared by PEG fractionation and ultracentrifugation was compared by tests in guinea pigs under the conditions of intraconjunctival challenge 2 weeks after a single injection of 40-200 micrograms of ribosomes. The mean resistance rate (percentage of protected eyes) was almost the same with both preparations, 67% and 65%, while in the control (nonimmunized) group only 13% of eyes were resistant to challenge. In monkey tests two injections of ribosomal vaccine obtained by PEG fractionation ensured a high protective effect against dysentery. No clinical signs of dysentery were observed in two groups of the test animals (totaling 10 monkeys) immunized 5 and 16 weeks before oral challenge with a dose of 75 X 10(9) virulent shigellae, which caused dysentery of moderate severity in all 5 control monkeys. The low toxicity and high protective potency of ribosomes isolated from S. sonnei by PEG fractionation makes it possible to use this method for the large-scale production of ribosomal vaccine. PMID:6395593

Levenson, V I; Rukhadze, E Z; Fedosova, V G; Dzhikidze, E K; Stasilevich, Z K

1984-11-01

44

Identifying Recalled Products  

MedlinePLUS Videos and Cool Tools

... search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics ... Cosmetics Dietary Supplements Drugs Food Medical Devices Nutrition Radiation-Emitting Products Tobacco Products Vaccines, Blood & Biologics Articulos ...

45

IRRIGATION FOR VACCINE PRODUCTION IN PHARMACEUTICAL TOBACCO  

Technology Transfer Automated Retrieval System (TEKTRAN)

Biotechnology companies in North America and Europe have engineered plants to produce recombinant proteins for therapeutic drugs and vaccines. Chlorogen, Inc. located in St. Louis, Missouri, inserted the protective antigen (PA) gene from Bacillus anthracis into tobacco (Nicotiana tabacum cv LAMD 60...

46

Biological and phylogenetic characterization of a genotype VII Newcastle disease virus from Venezuela: Efficacy of vaccination  

Technology Transfer Automated Retrieval System (TEKTRAN)

Here we describe the characterization a virulent genotype VII Newcastle disease virus (NDV) from Venezuela and evaluate the efficacy of heterologous genotype commercial vaccination under field and controlled rearing conditions. Biological pathotyping and molecular analysis were applied. Results sh...

47

Antigenicity of Streptococcus agalactiae extracellular products and vaccine efficacy.  

PubMed

Streptococcus agalactiae is a major bacterial pathogen that is the cause of serious economic losses in many species of freshwater, marine and estuarine fish worldwide. A highly efficacious S. agalactiae vaccine was developed using extracellular products (ECP) and formalin-killed whole cells of S. agalactiae. The vaccine efficacy following storage of S. agalactiae ECP and formalin-killed S. agalactiae cells at 4 degrees C for 1 year was determined. The stored ECP containing S. agalactiae formalin-killed cells failed to prevent morbidity and mortality among the vaccinated fish, and the relative percentage survival was 29. Serum antibody responses of the stored ECP and freshly prepared ECP against soluble whole cell extract of S. agalactiae indicated that significantly less antibody was produced in fish immunized with stored ECP and S. agalactiae cells than in those fish immunized with freshly prepared ECP and S. agalactiae cells at day 31 post-vaccination. Silver staining of sodium dodecyl sulphate-polyacrylamide gels and immunostaining of Western blots with tilapia antiserum to S. agalactiae revealed that predominant 54 and 55 kDa bands were present in the freshly prepared ECP fraction. The 55 kDa band was absent from the stored ECP and new bands below 54 kDa appeared on the Western blot. The results of this study on S. agalactiae ECP provide evidence for a correlation between protection and antibody production to ECP and for the importance of the 55 kDa ECP antigen for vaccine efficacy. PMID:15813862

Pasnik, D J; Evans, J J; Panangala, V S; Klesius, P H; Shelby, R A; Shoemaker, C A

2005-04-01

48

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

49

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

50

9 CFR 114.18 - Reprocessing of biological products.  

Code of Federal Regulations, 2010 CFR

...false Reprocessing of biological products. 114.18...SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS...PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS § 114.18 Reprocessing of biological products. The...

2010-01-01

51

Enhancing the Role of Veterinary Vaccines Reducing Zoonotic Diseases of Humans: Linking Systems Biology with Vaccine Development  

PubMed Central

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 and Ficht (Adams et al. 2009; Ficht et al. 2009). 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. PMID:21651944

Adams, L. Garry; 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.

2011-01-01

52

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

53

Establishment of a biological reference preparation for hepatitis A vaccine (inactivated, non-adsorbed).  

PubMed

A reference standard calibrated in International Units (IU) is needed for the in vitro potency assay of hepatitis A vaccines prepared by formalin-inactivation of purified hepatitis A virus grown in cell cultures. Thus, a project was launched by the European Directorate for the Quality of Medicines & HealthCare (EDQM) to establish one or more non-adsorbed inactivated hepatitis A vaccine reference preparation(s) as working standard(s), calibrated against the 1st International Standard (IS), for the in vitro potency assay (ELISA) of all vaccines present on the European market. Four non-adsorbed liquid preparations of formalin-inactivated hepatitis A antigen with a known antigen content were obtained from 3 manufacturers as candidate Biological Reference Preparations (BRPs). Thirteen laboratories participated in the collaborative study. They were asked to use an in vitro ELISA method adapted from a commercially available kit for the detection of antibodies to hepatitis A virus. In-house validated assays were to be run in parallel, where available. Some participants also included commercially available hepatitis A vaccines in the assays, after appropriate desorption. During the collaborative study, several participants using the standard method were faced with problems with some of the most recent lots of the test kits. Due to these problems, the standard method did not perform satisfactorily and a high number of assays were invalid, whereas the in-house methods appeared to perform better. Despite this, the overall mean results of the valid assays using both methods were in agreement. Nonetheless, it was decided to base the assignment of the potency values on the in-house methods only. The results showed that all candidate BRPs were suitable for the intended purpose. However, based on availability of the material and on the results of end-product testing, 2 candidate reference preparations, Samples C and D, were selected. Both were from the same batch but filled on different days; no statistically significant difference in potency was observed. They were thus combined in 1 single batch. The candidate preparation (Sample C/D) was adopted at the June 2009 session of the European Pharmacopoeia (Ph. Eur.) Commission as the Ph. Eur. BRP batch 1 for hepatitis A vaccine (inactivated, non-adsorbed), with an assigned potency of 12 IU/ml for in vitro antigen content assays. Accelerated degradation studies have been initiated. The preliminary data show that the BRP is stable at the recommended storage temperature (< -50 degrees C). The BRP will be monitored at regular intervals throughout its lifetime. PMID:20223187

Stalder, J; Costanzo, A; Daas, A; Rautmann, G; Buchheit, K-H

2010-04-01

54

Vaccines  

MedlinePLUS Videos and Cool Tools

Vaccinations are injections of antigens into the body. Once the antigens enter the blood, they circulate along ... suppressor T cells stop the attack. After a vaccination, the body will have a memory of an ...

55

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

56

9 CFR 113.50 - Ingredients of biological products.  

Code of Federal Regulations, 2010 CFR

...false Ingredients of biological products. 113.50...SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS...50 Ingredients of biological products. All ingredients used in a licensed biological product...

2010-01-01

57

Transgenic crops for the production of recombinant vaccines and anti-microbial antibodies.  

PubMed

Plants can be used to produce inexpensive and highly immunogenic vaccines, particularly those aimed against mucosal pathogens. Several plant-derived vaccines have already completed early-phase clinical trials and many more are in the pipeline. The number of products in development has increased as the production technology itself has evolved, reflecting a better understanding of plant molecular biology, more sophisticated genetic engineering techniques, and more recently the development of tools and strategies to increase yields and engineer specific glycan groups on plant-derived glycoproteins. There are many different platforms including whole-plant transient expression systems based on Agrobacterium and/or plant viruses, contained systems based on cultured plant cells or aquatic plants, and stable transgenic plants expressing recombinant proteins in leaves, seeds, fruits or tubers/roots. Although the transient systems are rapid and high-yielding, stable transgenic plants are more scalable and may ultimately provide for more economical large-scale production, which was the original vision of 'molecular farming'. Grain crops such as cereals and legumes are particularly valuable because recombinant proteins expressed in seeds are stable at ambient temperatures and any bioload can be reduced by surface sterilization. Seeds also present interesting formulation options, e.g. the use of seed-specific storage organelles for encapsulation and the slow release of mucosal vaccines. In this article, we review the current status and recent developments in the area of molecular farming in crop plants, focusing particularly on engineered seeds as production and delivery vehicles for recombinant vaccines and antibodies. PMID:21346415

Peters, Jenny; Stoger, Eva

2011-03-01

58

A glance at Taenia saginata infection, diagnosis, vaccine, biological control and treatment.  

PubMed

The Taenia saginata taeniasis-cysticercosis complex is a cosmopolitan zoonosis of great medical, veterinary and economic importance where humans play an important role as the carrier of adult stage and cattle as carrier of the larval stage of the parasite. Here we reviewed aspects concerning diagnosis, vaccine development, biological control and treatment of the disease. PMID:20701576

Silva, Claudio V; Costa-Cruz, Julia M

2010-10-01

59

Vaccination against histomonosis prevents a drop in egg production in layers following challenge.  

PubMed

The effect of attenuated Histomonas meleagridis on pullets was investigated and the protection of vaccinated adult laying hens against a severe challenge was studied in the same experimental setting. Four groups of 25 pullets were set up at 18 weeks of life and birds in two groups were vaccinated with in vitro-attenuated H. meleagridis. Chickens in two groups (vaccinated and non-vaccinated) were challenged 5 weeks later with virulent histomonads, while the remaining groups were retained until termination of the study 11 weeks post vaccination. Vaccination of pullets did not have any impact on their subsequent performance. Egg production of non-vaccinated but challenged birds dropped significantly (P ? 0.05) between 2 and 4 weeks post challenge (p.c.) to 58.7%, compared with 90% in control chickens. At 4 weeks p.c., the drop in egg production in vaccinated and challenged birds was significantly lower (P=0.02) than in non-protected layers. Pathological changes were found only in challenged birds 2 and 6 weeks p.c. Several non-vaccinated birds showed severe lesions in the caeca with sporadic involvement of the liver and atrophy of the reproductive tract. Vaccination prior to challenge reduced the incidence of pathological findings. For the first time, vaccination of pullets with in vitro-attenuated histomonads could be shown to be an effective and safe prophylactic tool to prevent a severe drop in egg production of commercial layers following experimental infection. PMID:23391185

Liebhart, D; Sulejmanovic, T; Grafl, B; Tichy, A; Hess, M

2013-02-01

60

Biological Safety Cabinets n Product protection  

E-print Network

2.7 #12;Biological Safety Cabinets Purpose n Product protection n Personal protection n Environmental protection 2.7 #12;Biological Safety Cabinets Types A. Class I n inward airflow protects worker n.7 #12;Biological Safety Cabinets Types Class II n Type A 30% exhausted to room n Type B3 30% exhausted

Collins, Gary S.

61

Do Baby Products Prevent SIDS?  

MedlinePLUS

... En Español Enter Search terms Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary ... Veterinary Children's Health Cosmetics Dietary Supplements Drugs Food Medical Devices Nutrition Radiation-Emitting Products Tobacco Products Vaccines, Blood & ...

62

Vaccinations  

MedlinePLUS

... be spread from animals to people. For example, rabies is a serious, often fatal, disease that can ... animals to people. By vaccinating your pets for rabies, you are protecting your family as well as ...

63

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

64

[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

65

9 CFR 114.6 - Mixing biological products.  

Code of Federal Regulations, 2010 CFR

...2010-01-01 false Mixing biological products. 114.6 ...SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS...PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS § 114.6 Mixing biological products. Each...

2010-01-01

66

Calibration of the Ph. Eur. Biological Reference Preparation (BRP) for tetanus vaccine (adsorbed) batch 3.  

PubMed

A joint collaborative study was organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the World Health Organization (WHO)/National Institute for Biological Standards and Control (NIBSC) to establish replacement batches for the European Pharmacopoeia (Ph. Eur.) Tetanus Vaccine (adsorbed) Biological Reference Preparation (BRP) batch 2 and for the WHO 3rd International Standard (IS) for Tetanus toxoid (adsorbed). Two freeze-dried stabilised tetanus vaccine (adsorbed) candidate preparations (Preparation A, 08/218 and Preparation B, 08/102) were calibrated against the current 3rd IS/BRP batch 2 (Preparation C) using challenge methods in guinea pigs and mice as described in the Ph. Eur. general chapter 2.7.8. Assay of tetanus vaccine (adsorbed). They were also assayed by serology methods. The WHO 2nd IS for Tetanus toxoid adsorbed (TEXA-2) was additionally included in the sample panel as Preparation D. Thirty-four laboratories (regulatory organisations and manufacturers) from 22 countries participated in the collaborative study. The majority of participants performed 2 independent challenge tests. Nine laboratories performed challenge assays in guinea pigs and 30 laboratories performed challenge assays in mice. Eight laboratories performed serology in guinea pigs and 1 laboratory performed serology in mice. For Preparation A, the geometric mean (GM) potency estimate (with 95 % confidence interval (CI)) in guinea pigs for all laboratories that provided valid results (n = 6) was 488.5 (354.2-673.6) IU/ampoule. For valid mouse assays (n = 25) the GM potency (with 95 % CI) was 259.8 (223.5-302.0) IU/ampoule. The inter-laboratory geometric coefficient of variation (GCV) was 36 % for guinea pig assays and 45 % for mouse assays. This compared favourably with the calibration of the 3rd IS/BRP batch 2 where the inter-laboratory GCV was 36 % and 42 % in guinea pigs and mice, respectively. For Preparation B, the GM potency estimate (with 95 % CI) in guinea pigs for all laboratories that provided valid results (n = 6) was 107.9 (64.1-181.7) IU/ampoule. For valid mouse assays (n = 24) the GM potency (with 95 % CI) was 147.9 (126.3-173.1) IU/ampoule. The inter-laboratory GCV was 64.3 % for guinea pig assays and 45.2 % for mouse assays. From the collaborative study, Preparation A appeared more suitable to be the replacement Ph. Eur. BRP as it is similar to the Tetanus vaccine (adsorbed) BRP batch 2, except for nature of the stabiliser. Preparation A was confirmed to have higher potency, readily detectable tetanus toxoid, and confirmed satisfactory stability and performance in challenge assays. Preparation A was adopted in January 2011 by the Ph. Eur. Commission as the Tetanus vaccine (adsorbed) BRP batch 3, with assigned potencies of 490 IU/ampoule in the guinea pig challenge assay and of 260 IU/ampoule in the mouse challenge assay. The same Preparation A was adopted in October 2010 as the WHO 4th IS for Tetanus toxoid (adsorbed), with the assigned activity of 490 IU/ampoule from guinea pig challenge assays. A follow-up study (reporting study) was organised by the EDQM to assess the impact of the potency assigned to the BRP batch 3 for mouse challenge assays on the outcome of batch release testing in Europe. Eight laboratories including official medicines control laboratories (OMCLs) and manufacturers reported the results of their routine testing, using the BRP batch 3 in addition to their regular reference preparation. For each tested product, participants calculated the potency relative to their routine reference and relative to the BRP batch 3. No common sample panel was distributed to participants. In total, data on 40 batches of different marketed tetanus vaccines were reported. Overall, a good concordance was observed between the potencies calculated relative to the BRP batch 2 and relative to the BRP batch 3. On average, the potency estimates were 10 % lower when expressed relative to the BRP batch 3. Cases of discrepant decisions for batch release were very limited and affected mainly batches with

Tierney, R; Hockley, J; Rigsby, P; Terao, E; Daas, A; Buchheit, K-H; Sesardic, D

2011-06-01

67

Biological production of products from waste gases  

DOEpatents

A method and apparatus are designed for converting waste gases from industrial processes such as oil refining, and carbon black, coke, ammonia, and methanol production, into useful products. The method includes introducing the waste gases into a bioreactor where they are fermented to various products, such as organic acids, alcohols, hydrogen, single cell protein, and salts of organic acids by anaerobic bacteria within the bioreactor. These valuable end products are then recovered, separated and purified.

Gaddy, James L. (Fayetteville, AR)

2002-01-22

68

Toxicology/Cell Biology Ruminant Production  

E-print Network

Ken Adler Toxicology/Cell Biology MBS Mark Alley Ruminant Production PHP Glen Almond Swine Health & Production PHP Kevin Anderson Ruminant Production PHP Nigel Campbell Anesthesiology MBS Wolfgang Baeumer Fogle Immunology PHP Michael Dykstra Electron Microscopy PHP Derek Foster Ruminant Medicine PHP Kelli

Langerhans, Brian

69

9 CFR 106.1 - Biological products; exemption.  

Code of Federal Regulations, 2010 CFR

... 2010-01-01 false Biological products; exemption. ...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS...AND VECTORS EXEMPTION FOR BIOLOGICAL PRODUCTS USED IN DEPARTMENT...SUPERVISION § 106.1 Biological products; exemption....

2010-01-01

70

9 CFR 115.2 - Inspections of biological products.  

Code of Federal Regulations, 2010 CFR

... false Inspections of biological products. 115.2 Section...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS...115.2 Inspections of biological products. (a) Any biological product, the...

2010-01-01

71

Severe acute respiratory syndrome (SARS) S protein production in plants: Development of recombinant vaccine  

Microsoft Academic Search

In view of a recent spread of severe acute respiratory syndrome (SARS), there is a high demand for production of a vaccine to prevent this disease. Recent studies indicate that SARS-coronavirus (CoV) spike protein (S protein) and its truncated fragments are considered the best candidates for generation of the recombinant vaccine. Toward the development of a safe, effective, and inexpensive

Natalia Pogrebnyak; Maxim Golovkin; Vyacheslav Andrianov; Sergei Spitsin; Yuriy Smirnov; Richard Egolf; Hilary Koprowski

2005-01-01

72

MMR Vaccine (Measles, Mumps, and Rubella)  

MedlinePLUS

Attenuvax® Measles Vaccine ... R-Vax® II (as a combination product containing Measles Vaccine, Rubella Vaccine) ... M-R® II (as a combination product containing Measles Vaccine, Mumps Vaccine, Rubella Vaccine)

73

Development of influenza vaccine production capacity by the Government Pharmaceutical Organization of Thailand: Addressing the threat of an influenza pandemic  

Microsoft Academic Search

In 2005, a year after highly pathogenic avian influenza outbreaks in Thailand, the Thai Government issued a National Strategy Plan for Pandemic Influenza Preparedness, a major objective of which was the domestic production of seasonal influenza vaccine. It was considered that sustained influenza vaccine production was the best guarantee of a pandemic vaccine in the event of a future pandemic.

Somchaiya Surichan; Ponthip Wirachwong; Wutichai Supachaturas; Kanchala Utid; Sompone Theerasurakarn; Pimsuk Langsanam; Pattharachai Lakornrach; Ladda Nitisaporn; Chanpen Chansikkakorn; Wilak Vangkanonta; Ruangchai Kaweepornpoj; Kittisak Poopipatpol; Sit Thirapakpoomanunt; Somchai Srichainak; Witit Artavatkun; Vichai Chokevivat; Suwit Wibulpolprasert

2011-01-01

74

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

75

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

76

Vaccine production capacity for seasonal and pandemic (H1N1) 2009 influenza.  

PubMed

The first influenza pandemic of the 21st century, due to a new strain of A(H1N1) virus, was declared on 11 June 2009 by the Director-General of the World Health Organization. Fortunately, the international community, including influenza vaccine manufacturers, has been increasing its preparedness for such an event, triggered by the need to stem the spread of the highly pathogenic avian influenza A(H5N1) virus over recent years. Today, the development of a pandemic influenza vaccine in the fastest possible time is a global priority. However, two major issues need to be taken into consideration: how long will it take to produce sufficient pandemic vaccine doses to immunize the global population at risk, including poor populations that have no resources to purchase the vaccine; and how will pandemic vaccine production affect availability of trivalent vaccine for the forthcoming 2009-2010 influenza season. To address these questions, WHO carried out a survey in May 2009 among influenza vaccine manufacturers on their planned seasonal and pandemic production with a view to developing recommendations on the distribution and use of pandemic influenza vaccine. PMID:19563891

Collin, Nicolas; de Radiguès, Xavier

2009-08-20

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

Vaccination of biological cellulose fibers with glucose: a gateway to novel nanocomposites.  

PubMed

This work introduces, for the first time worldwide, the means to preserve and protect the natural nanoporous structure of the never-dried plant cell wall, against the irreversible collapse, which occurs due to drying. Simultaneously, these means, used for the above-mentioned aim, provide a gateway to novel nanocomposite materials, which retain the super reactive and super absorbent properties of the never-dried biological cellulose fibers. The present work showed, for the first time worldwide, that glucose can be vaccinated into the cell wall micropores or nanostructure of the never-dried biological cellulose fibers, by simple new techniques, to create a reactive novel nanocomposite material possessing surprising super absorbent properties. Inoculation of the never dried biological cellulose fibers, with glucose, prevented the collapse of the cell wall nanostructure, which normally occurs due to drying. The nanocomposite, produced after drying of the glucose inoculated biological cellulose, retained the super absorbent properties of the never dried biological cellulose fibers. It was found that glucose under certain circumstances grafts to the never dried biological cellulose fibers to form a novel natural nanocomposite material. About 3-8% (w/w) glucose remained grafted in the novel nanocomposite. PMID:17950824

Fahmy, Tamer Y A; Mobarak, Fardous

2008-01-01

79

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.

80

Assessment of packed bed bioreactor systems in the production of viral vaccines  

PubMed Central

Vaccination is believed to be the most effective method for the prevention of infectious diseases. Thus it is imperative to develop cost effective and scalable process for the production of vaccines so as to make them affordable for mass use. In this study, performance of a novel disposable iCELLis fixed bed bioreactor system was investigated for the production of some viral vaccines like Rabies, Hepatitis-A and Chikungunya vaccines in comparison to conventional systems like the commercially available packed bed system and roller bottle system. Vero and MRC-5 cell substrates were evaluated for growth parameters in all the three systems maintaining similar seeding density, multiplicity of infection (MOI) and media components. It was observed that Vero cells showed similar growth in all the three bioreactors whereas MRC-5 cells showed better growth in iCELLis Nano system and roller bottle system. Subsequently, the virus infection and antigen production studies also revealed that for Hepatitis-A and Chikungunya iCELLis Nano bioreactor system was better to the commercial packed bed bioreactor and roller bottle systems. Although for rabies antigen production commercially available packed bed bioreactor system was found to be better. This study shows that different bioreactor platforms may be employed for viral vaccine production and iCELLis Nano is one of such new convenient and a stable platform for production of human viral vaccines. PMID:24949260

2014-01-01

81

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

82

Use of Staby(®) technology for development and production of DNA vaccines free of antibiotic resistance gene.  

PubMed

The appearance of new viruses and the cost of developing certain vaccines require that new vaccination strategies now have to be developed. DNA vaccination seems to be a particularly promising method. For this application, plasmid DNA is injected into the subject (man or animal). This plasmid DNA encodes an antigen that will be expressed by the cells of the subject. In addition to the antigen, the plasmid also encodes a resistance to an antibiotic, which is used during the construction and production steps of the plasmid. However, regulatory agencies (FDA, USDA and EMA) recommend to avoid the use of antibiotics resistance genes. Delphi Genetics developed the Staby(®) technology to replace the antibiotic-resistance gene by a selection system that relies on two bacterial genes. These genes are small in size (approximately 200 to 300 bases each) and consequently encode two small proteins. They are naturally present in the genomes of bacteria and on plasmids. The technology is already used successfully for production of recombinant proteins to achieve higher yields and without the need of antibiotics. In the field of DNA vaccines, we have now the first data validating the innocuousness of this Staby(®) technology for eukaryotic cells and the feasibility of an industrial production of an antibiotic-free DNA vaccine. Moreover, as a proof of concept, mice have been successfully vaccinated with our antibiotic-free DNA vaccine against a deadly disease, pseudorabies (induced by Suid herpesvirus-1). PMID:24051431

Reschner, Anca; Scohy, Sophie; Vandermeulen, Gaëlle; Daukandt, Marc; Jacques, Céline; Michel, Benjamin; Nauwynck, Hans; Xhonneux, Florence; Préat, Véronique; Vanderplasschen, Alain; Szpirer, Cédric

2013-10-01

83

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

84

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

85

Calibration of European pharmacopoeia biological reference preparation for diphtheria vaccine (adsorbed) batch 4.  

PubMed

A collaborative study was organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the National Institute for Biological Standards and Control (NIBSC) to establish replacement batches of the current World Health Organization (WHO) International Standard (IS) and European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Diphtheria Vaccine (Adsorbed). Two candidates were assayed against the current 3rd IS/BRP batch 3 for Diphtheria Vaccine (Adsorbed) with an assigned potency of 160 IU/ampoule using established WHO/Ph. Eur. challenge methods in guinea pigs as described in the Ph. Eur. general chapter 2.7.6. Assay of diphtheria vaccine (adsorbed). Twenty-one laboratories (regulatory organisations and manufacturers) from 17 countries participated in the study. Two freeze-dried, stabilised diphtheria vaccine (adsorbed) preparations were included in the study: Preparation A (07/218) and Preparation B (07/216). As stocks of the 3rd IS were very low, the Diphtheria vaccine (adsorbed) BRP batch 3, which is identical to the 3rd IS but which was kept at the EDQM, was used for the calibration (coded Preparation C). The majority of participants performed 2 independent challenge tests. Five laboratories performed the intradermal challenge test, 16 laboratories performed the systemic challenge test. For Preparation A, the unweighted geometric mean potency estimate (with 95 % confidence limits) for all laboratories that provided valid results (n = 17) was 97.2 (89.5-105.6) IU/ampoule. For systemic challenge assays (n = 14) the unweighted geometric mean potency was 97.0 (88.1-106.7) IU/ampoule. The between-laboratory GCV was 17.4 % for all assays and 18.0 % for systemic challenge assays. There was no significant difference in estimates for intradermal or systemic challenge (p = 0.45). For Preparation B the unweighted geometric mean potency estimate (with 95 % confidence limits) for all laboratories that provided valid results (n = 19) was 213.4 (185.7-245.4) IU/ampoule. For systemic challenge assays (n = 14) the unweighted geometric mean potency was 202.0 (170.4-239.5) IU/ampoule. The between-laboratory GCV was 33.5 % for all assays and 34.3 % for systemic challenge assays. For both preparations there is a good agreement between results obtained from systemic and intradermal challenge methods. Greater between-laboratory variability was observed for systemic assays than for intradermal challenge assays, although the small number of intradermal assays performed in the study makes comparison difficult. The GCV for all assays was 17.4 % for potency estimates of Preparation A and 33.5 % for Preparation B. This compares favourably with the calibration of the current standard where the between-laboratory GCV for all assays was 28.3 %. From the collaborative study both Preparation A and Preparation B appeared suitable to replace the current Diphtheria vaccine (adsorbed) BRP batch 3. Due to the similarity of Preparation A with the current BRP batch 3, the Ph. Eur. Commission adopted Preparation A as Diphtheria vaccine (adsorbed) BRP batch 4 with an assigned potency of 97 IU/ampoule. PMID:20144448

Stickings, P; Rigsby, P; Buchheit, K-H; Sesardic, D

2009-10-01

86

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

87

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

PubMed

Several proposals are offered for production of high-quality vaccines within developing countries. The World Health Organization's Vaccine Supply and Quality (VSQ) team from the Global Program for Vaccines and Immunization (GPV) visited 10 countries (Bangladesh, Brazil, Egypt, India, Indonesia, Iran, Mexico, Pakistan, Philippines, and South Africa) out of 14 priority countries (China, Russia, Thailand, and Vietnam were not visited) producing vaccines and found only two with a quality control system that was acceptable. Vaccine-producing countries are urged to consider the full costs of production that include necessary infrastructure, an independent national control authority and laboratory, manufacturers with managerial autonomy, and manufacturers with good management, a qualified staff, and adequate technology. UNICEF has urged both private and public sectors to combine forces in bringing down the price of new vaccines for distribution to a very large market. Some imaginative proposals were made by some manufacturers for vaccine production and supply for a range of less traditional vaccines. The Director of the Massachusetts Public Health Biologic Laboratories proposed the formation of a consortium of vaccine manufacturers who would support public health priorities for market-affordable, simple vaccines against the major childhood diseases. The aim would be international validation of high-quality local vaccine production in developing countries, ease of research collaboration, improvement in information exchange between countries, and structured assistance. Lack of political commitment has been blamed for poor quality local production. A small cooperative effort among some Latin American countries, the Pan American Association's Regional Vaccine System for Latin America (SIREVA), is backed by the Children's Vaccine Initiative. SIREVA is a consortium of manufacturers in Brazil, Chile, and Mexico that plans joint development of some vaccines. Donor assistance is suggested for UNICEF's new targeting strategy and global vaccine fund for well-defined and specific needs. UNICEF is the main distributor of vaccines to developing countries and aims for program sustainability and distribution of the new vaccines. PMID:12290725

1995-10-01

88

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

89

Design of clinical trials for therapeutic cancer vaccines development  

Microsoft Academic Search

Advances in molecular and cellular biology as well as biotechnology led to definition of a group of drugs referred to as medicinal products of advanced technologies. It includes gene therapy products, somatic cell therapeutics and tissue engineering. Therapeutic cancer vaccines including whole cell tumor cells vaccines or gene modified whole cells belong to somatic therapeutics and\\/or gene therapy products category.

Jacek Mackiewicz; Andrzej Mackiewicz

2009-01-01

90

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

91

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

E-print Network

Biological Hydrogen Production Using Synthetic Wastewater Conclusion ·Biotin and glutamic acid are not required for biological hydrogen production. ·MgSO4 .7H2O is a required nutrient, but hydrogen production work should focus on minimizing the lag time in biological hydrogen production, by varying nutrient

Barthelat, Francois

92

Vaccines  

Technology Transfer Automated Retrieval System (TEKTRAN)

Antigens that are processed by antigen-processing cells via the exogenous pathway elicit antibodies. Thus, extracellular bacteria (live or killed), inactivated viral particles, portions (subunits) of virus, and products are processed by the exogenous pathway. Epitopes are presented to the immune sys...

93

9 CFR 113.3 - Sampling of biological products.  

Code of Federal Regulations, 2013 CFR

...purity, safety, or potency tests. Biological product in final container shall be selected to test for viable bacteria and fungi. (ii) Viable liquid biological products; samples shall be in final containers and shall be randomly selected at the...

2013-01-01

94

9 CFR 113.3 - Sampling of biological products.  

Code of Federal Regulations, 2011 CFR

...purity, safety, or potency tests. Biological product in final container shall be selected to test for viable bacteria and fungi. (ii) Viable liquid biological products; samples shall be in final containers and shall be randomly selected at the...

2011-01-01

95

9 CFR 113.3 - Sampling of biological products.  

Code of Federal Regulations, 2014 CFR

...purity, safety, or potency tests. Biological product in final container shall be selected to test for viable bacteria and fungi. (ii) Viable liquid biological products; samples shall be in final containers and shall be randomly selected at the...

2014-01-01

96

9 CFR 113.3 - Sampling of biological products.  

Code of Federal Regulations, 2012 CFR

...purity, safety, or potency tests. Biological product in final container shall be selected to test for viable bacteria and fungi. (ii) Viable liquid biological products; samples shall be in final containers and shall be randomly selected at the...

2012-01-01

97

Advances and challenges in the development and production of effective plant-based influenza vaccines.  

PubMed

Influenza infections continue to present a major threat to public health. Traditional modes of influenza vaccine manufacturing are failing to satisfy the global demand because of limited scalability and long production timelines. In contrast, subunit vaccines (SUVs) can be produced in heterologous expression systems in shorter times and at higher quantities. Plants are emerging as a promising platform for SUV production due to time efficiency, scalability, lack of harbored mammalian pathogens and possession of the machinery for eukaryotic post-translational protein modifications. So far, several organizations have utilized plant-based transient expression systems to produce SUVs against influenza, including vaccines based on virus-like particles. Plant-produced influenza SUV candidates have been extensively evaluated in animal models and some have shown safety and immunogenicity in clinical trials. Here, the authors review ongoing efforts and challenges to producing influenza SUV candidates in plants and discuss the likelihood of bringing these products to the market. PMID:25487788

Yusibov, Vidadi; Kushnir, Natasha; Streatfield, Stephen J

2014-12-01

98

9 CFR 112.6 - Packaging biological products.  

Code of Federal Regulations, 2010 CFR

...2010-01-01 false Packaging biological products. 112.6 Section...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS...LABELING § 112.6 Packaging biological products. (a) Each...multiple-dose final container of a biological product which...

2010-01-01

99

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

100

Levels of humoral antibodies induced by different inactivated vaccines correlate with egg production in commercial layers challenged with virulent Newcastle disease virus  

Technology Transfer Automated Retrieval System (TEKTRAN)

To evaluate the relationship between humoral antibodies from homologous and heterologous vaccines and egg production, twenty-two week-old commercial layers previously vaccinated with four live B1 vaccines were boosted with two different inactivated Newcastle disease virus (NDV) vaccines, a virulent ...

101

Sweeten PAMPs: Role of Sugar Complexed PAMPs in Innate Immunity and Vaccine Biology  

PubMed Central

Innate sensors play a critical role in the early innate immune responses to invading pathogens through sensing of diverse biochemical signatures also known as pathogen associated molecular patterns (PAMPs). These biochemical signatures primarily consist of a major family of biomolecules such as proteins, lipids, nitrogen bases, and sugar and its complexes, which are distinct from host molecules and exclusively expressed in pathogens and essential to their survival. The family of sensors known as pattern recognition receptors (PRRs) are germ-line encoded, evolutionarily conserved molecules, and consist of Toll-like receptors (TLRs), RIG-I-like receptors (RLRs), NOD-like receptors (NLRs), C-type lectin-like receptors (CLRs), and DNA sensors. Sensing of PAMP by PRR initiates the cascade of signaling leading to the activation of transcription factors, such as NF-?B and interferon regulatory factors (IRFs), resulting in a variety of cellular responses, including the production of interferons (IFNs) and pro-inflammatory cytokines. In this review, we discuss sensing of different types of glycosylated PAMPs such as ?-glucan (a polymeric sugar) or lipopolysaccharides, nucleic acid, and so on (sugar complex PAMPs) by different families of sensors, its role in pathogenesis, and its application in development of potential vaccine and vaccine adjuvants. PMID:24032031

Mahla, Ranjeet Singh; Reddy, Madhava C.; Prasad, D. Vijaya Raghava; Kumar, Himanshu

2013-01-01

102

Biological and phylogenetic characterization of a genotype VII Newcastle disease virus from Venezuela: efficacy of field vaccination.  

PubMed

Here we report the biological and molecular characterization of a virulent genotype VII Newcastle disease virus (NDV) circulating in Venezuela and the assessment of the vaccination efficacy under field conditions compared to controlled rearing conditions. Biological pathotyping showed a mean embryo dead time of 50 h and an intracerebral pathogenicity index of 1.86. Sequence-based phylogenetic analysis demonstrated that the virus belongs to genotype VII in class II (a genotype often found in Asia and Africa), representing the first report of the presence of this genotype in the continent of South America. A vaccine-challenge trial in commercial broilers reared in fields or in a experimental setting included dual (live/killed) priming of 1-day-old chicks plus two live NDV and infectious bursal disease virus (IBDV) field vaccinations at days 7 and 17, followed by a very stringent genotype VII NDV challenge at day 28. Serology for NDV and IBDV, bursal integrity, and protection against NDV lethal challenge were assessed. At 28 days, field vaccinates showed significantly lower NDV (1,356 versus 2,384) and higher IBD (7,295 versus 1,489) enzyme-linked immunosorbent assay (ELISA) antibody titers than the experimentally reared birds. A lower bursal size and bursa-body weight ratio (P < 0.05) and higher bursa lesion score were also detected in the field set. Only 57.1% of field vaccinates survived the lethal challenge, differing (P < 0.05) from 90.5% survival in the experimental farm. Overall, results confirmed the presence of the genotype VII viruses in South America and suggest that field-associated factors such as immunosuppression compromise the efficacy of the vaccination protocols implemented. PMID:22238433

Perozo, Francisco; Marcano, Rosmar; Afonso, Claudio L

2012-04-01

103

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

104

Varicella (Chickenpox) Vaccine  

MedlinePLUS

ProQuad® (as a combination product containing Measles Vaccine, Mumps Vaccine, Rubella Vaccine, Varicella Vaccine) ... up to about 1 person in 5) and measles-like rash (about 1 person in 20) than MMR and varicella vaccines given separately. Moderate Problems:Seizure (jerking or staring) ...

105

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

E-print Network

(Munoz-Zanzi et al., 2002). This leaves a period of time during which calves are vulnerable to infection. It has been shown that a single dose of modified-live virus (MLV) vaccine containing BVD administered to calves at 4 to 5 weeks of age could... licensed vaccines are conventional vaccines containing either killed or modified-live (MLV) whole bacteria or viruses. Most of the killed vaccines contain either aluminum hydroxide or oil and water adjuvants, which have been used for many years...

Horne, Willy J.

2010-01-16

106

Production of a recombinant vaccine candidate against Burkholderia pseudomallei exploiting the bacterial N-glycosylation machinery  

PubMed Central

Vaccines developing immune responses toward surface carbohydrates conjugated to proteins are effective in preventing infection and death by bacterial pathogens. Traditional production of these vaccines utilizes complex synthetic chemistry to acquire and conjugate the glycan to a protein. However, glycoproteins produced by bacterial protein glycosylation systems are significantly easier to produce, and could possible be used as vaccine candidates. In this work, we functionally expressed the Burkholderia pseudomallei O polysaccharide (OPS II), the Campylobacter jejuni oligosaccharyltransferase (OTase), and a suitable glycoprotein (AcrA) in a designer E. coli strain with a higher efficiency for production of glycoconjugates. We were able to produce and purify the OPS II-AcrA glycoconjugate, and MS analysis confirmed correct glycan was produced and attached. We observed the attachment of the O-acetylated deoxyhexose directly to the acceptor protein, which expands the range of substrates utilized by the OTase PglB. Injection of the glycoprotein into mice generated an IgG immune response against B. pseudomallei, and this response was partially protective against an intranasal challenge. Our experiments show that bacterial engineered glycoconjugates can be utilized as vaccine candidates against B. pseudomallei. Additionally, our new E. coli strain SDB1 is more efficient in glycoprotein production, and could have additional applications in the future. PMID:25120536

Garcia-Quintanilla, Fatima; Iwashkiw, Jeremy A.; Price, Nancy L.; Stratilo, Chad; Feldman, Mario F.

2014-01-01

107

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 ... storage, and should be discarded. Other Non-Blood Biologicals Requiring Refrigeration or Frozen Storage The information above ...

108

Biological production of ethanol from coal  

SciTech Connect

Due to the abundant supply of coal in the United States, significant research efforts have occurred over the past 15 years concerning the conversion of coal to liquid fuels. Researchers at the University of Arkansas have concentrated on a biological approach to coal liquefaction, starting with coal-derived synthesis gas as the raw material. Synthesis gas, a mixture of CO, H[sub 2], CO[sub 2], CH[sub 4] and sulfur gases, is first produced using traditional gasification techniques. The CO, CO[sub 2] and H[sub 2] are then converted to ethanol using a bacterial culture of Clostridium 1jungdahlii. Ethanol is the desired product if the resultant product stream is to be used as a liquid fuel. However, under normal operating conditions, the wild strain'' produces acetate in favor of ethanol in conjunction with growth in a 20:1 molar ratio. Research was performed to determine the conditions necessary to maximize not only the ratio of ethanol to acetate, but also to maximize the concentration of ethanol resulting in the product stream.

Not Available

1992-12-01

109

Setting up a platform for plant-based influenza virus vaccine production in South Africa  

PubMed Central

Background During a global influenza pandemic, the vaccine requirements of developing countries can surpass their supply capabilities, if these exist at all, compelling them to rely on developed countries for stocks that may not be available in time. There is thus a need for developing countries in general to produce their own pandemic and possibly seasonal influenza vaccines. Here we describe the development of a plant-based platform for producing influenza vaccines locally, in South Africa. Plant-produced influenza vaccine candidates are quicker to develop and potentially cheaper than egg-produced influenza vaccines, and their production can be rapidly upscaled. In this study, we investigated the feasibility of producing a vaccine to the highly pathogenic avian influenza A subtype H5N1 virus, the most generally virulent influenza virus identified to date. Two variants of the haemagglutinin (HA) surface glycoprotein gene were synthesised for optimum expression in plants: these were the full-length HA gene (H5) and a truncated form lacking the transmembrane domain (H5tr). The genes were cloned into a panel of Agrobacterium tumefaciens binary plant expression vectors in order to test HA accumulation in different cell compartments. The constructs were transiently expressed in tobacco by means of agroinfiltration. Stable transgenic tobacco plants were also generated to provide seed for stable storage of the material as a pre-pandemic strategy. Results For both transient and transgenic expression systems the highest accumulation of full-length H5 protein occurred in the apoplastic spaces, while the highest accumulation of H5tr was in the endoplasmic reticulum. The H5 proteins were produced at relatively high concentrations in both systems. Following partial purification, haemagglutination and haemagglutination inhibition tests indicated that the conformation of the plant-produced HA variants was correct and the proteins were functional. The immunisation of chickens and mice with the candidate vaccines elicited HA-specific antibody responses. Conclusions We managed, after synthesis of two versions of a single gene, to produce by transient and transgenic expression in plants, two variants of a highly pathogenic avian influenza virus HA protein which could have vaccine potential. This is a proof of principle of the potential of plant-produced influenza vaccines as a feasible pandemic response strategy for South Africa and other developing countries. PMID:22536810

2012-01-01

110

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

111

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

112

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, René H.; van den Dobbelsteen, Germie P. J. M.; van der Pol, Leo A.

2013-01-01

113

Vaccination and acute phase mediator production in chickens challenged with low pathogenic avian influenza virus; novel markers for vaccine efficacy  

Technology Transfer Automated Retrieval System (TEKTRAN)

Methods to determine vaccine efficacy of low pathogenic avian influenza (LPAI) isolates are limited in poultry because experimental infections with LPAI virus in specific pathogen free chickens rarely causes clinical disease. The most commonly used method to compare LPAI vaccine efficacy is to quant...

114

Systems biological approaches to measure and understand vaccine immunity in humans  

PubMed Central

Recent studies have demonstrated the utility of using systems approaches to identify molecular signatures that can be used to predict vaccine immunity in humans. Such approaches are now being used extensively in vaccinology, and are beginning to yield novel insights about the molecular networks driving vaccine immunity. In this review, we present a broad review of the methodologies involved in these studies, and discuss the promise and challenges involved in this emerging field of “systems vaccinology.” PMID:23796714

Li, Shuzhao; Nakaya, Helder I; Kazmin, Dmitri A; Oh, Jason; Pulendran, Bali

2013-01-01

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

Natural products: chemical instruments to apprehend biological symphony.  

PubMed

As a striking variety of biological activities are elicited by natural products, these chemicals have been used for decades to study biological phenomena. Understanding how these products interfere with normal cell functions at a molecular level led to a wide range of discoveries including new signaling pathways and proteins. Moreover, as natural products often act as chemical inhibitors, such studies often allow the identification of their binding partners as relevant targets for drug design. This article aims to emphasize how natural products or engineered analogs can be used as chemical tools to apprehend some biological problems from the point of view of a chemical biologist. PMID:18219406

Pucheault, Mathieu

2008-02-01

117

Current biodefense vaccine programs and challenges.  

PubMed

The Defense Threat Reduction Agency's Joint Science and Technology Office manages the Chemical and Biological Defense Program's Science and Technology portfolio. The Joint Science and Technology Office's mission is to invest in transformational ideas, innovative people and actionable technology development for Chemical and Biological Defense solutions, with the primary goal to deliver Science and Technology products and capabilities to the warfighter and civilian population that outpace the threat. This commentary focuses on one thrust area within this mission: the Vaccine program of the Joint Science and Technology Office's Translational Medical Division. Here, we will describe candidate vaccines currently in the S&T pipeline, enabling technologies that should facilitate advanced development of these candidates into FDA licensed vaccines, and how the ever-changing biological threat landscape impacts the future of biodefense vaccines. PMID:23428906

Wolfe, Daniel N; Florence, William; Bryant, Paula

2013-07-01

118

Antibodies Elicited by Inactivated Propionibacterium acnes-Based Vaccines Exert Protective Immunity and Attenuate the IL-8 Production in Human Sebocytes: Relevance to Therapy for Acne Vulgaris  

PubMed Central

Propionibacterium acnes is a key pathogen involved in the progression of inflammation in acne vulgaris. We examined whether vaccination against P. acnes suppressed P. acnes-induced skin inflammation. Inactivation of P. acnes with heat was employed to create a P. acnes-based vaccine. Intranasal immunization in mice with this inactivated vaccine provoked specific antibodies against P. acnes. Most notably, immunization with inactivated vaccines generated in vivo protective immunity against P. acnes challenge and facilitated the resolution of ear inflammation in mice. In addition, antibodies elicited by inactivated vaccines effectively neutralized the cytotoxicity of P. acnes and attenuated the production of proinflammatory cytokine IL-8 in human sebocyte SZ95 cells. Intranasal immunization using heat-inactivated P. acnes-based vaccines provided a simple modality to develop acne vaccines. These observations highlight the concept that development of vaccines targeting microbial products may represent an alternative strategy to conventional antibiotic therapy. PMID:18463682

Nakatsuji, Teruaki; Liu, Yu-Tsueng; Huang, Cheng-Po; Gallo, Richard L.; Huang, Chun-Ming

2011-01-01

119

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

120

Coccidiosis in poultry: anticoccidial products, vaccines and other prevention strategies  

Microsoft Academic Search

Coccidiosis in chickens is a parasitic disease with great economic significance, which has been controlled successfully for decades using mainly anticoccidial products. However, large-scale and long-term use of anticoccidial drugs has led to the worldwide development of resistance against all these drugs. In order to minimize the occurrence of resistance, the rotation of various anticoccidial drugs in single and\\/or shuttle

H. W. Peek; W. J. M. Landman

2011-01-01

121

Production of a conjugate vaccine for Salmonella enterica serovar Typhi from Citrobacter Vi.  

PubMed

A conjugate vaccine for Salmonella enterica serovar Typhi was produced by chemically linking Vi, purified from Citrobacter, to the non-toxic mutant diphtheria toxin CRM(197) via an adipic dihydrazide spacer using N-(3-Dimethylaminopropyl)-N'-ethylcarbodiimide coupling chemistry. The polysaccharide purification process was developed based on Vi precipitation from culture supernatant with cetyl trimethylammonium bromide (CTAB), solubilization of the CTA-polysaccharide salt with ethanol followed by exchange of the CTA(+) counter ion with Na(+). The purified Vi polysaccharide was fully O-acetylated and with high purity. The conjugation process was optimized to obtain a scalable process that has been used for GMP production at pilot scale of vaccine currently in clinical trials. PMID:22172503

Micoli, F; Rondini, S; Pisoni, I; Giannelli, C; Di Cioccio, V; Costantino, P; Saul, A; Martin, L B

2012-01-20

122

9 CFR 113.3 - Sampling of biological products.  

Code of Federal Regulations, 2010 CFR

...samples of Coccidiosis Vaccine; (iv) Eighteen samples of Rabies Vaccine, Modified Live Virus; (v) Sixteen samples of all...Twenty-two single-dose or 14 multiple-dose samples of Rabies Vaccine, Killed Virus; (viii) Sixteen single-dose...

2010-01-01

123

RNAi suppression of rice endogenous storage proteins enhances the production of rice-based Botulinum neutrotoxin type A vaccine.  

PubMed

Mucosal vaccines based on rice (MucoRice) offer a highly practical and cost-effective strategy for vaccinating large populations against mucosal infections. However, the limitation of low expression and yield of vaccine antigens with high molecular weight remains to be overcome. Here, we introduced RNAi technology to advance the MucoRice system by co-introducing antisense sequences specific for genes encoding endogenous rice storage proteins to minimize storage protein production and allow more space for the accumulation of vaccine antigen in rice seed. When we used RNAi suppression of a combination of major rice endogenous storage proteins, 13 kDa prolamin and glutelin A in a T-DNA vector, we could highly express a vaccine comprising the 45 kDa C-terminal half of the heavy chain of botulinum type A neurotoxin (BoHc), at an average of 100 ?g per seed (MucoRice-BoHc). The MucoRice-Hc was water soluble, and was expressed in the cytoplasm but not in protein body I or II of rice seeds. Thus, our adaptation of the RNAi system improved the yield of a vaccine antigen with a high molecular weight. When the mucosal immunogenicity of the purified MucoRice-BoHc was examined, the vaccine induced protective immunity against a challenge with botulinum type A neurotoxin in mice. These findings demonstrate the efficiency and utility of the advanced MucoRice system as an innovative vaccine production system for generating highly immunogenic mucosal vaccines of high-molecular-weight antigens. PMID:22554467

Yuki, Yoshikazu; Mejima, Mio; Kurokawa, Shiho; Hiroiwa, Tomoko; Kong, Il Gyu; Kuroda, Masaharu; Takahashi, Yoko; Nochi, Tomonori; Tokuhara, Daisuke; Kohda, Tomoko; Kozaki, Shunji; Kiyono, Hiroshi

2012-06-13

124

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

125

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

Code of Federal Regulations, 2011 CFR

...2011-01-01 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...

2011-01-01

126

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

Code of Federal Regulations, 2014 CFR

...2014-01-01 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...

2014-01-01

127

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

128

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

Code of Federal Regulations, 2012 CFR

...2012-01-01 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...

2012-01-01

129

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

Code of Federal Regulations, 2013 CFR

...2013-01-01 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...

2013-01-01

130

Combination Vaccines  

PubMed Central

The combination of diphtheria, tetanus, and pertussis vaccines into a single product has been central to the protection of the pediatric population over the past 50 years. The addition of inactivated polio, Haemophilus influenzae, and hepatitis B vaccines into the combination has facilitated the introduction of these vaccines into recommended immunization schedules by reducing the number of injections required and has therefore increased immunization compliance. However, the development of these combinations encountered numerous challenges, including the reduced response to Haemophilus influenzae vaccine when given in combination; the need to consolidate the differences in the immunization schedule (hepatitis B); and the need to improve the safety profile of the diphtheria, tetanus, and pertussis combination. Here, we review these challenges and also discuss future prospects for combination vaccines. PMID:21572611

Skibinski, David AG; Baudner, Barbara C; Singh, Manmohan; O’Hagan, Derek T

2011-01-01

131

Biological production of ethanol from coal  

SciTech Connect

A batch kinetic study involving Clostridium lungdahlii in a mineral medium was carried out in order to provide baseline data for the effects of nutrients on product ratio and kinetics. The use of this minimal medium containing vitamins, minerals, select amino acids and salts showed both a lower maximum specific growth rate and a lower maximum specific uptake rate than found when using a complex medium supplemented with 0.01% yeast extract. At the same time, the product ratio was improved slightly in favor of ethanol over acetate. Future experiments will measure the effects of ammonia and phosphate limitation on product ratio and process kinetics.

Not Available

1990-01-01

132

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

133

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

134

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

135

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

136

21 CFR Appendix C to Subpart A of... - Indicative List of Products Covered by Subpart A  

Code of Federal Regulations, 2012 CFR

...and nonprescription drugs; —human biologicals including vaccines, and immunologicals; —veterinary pharmaceuticals, including...States); —intermediate products and active pharmaceutical ingredients or bulk pharmaceuticals (United States)/starting...

2012-04-01

137

21 CFR Appendix C to Subpart A of... - Indicative List of Products Covered by Subpart A  

Code of Federal Regulations, 2013 CFR

...and nonprescription drugs; —human biologicals including vaccines, and immunologicals; —veterinary pharmaceuticals, including...States); —intermediate products and active pharmaceutical ingredients or bulk pharmaceuticals (United States)/starting...

2013-04-01

138

21 CFR Appendix C to Subpart A of... - Indicative List of Products Covered by Subpart A  

Code of Federal Regulations, 2011 CFR

...and nonprescription drugs; —human biologicals including vaccines, and immunologicals; —veterinary pharmaceuticals, including...States); —intermediate products and active pharmaceutical ingredients or bulk pharmaceuticals (United States)/starting...

2011-04-01

139

21 CFR Appendix C to Subpart A of... - Indicative List of Products Covered by Subpart A  

Code of Federal Regulations, 2014 CFR

...and nonprescription drugs; —human biologicals including vaccines, and immunologicals; —veterinary pharmaceuticals, including...States); —intermediate products and active pharmaceutical ingredients or bulk pharmaceuticals (United States)/starting...

2014-04-01

140

75 FR 75682 - Reclassification of Category IIIA Biological Products, Bacterial Vaccines and Related Biological...  

Federal Register 2010, 2011, 2012, 2013, 2014

...8, 1978, submission, ``Susceptibility of Staphylococcus aureus Clinical Isolates to Gratia Bacteriophage...Mitsuma; and K. Kojima, ``Susceptibility of Staphylococcus aureus Clinical Isolates to Gratia...

2010-12-06

141

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

142

Biological pretreatment for production of lignocellulosic biofuel.  

PubMed

Lignocellulosic biomass was submitted to a biological pretreatment prior to a catalytic hydroliquefaction in order to produce biofuel. The biodegradation process was conducted over 3 months in a reactor under controlled conditions. During the biodegradation process the organic matter was characterised and its evolution was correlated with physico-chemical parameters. In parallel with the analysis of the lipidic fraction, analytical pyrolysis was used to monitor bacterial activity. The alterations of branched to linear fatty acids ratio and of mono- to diacids ratio were compared when determined by thermochemolysis and observed in the directly extractable lipids. The evolution of the phytol to the corresponding isoprenoic ketone ratio was observed to be dependent on the desorption technique since it decreases using headspace while it increases using pyrolysis. "Humic"/"fulvic acids" ratio, infrared spectroscopy and thermodifferential analysis were used to determine the degree of OM complexification. PMID:22617032

Lemée, L; Kpogbemabou, D; Pinard, L; Beauchet, R; Laduranty, J

2012-08-01

143

Collaborative study for the establishment of a European Pharmacopoeia Biological Reference Preparation for Clostridia antiserum for serological potency testing of veterinary clostridial vaccines.  

PubMed

The European Directorate for the Quality of Medicines (EDQM) has organised an international collaborative study, divided in two phases, aimed at producing and establishing a suitable reference serum for serological potency testing of clostridial vaccines for batch consistency demonstration. In phase 1 a series of pools produced from sera provided by each manufacturer and raised against the broadest range of antigens possible were blended to obtain TN titres which were representative of the range normally elicited by the vaccines under test. Detailed statistical analysis of the data was not possible since only a few laboratories were able to participate and because limited replication of the assays was possible. Nevertheless, sufficient data were collected to conclude that the blend of sera would provide a suitable reference material for use by all manufacturers and regulatory authorities in respect of in vitro assay methods for the five components for which it was primarily designed, i.e. Clostridium (C.) perfringens beta and epsilon, septicum, novy and tetani. On the basis of these results a production scale blend of the serum pools was prepared, filled and freeze-dried by EDQM as a single batch, referred to as candidate (c) Ph. Eur. Biological Reference Preparation (BRP). In phase 2 of the study a larger group of laboratories, including both manufacturers and official medicines control laboratories (OMCL), were invited to participate in a study comparing the activity of the proposed rabbit multicomponent reference serum with the existing equine monovalent World Health Organization (WHO) International Standard (IS). These studies necessarily were conducted according to the methods described in the currently applicable monographs i.e. by toxin neutralisation test in mice (TN) to provide a definitive value for the antitoxin activity of the reference preparation in respect of the five components studied. PMID:12678238

Lucken, R; Daas, A; Behr-Gross, M E

2002-01-01

144

Detection of endotoxin in biological products by the limulus test.  

PubMed

The limulus amebocyte lysate (LAL) test is established as a beneficial quality assurance measure for the parenteral drug industry because of its sensitivity, specificity, and simplicity. Limulus amebocyte lysate reacts with various forms of endotoxin to form an opaque gel under acceptable conditions of pH, temperature, and ionic content. Although certain materials and conditions may alter the lysate-endotoxin reaction, the test is not significantly limited by inhibition or non-specific activation. Many U.S. drug firms apply the LAL test generally for monitoring production water and other ingredients, for an in-process control, and as a supplemental end product test for pyrogenic contamination. Specific applications are made for bacterial and viral vaccines, antineoplastic agents, radiopharmaceuticals and drugs designed for intrathecal injection. Efforts to standardize LAL test technique and lysate potency continue. PMID:838151

Cooper, J F; Pearson, S M

1977-01-01

145

9 CFR 105.3 - Notices re: worthless, contaminated, dangerous, or harmful biological products.  

Code of Federal Regulations, 2010 CFR

...contaminated, dangerous, or harmful biological products. 105.3 Section...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS...REVOCATION, OR TERMINATION OF BIOLOGICAL LICENSES OR PERMITS § 105...dangerous, or harmful biological products. (a)...

2010-01-01

146

Salmonid alphavirus replication in mosquito cells: towards a novel vaccine production system.  

PubMed

Salmonid alphavirus (SAV) causes pancreas disease and sleeping disease in Atlantic salmon (Salmo salar) and rainbow trout (Oncorhynchus mykiss) and confers a major burden to the aquaculture industry. A commercial inactivated whole virus vaccine propagated in a salmon cell line at low temperature provides effective protection against SAV infections. Alphaviruses (family Togaviridae) are generally transmitted between vertebrate hosts via blood-sucking arthropod vectors, typically mosquitoes. SAV is unique in this respect because it can be transmitted directly from fish to fish and has no known invertebrate vector. Here, we show for the first time that SAV is able to complete a full infectious cycle within arthropod cells derived from the Asian tiger mosquito Aedes albopictus. Progeny virus is produced in C6/36 and U4.4. cells in a temperature-dependent manner (at 15 °C but not at 18 °C), can be serially passaged and remains infectious to salmonid Chinook salmon embryo cells. This suggests that SAV is not a vertebrate-restricted alphavirus after all and may have the potential to replicate in invertebrates. The current study also shows the ability of SAV to be propagated in mosquito cells, thereby possibly providing an alternative SAV production system for vaccine applications. PMID:24418177

Hikke, Mia C; Verest, Marjan; Vlak, Just M; Pijlman, Gorben P

2014-09-01

147

Recombinant plants provide a new approach to the production of bacterial polysaccharide for vaccines.  

PubMed

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; Whitelam, Garry C; Andrew, Peter W

2014-01-01

148

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

149

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

150

Risk analysis for plant-made vaccines Dwayne D. Kirk1,  

E-print Network

Risk analysis for plant-made vaccines Dwayne D. Kirk1, *, Kim McIntosh1 , Amanda M Walmsley1, Tempe, AZ, 85287, USA 2 Agricultural and Biological Risk Assessment, Montana State University, Bozeman, regulation, risk, transgenic plant Abstract The production of vaccines in transgenic plants was first

Peterson, Robert K. D.

151

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

152

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

153

Synthetic biology of avermectin for production improvement and structure diversification.  

PubMed

Natural products are still key sources of current clinical drugs and innovative therapeutic agents. Since wild-type microorganisms only produce natural products in very small quantities, yields of production strains need to be improved by breaking down the precise genetic and biochemical circuitry. Herein, we use avermectins as an example of production improvement and chemical structure diversification by synthetic biology. Avermectins are macrocyclic lactones produced by Streptomyces avermitilis and are well known and widely used for antiparasitic therapy. Given the importance of this molecule and its derivatives, many efforts and strategies were employed to improve avermectin production and generate new active analogues. This review describes the current status of synthetic strategies successfully applied for developing natural-product-producing strains and discusses future prospects for the application of enhanced avermectin production. PMID:24478271

Zhuo, Ying; Zhang, Tao; Wang, Qi; Cruz-Morales, Pablo; Zhang, Buchang; Liu, Mei; Barona-Gómez, Francisco; Zhang, Lixin

2014-03-01

154

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

155

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

156

PRODUCTION AND BIOLOGICAL SIGNIFICANCE OF METHYLATED TRIVALENT ARSENICALS  

EPA Science Inventory

PRODUCTION AND BIOLOGICAL SIGNIFICANCE OF METHYLATED TRIVALENT ARSENICALS Miroslav Styblo1,2,*, Zuzana Drobna1, Felecia S. Walton1, Ilona Jaspers1,2, Shan Lin3, Stephen B. Waters3, David J. Thomas4 1Department of Pediatrics, 2Center for Environmental Medicine an...

157

Is biological productivity enhanced at the New England shelfbreak front?  

E-print Network

contains a persistent thermohaline shelfbreak front [Houghton et al., 2009; Linder and Gawarkiewicz, 1998Is biological productivity enhanced at the New England shelfbreak front? Weifeng G. Zhang,1 Dennis of the mean seasonal circulation offshore of southern New England predicts upwelling at the shelfbreak front

McGillicuddy Jr., Dennis J.

158

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

E-print Network

Home Biology Medicine Technology Products News Definition Dictionary Movies Links Tags Search RSS Biology Definition Medicine Definition Biology Technology Medicine Technology Biology Dictionary Medicine Dictionary Biology Navigation Medical Navigation HOME >> BIOLOGY >> TECHNOLOGY M Researchers write protein

Espinosa, Horacio D.

159

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

160

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

161

Mechanism of action for anti-radiation vaccine in reducing the biological impact of high-dose gamma irradiation  

NASA Astrophysics Data System (ADS)

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 high-dose gamma irradiation. These radiation-induced toxins, which we have named specific radiation determinants (SRD), were generated in the irradiated tissues and then 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 naïve 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 they 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.

162

Establishment of Canine RNA Polymerase I-Driven Reverse Genetics for Influenza A Virus: Its Application for H5N1 Vaccine Production  

Microsoft Academic Search

In the event of a new influenza pandemic, vaccines whose antigenicities match those of circulating strains must be rapidly produced. Here, we established an alternative reverse genetics system for influenza virus using the canine polymerase I (PolI) promoter sequence that works efficiently in the Madin-Darby canine kidney cell line, a cell line approved for human vaccine production. Using this system,

Shin Murakami; Taisuke Horimoto; Shinya Yamada; Satoshi Kakugawa; Hideo Goto; Yoshihiro Kawaoka

2008-01-01

163

Vaccine Safety  

MedlinePLUS

... in history. CDC's Immunization Safety Office identifies possible vaccine side effects and conducts studies to determine whether a health problem is caused by a specific vaccine. About Vaccine Safety Vaccines Safety Basics Vaccines: Hib, ...

164

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

165

DNA vaccines: ready for prime time?  

PubMed Central

Since the discovery, over a decade and a half ago, that genetically engineered DNA can be delivered in vaccine form and elicit an immune response, there has been much progress in understanding the basic biology of this platform. A large amount of data has been generated in preclinical model systems, and more sustained cellular responses and more consistent antibody responses are being observed in the clinic. Four DNA vaccine products have recently been approved, all in the area of veterinary medicine. These results suggest a productive future for this technology as more optimized constructs, better trial designs and improved platforms are being brought into the clinic. PMID:18781156

Kutzler, Michele A.; Weiner, David B.

2015-01-01

166

IMMUNOLOGY AND MOLECULAR BIOLOGY Microsatellite Markers Linked to Salmonella enterica Serovar Enteritidis Vaccine Response in Young F1 Broiler-Cross Chicks1  

Microsoft Academic Search

Reduction in Salmonella enteritidis (SE) con- tamination is of importance for poultry production as well as for food safety. The objectives of this study were to identify potential genetic markers of antibody response to SE vaccine in young broiler chicks and then to confirm this linkage in broiler-cross offspring, as well as to explore interactions of marker alleles with dam

M. G. Kaiser; N. Deeb; S. J. Lamont

167

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

168

Vaccines against poverty.  

PubMed

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

2014-08-26

169

Foot and mouth disease virus vaccines.  

PubMed

Foot and mouth disease (FMD) is a highly infectious and economically devastating disease of livestock. Although vaccines, available since the early 1900s, have been instrumental in eradicating FMD from parts of the world, the disease still affects millions of animals around the globe and remains the main sanitary barrier to the commerce of animals and animal products. Currently available inactivated antigen vaccines applied intramuscularly to individual animals, confer serotype and subtype specific protection in 1-2 weeks but fail to induce long-term protective immunity. Among the limitations of this vaccine are potential virus escape from the production facility, short shelf life of formulated product, short duration of immunity and requirement of dozens of antigens to address viral antigenic diversity. Here we review novel vaccine approaches that address some of these limitations. Basic research and the combination of reliable animal inoculation models, reverse genetics and computational biology tools will allow the rational design of safe and effective FMD vaccines. These vaccines should address not only the needs of FMD-free countries but also allow the progressive global control and eradication of this devastating disease. PMID:19837296

Rodriguez, Luis L; Grubman, Marvin J

2009-11-01

170

Pilot-Scale Production and Characterization of Paramyosin, a Vaccine Candidate for Schistosomiasis Japonica  

Microsoft Academic Search

Despite effective chemotherapy, schistosomiasis remains a major public health problem in the developing world, with at least 200 million active infections resulting in significant morbidity. Rapid reinfection after treatment, accompanied by extensive residual morbidity, mandates alternative control strategies, including vaccine development. Paramyosin, a myofibrillar protein found only in invertebrates, has been widely studied as a vaccine candidate for both Schistosoma

Mario Jiz; Hai-Wei Wu; Rui Meng; Sunthorn Pond-Tor; Mindy Reynolds; Jennifer F. Friedman; Remigio Olveda; Luz Acosta; Jonathan D. Kurtis

2008-01-01

171

Differences of circulating Bordetella pertussis population in Argentina from the strain used in vaccine production  

Microsoft Academic Search

In Argentina, as in other countries, the number of pertussis cases has been increasing, even in highly vaccinated zones. Many reports suggest that the decline of vaccine efficacy due to antigenic shifts in the circulating Bordetella pertussis might be among the factors that contribute to pertussis re-emergence in different parts of the world. To evaluate the incidence of this factor

M. Fingermann; J. Fernández; F. Sisti; M. E. Rodríguez; B. Gatti; D. Bottero; A. Graieb; M. E. Gaillard; S. González Ayala; F. R. Mooi; H. Lopardo; D. Hozbor

2006-01-01

172

Differences of circulating Bordetella pertussis population in Argentina from the strain used in vaccine production  

Microsoft Academic Search

In Argentina, as in other countries, the number of pertussis cases has been increasing, even in highly vaccinated zones. Many reports suggest that the decline of vaccine efficacy due to antigenic shifts in the circulating Bordetella pertussis might be among the factors that contribute to pertussis re-emergence in different parts of the world. To evaluate the incidence of this factor

M Fingermann; J Fernández; F Sisti; M E Rodríguez; B Gatti; D Bottero; A Graieb; M E Gaillard; S González Ayala; F R Mooi; H Lopardo; D Hozbor

2007-01-01

173

Biological sample preparation: attempts on productivity increasing in bioanalysis.  

PubMed

Sample preparation is an important step of any biomedical analysis. Development and validation of fast, reproducible and reliable sample preparation methods would be very helpful in increasing productivity. Except for a few direct injection methods, almost all biological samples should at least be diluted before any analysis. Sometimes dilution is not possible because of the low concentration of the target analyte in the sample, and alternative pretreatments, such as filtration, precipitation and sample clean up using different extraction methods, are needed. This review focuses on the recent achievements in the pretreatment of biological samples and investigates them in six categories (i.e., dilution, filtration/dialysis, precipitation, extraction [solid-phase extraction, liquid-liquid extraction], novel techniques [turbulent flow chromatography, immunoaffinity method, electromembrane extraction] and combined methods). Each category will be discussed according to its productivity rate and suitability for routine analysis, and the discussed methods will be compared according to the mentioned indices. PMID:25077628

Soltani, Somaieh; Jouyban, Abolghasem

2014-01-01

174

China's emerging vaccine industry.  

PubMed

The Chinese vaccine industry is developing rapidly due to an emerging and large market for current and new vaccines, a large potential for local vaccine manufacturing both in the public and private domain, and a governmental orientation towards national vaccine self-sufficiency. There are currently over 40 companies and institutions manufacturing a large variety of traditional (EPI) and some new vaccines. The innovative development capacity of state vaccine institutions is stimulated by significant government investments. Various Chinese influenza manufacturers were in 2009 among the first worldwide to obtain national license for their pandemic H1N1 flu vaccines. It is of interest to note that private but also governmental entities are committed to raise manufacturing quality standards to reach WHO prequalification. It is expected that WHO prequalification for at least one product from a Chinese manufacturer will have been obtained by 2011. This will open the door to the global market for Chinese vaccines. PMID:20523120

Hendriks, Jan; Liang, Yan; Zeng, Bing

2010-07-01

175

Ethics of vaccination programs.  

PubMed

Ethical issues are present at each stage in the vaccine product life cycle, the period extending from the earliest stages of research through the eventual design and implementation of global vaccination programs. Recent developments highlight fundamental principles of vaccine ethics and raise unique issues for ongoing vaccination activities worldwide. These include the 2009-10 H1N1 pandemic influenza vaccination campaign, renewed attention to the potential global eradication of polio, and the ongoing evaluation of vaccine risk controversies, most notably the alleged link between childhood vaccines and autism. These cases present ethical challenges for public health policy-makers, scientists, physicians, and other stakeholders in their efforts to improve the health of individuals, communities, and nations through vaccination. PMID:22440783

Schwartz, Jason L; Caplan, Arthur L

2011-10-01

176

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

177

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

178

78 FR 32668 - Draft Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood...  

Federal Register 2010, 2011, 2012, 2013, 2014

...an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture...an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or...

2013-05-31

179

77 FR 30887 - Amendments to Sterility Test Requirements for Biological Products; Correction  

Federal Register 2010, 2011, 2012, 2013, 2014

...AND HUMAN SERVICES Food and Drug Administration...Test Requirements for Biological Products; Correction AGENCY: Food and Drug Administration...SUMMARY: The Food and Drug Administration...provides manufacturers of biological products greater...

2012-05-24

180

78 FR 58311 - Complex Issues in Developing Drug and Biological Products for Rare Diseases; Public Workshop...  

Federal Register 2010, 2011, 2012, 2013, 2014

...HUMAN SERVICES Food and Drug Administration...Developing Drug and Biological Products for Rare Diseases; Public Workshop...Comments AGENCY: Food and Drug Administration...The Food and Drug Administration...Developing Drug and Biological Products for Rare Diseases.'' The...

2013-09-23

181

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.

182

Neonatal BCG vaccination induces IL-10 production by CD4+ CD25+ T cells.  

PubMed

To determine the optimal time of Bacillus Calmette-Guerin (BCG) vaccination for induction of Th1 immunity, we measured the interferon (IFN)-? and interleukin (IL)-10 secretion in purified protein derivative (PPD)-stimulated peripheral blood mononuclear cell (PBMC) cultures in newborns vaccinated at birth or 2nd month of life. Moreover, role of CD4(+) CD25(+) T cells was studied by depletion assay at 8th month. Nineteen term and healthy newborns were randomized into two groups: Group I composed of 10 newborns vaccinated with BCG at birth and the remaining 9 (group II) at 2nd month of life. PBMCs were isolated at birth, 2nd and 8th months of age, and PPD-stimulated IL-10, 5 and IFN-? secretion were assessed. The same measurements were repeated for IL-10 and IFN-? after the depletion of CD4(+) CD25(+) T cells at the 8th month. Children vaccinated at birth demonstrated higher PPD-stimulated IFN-? and IL-10 levels at 2 months of age when compared to non-vaccinated ones (p = 0.038 and p = 0.022, respectively), whereas at 8 months, no significant differences were detected between the two groups. Moreover, CD4(+) CD25(+)-depleted T-cell cultures resulted in lower PPD-stimulated IL-10 levels in those vaccinated at birth when compared to non-depleted condition at the 8th month (p < 0.001). BCG at birth upregulated PPD-stimulated IFN-? secretion at the 2nd month and remained still detectable at 8 month after the vaccination, whereas those vaccinated at the 2nd month of life lacked that increase in IFN-? response at the same time-point. Furthermore, depletion assays suggest that CD4(+) CD25(+) T cells are involved in PPD-stimulated IL-10 secretion in response to BCG vaccination. PMID:20977501

Akkoc, Tunc; Aydogan, Metin; Yildiz, Aysegul; Karakoc-Aydiner, Elif; Eifan, Aarif; Keles, Sevgi; Akin, Mustafa; Kavuncuoglu, Sultan; Bahceciler, Nerin N; Barlan, Isil B

2010-11-01

183

Probiotics, immunostimulants, plant products and oral vaccines, and their role as feed supplements in the control of bacterial fish diseases.  

PubMed

There is a rapidly increasing literature pointing to the success of probiotics, immunostimulants, plant products and oral vaccines in immunomodulation, namely stimulation of the innate, cellular and/or humoral immune response, and the control of bacterial fish diseases. Probiotics are regarded as live micro-organisms administered orally and leading to health benefits. However, in contrast with the use in terrestrial animals, a diverse range of micro-organisms have been evaluated in aquaculture with the mode of action often reflecting immunomodulation. Moreover, the need for living cells has been questioned. Also, key subcellular components, including lipopolysaccharides, have been attributed to the beneficial effect in fish. Here, there is a link with immunostimulants, which may also be administered orally. Furthermore, numerous plant products have been reported to have health benefits, namely protection against disease for which stimulation of some immune parameters has been reported. Oral vaccines confer protection against some diseases, although the mode of action is usually linked to humoral rather than the innate and cellular immune responses. This review explores the relationship between probiotics, immunostimulants, plant products and oral vaccines. PMID:25287254

Newaj-Fyzul, A; Austin, B

2014-10-01

184

Do Not Give Infants Cough and Cold Products Designed for Older Children  

MedlinePLUS

... Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Drugs Home Drugs Resources for You ... pharmacies and other retail outlets today. Since infant formulations of cough and cold products were voluntarily removed ...

185

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

186

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

187

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

188

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

189

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

190

9 CFR 113.313 - Measles Vaccine.  

Code of Federal Regulations, 2014 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...

2014-01-01

191

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

192

9 CFR 113.303 - Bluetongue Vaccine.  

Code of Federal Regulations, 2014 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....

2014-01-01

193

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

194

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

195

Possible Side Effects of Chickenpox Vaccine  

MedlinePLUS

... or not. Possible reactions after ProQuad® (or MMRV) vaccination Children who get the first dose of ProQuad® ... MMRV) Vaccine Aspirin use and possible reactions after vaccination You should not take aspirin products for 6 ...

196

Original article Vaccination against swine enzootic pneumonia  

E-print Network

Original article Vaccination against swine enzootic pneumonia in field conditions: effect of vaccination against swine enzootic pneumonia in different production systems (closed or one-site, and open of macroscopic diagnosis in field conditions. pig / Mycoplasma hyopneumoniae / enzootic pneumonia / vaccine

Paris-Sud XI, Université de

197

Role of Pharmacovigilance on Vaccines Control*  

PubMed Central

The pharmacovigilance of vaccines is defined as the science and activities relating to the detection, assessment, understanding, prevention and communication of adverse events of immunization, or any other vaccine, or issues related with immunization. The strengthening of pharmacovigilance is very important in every country because it helps professional health care workers to avoid the problems with immunization, protect the health of people from adverse events during immunization. The success of the immunization system is reducing morbidity and mortality related to the vaccine. The vaccines are biological products used to prevent infectious diseases, but sometimes the vaccines can cause some AEFI (Adverse Events Following Immunization). The detection of adverse events following correct immunization is one very important step for prevention of problems in the immunization system. The vaccines are injected into an infant body on the day of their birth and the safety of these products is vital. In Albania, the Pharmacovigilance department is established as the structure of the National Center of Drug Control. The strengthening of pharmacovigilance in Albania and other countries is necessary, because this will help to identify the risk and the risk factors, and to avoid or minimize the harms.

Kuçuku, Merita

2012-01-01

198

Novel vaccination approaches against equine alphavirus encephalitides.  

PubMed

The current production of inactivated vaccines for the prevention of equine alphavirus encephalitides caused by Eastern, Western and Venezuelan Equine Encephalitis viruses (EEEV, WEEV, VEEV) involves the manipulation of large quantities of infectious viral particles under biosafety level 3 containment laboratories with the potential risk of transmission to the operators. Moreover, these vaccines are not capable of inducing a long-lasting immunity. Modified live vaccines, which were also attempted, maintain residual virulence and neurotropism, causing disease in both horses and humans. Therefore, the production of an efficacious second generation vaccine which could be used in the prevention of alphavirus infection without the need to manipulate infectious viral particles under high biocontainment conditions could be of great benefit for the worldwide horse industry. Furthermore, equine alphaviruses are considered as biological threat agents. Subunit, chimeric, gene-deleted live mutants, DNA and adenovirus-vectored alphavirus vaccines have been evaluated; such approaches are reviewed in this work. Climate changes, together with modifications in bird and vector ecology, are leading to the arise of emerging pathogens in new geographical locations, and these zoonotic New World arboviruses are gaining concern. Novel vaccine development does show a promising future for prevention of these infections in both horses and humans. PMID:24295803

Carossino, Mariano; Thiry, Etienne; de la Grandière, Ana; Barrandeguy, Maria E

2014-01-01

199

Unraveling the Convoluted Biological Roles of Type I Interferons in Infection and Immunity: A Way Forward for Therapeutics and Vaccine Design  

PubMed Central

It has been well-established that type I interferons (IFN-Is) have pleiotropic effects and play an early central role in the control of many acute viral infections. However, their pleiotropic effects are not always beneficial to the host and in fact several reports suggest that the induction of IFN-Is exacerbate disease outcomes against some bacterial and chronic viral infections. In this brief review, we probe into this mystery and try to develop answers based on past and recent studies evaluating the roles of IFN-Is in infection and immunity as this is vital for developing effective IFN-Is based therapeutics and vaccines. We also discuss the biological roles of an emerging IFN-I, namely IFN-?, and discuss its potential use as a mucosal therapeutic and/or vaccine adjuvant. Overall, we anticipate the discussions generated in this review will provide new insights for better exploiting the biological functions of IFN-Is in developing efficacious therapeutics and vaccines in the future. PMID:25221557

Wijesundara, Danushka Kumara; Xi, Yang; Ranasinghe, Charani

2014-01-01

200

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

201

Production of a subunit vaccine candidate against porcine post-weaning diarrhea in high-biomass transplastomic tobacco.  

PubMed

Post-weaning diarrhea (PWD) in piglets is a major problem in piggeries worldwide and results in severe economic losses. Infection with Enterotoxigenic Escherichia coli (ETEC) is the key culprit for the PWD disease. F4 fimbriae of ETEC are highly stable proteinaceous polymers, mainly composed of the major structural subunit FaeG, with a capacity to evoke mucosal immune responses, thus demonstrating a potential to act as an oral vaccine against ETEC-induced porcine PWD. In this study we used a transplastomic approach in tobacco to produce a recombinant variant of the FaeG protein, rFaeG(ntd/dsc), engineered for expression as a stable monomer by N-terminal deletion and donor strand-complementation (ntd/dsc). The generated transplastomic tobacco plants accumulated up to 2.0 g rFaeG(ntd/dsc) per 1 kg fresh leaf tissue (more than 1% of dry leaf tissue) and showed normal phenotype indistinguishable from wild type untransformed plants. We determined that chloroplast-produced rFaeG(ntd/dsc) protein retained the key properties of an oral vaccine, i.e. binding to porcine intestinal F4 receptors (F4R), and inhibition of the F4-possessing (F4+) ETEC attachment to F4R. Additionally, the plant biomass matrix was shown to delay degradation of the chloroplast-produced rFaeG(ntd/dsc) in gastrointestinal conditions, demonstrating a potential to function as a shelter-vehicle for vaccine delivery. These results suggest that transplastomic plants expressing the rFaeG(ntd/dsc) protein could be used for production and, possibly, delivery of an oral vaccine against porcine F4+ ETEC infections. Our findings therefore present a feasible approach for developing an oral vaccination strategy against porcine PWD. PMID:22879967

Kolotilin, Igor; Kaldis, Angelo; Devriendt, Bert; Joensuu, Jussi; Cox, Eric; Menassa, Rima

2012-01-01

202

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

203

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

204

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

Code of Federal Regulations, 2012 CFR

...2012-01-01 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...

2012-01-01

205

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

Code of Federal Regulations, 2013 CFR

...2013-01-01 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...

2013-01-01

206

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

Code of Federal Regulations, 2011 CFR

...2011-01-01 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...

2011-01-01

207

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

Code of Federal Regulations, 2014 CFR

...2014-01-01 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...

2014-01-01

208

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

Federal Register 2010, 2011, 2012, 2013, 2014

...pandemic influenza? 3. Improving availability for developing countries. How can we support and stimulate demand for seasonal flu vaccine in middle and lower income countries? Are there other [[Page 55777

2010-09-14

209

Production of a Particulate Hepatitis C Vaccine Candidate by an Engineered Lactococcus lactis Strain?  

PubMed Central

Vaccine delivery systems based on display of antigens on bioengineered bacterial polyester inclusions can stimulate cellular immune responses. The food-grade Gram-positive bacterium Lactococcus lactis was engineered to produce spherical polyhydroxybutyrate (PHB) inclusions which abundantly displayed the hepatitis C virus core (HCc) antigen. In mice, the immune response induced by this antigen delivery system was compared to that induced by vaccination with HCc antigen displayed on PHB beads produced in Escherichia coli, to PHB beads without antigen produced in L. lactis or E. coli, or directly to the recombinant HCc protein. Vaccination site lesions were minimal in all mice vaccinated with HCc PHB beads or recombinant protein, all mixed in the oil-in-water adjuvant Emulsigen, while vaccination with the recombinant protein in complete Freund's adjuvant produced a marked inflammatory reaction at the vaccination site. Vaccination with the PHB beads produced in L. lactis and displaying HCc antigen produced antigen-specific cellular immune responses with significant release of gamma interferon (IFN-?) and interleukin-17A (IL-17A) from splenocyte cultures and no significant antigen-specific serum antibody, while the PHB beads displaying HCc but produced in E. coli released IFN-? and IL-17A as well as the proinflammatory cytokines tumor necrosis factor alpha (TNF-?) and IL-6 and low levels of IgG2c antibody. In contrast, recombinant HCc antigen in Emulsigen produced a diverse cytokine response and a strong IgG1 antibody response. Overall it was shown that L. lactis can be used to produce immunogenic PHB beads displaying viral antigens, making the beads suitable for vaccination against viral infections. PMID:21984246

Parlane, Natalie A.; Grage, Katrin; Lee, Jason W.; Buddle, Bryce M.; Denis, Michel; Rehm, Bernd H. A.

2011-01-01

210

Pyrazole containing natural products: synthetic preview and biological significance.  

PubMed

A large number of structurally diverse natural compounds containing azole nucleus constitute an important class of biologically active heterocycles that are gaining more attention in the field of medicinal chemistry. Among azoles, pyrazoles are rarely found in nature probably due to difficulty in the formation of N-N bond by living organisms. However, they exhibit numerous biological activities, including anti-diabetic, antiviral, anticancer, anti-inflammatory, antibacterial and antifungal activities. The present review is an attempt to understand the chemistry along with medicinal importance of pyrazole containing natural products reported till date which would certainly help the scientific community to bring further developments in the isolation and synthetic methodologies for pyrazole based novel bioactive compounds. PMID:24099993

Kumar, Vinod; Kaur, Kamalneet; Gupta, Girish Kumar; Sharma, Anil Kumar

2013-11-01

211

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

E-print Network

Home Biology Medicine Technology Products News Definition Dictionary Movies Links Tags Search RSS Products Medicine Products Biology Definition Medicine Definition Biology Technology Medicine Technology year old protein reveals evolutions steps 7. Scientists retrace evolution with first atomic structure

Bennett, Gisele

212

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

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

2014-01-01

213

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

214

Research toward Malaria Vaccines  

NASA Astrophysics Data System (ADS)

Malaria exacts a toll of disease to people in the Tropics that seems incomprehensible to those only familiar with medicine and human health in the developed world. The methods of molecular biology, immunology, and cell biology are now being used to develop an antimalarial vaccine. The Plasmodium parasites that cause malaria have many stages in their life cycle. Each stage is antigenically distinct and potentially could be interrupted by different vaccines. However, achieving complete protection by vaccination may require a better understanding of the complexities of B- and T-cell priming in natural infections and the development of an appropriate adjuvant for use in humans.

Miller, Louis H.; Howard, Russell J.; Carter, Richard; Good, Michael F.; Nussenzweig, Victor; Nussenzweig, Ruth S.

1986-12-01

215

Influence of an immunopotentiator Polyoxidonium on cytokine profile and antibody production in children vaccinated with Priorix.  

PubMed

60 children aged 1-2 years old (32 boys and 28 girls) were vaccinated with Priorix. Vaccinated children included healthy control (19 children, group 1), and children with immunological disturbances such as episodes of respiratory infection. From the latter group, 20 children did not receive (group 2), and 21 children received 0.15 mg/kg of Polyoxidonium simultaneously with the vaccine (group 3).On days 7 and 30 after vaccination, CD-markers on lymphocytes and concentration of specific antibodies, as well as levels of 11 cytokines in serum were evaluated by flow cytometry, ELISA, and multiplex techniques respectively. It was found that injection of Polyoxidonium skewed T helper differentiation to Th2 type. Antibody responses were significantly higher in children with preferable Th2 responses. Children from group 3 possessed higher titers of specific IgG-antibodies. Our study shows that Polyoxidonium could smooth out the immune reaction on vaccination. It is important for children with some immunological disturbances. PMID:22385273

Toptygina, Anna; Semikina, Elena; Alioshkin, Vladimir

2012-10-01

216

Vaccine hesitancy  

PubMed Central

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

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

2013-01-01

217

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

218

DNA array and biological characterization of the impact of the maturation status of mouse dendritic cells on their phenotype and antitumor vaccination efficacy.  

PubMed

We systematically investigated the impact of the relative maturation levels of dendritic cells (DCs) on their cell surface phenotype, expression of cytokines and chemokines/chemokine receptors (by DNA array and RNase protection analyses), biological activities, and abilities to induce tumor immunity. Mature DCs expressed significantly heightened levels of their antigen-presenting machinery (e.g., CD54, CD80, CD86) and numerous cytokines and chemokines/chemokine receptors (i.e., Flt-3L, G-CSF, IL-1alpha and -1beta, IL-6, IL-12, CCL-2, -3, -4, -5, -17, and -22, MIP-2, and CCR7) and were significantly better at inducing effector T cell responses in vitro. Furthermore, mice vaccinated with tumor peptide-pulsed mature DCs better survived challenge with a weakly immunogenic tumor (8 of 8 survivors) than did mice vaccinated with less mature (3 of 8 survived) or immature (0 of 8 survivors) DCs. Nevertheless, intermediate-maturity DCs expressed substantial levels of Flt-3L, IGF-1, IL-1alpha and -1beta, IL-6, CCL-2, -3, -4, -9/10, -17, and -22, MIP-2, osteopontin, CCR-1, -2, -5, and -7, and CXCR-4. Taken together, our data clearly underscore the critical nature of employing DCs of full maturity for DC-based antitumor vaccination strategies. PMID:11902830

Chen, Z; Dehm, S; Bonham, K; Kamencic, H; Juurlink, B; Zhang, X; Gordon, J R; Xiang, J

2001-11-25

219

The biological relevance of virus neutralisation sites for virulence and vaccine protection in the guinea pig model of foot-and-mouth disease.  

PubMed

Five neutralisation epitopes have been defined for the O1 Kaufbeuren strain of foot-and-mouth disease virus (FMDV) by neutralising murine monoclonal antibodies (Mabs). A mutant virus which is resistant to all these Mabs also resists neutralisation by bovine polyclonal sera, and this characteristic was exploited in the current study to investigate the biological relevance of neutralisation sites in FMDV virulence and vaccine protection. The five site neutralisation-resistant mutant was shown to be as pathogenic as wild-type virus in the guinea pig model of FMD. Guinea pigs were protected in cross-challenge studies from virulent wild-type and mutant viruses using either wild-type or mutant 146S antigen as inactivated whole virus vaccine. Furthermore, hyperimmune sera raised to either wild-type or mutant antigen offered passive protection against wild-type challenge, in spite of the serum raised against the mutant antigen having minimal neutralising activity in vitro. These results imply that virus neutralisation, at least as defined by the in vitro assay, may not play an essential role in the mechanism of immunity induced by whole inactivated FMDV vaccines. PMID:9683571

Dunn, C S; Samuel, A R; Pullen, L A; Anderson, J

1998-07-20

220

Production of Inactivated Influenza H5N1 Vaccines from MDCK Cells in Serum-Free Medium  

PubMed Central

Background Highly pathogenic influenza viruses pose a constant threat which could lead to a global pandemic. Vaccination remains the principal measure to reduce morbidity and mortality from such pandemics. The availability and surging demand for pandemic vaccines needs to be addressed in the preparedness plans. This study presents an improved high-yield manufacturing process for the inactivated influenza H5N1 vaccines using Madin-Darby canine kidney (MDCK) cells grown in a serum-free (SF) medium microcarrier cell culture system. Principal Finding The current study has evaluated the performance of cell adaptation switched from serum-containing (SC) medium to several commercial SF media. The selected SF medium was further evaluated in various bioreactor culture systems for process scale-up evaluation. No significant difference was found in the cell growth in different sizes of bioreactors studied. In the 7.5 L bioreactor runs, the cell concentration reached to 2.3×106 cells/mL after 5 days. The maximum virus titers of 1024 Hemagglutinin (HA) units/50 µL and 7.1±0.3×108 pfu/mL were obtained after 3 days infection. The concentration of HA antigen as determined by SRID was found to be 14.1 µg/mL which was higher than those obtained from the SC medium. A mouse immunogenicity study showed that the formalin-inactivated purified SF vaccine candidate formulated with alum adjuvant could induce protective level of virus neutralization titers similar to those obtained from the SC medium. In addition, the H5N1 viruses produced from either SC or SF media showed the same antigenic reactivity with the NIBRG14 standard antisera. Conclusions The advantages of this SF cell-based manufacturing process could reduce the animal serum contamination, the cost and lot-to-lot variation of SC medium production. This study provides useful information to manufacturers that are planning to use SF medium for cell-based influenza vaccine production. PMID:21283675

Hu, Alan Yung-Chih; Tseng, Yu-Fen; Weng, Tsai-Chuan; Liao, Chien-Chun; Wu, Johnson; Chou, Ai-Hsiang; Chao, Hsin-Ju; Gu, Anna; Chen, Janice; Lin, Su-Chen; Hsiao, Chia-Hsin; Wu, Suh-Chin; Chong, Pele

2011-01-01

221

Vaccination and anaphylaxis  

Microsoft Academic Search

The incidence of anaphylactic or severe allergic reactions to vaccines is very low, less than one case per million vaccine\\u000a doses. Larger studies from later years report no deaths. The cause of the reaction is usually not the immunizing antigen itself,\\u000a but rather some other vaccine ingredient such as egg protein from the production process or gelatin added as a

Hanne Nokleby

2006-01-01

222

An alternative approach to combination vaccines: intradermal administration of isolated components for control of anthrax, botulism, plague and staphylococcal toxic shock  

PubMed Central

Background Combination vaccines reduce the total number of injections required for each component administered separately and generally provide the same level of disease protection. Yet, physical, chemical, and biological interactions between vaccine components are often detrimental to vaccine safety or efficacy. Methods As a possible alternative to combination vaccines, we used specially designed microneedles to inject rhesus macaques with four separate recombinant protein vaccines for anthrax, botulism, plague and staphylococcal toxic shock next to each other just below the surface of the skin, thus avoiding potentially incompatible vaccine mixtures. Results The intradermally-administered vaccines retained potent antibody responses and were well- tolerated by rhesus macaques. Based on tracking of the adjuvant, the vaccines were transported from the dermis to draining lymph nodes by antigen-presenting cells. Vaccinated primates were completely protected from an otherwise lethal aerosol challenge by Bacillus anthracis spores, botulinum neurotoxin A, or staphylococcal enterotoxin B. Conclusion Our results demonstrated that the physical separation of vaccines both in the syringe and at the site of administration did not adversely affect the biological activity of each component. The vaccination method we describe may be scalable to include a greater number of antigens, while avoiding the physical and chemical incompatibilities encountered by combining multiple vaccines together in one product. PMID:18768085

Morefield, Garry L; Tammariello, Ralph F; Purcell, Bret K; Worsham, Patricia L; Chapman, Jennifer; Smith, Leonard A; Alarcon, Jason B; Mikszta, John A; Ulrich, Robert G

2008-01-01

223

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

224

Adjuvants for allergy vaccines  

PubMed Central

Allergen-specific immunotherapy is currently performed via either the subcutaneous or sublingual routes as a treatment for type I (IgE dependent) allergies. Aluminum hydroxide or calcium phosphate are broadly used as adjuvants for subcutaneous allergy vaccines, whereas commercial sublingual vaccines rely upon high doses of aqueous allergen extracts in the absence of any immunopotentiator. Adjuvants to be included in the future in products for allergen specific immunotherapy should ideally enhance Th1 and CD4+ regulatory T cell responses. Imunomodulators impacting dendritic or T cell functions to induce IL10, IL12 and IFN? production are being investigated in preclinical allergy models. Such candidate adjuvants encompass synthetic or biological immunopotentiators such as glucocorticoids, 1,25-dihydroxy vitamin D3, selected probiotic strains (e.g., Lactobacillus and Bifidobacterium species) as well as TLR2 (Pam3CSK4), TLR4 (monophosphoryl lipid A, synthetic lipid A analogs) or TLR9 (CpGs) ligands. Furthermore, the use of vector systems such as mucoadhesive particules, virus-like particles or liposomes are being considered to enhance allergen uptake by tolerogenic antigen presenting cells present in mucosal tissues. PMID:23095872

Moingeon, Philippe

2012-01-01

225

Adjuvants for allergy vaccines.  

PubMed

Allergen-specific immunotherapy is currently performed via either the subcutaneous or sublingual routes as a treatment for type I (IgE dependent) allergies. Aluminum hydroxide or calcium phosphate are broadly used as adjuvants for subcutaneous allergy vaccines, whereas commercial sublingual vaccines rely upon high doses of aqueous allergen extracts in the absence of any immunopotentiator. Adjuvants to be included in the future in products for allergen specific immunotherapy should ideally enhance Th1 and CD4+ regulatory T cell responses. Imunomodulators impacting dendritic or T cell functions to induce IL10, IL12 and IFN? production are being investigated in preclinical allergy models. Such candidate adjuvants encompass synthetic or biological immunopotentiators such as glucocorticoids, 1,25-dihydroxy vitamin D3, selected probiotic strains (e.g., Lactobacillus and Bifidobacterium species) as well as TLR2 (Pam3CSK4), TLR4 (monophosphoryl lipid A, synthetic lipid A analogs) or TLR9 (CpGs) ligands. Furthermore, the use of vector systems such as mucoadhesive particules, virus-like particles or liposomes are being considered to enhance allergen uptake by tolerogenic antigen presenting cells present in mucosal tissues. PMID:23095872

Moingeon, Philippe

2012-10-01

226

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

227

The Optimal Composition of Influenza Vaccines Subject to Random Production Yields  

E-print Network

Analysis Society Student Paper Competition in 2007. #12;2 1. Introduction According to the World Health cost of $3-18 billion (WHO 2005). In light of the proven efficacy and safety of vaccines, the WHO composition for the northern hemisphere for the flu season which begins the following October. In the U

228

AGE DIFFERENCE IN LYMPHOCYTE PROLIFERATION, IL-2 AND IFN-Y PRODUCTION FOLLOWING SALMONELLA ENTERITIDIS VACCINATION.  

Technology Transfer Automated Retrieval System (TEKTRAN)

The present study was conducted to investigate the effect of age on cell-mediated immune responses to different antigens from Salmonella serovar Enteritidis (SE) following vaccination with the commercially available heat-the killed bacterin. Eight-month- and 4-week-old chickens were given two subcu...

229

In planta Production of Flock House Virus Transencapsidated RNA and Its Potential Use as a Vaccine.  

PubMed

We have developed a transencapsidated vaccine delivery system based on the insect virus, Flock House virus (FHV). FHV is attractive due to its small genome size, simple organization, and nonpathogenic characteristics. With the insertion of a Tobacco mosaic virus (TMV) origin of assembly (Oa), the independently replicating FHV RNA1 can be transencapsidated by TMV coat protein. In this study, we demonstrated that the Oa-adapted FHV RNA1 transencapsidation process can take place in planta, by using a bipartite plant expression vector system, where TMV coat protein is expressed by another plant virus vector, Foxtail mosaic virus (FoMV). Dual infection in the same cell by both FHV and FoMV was observed. Though an apparent classical coat protein-mediated resistance repressed FHV expression, this was overcome by delaying inoculation of the TMV coat protein vector by 3 days after FHV vector inoculation. Expression of the transgene marker in animals by these in vivo-generated transencapsidated nanoparticles was confirmed by mouse vaccination, which also showed an improved vaccine response compared to similar in vitro-produced vaccines. PMID:25432792

Zhou, Yiyang; Maharaj, Payal D; Mallajosyula, Jyothi K; McCormick, Alison A; Kearney, Christopher M

2014-11-29

230

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

PubMed

Combination vaccines have been endorsed as a means to decrease the number of injections needed to complete the childhood immunization schedule, yet anecdotal reports suggest that private providers lose money on combination vaccines. The objective of this study was to determine whether practices purchasing combination vaccines had significantly different vaccine costs and reimbursement compared to practices that were not purchasing combination vaccines. Using cross-sectional purchase and insurer payment data collected from a targeted sample of private practices in five US states, we calculated the average total vaccine cost and reimbursement across the childhood immunization schedule. The average vaccine purchase cost across the childhood schedule was significantly higher for practices using a combined vaccine with diphtheria, tetanus, acellular pertussis vaccine, inactivated polio vaccine, and Hepatitis B vaccine (DTaP-IPV-HepB) than for practices using either separate vaccine products or a combined vaccine with Haemophilus influenzae, type b vaccine and Hepatitis B vaccine (Hib-HepB). The average insurer payment for vaccine administration across the childhood schedule was significantly lower for practices using DTaP-IPV-HepB combination vaccine than for practices using separate vaccine products. This study appears to validate anecdotal reports that vaccine purchase costs and insurer payment for combination vaccines can have a negative financial impact for practices that purchase childhood vaccines. PMID:21389778

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

2011-04-01

231

Is biological productivity enhanced at the New England shelfbreak front?  

NASA Astrophysics Data System (ADS)

A two-dimensional (cross-shelf) numerical model of the mean seasonal circulation offshore of southern New England predicts upwelling at the shelfbreak front. Expected ramifications of this upwelling include enhancement of nutrient supply, phytoplankton biomass, and productivity. However, seasonal climatologies of chlorophyll based on both in situ data and satellite observations show no mean enhancement at the front. We investigate this apparent discrepancy with a four-component planktonic ecosystem model coupled to the two-dimensional physical model. Nutrient fields are restored to climatological values at depth, and upper ocean values evolve freely according to physical and biological forcing. Vertical diffusivity is based on seasonally averaged surface and bottom mixed layer depths compiled from in situ observations. The model reproduces the general pattern of the observed cross-shelf and seasonal variations of the chlorophyll distribution. It predicts a local enhancement of phytoplankton productivity at the shelfbreak in spring and summer as a result of the persistently upwelled nutrient-rich slope water. In the model, zooplankton grazing prevents accumulation of phytoplankton biomass at the site of the upwelling. The predicted enhancement of primary productivity (but not phytoplankton biomass) at the shelfbreak constitutes a hypothesis that could be tested in the future with suitable measurements from regional long-term observatories, such as the Ocean Observatories Initiative Pioneer Array.

Zhang, Weifeng G.; McGillicuddy, Dennis J.; Gawarkiewicz, Glen G.

2013-01-01

232

Biological production of ethanol from coal. Final report  

SciTech Connect

Due to the abundant supply of coal in the United States, significant research efforts have occurred over the past 15 years concerning the conversion of coal to liquid fuels. Researchers at the University of Arkansas have concentrated on a biological approach to coal liquefaction, starting with coal-derived synthesis gas as the raw material. Synthesis gas, a mixture of CO, H{sub 2}, CO{sub 2}, CH{sub 4} and sulfur gases, is first produced using traditional gasification techniques. The CO, CO{sub 2} and H{sub 2} are then converted to ethanol using a bacterial culture of Clostridium 1jungdahlii. Ethanol is the desired product if the resultant product stream is to be used as a liquid fuel. However, under normal operating conditions, the ``wild strain`` produces acetate in favor of ethanol in conjunction with growth in a 20:1 molar ratio. Research was performed to determine the conditions necessary to maximize not only the ratio of ethanol to acetate, but also to maximize the concentration of ethanol resulting in the product stream.

Not Available

1992-12-01

233

Anthrax vaccination strategies  

PubMed Central

The biological attack conducted through the U.S. postal system in 2001 broadened the threat posed by anthrax from one pertinent mainly to soldiers on the battlefield to one understood to exist throughout our society. The expansion of the threatened population placed greater emphasis on the reexamination of how we vaccinate against Bacillus anthracis. The currently-licensed Anthrax Vaccine, Adsorbed (AVA) and Anthrax Vaccine, Precipitated (AVP) are capable of generating a protective immune response but are hampered by shortcomings that make their widespread use undesirable or infeasible. Efforts to gain U.S. Food and Drug Administration (FDA) approval for licensure of a second generation recombinant protective antigen (rPA)-based anthrax vaccine are ongoing. However, this vaccine's reliance on the generation of a humoral immune response against a single virulence factor has led a number of scientists to conclude that the vaccine is likely not the final solution to optimal anthrax vaccine design. Other vaccine approaches, which seek a more comprehensive immune response targeted at multiple components of the B. anthracis organism, are under active investigation. This review seeks to summarize work that has been done to build on the current PA-based vaccine methodology and to evaluate the search for future anthrax prophylaxis strategies. PMID:19729034

Cybulski, Robert J.; Sanz, Patrick; O'Brien, Alison D.

2009-01-01

234

Production and Evaluation of a Recombinant Chimeric Vaccine against Clostridium botulinum Neurotoxin Types C and D  

PubMed Central

Bovine botulism is a fatal disease that is caused by botulinum neurotoxins (BoNTs) produced by Clostridium botulinum serotypes C and D and that causes great economic losses, with nearly 100% lethality during outbreaks. It has also been considered a potential source of human food-borne illness in many countries. Vaccination has been reported to be the most effective way to control bovine botulism. However, the commercially available toxoid-based vaccines are difficult and hazardous to produce. Neutralizing antibodies targeted against the C-terminal fragment of the BoNT heavy chain (HC) are known to confer efficient protection against lethal doses of BoNTs. In this study, a novel recombinant chimera, consisting of Escherichia coli heat-labile enterotoxin B subunit (LTB), a strong adjuvant of the humoral immune response, fused to the HC of BoNT serotypes C and D, was produced in E. coli. Mice vaccinated with the chimera containing LTB and an equivalent molar ratio of the chimera without LTB plus aluminum hydroxide (Al(OH)3) developed 2 IU/mL of antitoxins for both serotypes. Guinea pigs immunized with the recombinant chimera with LTB plus Al(OH)3 developed a protective immune response against both BoNT/C (5 IU/mL) and BoNT/D (10 IU/mL), as determined by a mouse neutralization bioassay with pooled sera. The results achieved with guinea pig sera fulfilled the requirements of commercial vaccines for prevention of botulism, as determined by the Brazilian Ministry of Agriculture, Livestock and Food, Supply. The presence of LTB was essential for the development of a strong humoral immune response, as it acted in synergism with Al(OH)3. Thus, the vaccine described in this study is a strong candidate for the control of botulism in cattle. PMID:23936080

Gil, Luciana A. F.; da Cunha, Carlos Eduardo P.; Moreira, Gustavo M. S. G.; Salvarani, Felipe M.; Assis, Ronnie A.; Lobato, Francisco Carlos F.; Mendonça, Marcelo; Dellagostin, Odir A.; Conceição, Fabricio R.

2013-01-01

235

Vaccination against infectious diseases: what is promising?  

PubMed

Vaccination has proven to be one of the best weapons protecting the mankind against infectious diseases. Along with the huge progress in microbiology, numerous highly efficacious and safe vaccines have been produced by conventional technology (cultivation), by the use of molecular biology (genetic modification), or by synthetic chemistry. Sterilising prevention is achieved by the stimulation of antibody production, while the stimulation of cell-mediated immune responses may prevent the outbreak of disease in consequence of an acute or reactivated infection. From several examples, two rules are deduced to evaluate the perspectives of future vaccine developments: They are promising, if (1) the natural infectious disease induces immunity or (2) passive immunisation (transfer of antibodies, adoptive transfer of lymphocytes) is successful in preventing infection. PMID:25064610

Doerr, Hans Wilhelm; Berger, Annemarie

2014-12-01

236

21 CFR 610.68 - Exceptions or alternatives to labeling requirements for biological products held by the Strategic...  

Code of Federal Regulations, 2010 CFR

...alternatives to labeling requirements for biological products held by the Strategic National... 610.68 Section 610.68 Food and Drugs FOOD AND DRUG ADMINISTRATION...CONTINUED) BIOLOGICS GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling...

2010-04-01

237

Collaborative study for the establishment of two European Pharmacopoeia Biological Reference Preparations for serological potency testing of tetanus vaccines for veterinary use.  

PubMed

The European Directorate for the Quality of Medicines (EDQM) has organised an international collaborative study, divided into two phases, aimed at producing and establishing two suitable reference sera for serological potency testing of tetanus vaccines for veterinary use for batch consistency demonstration. In phase I pools of sera were produced by immunising guinea pigs and rabbits with tetanus toxoid using the immunisation schedule prescribed by the European Pharmacopoeia (Ph. Eur.) for potency testing of tenanus vaccines for veterinary use. Following aliquoting and freeze-drying, characterization of the materials by immunochemical and biological assays enabled us to conclude that the sera should be suitable reference materials in respect of in-vitro assay methods for Clostridium (C.) tetani. The candidate (c) Ph. Eur. Biological Reference Preparations (BRP) were calibrated by Toxin Binding Inhibition test (ToBI) in phase II of the study by a large group of laboratories, including both manufacturers and official medicines control laboratories (OMCL). The activity of the proposed reference sera was determined by comparison with the existing equine monovalent World Health Organization (WHO) International Standard (IS). This study enabled us to provide a definitive value for the antitoxin activity of the reference preparations in respect of their anti-tetanus antibody content. PMID:12678226

Lensing, H H; Behr-Gross, M E; Daas, A; Spieser, J M

2002-01-01

238

Tuberculosis vaccine development: recent progress.  

PubMed

Recent years have seen a renewed effort to develop new vaccines against tuberculosis. As a result, several promising avenues of research have developed, including the production of recombinant vaccines, auxotrophic vaccines, DNA vaccines and subunit vaccines. In this article we briefly review this work, as well as consider the pros and cons of the animal models needed to test these new vaccines. Screening to date has been carried out in mouse and guinea pig models, which have been used to obtain basic information such as the effect of the vaccine on bacterial load, and whether the vaccine can prevent or reduce lung pathology. The results to date lead us to be optimistic that new candidate vaccines could soon be considered for evaluation in clinical trials. PMID:11239788

Orme, I M; McMurray, D N; Belisle, J T

2001-03-01

239

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

240

Establishment of the European Pharmacopoeia Biological Reference Preparation (Ph. Eur. BRP) for hepatitis A vaccine type B (Aventis Pasteur) batch 2.  

PubMed

A collaborative study was organised by the European Directorate for the Quality of Medicines with the goal to calibrate a candidate European Pharmacopoeia Biological Reference Preparation (Ph. Eur. BRP) for hepatitis A vaccine (adsorbed, inactivated) type B (Aventis Pasteur) batch 2 against the International Standard using the antigen content- and immunogenicity assay. Nine laboratories participated in the study; seven carried out both assays. Three samples were to be assayed, sample A, the 1st International Standard for hepatitis A vaccine (inactivated), sample B, the candidate BRP and sample C, the hepatitis A vaccine BRP type B (Aventis Pasteur) batch 1. Samples B and C represent the currently marketed vaccine and contain an antigen that is formalin inactivated and alum adjuvanted. For samples B and C, desorption was necessary prior to the antigen content assay; a proprietary desorption procedure had to be used. Due to an insufficient number of samples, sample C could only be tested in the antigen content assay. Samples A and B had to be tested in 3 independent experiments in the immunogenicity assay; an assay had to be used that produced a dose response curve. All three samples had to be tested also in three independent experiments in the antigen content assay using a standard method. The results from the immunogenicity assays were submitted to probit analyses, the results from the antigen content assays to parallel line analyses on log transformed responses. Based on the results of the collaborative study, the candidate BRP batch 2 appeared suitable as reference preparation for the immunogenicity assay of adsorbed, inactivated hepatitis A vaccines from Aventis Pasteur. A potency value of 262 IU/ml was assigned based on the calibration against the 1st International Standard. The attempt to reproduce the in vitro potency of the BRP batch 1 in the current study failed; only about 50% of the previously established potency was found. It was hypothesised that this loss in potency might be due to ageing of the antigen which changed adsorption behaviour, and subsequently would lead to reduced desorption and lower in vitro potency. Additional experiments were performed to investigate this hypothesis. For older vaccines a much lower degree of desorption and thus a much lower in vitro potency was found, when using the proprietary desorption method. With more vigorous desorption procedures, this problem could only partly be overcome. Thus the results obtained in the antigen content assay in the collaborative study and in the additional experiments did not allow proposing the candidate reference preparation for use in the antigen content assay for hepatitis A vaccine from Aventis Pasteur. The candidate BRP was adopted by the European Pharmacopoeia Commission at its session in March 2002 as Ph. Eur. BRP for hepatitis A vaccine (adsorbed, inactivated) type B (Aventis Pasteur) batch 2 to be used for the immunogenicity assay. PMID:12448033

Buchheit, K H; Daas, A

2002-06-01

241

VACCINE INFORMATION STATEMENT Influenza Vaccine  

E-print Network

VACCINE INFORMATION STATEMENT Influenza Vaccine What You Need to Know (Flu Vaccine, Live, Intranasal) 2013-2014 Many Vaccine Information Statements are available in Spanish and other languages. See idiomas. Visite www.immunize.org/vis 1 Why get vaccinated? Influenza ("flu") is a contagious disease

Oklahoma, University of

242

Hormones in international meat production: biological, sociological and consumer issues.  

PubMed

Beef and its products are an important source of nutrition in many human societies. Methods of production vary and include the use of hormonal compounds ('hormones') to increase growth and lean tissue with reduced fat deposition in cattle. The hormonal compounds are naturally occurring in animals or are synthetically produced xenobiotics and have oestrogenic (oestradiol-17beta and its esters; zeranol), androgenic (testosterone and esters; trenbolone acetate) or progestogenic (progesterone; melengestrol acetate) activity. The use of hormones as production aids is permitted in North American countries but is no longer allowed in the European Union (EU), which also prohibits the importation of beef and its products derived from hormone-treated cattle. These actions have resulted in a trade dispute between the two trading blocs. The major concern for EU authorities is the possibility of adverse effects on human consumers of residues of hormones and metabolites. Methods used to assess possible adverse effects are typical of those used by international agencies to assess acceptability of chemicals in human food. These include analysis of quantities present in the context of known biological activity and digestive, absorptive, post-absorptive and excretory processes. Particular considerations include the low quantities of hormonal compounds consumed in meat products and their relationships to endogenous production particularly in prepubertal children, enterohepatic inactivation, cellular receptor- and non-receptor-mediated effects and potential for interference with growth, development and physiological function in consumers. There is particular concern about the role of oestradiol-17beta as a carcinogen in certain tissues. Now subject to a 'permanent' EU ban, current evidence suggests that certain catechol metabolites may induce free-radical damage of DNA in cell and laboratory animal test systems. Classical oestrogen-receptor mediation is considered to stimulate proliferation in cells maintaining receptivity. Mathematical models describing quantitative relationships between consumption of small amounts of oestrogens in meat in addition to greater concentrations from endogenous production, chemical stoichiometry at cellular level and human pathology have not been developed. Such an approach will be necessary to establish 'molecular materiality' of the additional hormone intake as a component of relative risk assessment. The other hormones, although generally less well researched, are similarly subject to a range of tests to determine potentially adverse effects. The resulting limited international consensus relates to the application of the 'precautionary principle' and non-acceptance by the European Commission of the recommendations of the Codex Alimentarius Commission, which determined that meat from cattle, hormone-treated according to good practice, was safe for human consumers. The present review considers the hormone issue in the context of current international social methodology and regulation, recent advances in knowledge of biological activity of hormones and current status of science-based evaluation of food safety and risk for human consumers. PMID:19087409

Galbraith, Hugh

2002-12-01

243

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; W?grzyn, Alicja

2007-01-01

244

HPV vaccine  

MedlinePLUS

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

245

Competency development in antibody production in cancer cell biology  

SciTech Connect

This is the final report of a three-year, Laboratory Directed Research and Development (LDRD) project at Los Alamos National Laboratory (LANL). The main objective of this project was to develop a rapid recombinant antibody production technology. To achieve the objective, the authors employed (1) production of recombinant antigens that are important for cell cycle regulation and DNA repair, (2) immunization and specific selection of antibody-producing lymphocytes using the flow cytometry and magnetic bead capturing procedure, (3) construction of single chain antibody library, (4) development of recombinant vectors that target, express, and regulate the expression of intracellular antibodies, and (5) specific inhibition of tumor cell growth in tissue culture. The authors have accomplished (1) optimization of a selection procedure to isolate antigen-specific lymphocytes, (2) optimization of the construction of a single-chain antibody library, and (3) development of a new antibody expression vector for intracellular immunization. The future direction of this research is to continue to test the potential use of the intracellular immunization procedure as a tool to study functions of biological molecules and as an immuno-cancer therapy procedure to inhibit the growth of cancer cells.

Park, M.S.

1998-12-01

246

Biological removal of cationic fission products from nuclear wastewater.  

PubMed

Nuclear energy is becoming a preferred energy source amidst rising concerns over the impacts of fossil fuel based energy on global warming and climate change. However, the radioactive waste generated during nuclear power generation contains harmful long-lived fission products such as strontium (Sr). In this study, cationic strontium uptake from solution by microbial cultures obtained from mine wastewater is evaluated. A high strontium removal capacity (q(max)) with maximum loading of 444 mg/g biomass was achieved by a mixed sulphate reducing bacteria (SRB) culture. Sr removal in SRB was facilitated by cell surface based electrostatic interactions with the formation of weak ionic bonds, as 68% of the adsorbed Sr(2+) was easily desorbed from the biomass in an ion exchange reaction with MgCl?. To a lesser extent, precipitation reactions were also found to account for the removal of Sr from aqueous solution as about 3% of the sorbed Sr was precipitated due to the presence of chemical ligands while the remainder occurred as an immobile fraction. Further analysis of the Sr-loaded SRB biomass by scanning electron microscopy (SEM) coupled to energy dispersive X-ray (EDX) confirmed extracellular Sr(2+) precipitation as a result of chemical interaction. In summary, the obtained results demonstrate the prospects of using biological technologies for the remediation of industrial wastewaters contaminated by fission products. PMID:21245563

Ngwenya, N; Chirwa, E M N

2011-01-01

247

Production and characterization of vaccines based on flaviviruses defective in replication  

SciTech Connect

To develop new vaccine candidates for flavivirus infections, we have engineered two flaviviruses, yellow fever virus (YFV) and West Nile virus (WNV), that are deficient in replication. These defective pseudoinfectious viruses (PIVs) lack a functional copy of the capsid (C) gene in their genomes and are incapable of causing spreading infection upon infection of cells both in vivo and in vitro. However, they produce extracellular E protein in form of secreted subviral particles (SVPs) that are known to be an effective immunogen. PIVs can be efficiently propagated in trans-complementing cell lines making high levels of C or all three viral structural proteins. PIVs derived from YFV and WNV, demonstrated very high safety and immunization produced high levels of neutralizing antibodies and protective immune response. Such defective flaviviruses can be produced in large scale under low biocontainment conditions and should be useful for diagnostic or vaccine applications.

Mason, Peter W. [Department of Microbiology and Immunology, University of Texas Medical Branch, 301 University Boulevard, Galveston, TX 77555-1019 (United States); Department of Pathology, University of Texas Medical Branch, 301 University Boulevard, Galveston, TX 77555-1019 (United States); Sealy Center for Vaccine Development, University of Texas Medical Branch, 301 University Boulevard, Galveston, TX 77555-1019 (United States); Shustov, Alexandr V. [Department of Microbiology and Immunology, University of Texas Medical Branch, 301 University Boulevard, Galveston, TX 77555-1019 (United States); Frolov, Ilya [Department of Microbiology and Immunology, University of Texas Medical Branch, 301 University Boulevard, Galveston, TX 77555-1019 (United States)]. E-mail: ivfrolov@utmb.edu

2006-08-01

248

Plant-based rapid production of recombinant subunit hemagglutinin vaccines targeting H1N1 and H5N1 influenza.  

PubMed

In 2009, a novel H1N1 swine influenza virus was isolated from infected humans in Mexico and the United States, and rapidly spread around the world. Another virus, a highly pathogenic avian influenza virus of the H5N1 subtype, identified by the World Health Organization as a potential pandemic threat in 1997, continues to be a significant risk. While vaccination is the preferred strategy for the prevention and control of influenza infections, the traditional egg-based approach to producing influenza vaccines does not provide sufficient capacity and adequate speed to satisfy global needs to combat newly emerging strains, seasonal or potentially pandemic. Significant efforts are underway to develop and implement new cell substrates with improved efficiency for influenza vaccine development and manufacturing. In recent years, plants have been used to produce recombinant proteins including subunit vaccines and antibodies. The main advantages of using plant systems for the production of vaccine antigens against influenza are their independence from pathogenic viruses, and cost and time efficiency. Here, we describe the large-scale production of recombinant hemagglutinin proteins from A/California/04/09 (H1N1) and A/Indonesia/05/05 (H5N1) strains of influenza virus in Nicotiana benthamiana plants, and their immunogenicity (serum hemagglutination inhibition and virus neutralizing antibodies), and safety in animal models. These results support the testing of these candidate vaccines in human volunteers and also the utility of our plant expression system for large-scale recombinant influenza vaccine production. PMID:21266846

Shoji, Yoko; Chichester, Jessica A; Jones, Mark; Manceva, Slobodanka D; Damon, Emily; Mett, Vadim; Musiychuk, Konstantin; Bi, Hong; Farrance, Christine; Shamloul, Moneim; Kushnir, Natasha; Sharma, Satish; Yusibov, Vidadi

2011-01-01

249

HPLC-based quantification of haemagglutinin in the production of egg- and MDCK cell-derived influenza virus seasonal and pandemic vaccines.  

PubMed

The haemagglutinin (HA) content is an important specification of influenza vaccines. Recently, a reversed-phase high performance liquid chromatography (RP-HPLC) method for quantification of HA in PER.C6 cell culture-based whole virus vaccines has been reported, having a high sensitivity, precision, broad range, and high sample throughput [Kapteyn JC, Drissi Saidi M, Dijkstra R, Kars C, Tjon CMS-K, Weverling GJ et al. Haemagglutinin quantification and identification of influenza A&B strains propagated in PER.C6 cells: a novel RP-HPLC method. Vaccine 2006;24:3137-44]. This RP-HPLC assay is based on measuring the peak area of HA1, the hydrophilic subunit of HA, which turned out to be proportional to the amount of HA analyzed. Here, we present data demonstrating that this RP-HPLC method is also highly suitable for HA quantification of active and BPL- or formaldehyde-inactivated egg-based and MDCK cell-based whole virus samples, including egg allantoic harvest, and in final (monovalent) subunit vaccines, including those for pandemic H5N1 strains and for virosomal vaccines. In addition, the RP-HPLC assay was demonstrated to be a very powerful tool in the early stages of seasonal influenza vaccine production, when homologous serial radial immunodiffusion (SRID) reagents are not yet available, enabling fast and reliable viral growth studies in eggs in order to select the best growing virus strains or reassortants for the production of the seasonal trivalent influenza vaccine. Because of its high sensitivity, the RP-HPLC assay has shown its enormous value in supporting small scale MDCK-based (H5N1) influenza virus production models. Finally, the observed differences between HA1 molecules from various HA subtypes in UV absorbance, FLD response, and in the actual retention times in RP-HPLC are discussed in relation to the primary structure of the HA1 molecules studied. PMID:19110022

Kapteyn, J C; Porre, A M; de Rond, E J P; Hessels, W B; Tijms, M A; Kessen, H; Slotboom, A M E; Oerlemans, M A; Smit, D; van der Linden, J; Schoen, P; Thus, J L G

2009-02-25

250

Vaccine acceptance  

PubMed Central

The United Kingdom has had a long history with vaccine acceptability dating back to Edward Jenner’s theory of small pox vaccination. More recently, the discredited, Wakefield study published in 1998 continues to cause MMR skepticism. In pregnant women pertussis vaccination has been considerably more successful than influenza vaccination. Influenza vaccine uptake in healthcare workers remains poor. The media, politicians, and health reforms have contributed to the mixed coverage for these vaccines. In this article we examine vaccine acceptability from a UK perspective, and consider the future impact this is likely to have on the introduction of rotavirus and shingles vaccine in the UK in 2013. PMID:24025731

Ford, John A; Mahgoub, Hamid; Shankar, Ananda Giri

2013-01-01

251

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 for a vaccine, but here I use standard techniques from mathematical epidemiology to show that such vaccines the fraction of the population that must be vaccinated to eradicate this disease as ! (R0 "1)/(1" #)R0. Here

Day, Troy

252

Antiradiation vaccine: Technology and development of prophylaxis, prevention and treatment of biological consequences from Heavy Ion irradiation.  

NASA Astrophysics Data System (ADS)

Introduction: An anti-radiation vaccine could be an important part of a countermeasures reg-imen for effective radioprotection, immunoprophylaxis and immunotherapy of the acute radi-ation syndromes (ARS) after gamma-irradiation, neutron irradiation or heavy ion irradiation. Reliable protection of non-neoplastic regions of patients with different forms of cancer which undergo to heavy ion therapy ( e.g. Hadron-therapy) can significantly extend the efficiency of the therapeutic course. The protection of cosmonauts astronauts from the heavy ion ra-diation component of space radiation with specific immunoprophylaxis by the anti-radiation vaccine may be an important part of medical management for long term space missions. Meth-ods and experiments: 1. The Antiradiation Vaccine preparation -standard (mixture of toxoid form of Radiation Toxins -SRD-group) which include Cerebrovascular RT Neurotoxin, Car-diovascular RT Neurotoxin, Gastrointestinal RT Neurotoxin, Hematopoietic RT Hematotoxin. Radiation Toxins Specific Radiation Determinant Group were isolated from a central lymph of gamma-irradiated animals with Cerebrovascular, Cardiovascular, Gastrointestiinal, Hematopoi-etic forms of ARS. Devices for ?-radiation are "Panorama", "Puma". 2. Heavy ion exposure was accomplished at Department of Scientific Research Institute of Nuclear Physics, Dubna, Russia. The heavy ions irradiation was generated in heavy ion (Fe56) accelerator -UTI. Heavy Ion linear transfer energy -2000-2600 KeV mkm, 600 MeV U. Absorbed Dose -3820 Rad. 3. Experimental Design: Rabbits from all groups were irradiated by heavy ion accelerator. Group A -control -10 rabbits; Group B -placebo -5 rabbits; Group C -radioprotectant Cystamine (50 mg kg)-5 rabbits, 15 minutes before irradiation -5 rabbits; Group D -radioprotectant Gammafos (Amifostine -400mg kg ), -5 rabbits; Group E -Antiradiation Vaccine: subcuta-neus administration or IM -2 ml of active substance, 14 days before irradiation -5 rabbits. 4. Results: Group A -100% mortality within two hours after heavy ion irradiation with clinical symptoms of the acute cerebrovascular and cardiovascular syndromes. Group B -100% mortal-ity within 15 hours following irradiation. Group C -100% mortality within 14-15 hours after irradiation. Group D -100% mortality within 15-16 hours after irradiation. In groups A-D, development of the acute radiation cerebrovascular and cardiovascular syndromes as well as ex-tensive burns of skin caused rapid death. Group E -100% mortality in 280-290 hours (12 days) following heavy ion irradiation while animals were exhibiting a combination or individual forms of the acute cerebrovascular, cardiovascular, and gastrointestinal forms and focal skin burns. Discussion: The Antiradiation Vaccine (ARV) and specific immune-prophylaxis are an effective method of neutralization of Radiation Toxins. Vaccination with the ARV significantly extended the survival time after irradiation with heavy ions from two hours up to 300 hours. Clinical signs, clinical features, symptoms were somewhat attenuated. Degree of clinical forms of the Acute Radiation Syndromes were diminished in their severity. Groups A-D demonstrated an extremely severe degree (Degree 4) of Cerebrovascular and Cardiovascular forms of the Acute Radiation Syndromes and lethality 100% was registered in a short time after irradiation. Radi-ation induced burns in this groups (with Cutaneous sub-syndrome of ARS -Degree 4) that were deep with extensive and total dysfunction and possible muscle involvement developed. Animals from group E -Radioprotectant -anti-radiation vaccine had demonstrated later development of the severe Degree 3 or even Degree 2-3 forms of Cerebrovascular and Cardiovascular forms of the ARS and a survival time of irradiated animals was significantly prolonged. Cutaneous sub-syndrome developed in Degree 3 or Degree 2-3. Our results have demonstrated the potential radioprotection efficacy of specific immune-prophylaxis with the Antiradiation vaccine against heavy ion irradiation.

Popov, Dmitri; Maliev, Vecheslav

253

Miocene Global Carbon Isotope Shifts and Marine Biological Productivity.  

NASA Astrophysics Data System (ADS)

The Miocene contains two major global carbon isotope shifts: a negative shift during the late Miocene (~8-6 Ma) and a positive shift during the mid-Miocene (16-14 Ma). We aim at deciphering possible changes in marine biological export productivity during these shifts by calculating paleoproductivity in gC/cm*ky from benthic foraminiferal numbers and accumulation rates at a number of sites spanning the world oceans. Our previous work has illustrated that the onset of the late Miocene negative d 13C shift, which has been attributed to enhanced erosion of terrestrial biomass and expansion of C4 plants, is also accompanied by an increase in marine export productivity from lower than present day values up to 2-3 times modern values at six sites (982, 1088, 721, 846, 1146, 1172; Diester-Haass et al, in press; Diester-Haass et al., in preparation). The Mid-Miocene 'Monterey Event', on the other hand, has been attributed to sequestration of organic material in circum-Pacific basins (Vincent and Berger, 1985) or wide spread deposition of brown coal and drowning of carbonate platforms (Föllmi et al., 2005) . For this particular time interval, our initial results from Site 608 (Atlantic Ocean) reveal relatively constant paleoproductivity values similar to modern ones ( about 10 gC/cm*ky) until 16.5 Ma, after which time paleoproductivity begins to increase until the end of our record at 11 Ma. Superimposed on the trend of generally increasing productivity, there are a number of productivity minima spaced roughly 0.5 million years apart. The long term trend in the paleoproductivity finds some similarities in the global composite benthic foraminiferal d 13C record as both proxies show an overall increase until ~14 Ma. Thereafter, however, paleoproductivity continues to increase while d 13C values decrease marking the end of the Monterey excursion. Stable isotope analyses from these same intervals will show to what extend the smaller scale fluctuations in paleoproductivity can be related to changes in the d13C of the oceanic reservoir or regional water masses. Diester-Haass, L., Billups, K., Emeis, K-C., 2005, Paleoceanography, in press. Vincent, E. and Berger, W., 1985, In: The carbon cycle and atmospheric CO2: Natural variations Archaen to present, edited by Sunquist, E.T. and Broecker, W.S., Am.Geophys. Union Monogr. 32,455-468 Föllmi, K.B. et al., 2005, Geol.Soc.Am.Bull., 117/5, 589-619.

Diester-Haass, L.; Billups, K.

2005-12-01

254

Biologic activity of irradiated, autologous, GM-CSF-secreting leukemia cell vaccines early after allogeneic stem cell transplantation  

PubMed Central

Through an immune-mediated graft-versus-leukemia effect, allogeneic hematopoietic stem cell transplantation (HSCT) affords durable clinical benefits for many patients with hematologic malignancies. Nonetheless, subjects with high-risk acute myeloid leukemia or advanced myelodysplasia often relapse, underscoring the need to intensify tumor immunity within this cohort. In preclinical models, allogeneic HSCT followed by vaccination with irradiated tumor cells engineered to secrete GM-CSF generates a potent antitumor effect without exacerbating the toxicities of graft-versus-host disease (GVHD). To test whether this strategy might be similarly active in humans, we conducted a Phase I clinical trial in which high-risk acute myeloid leukemia or myelodysplasia patients were immunized with irradiated, autologous, GM-CSF-secreting tumor cells early after allogeneic, nonmyeloablative HSCT. Despite the administration of a calcineurin inhibitor as prophylaxis against GVHD, vaccination elicited local and systemic reactions that were qualitatively similar to those previously observed in nontransplanted, immunized solid-tumor patients. While the frequencies of acute and chronic GVHD were not increased, 9 of 10 subjects who completed vaccination achieved durable complete remissions, with a median follow-up of 26 months (range 12–43 months). Six long-term responders showed marked decreases in the levels of soluble NKG2D ligands, and 3 demonstrated normalization of cytotoxic lymphocyte NKG2D expression as a function of treatment. Together, these results establish the safety and immunogenicity of irradiated, autologous, GM-CSF-secreting leukemia cell vaccines early after allogeneic HSCT, and raise the possibility that this combinatorial immunotherapy might potentiate graft-versus-leukemia in patients. PMID:19717467

Ho, Vincent T.; Vanneman, Matthew; Kim, Haesook; Sasada, Tetsuro; Kang, Yoon Joong; Pasek, Mildred; Cutler, Corey; Koreth, John; Alyea, Edwin; Sarantopoulos, Stefanie; Antin, Joseph H.; Ritz, Jerome; Canning, Christine; Kutok, Jeffery; Mihm, Martin C.; Dranoff, Glenn; Soiffer, Robert

2009-01-01

255

Antiradiation vaccine: Technology and development of prophylaxis, prevention and treatment of biological consequences from Heavy Ion irradiation  

Microsoft Academic Search

Introduction: An anti-radiation vaccine could be an important part of a countermeasures reg-imen for effective radioprotection, immunoprophylaxis and immunotherapy of the acute radi-ation syndromes (ARS) after gamma-irradiation, neutron irradiation or heavy ion irradiation. Reliable protection of non-neoplastic regions of patients with different forms of cancer which undergo to heavy ion therapy ( e.g. Hadron-therapy) can significantly extend the efficiency of

Dmitri Popov; Vecheslav Maliev

2010-01-01

256

78 FR 19492 - Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product...  

Federal Register 2010, 2011, 2012, 2013, 2014

...HEALTH AND HUMAN SERVICES Food and Drug Administration...Between FDA and Biosimilar Biological Product Sponsors or Applicants...Availability AGENCY: Food and Drug Administration...amended the Federal Food, Drug, and Cosmetic...program for biosimilar biological products. FDA has...

2013-04-01

257

78 FR 78796 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products...  

Federal Register 2010, 2011, 2012, 2013, 2014

...HEALTH AND HUMAN SERVICES Food and Drug Administration...for Approved Drugs and Biological Products; Correction...Comment Period AGENCY: Food and Drug Administration...SUMMARY: The Food and Drug Administration...of an approved drug or biological product to change...

2013-12-27

258

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

259

Synthetic Biology for Therapeutic Applications.  

PubMed

Synthetic biology is a relatively new field with the key aim of designing and constructing biological systems with novel functionalities. Today, synthetic biology devices are making their first steps in contributing new solutions to a number of biomedical challenges, such as emerging bacterial antibiotic resistance and cancer therapy. This review discusses some synthetic biology approaches and applications that were recently used in disease mechanism investigation and disease modeling, drug discovery and production, as well as vaccine development and treatment of infectious diseases, cancer, and metabolic disorders. PMID:25098838

Abil, Zhanar; Xiong, Xiong; Zhao, Huimin

2014-08-13

260

Escherichia coli heat-labile toxin subunit B fusions with Streptococcus sobrinus antigens expressed by Salmonella typhimurium oral vaccine strains: importance of the linker for antigenicity and biological activities of the hybrid proteins.  

PubMed Central

A set of vectors possessing the genes for aspartate semialdehyde dehydrogenase (asd) and the B subunit of the heat-labile enterotoxin of Escherichia coli (LT-B) has been developed. These vectors allow operon or gene fusions of foreign gene epitopes at the C-terminal end of LT-B. Two groups of vectors have been constructed with and without leader sequences to facilitate placing of the foreign antigen in different cell compartments. Two Streptococcus sobrinus genes coding for principal colonization factors, surface protein antigen A (SpaA), and dextranase (Dex), have been fused into the 3' end of the LT-B gene. Resulting protein fusions of approximately 120 to 130 kDa are extremely well recognized by antibodies directed against both SpaA and Dex as well as against LT-B domains and retain the enzymatic activity of dextranase and the biological activity of LT-B in that they bind to GM1 gangliosides. Maximum antigenicity was obtained with the vector possessing an intervening linker of at least six amino acids with two proline residues. Some of the fusion proteins also exhibited another property of LT-B in that they were exported into the periplasm where they oligomerized. LT-B-SpaA and LT-B-Dex hybrid proteins are expressed stably and at a high level in avirulent Salmonella typhimurium vaccine strains which are being used to investigate their immunogenicity and types of induced immune responses. The fusion vectors will also be useful for production and purification of LT-B fusion antigens to be used and evaluated in other vaccine compositions. Images PMID:8432584

Jagusztyn-Krynicka, E K; Clark-Curtiss, J E; Curtiss, R

1993-01-01

261

VACCINE INFORMATION STATEMENT Influenza Vaccine  

E-print Network

, like any medicine, there is a chance of side effects. These are usually mild and go away on their ownVACCINE INFORMATION STATEMENT Influenza Vaccine What You Need to Know (Flu Vaccine, Inactivated or Recombinant) 2014-2015 Many Vaccine Information Statements are available in Spanish and other languages. See

Lien, Jyh-Ming

262

Regulatory issues surrounding the temporary authorisation of animal vaccination in emergency situations: the example of bluetongue in Europe.  

PubMed

A marketing authorisation for a veterinary vaccine is granted after the quality, safety and efficacy of the product have been assessed in accordance with legal standards. The assessment includes complete characterisation and identification of seed material and ingredients, laboratory and host animal safety and efficacy studies, stability studies, and post-licensing monitoring of field performance. This assessment may not be possible during the emergence of a new animal disease, but several mechanisms exist to allow for the availability of products in an emergency animal health situation, e.g. autogenous biologics, conditional licences, experimental and emergency use authorisations, the importation of products in use elsewhere in the world and pre-approved vaccine banks. Using the emergence of bluetongue in northern Europe as an example, the regulatory issues regarding the temporary authorisation of animal vaccination are described. Several conditions must be fulfilled before a temporary authorisation can be granted, e.g. inactivated vaccines should be used in order to exclude reversion to virulence and reassortment between vaccine viruses and/or field strains of the bluetongue virus; decision-making must be supported by scientific evidence and risk analysis; there must be a complete census of the susceptible animals that were vaccinated; vaccination protocols must be adhered to and there must be a scheme allowing for registration, delivery and follow-up of vaccination, and monitoring, analysis and, possibly, adjustment of field use of the vaccination. This temporary authorisation must be replaced by a full authorisation as quickly as possible. PMID:17892160

Saegerman, C; Hubaux, M; Urbain, B; Lengelé, L; Berkvens, D

2007-08-01

263

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

264

9 CFR 113.302 - Distemper Vaccine-Mink.  

Code of Federal Regulations, 2010 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...

2010-01-01

265

9 CFR 113.302 - Distemper Vaccine-Mink.  

Code of Federal Regulations, 2014 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...

2014-01-01

266

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

267

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

268

Influenza vaccines: unmet needs and recent developments.  

PubMed

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; Kim, Woo Joo

2013-12-01

269

Developing new smallpox vaccines.  

PubMed Central

New stockpiles of smallpox vaccine are required as a contingency for protecting civilian and military personnel against deliberate dissemination of smallpox virus by terrorists or unfriendly governments. The smallpox vaccine in the current stockpile consists of a live animal poxvirus (Vaccinia virus [VACV]) that was grown on the skin of calves. Because of potential issues with controlling this earlier manufacturing process, which included scraping VACV lesions from calfskin, new vaccines are being developed and manufactured by using viral propagation on well-characterized cell substrates. We describe, from a regulatory perspective, the various strains of VACV, the adverse events associated with calf lymph-propagated smallpox vaccine, the issues regarding selection and use of cell substrates for vaccine production, and the issues involved in demonstrating evidence of safety and efficacy. PMID:11747717

Rosenthal, S. R.; Merchlinsky, M.; Kleppinger, C.; Goldenthal, K. L.

2001-01-01

270

Antibody and cell-mediated immune response to whole virion and split virion influenza vaccine in patients with inflammatory bowel disease on maintenance immunosuppressive and biological therapy.  

PubMed

Abstract Objective. Influenza vaccination is recommended for inflammatory bowel disease (IBD) patients on immunosuppressive therapy. The objective was to evaluate the antibody and cell-mediated immune response to the split and whole virion influenza vaccine in patients with IBD treated with anti-TNF-? and immunosuppressive therapy. Patients and methods.One hundred and fifty-six immunocompromised IBD patients were vaccinated. Fifty-three patients (control group) refused vaccination. Split virion vaccine and whole virion vaccine were used. Serum samples were obtained for pre- and postimmunization antibody titers to influenza vaccine (A/California/7/2009 [H1N1], A/Victoria/361/2011 [H3N2], B/Wisconsin/1/2010-like B/Hubei-Wujiagang/158/2009). Cell-mediated response was evaluated using an interferon (INF)-?, interleukine (IL)-2 and tumor necrosis factor (TNF)-? ELISA. Results. Postimmunization titers of both influenza subtypes increased significantly after the administration of split virion vaccines compared to the controls and to those who received whole virion vaccine. The antibody titers of Influenza B also increased significantly in patients immunized with split vaccine and treated with anti-TNF-? therapy. After influenza vaccination, the level of serum IL-2 significantly decreased. No serious side effects developed occurred after influenza vaccination, and the influenza-like symptoms did not differ significantly between vaccinated versus control patients. The relapse of the disease was observed in only 10% of the patients and was more common in vaccinated than in control subjects. Conclusion. Split virion vaccines seem to be more effective than whole virion vaccines. Measuring the antibody responses is worthwhile in patients treated with immunosuppressants to determine the efficacy of influenza vaccination. PMID:25384624

Bálint, Anita; Farkas, Klaudia; Éva, Pallagi-Kunstár; Terhes, Gabriella; Urbán, Edit; Sz?cs, Mónika; Nyári, Tibor; Bata, Zsuzsanna; Nagy, Ferenc; Szepes, Zoltán; Miheller, Pál; L?rinczy, Katalin; Lakatos, Péter László; Lovász, Barbara; Tamás, Szamosi; Kulcsár, Andrea; Berényi, Anna; Tör?csik, Dalma; Daróczi, Tímea; Saródi, Zoltán; Wittmann, Tibor; Molnár, Tamás

2015-02-01

271

9 CFR 101.3 - Biological products and related terms.  

Code of Federal Regulations, 2012 CFR

...product. (n) Toxoid. An inactivated bacterial product which consists of a sterile, antigenic toxin or toxic growth product, which has resulted from the growth of bacterial organisms in a culture medium from...

2012-01-01

272

9 CFR 101.3 - Biological products and related terms.  

Code of Federal Regulations, 2013 CFR

...product. (n) Toxoid. An inactivated bacterial product which consists of a sterile, antigenic toxin or toxic growth product, which has resulted from the growth of bacterial organisms in a culture medium from...

2013-01-01

273

9 CFR 101.3 - Biological products and related terms.  

Code of Federal Regulations, 2011 CFR

...product. (n) Toxoid. An inactivated bacterial product which consists of a sterile, antigenic toxin or toxic growth product, which has resulted from the growth of bacterial organisms in a culture medium from...

2011-01-01

274

9 CFR 101.3 - Biological products and related terms.  

Code of Federal Regulations, 2014 CFR

...product. (n) Toxoid. An inactivated bacterial product which consists of a sterile, antigenic toxin or toxic growth product, which has resulted from the growth of bacterial organisms in a culture medium from...

2014-01-01

275

9 CFR 101.3 - Biological products and related terms.  

Code of Federal Regulations, 2010 CFR

...product. (n) Toxoid. An inactivated bacterial product which consists of a sterile, antigenic toxin or toxic growth product, which has resulted from the growth of bacterial organisms in a culture medium from...

2010-01-01

276

MDCK and Vero cells for influenza virus vaccine production: a one-to-one comparison up to lab-scale bioreactor cultivation  

Microsoft Academic Search

Over the last decade, adherent MDCK (Madin Darby canine kidney) and Vero cells have attracted considerable attention for production\\u000a of cell culture-derived influenza vaccines. While numerous publications deal with the design and the optimization of corresponding\\u000a upstream processes, one-to-one comparisons of these cell lines under comparable cultivation conditions have largely been neglected.\\u000a Therefore, a direct comparison of influenza virus production

Yvonne Genzel; Christian Dietzsch; Erdmann Rapp; Jana Schwarzer; Udo Reichl

2010-01-01

277

Protein carriers of conjugate vaccines  

PubMed Central

The immunogenicity of polysaccharides as human vaccines was enhanced by coupling to protein carriers. Conjugation transformed the T cell-independent polysaccharide vaccines of the past to T cell-dependent antigenic vaccines that were much more immunogenic and launched a renaissance in vaccinology. This review discusses the conjugate vaccines for prevention of infections caused by Hemophilus influenzae type b, Streptococcus pneumoniae, and Neisseria meningitidis. Specifically, the characteristics of the proteins used in the construction of the vaccines including CRM, tetanus toxoid, diphtheria toxoid, Neisseria meningitidis outer membrane complex, and Hemophilus influenzae protein D are discussed. The studies that established differences among and key features of conjugate vaccines including immunologic memory induction, reduction of nasopharyngeal colonization and herd immunity, and antibody avidity and avidity maturation are presented. Studies of dose, schedule, response to boosters, of single protein carriers with single and multiple polysaccharides, of multiple protein carriers with multiple polysaccharides and conjugate vaccines administered concurrently with other vaccines are discussed along with undesirable consequences of conjugate vaccines. The clear benefits of conjugate vaccines in improving the protective responses of the immature immune systems of young infants and the senescent immune systems of the elderly have been made clear and opened the way to development of additional vaccines using this technology for future vaccine products. PMID:23955057

Pichichero, Michael E

2013-01-01

278

Argentine hemorrhagic fever vaccines.  

PubMed

Argentine hemorrhagic fever (AHF), an acute disease caused by Junin virus (JUNV, Arenaviridae), has been an important issue to public health in Argentina since the early 1950s. The field rodent Calomys musculinus is JUNV natural reservoir and human disease is a consequence of contact with infected rodents. A steady extention of AHF endemic area is being observed since the first reports of the disease. Important achievements have been made in: (a) improvement of methods for the etiological diagnosis; (b) implementation and validation of therapeutical measures; (c) development of vaccines to protect against AHF. Reference is made to different research strategies used to obtain anti-AHF vaccines in the past and anti-arenaviral diseases in the present. Information is updated on features and field performance of Candid #1 vaccine, a live attenuted vaccine currently used to prevent AHF. This vaccine was developed through a joint international effort that envisioned it as an orphan drug. With transferred technology, Argentine government was committed to be Candid #1 manufacturer and to register this vaccine as a novel medical product under the Argentine regulatory authority. Candid #1 vaccine is the first one used to control an arenaviral hemorrhagic fever, the first live viral vaccine to be manufactured and registered in Argentina, reaching its target population through governmental effort. PMID:21451263

Ambrosio, Ana; Saavedra, Maria; Mariani, Mauricio; Gamboa, Graciela; Maiza, Andrea

2011-06-01

279

Advances in influenza vaccination  

PubMed Central

Influenza virus infections yearly cause high morbidity and mortality burdens in humans, and the development of a new influenza pandemic continues to threaten mankind as a Damoclean sword. Influenza vaccines have been produced by using egg-based virus growth and passaging techniques that were developed more than 60 years ago, following the identification of influenza A virus as an etiological agent of seasonal influenza. These vaccines aimed mainly at eliciting neutralizing antibodies targeting antigenically variable regions of the hemagglutinin (HA) protein, which requires regular updates to match circulating seasonal influenza A and B virus strains. Given the relatively limited protection induced by current seasonal influenza vaccines, a more universal influenza vaccine that would protect against more—if not all—influenza viruses is among the largest unmet medical needs of the 21st century. New insights into correlates of protection from influenza and into broad B- and T-cell protective anti-influenza immune responses offer promising avenues for innovative vaccine development as well as manufacturing strategies or platforms, leading to the development of a new generation of vaccines. These aim at the rapid and massive production of influenza vaccines that provide broad protective and long-lasting immunity. Recent advances in influenza vaccine research demonstrate the feasibility of a wide range of approaches and call for the initiation of preclinical proof-of-principle studies followed by clinical trials in humans. PMID:24991424

Reperant, Leslie A.; Rimmelzwaan, Guus F.

2014-01-01

280

Vaccines and autoimmunity.  

PubMed

Vaccines have eradicated or controlled many infectious diseases, saving each year millions of lives and quality of life of many other millions of people. In spite of the success of vaccines over the last two centuries, parents (and also some health care workers) gloss over the devastating consequences of diseases, which are now avoided thanks to vaccines, and direct their attention to possible negative effects of immunization. Three immunological objections are raised: vaccines cause antigenic overload, natural immunity is safer and better than vaccine-induced immunity, and vaccines induce autoimmunity. The last point is examined in this review. Theoretically, vaccines could trigger autoimmunity by means of cytokine production, anti-idiotypic network, expression of human histocompatibility leukocyte antigens, modification of surface antigens and induction of novel antigens, molecular mimicry, bystander activation, epitope spreading, and polyclonal activation of B cells. There is strong evidence that none of these mechanisms is really effective in causing autoimmune diseases. Vaccines are not a source of autoimmune diseases. By contrast, absolute evidence exists that infectious agents can trigger autoimmune mechanisms and that they do cause autoimmune diseases. PMID:23755743

De Martino, M; Chiappini, E; Galli, L

2013-01-01

281

Chemokines as Cancer Vaccine Adjuvants  

PubMed Central

We are witnessing a new era of immune-mediated cancer therapies and vaccine development. As the field of cancer vaccines advances into clinical trials, overcoming low immunogenicity is a limiting step in achieving full success of this therapeutic approach. Recent discoveries in the many biological roles of chemokines in tumor immunology allow their exploitation in enhancing recruitment of antigen presenting cells (APCs) and effector cells to appropriate anatomical sites. This knowledge, combined with advances in gene therapy and virology, allows researchers to employ chemokines as potential vaccine adjuvants. This review will focus on recent murine and human studies that use chemokines as therapeutic anti-cancer vaccine adjuvants. PMID:24967094

Bobanga, Iuliana D.; Petrosiute, Agne; Huang, Alex Y.

2014-01-01

282

Chloroplast-derived vaccines against human diseases: achievements, challenges and scopes.  

PubMed

Infectious diseases represent a continuously growing menace that has severe impact on health of the people worldwide, particularly in the developing countries. Therefore, novel prevention and treatment strategies are urgently needed to reduce the rate of these diseases in humans. For this reason, different options can be considered for the production of affordable vaccines. Plants have been proved as an alternative expression system for various compounds of biological importance. Particularly, plastid genetic engineering can be potentially used as a tool for cost-effective vaccine production. Antigenic proteins from different viruses and bacteria have been expressed in plastids. Initial immunological studies of chloroplast-derived vaccines have yielded promising results in animal models. However, because of certain limitations, these vaccines face many challenges on production and application level. Adaptations to the novel approaches are needed, which comprise codon usage and choice of proven expression cassettes for the optimal yield of expressed proteins, use of inducible systems, marker gene removal, selection of specific antigens with high immunogenicity and development of tissue culture systems for edible crops to prove the concept of low-cost edible vaccines. As various aspects of plant-based vaccines have been discussed in recent reviews, here we will focus on certain aspects of chloroplast transformation related to vaccine production against human diseases. PMID:21447052

Lössl, Andreas G; Waheed, Mohammad T

2011-06-01

283

Modified vaccinia virus ankara (MVA) as production platform for vaccines against influenza and other viral respiratory diseases.  

PubMed

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

2014-07-01

284

Intranasal Vaccination with a Secreted Chlamydial Protein Enhances Resolution of Genital Chlamydia muridarum Infection, Protects against Oviduct Pathology, and Is Highly Dependent upon Endogenous Gamma Interferon Production?  

PubMed Central

There is currently no licensed vaccine against Chlamydia trachomatis, the leading cause of sexually transmitted bacterial disease worldwide. Conventional vaccination attempts using surface-exposed chlamydial antigens have achieved only partial success. We have employed a novel vaccination strategy using a secreted protein, chlamydial protease-like activity factor (CPAF), which has been shown to degrade host major histocompatibility complex transcription factors and keratin-8 and therefore may allow immune evasion and establishment of a productive infection. Intranasal immunization using recombinant CPAF (rCPAF) plus interleukin-12 (IL-12) (rCPAF+IL-12 immunization) was used to assess the protective immunity against genital Chlamydia muridarum infection in BALB/c mice. rCPAF+IL-12 immunization induced robust gamma interferon (IFN-?) production and minimal IL-4 production by splenocytes upon in vitro recall with rCPAF. The total and immunoglobulin G2a (IgG2a) anti-rCPAF antibody levels in serum were significantly elevated after rCPAF+IL-12 vaccination, as were the total antibody, IgG2a, and IgA levels in bronchoalveolar lavage and vaginal fluids when the animals were compared to animals that received rCPAF alone. rCPAF+IL-12-vaccinated mice displayed significantly reduced bacterial shedding upon chlamydial challenge and accelerated resolution of infection compared to mock-immunized (phosphate-buffered saline) animals. Moreover, rCPAF+IL-12-immunized animals exhibited protection against pathological consequences of chlamydial infection, including the development of hydrosalpinx and oviduct dilatation. This vaccination regimen also reduced the development of fibrosis and the influx of neutrophils into the upper genital tract when the animals were compared to mock-immunized (phosphate-buffered saline) animals after bacterial challenge. rCPAF+IL-12-mediated resolution of the bacterial infection and protection against Chlamydia-induced inflammatory disease were highly dependent on endogenous IFN-? production. Together, these results demonstrate that secreted chlamydial antigens may be novel vaccine candidates to induce protective immunity. PMID:17118987

Murthy, Ashlesh K.; Chambers, James P.; Meier, Patricia A.; Zhong, Guangming; Arulanandam, Bernard P.

2007-01-01

285

Vaccine therapy for pancreatic cancer  

PubMed Central

Pancreatic cancer is a lethal disease and currently available therapies have significant limitations. Pancreatic cancer is thus an ideal setting for the development of novel treatment modalities such as immunotherapy. However, relevant obstacles must be overcome for immunotherapeutic regimens against pancreatic cancer to be successful. Vaccine therapy relies on the administration of biological preparations that include an antigen that (at least ideally) is specifically expressed by malignant cells, boosting the natural ability of the immune system to react against neoplastic cells. There are a number of ways to deliver anticancer vaccines. Potent vaccines stimulate antigen presentation by dendritic cells, hence driving the expansion of antigen-specific effector and memory T cells. Unlike vaccines given as a prophylaxis against infectious diseases, anticancer vaccines require the concurrent administration of agents that interfere with the natural predisposition of tumors to drive immunosuppression. The safety and efficacy of vaccines against pancreatic cancer are nowadays being tested in early phase clinical trials. PMID:24498551

Salman, Bulent; Zhou, Donger; Jaffee, Elizabeth M; Edil, Barish H; Zheng, Lei

2013-01-01

286

Vaccines (immunizations) - overview  

MedlinePLUS

... diphtheria, mumps, measles, pertussis (whooping cough), meningitis, and polio. Many of these infections can cause serious or ... MMR - vaccine Pneumococcal conjugate vaccine Pneumococcal polysaccharide ... (vaccine) Rotavirus vaccine Tdap vaccine Tetanus - vaccine

287

Annual World Vaccine Congress 2014.  

PubMed

The 14th Annual World Vaccine Congress was held in Washington DC, March 24-26, 2014 ( http://www.terrapinn.com/vaccine2014 ). More than 400 experts from different regions participated in this scientific event for vaccine professionals from industry, academia, non-profit organizations and government to discuss challenges and successes from all the major vaccine stakeholders. In more than 70 presentations, round tables, and plenary discussions major topics like emerging and re-emerging infectious disease, vaccine production, and innovative technologies were debated. While most contributions focused on specific questions in vaccine research development, some like the one by a representative of the Bill and Melinda Gates Foundation (BMGF) reported about supply chain, logistics topics, and challenges in vaccine implementation. PMID:25483655

Derwand, Roland

2014-07-01

288

Live attenuated vaccines against pertussis.  

PubMed

The intensive use of pertussis vaccines has dramatically reduced the incidence of whooping cough during the 20th century. However, recent outbreaks in countries with high vaccination coverage illustrate the shortcomings of current vaccination regimens, and immunity induced by the most recent, acellular vaccines wanes much faster than anticipated. As an alternative, live attenuated vaccine candidates have recently been developed in order to mimic natural infection, which induces long-lasting immunity. One of them has successfully completed a Phase I trial in humans and is now undergoing further product and clinical developments. This article describes the development of such vaccines, discusses their advantages over existing vaccines and their interesting bystander properties as powerful anti-inflammatory agents, which widens their potential use far beyond that for protection against whooping cough. PMID:25085735

Locht, Camille; Mielcarek, Nathalie

2014-09-01

289

Polio Vaccination  

MedlinePLUS

... CDC.gov . Vaccines and Immunizations Share Compartir Polio Vaccination Pronounced [PO-lee-oh] On this Page What ... 2000, OPV was no longer recommended for routine immunization in the United States. However, OPV continues to ...

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, 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

292

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

293

9 CFR 113.332 - Tenosynovitis Vaccine.  

Code of Federal Regulations, 2014 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...

2014-01-01

294

9 CFR 113.318 - Pseudorabies Vaccine.  

Code of Federal Regulations, 2014 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....

2014-01-01

295

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

296

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

297

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

298

Biological production of ethanol from waste gases with Clostridium ljungdahlii  

DOEpatents

A method and apparatus for converting waste gases from industrial processes such as oil refining, carbon black, coke, ammonia, and methanol production, into useful products is disclosed. The method includes introducing the waste gases into a bioreactor where they are fermented to various product, such as organic acids, alcohols H.sub.2, SCP, and salts of organic acids by anaerobic bacteria within the bioreactor. These valuable end products are then recovered, separated and purified.

Gaddy, James L. (Fayetteville, AR)

2000-01-01

299

Religious Barriers to Measles Vaccination.  

PubMed

In 2014, the United States has experienced an increase in measles activity, the most since the elimination of the virus in 2000. The measles infection occurs in unvaccinated individuals. Communities and individuals choose to not vaccinate for a number of reasons, primarily citing religious and philosophical motives. Objections based upon religion most often center on the use of aborted human fetus tissue used in the rubella component of the combined vaccine products, and animal derived gelatins used in vaccine production. Objections among religious communities may also not be faith based, rather in some cases concerns related to lack of safety and efficacy of the vaccination result in refusal. PMID:25315714

Wombwell, Eric; Fangman, Mary T; Yoder, Alannah K; Spero, David L

2014-10-16

300

75 FR 61497 - Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request...  

Federal Register 2010, 2011, 2012, 2013, 2014

...what is already known about a drug, thereby saving time and resources and avoiding unnecessary duplication of human or animal testing. The implementation of an abbreviated approval pathway for biological products can present challenges given the...

2010-10-05

301

9 CFR 113.53 - Requirements for ingredients of animal origin used for production of biologics.  

Code of Federal Regulations, 2010 CFR

...sterilization of other sterilization methods acceptable to APHIS used to prepare a biological product shall be shown free of bacteria and fungi as prescribed in § 113.26. (c) Samples of each lot of ingredient of animal origin, except porcine...

2010-01-01

302

37 CFR 1.779 - Calculation of patent term extension for a veterinary biological product.  

Code of Federal Regulations, 2010 CFR

... 2010-07-01 false Calculation of patent term extension for a veterinary biological product...PATENT CASES Adjustment and Extension of Patent Term Extension of Patent Term Due to Regulatory Review § 1.779...

2010-07-01

303

37 CFR 1.779 - Calculation of patent term extension for a veterinary biological product.  

Code of Federal Regulations, 2012 CFR

... 2012-07-01 false Calculation of patent term extension for a veterinary biological product...PATENT CASES Adjustment and Extension of Patent Term Extension of Patent Term Due to Regulatory Review § 1.779...

2012-07-01

304

37 CFR 1.779 - Calculation of patent term extension for a veterinary biological product.  

Code of Federal Regulations, 2014 CFR

... 2014-07-01 false Calculation of patent term extension for a veterinary biological product...PATENT CASES Adjustment and Extension of Patent Term Extension of Patent Term Due to Regulatory Review § 1.779...

2014-07-01

305

37 CFR 1.779 - Calculation of patent term extension for a veterinary biological product.  

Code of Federal Regulations, 2013 CFR

... 2013-07-01 false Calculation of patent term extension for a veterinary biological product...PATENT CASES Adjustment and Extension of Patent Term Extension of Patent Term Due to Regulatory Review § 1.779...

2013-07-01

306

37 CFR 1.779 - Calculation of patent term extension for a veterinary biological product.  

Code of Federal Regulations, 2011 CFR

... 2011-07-01 false Calculation of patent term extension for a veterinary biological product...PATENT CASES Adjustment and Extension of Patent Term Extension of Patent Term Due to Regulatory Review § 1.779...

2011-07-01

307

Sex Roles: A Product of Socialization or a Biological Heritage.  

ERIC Educational Resources Information Center

This paper reviews selected studies of aggression in males and females and concludes that physiological, emotional and behavioral differences exist between the sexes. Primate studies, conducted by Harlow, are employed as evidence that sex differences in aggression are primarily biological and not primarily cultural phenomena. It is further…

Shaha, Steven H.

308

BIOLOGICAL CONTROL OF ARTHROPOD PESTS IN LIVESTOCK PRODUCTION  

Technology Transfer Automated Retrieval System (TEKTRAN)

Filth flies and poultry litter beetles have a wide array of natural enemies that can be exploited for augmentative biological control. Adult flies are subject to infection with entomogenous nematodes and the fungal pathogens Entomophthora muscae and Beauveria bassiana. Of these, B. bassiana has th...

309

The human papillomavirus vaccines.  

PubMed

Genital human papillomavirus (HPV) infection is the most common sexually transmitted infection (STI) among sexually active couples. Its annual incidence is approximately 5.5 million. Overall, an estimated 75% of sexually active men and women have been exposed to HPV at some point in their lives. HPV-16 and -18 account for about 70% of cancers of the cervix, vagina and anus, and for about 30%-40% of cancers of the vulva, penis and orophaynx. Cancer of the cervix uteri is the second most cancer among women worldwide. Cancer of the penis is a rare cancer, accounting for less than 0.5% of cancers in men. Spontaneous clearance of HPV infection is accompanied by humoral and cellular immune response against virus-specific antigens. Two vaccines, prophylactic and therapeutic ones, are considered. Prophylactic vaccines use L1 and L2 capsid proteins to induce production of conformationally-specific antibodies. They block HPV infection. Lone L1 and L2 proteins self-assemble into a capsid that is identical to the complete virion. In this way, an antibody-mediated response is induced before the body actually comes into contact with the live virion. Therapeutic vaccines are being developed to protect HPV-positive persons against tumor development. For these vaccines, researchers are targeting the activity of the E6 and E7 oncoproteines.On June 8, 2006, the U.S. Food and Drug Administration (FDA) approved an HPV vaccine for clinical use. The HPV vaccine that has been approved is the quadrivalent vaccine that consists of recombinant viral-like particles (VLPs) of HPV 6, 11, 16, 18 mixed with an aluminum-containing adjuvant. It is manufactured by Merck & Co., Inc. and sold under the name of Gardasil?. The new vaccine is approved for use in females 9-26 years of age. The primary target population for vaccination should be females aged 11-12 years. However, vaccination can be given to girls as young as 9 years of age. Vaccination can receive women aged 13-26 years who have been sexually active. There are still no data on the vaccine efficacy in women older than 26, and currently no data to demonstrate the efficacy of vaccination in males; male subjects should not be vaccinated until such data become available. The vaccine is to be administered intramuscularly either into the deltoid muscle of the arm or the high anteriolateral area of the leg. Each patient receives three 0.5 mL doses given according to the following schedule: first dose is given at the elected date, second dose two months after the first dose, and third dose six months after the first dose. According to statements from Merck, the list price of the vaccine is 120 USD per dose. GlaxoSmithKline is now conducting a phase III trial of a bivalent (HPV 16, 18) vaccine, and it is going to be presented under the name of Cervarix. Similar results to those obtained with the quadrivalent HPV vaccine have been reported with the bivalent vaccine. It is expected to be released in June next year. Evaluation of the HPV vaccine efficiency in preventing dysplasia and cancer has been recommended as a globally accepted endpoint for population based studies. PMID:17010274

Ljubojevi?, Suzana

2006-01-01

310

Importance of systems biology in engineering microbes for biofuel production  

SciTech Connect

Microorganisms have been rich sources for natural products, some of which have found use as fuels, commodity chemicals, specialty chemicals, polymers, and drugs, to name a few. The recent interest in production of transportation fuels from renewable resources has catalyzed numerous research endeavors that focus on developing microbial systems for production of such natural products. Eliminating bottlenecks in microbial metabolic pathways and alleviating the stresses due to production of these chemicals are crucial in the generation of robust and efficient production hosts. The use of systems-level studies makes it possible to comprehensively understand the impact of pathway engineering within the context of the entire host metabolism, to diagnose stresses due to product synthesis, and provides the rationale to cost-effectively engineer optimal industrial microorganisms.

Mukhopadhyay, Aindrila; Redding, Alyssa M.; Rutherford, Becky J.; Keasling, Jay D.

2009-12-02

311

Optimization of a multi-stage, multi-subunit malaria vaccine candidate for the production in Pichia pastoris by the identification and removal of protease cleavage sites.  

PubMed

We demonstrated the successful optimization of a recombinant multi-subunit malaria vaccine candidate protein for production in the methylotrophic yeast Pichia pastoris by the identification and subsequent removal of two protease cleavage sites. After observing protein degradation in the culture supernatant of a fed-batch fermentation, the predominant proteolytic fragment of the secreted recombinant protein was analyzed by mass spectrometry. The MS data indicated the cleavage of an amino acid sequence matching the yeast KEX2-protease consensus motif EKRE. The cleavage in this region was completely abolished by the deletion of the EKRE motif in a modified variant. This modified variant was produced, purified, and used for immunization of rabbits, inducing high antigen specific antibody titers (2?×?10(6) ). Total IgG from rabbit immune sera recognized different stages of Plasmodium falciparum parasites in immunofluorescence assays, indicating native folding of the vaccine candidate. However, the modified variant was still degraded, albeit into different fragments. Further analysis by mass spectrometry and N-terminal sequencing revealed a second cleavage site downstream of the motif PEVK. We therefore removed a 17-amino-acid stretch including the PEVK motif, resulting in the subsequent production of the full-length recombinant vaccine candidate protein without significant degradation, with a yield of 53?mg per liter culture volume. We clearly demonstrate that the proteolytic degradation of recombinant proteins by endogenous P. pastoris proteases can be prevented by the identification and removal of such cleavage sites. This strategy is particularly relevant for the production of recombinant subunit vaccines, where product yield and stability play a more important role than for the production of a stringently-defined native sequence which is necessary for most therapeutic molecules. Biotechnol. Bioeng. 2014;9999: 1-10. © 2014 Wiley Periodicals, Inc. PMID:25335451

Spiegel, Holger; Schinkel, Helga; Kastilan, Robin; Dahm, Pia; Boes, Alexander; Scheuermayer, Matthias; Chudobová, Ivana; Maskus, Dominika; Fendel, Rolf; Schillberg, Stefan; Reimann, Andreas; Fischer, Rainer

2014-10-21

312

The case for a rational genome-based vaccine against malaria  

PubMed Central

Historically, vaccines have been designed to mimic the immunity induced by natural exposure to the target pathogen, but this approach has not been effective for any parasitic pathogen of humans or complex pathogens that cause chronic disease in humans, such as Plasmodium. Despite intense efforts by many laboratories around the world on different aspects of Plasmodium spp. molecular and cell biology, epidemiology and immunology, progress towards the goal of an effective malaria vaccine has been disappointing. The premise of rational vaccine design is to induce the desired immune response against the key pathogen antigens or epitopes targeted by protective immune responses. We advocate that development of an optimally efficacious malaria vaccine will need to improve on nature, and that this can be accomplished by rational vaccine design facilitated by mining genomic, proteomic and transcriptomic datasets in the context of relevant biological function. In our opinion, modern genome-based rational vaccine design offers enormous potential above and beyond that of whole-organism vaccines approaches established over 200 years ago where immunity is likely suboptimal due to the many genetic and immunological host-parasite adaptations evolved to allow the Plasmodium parasite to coexist in the human host, and which are associated with logistic and regulatory hurdles for production and delivery.

Proietti, Carla; Doolan, Denise L.

2015-01-01

313

The Adjuvant Double Mutant Escherichia coli Heat Labile Toxin Enhances IL-17A Production in Human T Cells Specific for Bacterial Vaccine Antigens  

PubMed Central

The strong adjuvant activity and low enterotoxicity of the novel mucosal adjuvant double mutant Escherichia coli heat labile toxin, LT(R192G/L211A) or dmLT, demonstrated in mice, makes this molecule a promising adjuvant candidate. However, little is known about the mechanisms responsible for the adjuvant effect of dmLT or whether dmLT also has an adjuvant function in humans. We investigated the effect of dmLT on human T cell responses to different bacterial vaccine antigens: the mycobacterial purified protein derivative (PPD) antigen, tested in individuals previously vaccinated with Bacillus Calmette-Guérin, the LT binding subunit (LTB), evaluated in subjects immunised with oral inactivated whole cell vaccines against enterotoxigenic Escherichia coli, and Streptococcus pneumoniae whole cell vaccine antigens, tested in subjects naturally exposed to pneumococci. We found that dmLT enhanced the production of IL-17A by peripheral blood mononuclear cells in response to all antigens tested. dmLT had comparable effects on IL-17A responses to PPD as the single mutant LT(R192G) adjuvant, which has demonstrated clinical adjuvant activity in humans. Neutralisation of IL-1? and IL-23, but not IL-6, suppressed the IL-17A-enhancing effect of dmLT. Furthermore, CD4+ T cells produced higher levels of IL-17A when stimulated with monocytes pulsed with PPD and dmLT compared to PPD alone, supporting an important role of antigen presenting cells in enhancing IL-17A responses. dmLT also potentiated mitogen-induced IL-17A and IL-13 production. However, dmLT had variable influences on IFN-? responses to the different stimuli tested. Our demonstration of a potent ability of dmLT to enhance human Th17 type T cell responses to bacterial vaccine antigens encourages further evaluation of the adjuvant function of dmLT in humans. PMID:23284753

Leach, Susannah; Clements, John D.; Kaim, Joanna; Lundgren, Anna

2012-01-01

314

The adjuvant double mutant Escherichia coli heat labile toxin enhances IL-17A production in human T cells specific for bacterial vaccine antigens.  

PubMed

The strong adjuvant activity and low enterotoxicity of the novel mucosal adjuvant double mutant Escherichia coli heat labile toxin, LT(R192G/L211A) or dmLT, demonstrated in mice, makes this molecule a promising adjuvant candidate. However, little is known about the mechanisms responsible for the adjuvant effect of dmLT or whether dmLT also has an adjuvant function in humans. We investigated the effect of DMLT on human T Cell responses to different bacterial vaccine antigens: the mycobacterial purified protein derivative (PPD) antigen, tested in individuals previously vaccinated with Bacillus Calmette-Guérin, the LT binding subunit (LTB), evaluated in subjects immunised with oral inactivated whole cell vaccines against enterotoxigenic Escherichia coli, and Streptococcus pneumoniae whole cell vaccine antigens, tested in subjects naturally exposed to pneumococci. We found that dmLT enhanced the production of IL-17A by peripheral blood mononuclear cells in response to all antigens tested. dmLT had comparable effects on IL-17A responses to PPD as the single mutant LT(R192G) adjuvant, which has demonstrated clinical adjuvant activity in humans. Neutralisation of IL-1? and IL-23, but not IL-6, suppressed the IL-17A-enhancing effect of dmLT. Furthermore, CD4+ T cells produced higher levels of IL-17A when stimulated with monocytes pulsed with PPD and dmLT compared to PPD alone, supporting an important role of antigen presenting cells in enhancing IL-17A responses. dmLT also potentiated mitogen-induced IL-17A and IL-13 production. However, dmLT had variable influences on IFN-? responses to the different stimuli tested.Our demonstration of a potent ability of dmLT to enhance human Th17 type T cell responses to bacterial vaccine antigens encourages further evaluation of the adjuvant function of dmLT in humans. PMID:23284753

Leach, Susannah; Clements, John D; Kaim, Joanna; Lundgren, Anna

2012-01-01

315

Mixed treatment comparison meta-analysis of porcine circovirus type 2 (PCV2) vaccines used in piglets.  

PubMed

Porcine circovirus type 2 (PCV2) vaccination is globally one of the most commonly used intervention strategies in growing pigs since several products became commercially available in 2006. While multiple trials have described the efficacy of individual PCV2 vaccines relative to non-vaccination, few studies provide product-to-product comparisons of efficacy. Given the well-documented efficacy of PCV2 vaccines, information about the comparative efficacy of available vaccines is more relevant to producers and veterinarians than comparison to non-vaccination. The objective of this study was to provide comparative estimates of changes in average daily gain effect associated with the use of the commercially available PCV2 vaccines. PubMed, CAB Abstracts, AGRICOLA, the USA Department of Agriculture Center for Veterinary Biologics database of licenses and provisions, and the proceedings of the Annual Meeting of the American Association of Swine Veterinarians, the Allen D. Leman Swine Conference, the Iowa State University Swine Disease Conference for Swine Practitioners, and the International Pig Veterinary Society Congress were used as the sources of information. Trials of licensed PCV2 vaccines administered according to manufacturers' specifications to intensively raised piglets with a known herd porcine reproductive and respiratory syndrome virus (PRRSV) status were considered relevant to the meta-analysis. Relevant studies had to report average daily gain (ADG) from weaning to finish and PCV2 infection had to be naturally occurring. PMID:25457512

da Silva, N; Carriquiry, A; O'Neill, K; Opriessnig, T; O'Connor, A M

2014-12-01

316

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

García-Ruiz, Cristina; Sarabia, Francisco

2014-01-01

317

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

318

Extraneous agent detection in vaccines--a review of technical aspects.  

PubMed

The quality and safety of commercial vaccines have a profound importance. Contrary to all precautions and efforts the use of biological material in vaccine development and production may lead to potential contamination of the vaccines with known and unknown extraneous agents (EAs). In veterinary field official lists of EAs have been compiled as legal framework to describe the potential agents, which must be tested during manufacture of vaccines. Nevertheless, detection of known and unknown contaminants in vaccines is a common duty for manufacturers and authorities of both veterinary and human field sharing similar needs of special technical approaches. State-of-art molecular methods such as randomly primed PCR combined with massive parallel sequencing (MPS) or microarrays may open new perspectives in extraneous agent testing. The robustness and efficacy of this technical approach in vaccine control was clearly demonstrated on a human vaccine example when porcine circovirus type 1 (PCV1) contamination was revealed in Rotarix, a human rotavirus vaccine. The consequences and implications are reviewed hereby from a veterinary regulatory point of view. PMID:22575785

Farsang, Attila; Kulcsár, Gábor

2012-07-01

319

Bacterial Protoplast-Derived Nanovesicles as Vaccine Delivery System against Bacterial Infection.  

PubMed

The notion that widespread infectious diseases could be best managed by developing potent, adjuvant-free vaccines has resulted in the use of various biological immune-stimulating components as new vaccine candidates. Recently, extracellular vesicles, also known as exosomes and microvesicles in mammalian cells and outer membrane vesicles in Gram-negative bacteria, have gained attention for the next generation vaccine. However, the more invasive and effective the vaccine is in delivery, the more risk it holds for severe immune toxicity. Here, in optimizing the current vaccine delivery system, we designed bacterial protoplast-derived nanovesicles (PDNVs), depleted of toxic outer membrane components to generate a universal adjuvant-free vaccine delivery system. These PDNVs exhibited significantly higher productivity and safety than the currently used vaccine delivery vehicles and induced strong antigen-specific humoral and cellular immune responses. Moreover, immunization with PDNVs loaded with bacterial antigens conferred effective protection against bacterial sepsis in mice. These nonliving nanovesicles derived from bacterial protoplast open up a new avenue for the creation of next generation, adjuvant-free, less toxic vaccines to be used to prevent infectious diseases. PMID:25506626

Kim, Oh Youn; Choi, Seng Jin; Jang, Su Chul; Park, Kyong-Su; Kim, Sae Rom; Choi, Jun Pyo; Lim, Ji Hwan; Lee, Seung-Woo; Park, Jaesung; Di Vizio, Dolores; Lötvall, Jan; Kim, Yoon-Keun; Gho, Yong Song

2015-01-14

320

Comparison of toxicities of acellular pertussis vaccine with whole cell pertussis vaccine in experimental animals.  

PubMed

There is no suitable animal model for pertussis encephalopathy in humans. In this study, we have compared the toxicity of acellular pertussis vaccine with whole cell pertussis vaccine in mice or guinea pigs. Two lots of acellular and two lots of whole cell vaccine produced in different countries were assayed in the test. 1. There was no statistical difference in mouse protective potency between these acellular or whole cell pertussis vaccines. 2. There were no differences in chemical ingredients between acellular and whole cell pertussis vaccines except for protein nitrogen content. The protein nitrogen content of whole cell vaccine was at least three times higher than that of the acellular product. 3. Anti-PT antibody productivity of the acellular vaccine was higher than that of the whole cell vaccine. 4. Anti-agglutinogen antibody productivity of the whole cell vaccine was higher than that of the acellular vaccine. 5. There was no pyrogenic activity with the acellular vaccine, but high pyrogenicity was seen with whole cell vaccine. 6. There was high body-weight decreasing toxicity in mice and guinea pigs by the whole cell vaccine. 7. The mice died when they received whole cell pertussis vaccine iv, but no deaths occurred in the mice which received acellular pertussis vaccine. PMID:1778317

Sato, Y; Sato, H

1991-01-01

321

Kinetic study of biological hydrogen production by anaerobic fermentation  

Microsoft Academic Search

The growth kinetics of hydrogen producing bacteria using three different substrates, namely sucrose, non-fat dry milk (NFDM), and food waste were investigated in dark fermentation through a series of batch experiments. The results showed that hydrogen production potential and hydrogen production rate increased with an increasing substrate concentration. The maximum hydrogen yields from sucrose, NFDM, and food waste were 234,

Wen-Hsing Chen; Shen-Yi Chen; Samir Kumar Khanal; Shihwu Sung

2006-01-01

322

Two Case Studies in the Scientific Method: Antisense Experiments and HIV Vaccination Studies.  

ERIC Educational Resources Information Center

Presents two recent cases that can be used in the classroom to illustrate the application of scientific methods in biological research: (1) the use of a complementary RNA or DNA molecule to block the production or translation of an mRNA molecule; and (2) the development of HIV trial vaccines. Contains 20 references. (WRM)

Guilfoile, Patrick

1999-01-01

323

The advent of human diploid cell rabies vaccine: impact on vaccine utilization in New Mexico.  

PubMed

Three months' experience with the newly licensed human diploid cell rabies vaccine in the New Mexico comprehensive consultation-biologics system was reviewed. Comparison with the same period in 1978 and 1979 showed no increase in vaccine utilization despite the advent of this simpler-to-use, safer rabies vaccine. Anti-rabies treatments appear to be minimally influenced by new vaccine technology when a comprehensive consultation system is available to support and guide the private physician. PMID:7468887

Mann, J M; Hoffman, R E; Rollag, O J; Bartol, L; Burkhart, M J

1981-04-01

324

The advent of human diploid cell rabies vaccine: impact on vaccine utilization in New Mexico.  

PubMed Central

Three months' experience with the newly licensed human diploid cell rabies vaccine in the New Mexico comprehensive consultation-biologics system was reviewed. Comparison with the same period in 1978 and 1979 showed no increase in vaccine utilization despite the advent of this simpler-to-use, safer rabies vaccine. Anti-rabies treatments appear to be minimally influenced by new vaccine technology when a comprehensive consultation system is available to support and guide the private physician. PMID:7468887

Mann, J M; Hoffman, R E; Rollag, O J; Bartol, L; Burkhart, M J

1981-01-01

325

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

326

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

327

Plant-Based Production of Recombinant Plasmodium Surface Protein Pf38 and Evaluation of its Potential as a Vaccine Candidate  

PubMed Central

Pf38 is a surface protein of the malarial parasite Plasmodium falciparum. In this study, we produced and purified recombinant Pf38 and a fusion protein composed of red fluorescent protein and Pf38 (RFP-Pf38) using a transient expression system in the plant Nicotiana benthamiana. To our knowledge, this is the first description of the production of recombinant Pf38. To verify the quality of the recombinant Pf38, plasma from semi-immune African donors was used to confirm specific binding to Pf38. ELISA measurements revealed that immune responses to Pf38 in this African subset were comparable to reactivities to AMA-1 and MSP119. Pf38 and RFP-Pf38 were successfully used to immunise mice, although titres from these mice were low (on average 1?11.000 and 1?39.000, respectively). In immune fluorescence assays, the purified IgG fraction from the sera of immunised mice recognised Pf38 on the surface of schizonts, gametocytes, macrogametes and zygotes, but not sporozoites. Growth inhibition assays using ?Pf38 antibodies demonstrated strong inhibition (?60%) of the growth of blood-stage P. falciparum. The development of zygotes was also effectively inhibited by ?Pf38 antibodies, as determined by the zygote development assay. Collectively, these results suggest that Pf38 is an interesting candidate for the development of a malaria vaccine. PMID:24278216

Feller, Tatjana; Thom, Pascal; Koch, Natalie; Spiegel, Holger; Addai-Mensah, Otchere; Fischer, Rainer; Reimann, Andreas; Pradel, Gabriele; Fendel, Rolf; Schillberg, Stefan; Scheuermayer, Matthias; Schinkel, Helga

2013-01-01

328

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

329

Smallpox Vaccines for Biodefense  

PubMed Central

Few diseases can match the enormous impact that smallpox has had on mankind. Its influence can be seen in the earliest recorded histories of ancient civilizations in Egypt and Mesopotamia. With fatality rates up to 30%, smallpox left its survivors with extensive scarring and other serious sequelae. It is estimated that smallpox killed 500 million people in the 19th and 20th centuries. Given the ongoing concerns regarding the use of variola as a biological weapon, this review will focus on the licensed vaccines as well as current research into next-generation vaccines to protect against smallpox and other poxviruses. PMID:19837292

Kennedy, Richard B.; Ovsyannikova, Inna; Poland, Gregory A.

2009-01-01

330

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

331

Biological productivity and carbon cycling in the Arctic Ocean  

Microsoft Academic Search

Primary production, bacterial production, particulate organic carbon fluxes and organic carbon burial rates were quantified\\u000a during the summer period of 1999 in the Arctic Ocean via14C uptake,3H uptake,234Th\\/238U disequilibrium and210Pbex dating, respectively. The integrated primary production in the water column was as high as 197 mmolC\\/(m2 · d) in the Chukchi\\u000a shelf and was 3.8 mmolC\\/(m2 · d) in the

Min Chen; Yipu Huang; Laodong Guo; Pinghe Cai; Weifeng Yang; Guangshan Liu; Yusheng Qiu

2002-01-01

332

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

333

Theory: Biological systems organize to maximize entropy production subject to information and biophysicochemical constraints.  

E-print Network

Theory: Biological systems organize to maximize entropy production subject to information that steady state systems with sufficient degrees of freedom will organize to maximize the rate of entropy production. While organized structures decrease the entropy of the system, they are maintained by external

Vallino, Joseph J.

334

Biological effects of low levels of radiation exposure. [Radiation hazards to man from radioactive consumer products  

Microsoft Academic Search

Some general perspective is provided concerning the orders of radiation dose equivalent levels associated with exposure of human populations to ionizing radiations from consumer products. This is followed by considerations of the biological effects and risks of low levels of radiation exposure. Some consumer products emit low-LET (i.e., low linear energy transfer) radiations beyond their confines and these penetrating radiations

Casarett

1977-01-01

335

Vaccine allergies  

PubMed Central

Currently, the increasing numbers of vaccine administrations are associated with increased reports of adverse vaccine reactions. Whilst the general adverse reactions including allergic reactions caused by the vaccine itself or the vaccine components, are rare, they can in some circumstances be serious and even fatal. In accordance with many IgE-mediated reactions and immediate-type allergic reactions, the primary allergens are proteins. The proteins most often implicated in vaccine allergies are egg and gelatin, with perhaps rare reactions to yeast or latex. Numerous studies have demonstrated that the injectable influenza vaccine can be safely administered, although with appropriate precautions, to patients with severe egg allergy, as the current influenza vaccines contain small trace amounts of egg protein. If an allergy is suspected, an accurate examination followed by algorithms is vital for correct diagnosis, treatment and decision regarding re-vaccination in patients with immediate-type reactions to vaccines. Facilities and health care professionals should be available to treat immediate hypersensitivity reactions (anaphylaxis) in all settings where vaccines are administered. PMID:24427763

2014-01-01

336

The U.S. vaccine and immunization enterprise: Working to sustain and foster vaccine innovation.  

PubMed

The U.S. vaccine and immunization enterprise has been successful in introducing new vaccines to the U.S. and global markets. The vaccine sector of the pharmaceutical industry is experiencing growth projected to increase through the next decade. Despite the successes and future promise, challenges exist for funding the research and development and delivery of new vaccines. Adult and adolescent vaccination coverage of routinely recommended vaccines remains low and financial barriers to vaccination have emerged due to the increased cost of vaccination including the increased price of newer vaccines. Because the development and manufacture of new vaccines rely on the sales of established vaccines and other products, high coverage rates are important to the vaccine industry. Moreover, government and foundation support can assist in the research and development and introduction of new vaccines, especially for those vaccines that are necessary for use in the developing world. Novel approaches are needed to encourage and expand partnerships to advance vaccine research and development. Manufacturers in emerging economies have an increasing role in providing innovative vaccines to the world. PMID:19713758

Shen, Angela K

2009-10-01

337

Biologicals production by recombinant DNA technology in Cuba.  

PubMed

During 1981 we started an intensive programme for the development of biotechnology in Cuba. The first project was related to the production of leucocyte interferon and the cloning an expression of these genes in prokaryotic and yeast cells. These products are currently obtained in large amounts and their physical and chemical characterization are presented. The use of mammalian cells in culture for the production of recombinant proteins has also been carried out. The results obtained with the expression and amplification of the hepatitis B surface antigen (HBsAg) in CHO cells are discussed and compared with that obtained in yeast. The construction of a recombinant vaccinia virus carrying the HBsAg was also achieved. The specific transcripts were characterized and the Ab levels tested in animals. The results presented here indicate that the host system is a very important aspect to be taken into consideration and in some cases mammalian cells appear to be the best choice. PMID:2503409

Herrera, L; Del la Fuente, J; Quinones, Y; Padron, G; Agraz, A; Vega, J; Perez, L; Silva, A; Santizo, C; Alvarez, R

1989-01-01

338

Molecular and biological characterization of the 5 human-bovine rotavirus (WC3)-based reassortant strains of the pentavalent rotavirus vaccine, RotaTeq (registered)  

SciTech Connect

RotaTeq (registered) is a pentavalent rotavirus vaccine that contains five human-bovine reassortant strains (designated G1, G2, G3, G4, and P1) on the backbone of the naturally attenuated tissue culture-adapted parental bovine rotavirus (BRV) strain WC3. The viral genomes of each of the reassortant strains were completely sequenced and compared pairwise and phylogenetically among each other and to human rotavirus (HRV) and BRV reference strains. Reassortants G1, G2, G3, and G4 contained the VP7 gene from their corresponding HRV parent strains, while reassortants G1 and G2 also contained the VP3 gene (genotype M1) from the HRV parent strain. The P1 reassortant contained the VP4 gene from the HRV parent strain and all the other gene segments from the BRV WC3 strain. The human VP7s had a high level of overall amino acid identity (G1: 95-99%, G2: 94-99% G3: 96-100%, G4: 93-99%) when compared to those of representative rotavirus strains of their corresponding G serotypes. The VP4 of the P1 reassortant had a high identity (92-97%) with those of serotype P1A[8] HRV reference strains, while the BRV VP7 showed identities ranging from 91% to 94% to those of serotype G6 HRV strains. Sequence analyses of the BRV or HRV genes confirmed that the fundamental structure of the proteins in the vaccine was similar to those of the HRV and BRV references strains. Sequences analyses showed that RotaTeq (registered) exhibited a high degree of genetic stability as no mutations were identified in the material of each reassortant, which undergoes two rounds of replication cycles in cell culture during the manufacturing process, when compared to the final material used to fill the dosing tubes. The infectivity of each of the reassortant strains of RotaTeq (registered) , like HRV strains, did not require the presence of sialic acid residues on the cell surface. The molecular and biologic characterization of RotaTeq (registered) adds to the significant body of clinical data supporting the consistent efficacy, immunogenicity, and safety of RotaTeq (registered) .

Matthijnssens, Jelle [Laboratory of Clinical and Epidemiological Virology, Department of Microbiology and Immunology, Rega Research Institute for Medical Research, University of Leuven, Leuven (Belgium); Joelsson, Daniel B.; Warakomski, Donald J.; Zhou, Tingyi; Mathis, Pamela K.; Maanen, Marc-Henri van; Ranheim, Todd S. [Bioprocess and Bioanalytical Research, Merck Research Laboratories, North Wales, PA 19454 (United States); Ciarlet, Max, E-mail: max_ciarlet@merck.co [Vaccines-Clinical Research Department, Merck Research Laboratories, North Wales, PA 19454 (United States)

2010-08-01

339

Collaborative study for the establishment of a European Phamacopoeia Biological reference preparation for Bordetella pertussis mouse antiserum for serological potency testing of acellular pertussis vaccines.  

PubMed

A collaborative study was organised by the European Directorate For the Quality of Medicines (EDQM) to assess the suitability of a candidate mouse antiserum as a European Pharmacopoeia Biological reference preparation (BRP) for acellular pertussis vaccine potency testing. The candidate antiserum was obtained by immunising mice with a five-component acellular pertussis vaccine: pertussis toxin (PT), filamentous haemagglutinin (FHA), pertactin (PRN) and Fimbrial 2/Fimbrial 3 (Fim 2&3). The study has been divided into two separate phases. Phase I was a pre-qualification study including three laboratories. This phase was aimed at pre-qualifying the candidate BRP (cBRP) and at documenting the impact of differences in the antibody detection methodology enzyme linked immunosorbent assay (ELISA) procedures on results of pertussis antisera calibration versus the currently used standard US standard pertussis antiserum (mouse) Lot 1 (SPAM-1) (United States Food and Drug Administration (USFDA) reference serum) and the cBRP. As no significant difference between the antibody titres determined by using the different ELISA methodologies was found, a large-scale study enrolling 13 laboratories (Phase II) was carried out, each participant performing its in-house methodology. Its aim was to calibrate the cBRP (in terms of the SPAM-1 reference) and to demonstrate its equivalence or superiority to internal references. The study showed that there was no difference in positive sera titres expressed relative to their corresponding internal reference (homologous situation) or the proposed standard (heterologous situation) reference. The cBRP can, therefore, reliably act as replacement for the in-house reference preparations. Further analysis of the outcome of this study enabled to assign to the cBRP a potency of 39, 138, 34 and 56 ELISA unit per millilitre, respectively, to its anti-PT, anti-FHA, anti-PRN and anti-Fim 2&3 antibody contents. The cBRP has been adopted by the European Pharmacopoeia Commission at its June 2000 session as Bordetella pertussis mouse anti-serum Ph Eur. BRP batch 1. PMID:12623057

Poirier, Bertrand; Bornstein, Nicole; Andre, Murielle; Marmonier, Denis; Pares, Monique; Vanhooren, Gerard; Rautmann, Guy; Behr-Gross, Marie-Emmanuelle; Dobbelaer, Roland; Fuchs, Florence

2003-03-01

340

Metabolic Engineering for Production of Biorenewable Fuels and Chemicals: Contributions of Synthetic Biology  

PubMed Central

Production of fuels and chemicals through microbial fermentation of plant material is a desirable alternative to petrochemical-based production. Fermentative production of biorenewable fuels and chemicals requires the engineering of biocatalysts that can quickly and efficiently convert sugars to target products at a cost that is competitive with existing petrochemical-based processes. It is also important that biocatalysts be robust to extreme fermentation conditions, biomass-derived inhibitors, and their target products. Traditional metabolic engineering has made great advances in this area, but synthetic biology has contributed and will continue to contribute to this field, particularly with next-generation biofuels. This work reviews the use of metabolic engineering and synthetic biology in biocatalyst engineering for biorenewable fuels and chemicals production, such as ethanol, butanol, acetate, lactate, succinate, alanine, and xylitol. We also examine the existing challenges in this area and discuss strategies for improving biocatalyst tolerance to chemical inhibitors. PMID:20414363

Jarboe, Laura R.; Zhang, Xueli; Wang, Xuan; Moore, Jonathan C.; Shanmugam, K. T.; Ingram, Lonnie O.

2010-01-01

341

Combination biological and microwave treatments of used rubber products  

DOEpatents

A process and resulting product is provided in which a vulcanized solid particulate, such as vulcanized crumb rubber, has select chemical bonds altered by biotreatment with thermophillic microorganisms selected from natural isolates from hot sulfur springs. Following the biotreatment, microwave radiation is used to further treat the surface and to treat the bulk interior of the crumb rubber. The resulting combined treatments render the treated crumb rubber more suitable for use in new rubber formulations. As a result, larger loading levels and sizes of the treated crumb rubber can be used in new rubber mixtures and good properties obtained from the new recycled products.

Fliermans, Carl B. (Augusta, GA); Wicks, George G. (Aiken, SC)

2002-01-01

342

Production of a novel multi-epitope peptide vaccine for cancer immunotherapy in TC-1 tumor-bearing mice.  

PubMed

In our previous research, several bioinformatic strategies were utilized to design an efficient multi-epitope peptide vaccine (MEV) against cancer. The designed vaccine consists of Wilms tumor-1 (WT-1) and human papillomavirus (HPV) E7 cytotoxic T lymphocyte (CTL) epitopes, tetanus toxin fragment C (TTFrC) and HLA-DR epitope (PADRE) helper T lymphocyte (HTL) epitopes and heparin-binding hemagglutinin (HBHA) as an immunostimulatory adjuvant. All segments were fused together by suitable linkers. In the current study, we cloned and expressed the designed MEV in E. coli. We subsequently performed in vivo preventative and therapeutic assays to evaluate antitumor efficacy of the vaccine against the HPV-16 E7-expressing murine tumor cell line TC-1 as a model for cancer immunotherapy. The results showed that in preventive experiments, vaccination with MEV significantly augmented the IgG antibody titer and the percentage of tumor-free mice compared to control groups (PBS and E7). Moreover, in therapeutic experiments, vaccination with MEV led to a reduction in the number of metastatic nodules, lung weights and the ratio of lung weights to body weights compared to other groups. In sum, our epitope vaccine could efficiently induce preventive and therapeutic antitumor immunity in TC-1 tumor bearing mice. PMID:25467837

Nezafat, Navid; Sadraeian, Mohammad; Rahbar, Mohammad Reza; Khoshnoud, Mohammad Javad; Mohkam, Milad; Gholami, Ahmad; Banihashemi, Mehrzad; Ghasemi, Younes

2015-01-01

343

Baculovirus as vaccine vectors.  

PubMed

Application of viral vectors derived from human viruses to mediate immune response in animals and humans has been greatly hampered by the problems associated with pre-existing immunity and associated toxicities. Among few non-human viral vectors, baculovirus has now evolved as a novel tool for vaccine vector development. With broad tissue tropism and expanded bio-safety profile suitably supplemented with intrinsic immunostimulatory properties, baculovirus has now attained a niche position in the arena of vaccine development. Recombinant envelope-modified baculovirus equipped with novel shuttle promoters for in vivo transduction has shown promising results in several animal models. Baculovirus mediated induction of systemic and mucosal immune responses through intranasal or oral administration has now open an entirely new way for the development of new generation vaccines. Gaining additional insight into the baculovirus biology and its interaction with non-native hosts will certainly promote this human-friendly virus as a potential vector for clinical applications. PMID:20394572

Madhan, Selvaraj; Prabakaran, Mookkan; Kwang, Jimmy

2010-06-01

344

Biological hydrogen production by Anabaena sp. – Yield, energy and CO 2 analysis including fermentative biomass recovery  

Microsoft Academic Search

This paper presents laboratory results of biological production of hydrogen by photoautrotophic cyanobacterium Anabaena sp. Additional hydrogen production from residual Cyanobacteria fermentation was achieved by Enterobacter aerogenes bacteria. The authors evaluated the yield of H2 production, the energy consumption and CO2 emissions and the technological bottlenecks and possible improvements of the whole energy and CO2 emission chain.The authors did not

Ana F. Ferreira; Ana C. Marques; Ana P. Batista; Paula A. S. S. Marques; Luísa Gouveia; Carla M. Silva

345

Bovine mammary stem cells: Cell biology meets production agriculture  

Technology Transfer Automated Retrieval System (TEKTRAN)

Mammary stem cells (MaSC) provide for net growth, renewal and turnover of mammary epithelial cells, and are therefore potential targets for strategies to increase production efficiency. Appropriate regulation of MaSC can potentially benefit milk yield, persistency, dry period management and tissue ...

346

Defossiling Fuel: How Synthetic Biology Can Transform Biofuel Production  

E-print Network

production is pre- dicted to peak soon, it is reason- able to assume that unconventional fossil fuel sources and economic energy volatility, and smoothing the transition from fossil fuels in the distant future energy economy that is largely independent of fossil fuels. Indeed, such an approach has been underway

347

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...

348

21 CFR 201.56 - Requirements on content and format of labeling for human prescription drug and biological products.  

Code of Federal Regulations, 2010 CFR

...Requirements on content and format of labeling for human prescription drug and biological products...ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL...Requirements on content and format of labeling for human prescription drug and biological...

2010-04-01

349

21 CFR 201.56 - Requirements on content and format of labeling for human prescription drug and biological products.  

Code of Federal Regulations, 2014 CFR

...Requirements on content and format of labeling for human prescription drug and biological products...ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL...Requirements on content and format of labeling for human prescription drug and biological...

2014-04-01

350

21 CFR 201.56 - Requirements on content and format of labeling for human prescription drug and biological products.  

Code of Federal Regulations, 2013 CFR

...Requirements on content and format of labeling for human prescription drug and biological products...ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL...Requirements on content and format of labeling for human prescription drug and biological...

2013-04-01

351

21 CFR 201.56 - Requirements on content and format of labeling for human prescription drug and biological products.  

Code of Federal Regulations, 2011 CFR

...Requirements on content and format of labeling for human prescription drug and biological products...ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL...Requirements on content and format of labeling for human prescription drug and biological...

2011-04-01

352

21 CFR 201.56 - Requirements on content and format of labeling for human prescription drug and biological products.  

Code of Federal Regulations, 2012 CFR

...Requirements on content and format of labeling for human prescription drug and biological products...ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL...Requirements on content and format of labeling for human prescription drug and biological...

2012-04-01

353

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...

354

Tick-borne Encephalitis Vaccines  

PubMed Central

Tick-borne encephalitis (TBE) is a disease that is found from western Europe across Asia and into Japan. In recent years the incidence rate has been increasing as has the endemic range of the virus. Tick-borne encephalitis is caused by three genetically distinct sutypes of viruses within a single TBE virus (TBEV) serocomplex. These three subtypes consist of Far-eastern subtype TBEV (TBEV-FE), Siberian subtype (TBEV-Sib) and European subtype (TBEV-Eu). Each of these subtypes cause clinically distinct diseases with varying degrees of severity. Development of the first vaccines for TBEV began in the late 1930s shortly after the first isolation of TBEV-FE in Russia. In the 1970s Austria began large scale vaccine production and a nationalized vaccine campaign that significantly reduced the incidence rate of TBE. Currently there are four licensed TBE vaccines, two in Europe and two in Russia. These vaccines are all quite similar formalin-inactivated virus vaccines but the each use a different virus strain for production. Published studies have shown that European vaccines are cross-protective in rodent studies and elicit cross-reactive neutralizing antibody responses in human vaccines. European vaccines have been licensed for a rapid vaccine schedule that could be used in response to a significant outbreak and reasonable neutralizing antibody titers can be achieved after a single dose although a second dose provides nearly complete and long-lasting protection. This review focuses on the current status of licensed TBE vaccines and provides a brief summary of technology currently being developed for new vaccines. PMID:23997980

Lehrer, Axel T; Holbrook, Michael R.

2012-01-01

355

Filovirus vaccines  

PubMed Central

Filoviruses can cause severe and often fatal hemorrhagic fever in humans and non-human primates (NHPs). Although there are currently no clinically proven treatments for filovirus disease, much progress has been made in recent years in the discovery of therapeutics and vaccines against these viruses. A variety of vaccine platforms have been shown to be effective against filovirus infection. This review summarizes the literature in this field, focusing on vaccines that have been shown to protect NHPs from infection. Furthermore, the uses of rodent models in vaccine development, as well as correlates of immunity, are discussed. PMID:21519188

Bradfute, Steven B; Dye, John M

2011-01-01

356

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

357

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

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

Ferrari, Luca; Borghetti, Paolo; De Angelis, Elena; Martelli, Paolo

2014-01-01

358

Advances in Antiviral vaccine development  

PubMed Central

Summary 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. While 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.

2013-01-01

359

Time-Ordered Product Expansions for Computational Stochastic Systems Biology  

PubMed Central

The time-ordered product framework of quantum field theory can also be used to understand salient phenomena in stochastic biochemical networks. It is used here to derive Gillespie’s Stochastic Simulation Algorithm (SSA) for chemical reaction networks; consequently, the SSA can be interpreted in terms of Feynman diagrams. It is also used here to derive other, more general simulation and parameter-learning algorithms including simulation algorithms for networks of stochastic reaction-like processes operating on parameterized objects, and also hybrid stochastic reaction/differential equation models in which systems of ordinary differ-ential equations evolve the parameters of objects that can also undergo stochastic reactions. Thus, the time-ordered product expansion (TOPE) can be used systematically to derive simulation and parameter-fitting algorithms for stochastic systems. PMID:23735739

Mjolsness, Eric

2013-01-01

360

Improvements in fermentative biological hydrogen production through metabolic engineering.  

PubMed

Replacement of fossil fuels with alternative energies is increasingly imperative in light of impending climate change and fossil fuel shortages. Biohydrogen has several potential advantages over other biofuels. Dark fermentation as a means of producing biohydrogen is attractive since a variety of readily available waste streams can be used. However, at present its practical application is prevented by the low yields obtained. Here the basic metabolisms leading to hydrogen production are outlined and current research to increase yields, either through modification of existing pathways, or by metabolic engineering to create new, higher yielding, pathways, is discussed. Inactivation of competing reactions and manipulation of culture conditions has lead to higher hydrogen yields, near those predicted by metabolic schemes. However, to be useful, hydrogen production must be increased beyond present limits. Several possibilities for surpassing those limits using metabolic engineering are presented. PMID:20692761

Hallenbeck, Patrick C; Ghosh, Dipankar

2012-03-01

361

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

362

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

363

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

364

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

365

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

366

Biological Production of Hydrogen Peroxide in Prochlorococcus-Dominated Oligotrophic Waters  

NASA Astrophysics Data System (ADS)

Hydrogen peroxide, which can serve as both an oxidant and a reductant, is important to trace metal cycling in marine environments. Hydrogen peroxide production is of particular interest in waters dominated by Prochlorococcus since these cyanobacteria have been shown to lack peroxide-destroying enzymes. We measured biological production of hydrogen peroxide in the Prochlorococcus-dominated oligotrophic waters of the North Pacific Subtropical Gyre. Samples, some of which were spiked with additional hydrogen peroxide, were incubated either in the dark or under a grow light over several hours, and total hydrogen peroxide concentration was measured at regular intervals. This allowed for simultaneous determination of production and decay rates. Both samples concentrated by filtration and samples of organisms concentrated by a net tow were also incubated and measured by the same methods. We will present rates of biological production and decay of hydrogen peroxide and compare them with rates for photochemical production in the same system.

Schneider, R.; Roe, K.; Voelker, B. M.; Hansel, C. M.

2012-12-01

367

Pilot scale production of the vaccine adjuvant Proteoliposome derived Cochleates (AFCo1) from Neisseria meningitidis serogroup B  

PubMed Central

The use of new adjuvants in vaccine formulations is a subject of current research. Only few parenteral adjuvants have been licensed. We have developed a mucosal and parenteral adjuvant known as AFCo1 (Adjuvant Finlay Cochleate 1, derived from proteoliposomes of N. meningitidis B) using a dialysis procedure to produce them on lab scale. The immunogenicity of the AFCo1 produced by dialysis has been already evaluated, but it was necessary to demonstrate the feasibility of a larger-scale manufacturing process. Therefore, we used a crossflow diafiltration system (CFS) that allows easy scale up to obtain large batches in an aseptic environment. The aim of this work was to produce AFCo1 on pilot scale, while conserving the adjuvant properties. The proteoliposomes (raw material) were resuspended in a buffer containing sodium deoxycholate and were transformed into AFCo1 under the action of a calcium forming buffer. The detergent was removed from the protein solution by diafiltration to a constant volume. In this CFS, we used a hollow fiber cartridge from Amicon (polysulfona cartridge of 10 kDa porosity, 1mm channel diameter of fiber and 0.45 m2 area of filtration), allowing production of a batch of up to 20 L. AFCo1 were successfully produced by tangential filtration to pilot scale. The batch passed preliminary stability tests. Nasal immunization of BALB/c mice, induced specific saliva IgA and serum IgG. The induction of Th1 responses were demonstrated by the induction of IgG2a, IFN? and not IL-5. The adjuvant action over Neisseria (self) antigens and with co-administered (heterologous) antigens such as ovalbumin and a synthetic peptide from haemolytic Streptococcus B was also demonstrated. PMID:23458578

2013-01-01

368

Vaccines for seasonal and pandemic influenza.  

PubMed

Seasonal influenza continues to have a huge annual impact in the United States, accounting for tens of millions of illnesses, hundreds of thousands of excess hospitalizations, and tens of thousands of excess deaths. Vaccination remains the mainstay for the prevention of influenza. In the United States, 2 types of influenza vaccine are currently licensed: trivalent inactivated influenza vaccine and live attenuated influenza vaccine. Both are safe and effective in the populations for which they are approved for use. Children, adults <65 years of age, and the elderly all receive substantial health benefits from vaccination. In addition, vaccination appears to be cost-effective, if not cost saving, across the age spectrum. Despite long-standing recommendations for the routine vaccination of persons in high-priority groups, US vaccination rates remain too low across all age groups. Important issues to be addressed include improving vaccine delivery to current and expanded target groups, ensuring timely availability of adequate vaccine supply, and development of even more effective vaccines. Development of a vaccine against potentially pandemic strains is an essential part of the strategy to control and prevent a pandemic outbreak. The use of existing technologies for influenza vaccine production would be the most straightforward approach, because these technologies are commercially available and licensing would be relatively simple. Approaches currently being tested include subvirion inactivated vaccines and cold-adapted, live attenuated vaccines. Preliminary results have suggested that, for some pandemic antigens, particularly H5, subvirion inactivated vaccines are poorly immunogenic, for reasons that are not clear. Data from evaluation of live pandemic vaccines are pending. Second-generation approaches designed to provide improved immune responses at lower doses have focused on adjuvants such as alum and MF59, which are currently licensed for influenza or other vaccines. Additional experimental approaches are required to achieve the ultimate goal for seasonal and pandemic influenza prevention--namely, the ability to generate broadly cross-reactive and durable protection in humans. PMID:17163383

Nichol, Kristin L; Treanor, John J

2006-11-01

369

Suggested guidelines for vaccination of pigs in Korea  

PubMed Central

There is no published guideline for the vaccination to pigs even though several vaccine companies suggested the program based on their products. It is very difficult to standardize the program because most of the veterinary vaccines are containing several multivalent antigens depending on the companies. Now, we are suggesting the vaccine programs based on the current situation. PMID:25648422

Lee, Won Hyung

2015-01-01

370

Microneedle patches for vaccine delivery  

PubMed Central

In today's medical industry, the range of vaccines that exist for administration in humans represents an eclectic variety of forms and immunologic mechanisms. Namely, these are the live attenuated viruses, inactivated viruses, subunit proteins, and virus-like particles for treating virus-caused diseases, as well as the bacterial-based polysaccharide, protein, and conjugated vaccines. Currently, a new approach to vaccination is being investigated with the concept of DNA vaccines. As an alternative delivery route to enhance the vaccination efficacy, microneedles have been devised to target the rich network of immunologic antigen-presenting cells in the dermis and epidermis layers under the skin. Numerous studies have outlined the parameters of microneedle delivery of a wide range of vaccines, revealing comparable or higher immunogenicity to conventional intramuscular routes, overall level of stability, and dose-sparing advantages. Furthermore, recent mechanism studies have begun to successfully elucidate the biological mechanisms behind microneedle vaccination. This paper describes the current status of microneedle vaccine research. PMID:24427762

Suh, Hyemee; Shin, Juhyung

2014-01-01

371

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

372

HPV Vaccine  

MedlinePLUS

... Why Is It a Problem? How Does the Vaccine Work? Side Effects Protecting Yourself Against HPV What Is HPV and ... when having sex. Side Effects Most of the side effects that people get from the HPV vaccine are minor. They may include swelling or pain ...

373

The International AIDS Vaccine Initiative (IAVI) in a Changing Landscape of Vaccine Development: A Public\\/Private Partnership as Knowledge Broker and Integrator  

Microsoft Academic Search

Vaccine production is now at the heart of the debate on development. This paper argues that, as well as economic policies to address market failures, development policies aimed at fostering vaccine innovation should also consider the institutional and organisational uncertainties. The International Aids Vaccine Initiative (IAVI), a product development PPP, is attempting to increase vaccine production for neglected diseases by

Joanna Chataway; Stefano Brusoni; Eugenia Cacciatori; Rebecca Hanlin; Luigi Orsenigo

2007-01-01

374

Therapeutic vaccination to treat chronic infectious diseases  

PubMed Central

A famous milestone in the vaccine field has been the first successful vaccination against smallpox, in 1798, by Edward Jenner. Using the vaccinia cowpox virus, Jenner was able to protect vaccinees from variola or smallpox. The Modified Virus Ankara (MVA) poxvirus strain has been one of the vaccines subsequently developed to prevent smallpox infection and was selected by the US government in their Biodefense strategy. Progress in molecular biology and immunology associated with MVA infection has led to the development of MVA as vaccine platform, both in the field of preventive and therapeutic vaccines. This later class of therapeutics has witnessed growing interest that has translated into an increasing number of vaccine candidates reaching the clinics. Among those, MVA-based therapeutic vaccines have addressed four major chronic infections including viral hepatitis, AIDS, human papillomavirus-linked pathologies and tuberculosis. Clinical trials encompass phase 1 and 2 and have started to show significant results and promises. PMID:22894957

Boukhebza, Houda; Bellon, Nadine; Limacher, Jean Marc; Inchauspé, Geneviève

2012-01-01

375

Vaccination against bovine babesiosis.  

PubMed

Bovine babesiosis is an important disease caused by Babesia bovis, B. bigemina, and B. divergens. Solid immunity develops after infection and this feature has been exploited with the use of live attenuated organisms as immunogens. Attributes of live vaccines include a durable immunity to heterologous challenge after one vaccination. To overcome disadvantages relating to poor quality control (risk of contamination and adverse reactions), production procedures have been modified to meet the requirements of codes of good manufacturing practice. This includes development of methods to allow production of cryopreserved vaccine and limit antigenic drift. Killed vaccines have also been used on a limited basis and consist of antigens extracted from cultured material or blood of infected calves, and given with adjuvant. The degree and duration of immunity against heterologous challenge is not well documented. Attempts are being made to develop subunit vaccines but the progress has been slow. A better understanding of the mechanisms involved in the expression of protective immunity against Babesia spp will aid in the identification of protective antigens. PMID:11193669

De Vos, A J; Bock, R E

2000-01-01

376

N-Glycosylation of cholera toxin B subunit in Nicotiana benthamiana: impacts on host stress response, production yield and vaccine potential  

PubMed Central

Plant-based transient overexpression systems enable rapid and scalable production of subunit vaccines. Previously, we have shown that cholera toxin B subunit (CTB), an oral cholera vaccine antigen, is N-glycosylated upon expression in transgenic Nicotiana benthamiana. Here, we found that overexpression of aglycosylated CTB by agroinfiltration of a tobamoviral vector causes massive tissue necrosis and poor accumulation unless retained in the endoplasmic reticulum (ER). However, the re-introduction of N-glycosylation to its original or an alternative site significantly relieved the necrosis and provided a high CTB yield without ER retention. Quantitative gene expression analysis of PDI, BiP, bZIP60, SKP1, 26S? proteasome and PR1a, and the detection of ubiquitinated CTB polypeptides revealed that N-glycosylation significantly relieved ER stress and hypersensitive response, and facilitated the folding/assembly of CTB. The glycosylated CTB (gCTB) was characterized for potential vaccine use. Glycan profiling revealed that gCTB contained approximately 38% plant-specific glycans. gCTB retained nanomolar affinity to GM1-ganglioside with only marginal reduction of physicochemical stability and induced an anti-cholera holotoxin antibody response comparable to native CTB in a mouse oral immunization study. These findings demonstrated gCTB's potential as an oral immunogen and point to a potential role of N-glycosylation in increasing recombinant protein yields in plants. PMID:25614217

Hamorsky, Krystal Teasley; Kouokam, J. Calvin; Jurkiewicz, Jessica M.; Nelson, Bailey; Moore, Lauren J.; Husk, Adam S.; Kajiura, Hiroyuki; Fujiyama, Kazuhito; Matoba, Nobuyuki

2015-01-01

377

N-Glycosylation of cholera toxin B subunit in Nicotiana benthamiana: impacts on host stress response, production yield and vaccine potential.  

PubMed

Plant-based transient overexpression systems enable rapid and scalable production of subunit vaccines. Previously, we have shown that cholera toxin B subunit (CTB), an oral cholera vaccine antigen, is N-glycosylated upon expression in transgenic Nicotiana benthamiana. Here, we found that overexpression of aglycosylated CTB by agroinfiltration of a tobamoviral vector causes massive tissue necrosis and poor accumulation unless retained in the endoplasmic reticulum (ER). However, the re-introduction of N-glycosylation to its original or an alternative site significantly relieved the necrosis and provided a high CTB yield without ER retention. Quantitative gene expression analysis of PDI, BiP, bZIP60, SKP1, 26S? proteasome and PR1a, and the detection of ubiquitinated CTB polypeptides revealed that N-glycosylation significantly relieved ER stress and hypersensitive response, and facilitated the folding/assembly of CTB. The glycosylated CTB (gCTB) was characterized for potential vaccine use. Glycan profiling revealed that gCTB contained approximately 38% plant-specific glycans. gCTB retained nanomolar affinity to GM1-ganglioside with only marginal reduction of physicochemical stability and induced an anti-cholera holotoxin antibody response comparable to native CTB in a mouse oral immunization study. These findings demonstrated gCTB's potential as an oral immunogen and point to a potential role of N-glycosylation in increasing recombinant protein yields in plants. PMID:25614217

Hamorsky, Krystal Teasley; Kouokam, J Calvin; Jurkiewicz, Jessica M; Nelson, Bailey; Moore, Lauren J; Husk, Adam S; Kajiura, Hiroyuki; Fujiyama, Kazuhito; Matoba, Nobuyuki

2015-01-01

378

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

379

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

380

New approaches to estimation of peat deposits for production of biologically active compounds  

NASA Astrophysics Data System (ADS)

It is known, that biologically active preparations from peat increase animals productivity as well as resistance against stress-factors and have adaptogeneous, antioxidant, immunomodulative properties. Optymal choice of peat deposits for the production of biologically active preparations supposes the detailed comparative analysis of peat properties from different deposits. For this the cadastre of peat of Ukraine is developed in the humic substances laboratory named after prof. Khristeva L.A. (Dnipropetrovsk Agrarian University, Ukraine). It based on the research of its physical and chemical properties, toxicity and biological activity, and called Biocadastre. The Biocadastre is based on the set of parameters, including the descriptions of physical and chemical properties (active acidity, degree of decomposition, botanical composition etc.), toxicity estimation (by parabyotyc, infusorial, inhibitor and other tests), biological activity indexes (growth-promoting, antioxidative, adaptogeneous, immunomodulative antistress and other actions). The blocks of Biocadastre indexes are differentiated, taking into account their use for creation the preparations for vegetable, animals and microorganisms. The Biocadastre will allow to choose the peat deposits, most suitable for the production of different biologically active preparations, both wide directed and narrow spectrum of action, depending on application fields (medicine, agriculture, veterinary medicine, microbiological industry, balneology, cosmetology).

Stepchenko, L. M.; Yurchenko, V. I.; Krasnik, V. G.; Syedykh, N. J.

2009-04-01

381

The Role of Synthetic Biology in the Design of Microbial Cell Factories for Biofuel Production  

PubMed Central

Insecurity in the supply of fossil fuels, volatile fuel prices, and major concerns regarding climate change have sparked renewed interest in the production of fuels from renewable resources. Because of this, the use of biodiesel has grown dramatically during the last few years and is expected to increase even further in the future. Biodiesel production through the use of microbial systems has marked a turning point in the field of biofuels since it is emerging as an attractive alternative to conventional technology. Recent progress in synthetic biology has accelerated the ability to analyze, construct, and/or redesign microbial metabolic pathways with unprecedented precision, in order to permit biofuel production that is amenable to industrial applications. The review presented here focuses specifically on the role of synthetic biology in the design of microbial cell factories for efficient production of biodiesel. PMID:22028591

Colin, Verónica Leticia; Rodríguez, Analía; Cristóbal, Héctor Antonio

2011-01-01

382

Biological production of acetaldehyde from ethanol using non-growing Pichia pastoris whole cells  

SciTech Connect

Acetaldehyde has been produced biologically using whole-cell Pichia Pass in a semibatch fermentor. Ethanol and air were fed continuously, and the product, acetaldehyde, was removed by the air stream. Operation of the reactor exceeded 100 h, maintaining high alcohol oxidase activity. Low cell-mass concentration (9.9 g/L) minimized product inhibition. Ethanol concentration in the broth, oxygen concentration in the air, and pH were evaluated for their effects on the fermentation process.

Chiang, Heien-Kun; Foutch, G.L. [Oklahoma State Univ., Stillwater, OK (United States); Fish, W.W. [Phillips Petroleum Co., Bartlesville, OK (United States)

1991-12-31

383

Synthesis and biological evaluation of a novel MUC1 glycopeptide conjugate vaccine candidate comprising a 4’-deoxy-4’-fluoro-Thomsen–Friedenreich epitope  

PubMed Central

Summary The development of selective anticancer vaccines that provide enhanced protection against tumor recurrence and metastasis has been the subject of intense research in the scientific community. The tumor-associated glycoprotein MUC1 represents a well-established target for cancer immunotherapy and has been used for the construction of various synthetic vaccine candidates. However, many of these vaccine prototypes suffer from an inherent low immunogenicity and are susceptible to rapid in vivo degradation. To overcome these drawbacks, novel fluorinated MUC1 glycopeptide-BSA/TTox conjugate vaccines have been prepared. Immunization of mice with the 4’F-TF-MUC1-TTox conjugate resulted in strong immune responses overriding the natural tolerance against MUC1 and producing selective IgG antibodies that are cross-reactive with native MUC1 epitopes on MCF-7 human cancer cells.

Gerlitzki, Bastian; Schmitt, Edgar

2015-01-01

384

On the Emerging Role of Chemistry in the Fashioning of Biologics: Synthesis of a Bidomainal Fucosyl GM1-Based Vaccine, for the Treatment of Small Cell Lung Cancer  

PubMed Central

The synthesis of the novel Small Cell Lung Cancer (SCLC) Fucosyl GM1-based vaccine construct, featuring insertion of the HLA-DR binding 15 amino acid sequence derived from Plasmodium Falciparum, is described. The resultant glycopeptide has been synthesized in an efficient manner. Finally, successful conjugation of the glycopeptide to the Keyhole Limpet Hemocyanin (KLH) carrier protein completed the preparation of the vaccine. PMID:19555091

Nagorny, Pavel; Kim, Woo Han; Wan, Qian; Lee, Dongjoo; Danishefsky, Samuel J.

2009-01-01

385

On the emerging role of chemistry in the fashioning of biologics: synthesis of a bidomainal fucosyl GM1-based vaccine for the treatment of small cell lung cancer.  

PubMed

The synthesis of the novel small cell lung cancer (SCLC) fucosyl GM1-based vaccine construct, featuring insertion of the HLA-DR binding 15 amino acid sequence derived from Plasmodium falciparum, is described. The resultant glycopeptide has been synthesized in an efficient manner. Finally, successful conjugation of the glycopeptide to the keyhole limpet hemocyanin (KLH) carrier protein completed the preparation of the vaccine. PMID:19555091

Nagorny, Pavel; Kim, Woo Han; Wan, Qian; Lee, Dongjoo; Danishefsky, Samuel J

2009-08-01

386

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

387

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

388

[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

389

Development of a new candidate H5N1 avian influenza virus for pre-pandemic vaccination production  

Technology Transfer Automated Retrieval System (TEKTRAN)

BACKGROUND. Highly pathogenic H5N1 avian influenza viruses currently circulating in birds have caused hundreds of human infections, and pose a significant pandemic threat. Vaccines are a major component of the public health sector preparedness for this likely event. The rapid evolution of H5N1 vi...

390

Establishment of European Pharmacopoeia (Ph. Eur.) Biological Reference Preparations (BRP) batch 2 for rDNA hepatitis B vaccine (method A and B).  

PubMed

A collaborative study was initiated by the European Directorate for the Quality of Medicines (EDQM), to assign a potency value for candidate batch 2 of European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Hepatitis B (rDNA) antigen in vitro assays, for both method A and method B by calibrating them against the Ph. Eur. BRPs, batch 1 for methods A and B respectively. The study was prompted by the observation that the first batch of BRP for method B appeared to have lost potency over time. BRP 1 for method A showed no loss in potency, however stocks of the material were nearing depletion. Eleven laboratories participated in the study and all reported results. Participants performed 3 independent assays using both method A and method B. Method A was used to assess BRPs for method A and method B was used to assess BRPs for method B. Since BRP 1B was suspected to have lost potency, an additional sample was included in the method B test in an attempt to clarify the situation. BRP 1B was also assayed in method A against BRP 1A in the hope of also attaining further information by comparing the results from this study to those obtained in the original study to establish the first batch of BRP [1]. Although it was not the primary aim of this study to correlate in vitro potency with the immunogenicity assay in mice, a number of interested parties also performed the mouse in vivo assay to obtain data on the behaviour of the candidate BRPs in this assay. For method A, potency estimates were satisfactory in terms of repeatability and reproducibility. The candidate material was therefore assigned a value of 16.6 micrograms/ml. For method B, it appeared that the observation of reduced in vitro potency of BRP1 was confirmed. Despite the attempt to clarify the situation with additional studies, it was not possible to assign a potency value with the results obtained. A small-scale collaborative study will be organised to determine an appropriate value for the candidate BRP for method B. The results from the in vivo study while highly variable showed no evidence of a shift in the in vivo potency for either BRP 1A or BRP 1B. It should be noted that the in vitro method for determination of hepatitis B vaccine potency is under revision due to the discontinuation of the Auszyme kit from Abbott, which is required to perform the current assays. Once an alternative assay has been established, the suitability of the reference preparations or establishment of new reference preparations will be required. The candidate material for method A BRP was adopted by the European Pharmacopoeia Commission at its session in November 2003, as the European Pharmacopoeia Hepatitis B vaccine (rDNA) method A, batch 2. PMID:14960264

Dobbelaer, R; Daas, A; Milne, C

2004-01-01

391

78 FR 29698 - Availability of an Environmental Assessment for Field Testing a Canine Lymphoma Vaccine, DNA  

Federal Register 2010, 2011, 2012, 2013, 2014

...Field Testing a Canine Lymphoma Vaccine, DNA AGENCY: Animal and Plant Health Inspection...an unlicensed Canine Lymphoma Vaccine, DNA. The environmental assessment, which is...Inc. Product: Canine Lymphoma Vaccine, DNA. Possible Field Test Locations:...

2013-05-21

392

Economics of vaccines revisited  

PubMed Central

Performing a total health economic analysis of a vaccine newly introduced into the market today is a challenge when using the conventional cost-effectiveness analysis we normally apply on pharmaceutical products. There are many reasons for that, such as: the uncertainty in the total benefit (direct and indirect) to be measured in a population when using a cohort model;1 appropriate rules about discounting the long-term impact of vaccines are absent jeopardizing therefore their value at the initial investment;2 the presence of opposite contexts when introducing the vaccine in developed vs. the developing world with high benefits, low initial health care investment for the latter vs. marginal benefit and high cost for the former; with a corresponding paradox for the vaccine becoming very cost-effective in low income countries but rather medium in middle low to high middle income countries;3 and the type of trial assessment for the newer vaccines is now often performed with immunogenicity reaction instead of clinical endpoints which still leaves questions on their real impact and their head-to-head comparison.4 PMID:23364247

Postma, Maarten J.; Standaert, Baudouin A.

2013-01-01

393

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

394

A downstream process for production of a viable and stable Bacillus cereus aquaculture biological agent.  

PubMed

Biological products offer advantages over chemotherapeutics in aquaculture. Adoption in commercial application is lacking due to limitations in process and product development that address key end user product requirements such as cost, efficacy, shelf life and convenience. In previous studies, we have reported on the efficacy, physiological robustness and low-cost spore production of a Bacillus cereus isolate (NRRL 100132). This study examines the development of suitable spore recovery, drying, formulation and tablet production from the fermentation product. Key criteria used for such downstream process unit evaluation included spore viability, recovery, spore balance, spore re-germination, product intermediate stability, end product stability and efficacy. A process flow sheet comprising vertical tube centrifugation, fluidised bed agglomeration and tablet pressing yielded a suitable product. The formulation included corn steep liquor and glucose to enhance subsequent spore regermination. Viable spore recovery and spore balance closure across each of the process units was high (>70% and >99% respectively), with improvement in recovery possible by adoption of continuous processing at large scale. Spore regermination was 97%, whilst a product half-life in excess of 5 years was estimated based on thermal resistance curves. The process resulted in a commercially attractive product and suitable variable cost of production. PMID:19921182

Lalloo, Rajesh; Maharajh, Dheepak; Görgens, Johann; Gardiner, Neil

2010-03-01

395

Intracellular Delivery of a Protein Antigen with an Endosomal-Releasing Polymer Enhances CD8 T-Cell Production and Prophylactic Vaccine Efficacy  

PubMed Central

Protein-based vaccines have significant potential as infectious disease and anticancer therapeutics, but clinical impact has been limited in some applications by their ability to generate a coordinated cellular immune response. Here, a pH-responsive carrier incorporating poly(propylacrylic acid) (PPAA was evaluated to test whether improved cytosolic delivery of a protein antigen could enhance CD8+ cytotoxic lymphocyte generation and prophylactic tumor vaccine responses. PPAA was directly conjugated to the model ovalbumin antigen via reducible disulfide linkages and was also tested in a particulate formulation after condensation with the cationic poly(dimethylaminoethyl methacrylate) (PDMAEMA). Intracellular trafficking studies revealed that both PPAA-containing formulations were stably internalized compared to control conjugates and evaded exocytotic pathways, leading to increased intracellular accumulation and potential access to the cytosolic MHC-1 antigen presentation pathway. In an EG.7-OVA mouse tumor protection model, both PPAA-containing carriers robustly inhibited tumor growth and led to an approximately 3.5 fold increase in the longevity of tumor free survival relative to controls. Mechanistically this response was attributed to the 8-fold increase in production of ovalbumin-specific CD8+ T-lymphocytes and an 11-fold increase in production of anti-ovalbumin IgG. Significantly, this is one of the first demonstrated examples of in vivo immunotherapeutic efficacy using soluble protein-polymer conjugates. These results suggest that carriers enhancing cytosolic delivery of protein antigens could lead to more robust CD8+ T-cell response and demonstrate the potential of pH-responsive PPAA-based carriers for therapeutic vaccine applications. PMID:21043513

Foster, Suzanne; Duvall, Craig L.; Crownover, Emily F.; Hoffman, Allan S.; Stayton, Patrick S.

2010-01-01

396

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

397

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

398

Oral vaccines  

PubMed Central

Oral vaccines are safe and easy to administer and convenient for all ages. They have been successfully developed to protect from many infectious diseases acquired through oral transmission. We recently found in animal models that formulation of oral vaccines in a nanoparticle-releasing microparticle delivery system is a viable approach for selectively inducing large intestinal protective immunity against infections at rectal and genital mucosae. These large-intestine targeted oral vaccines are a potential substitute for the intracolorectal immunization, which has been found to be effective against rectogenital infections but is not feasible for mass vaccination. Moreover, the newly developed delivery system can be modified to selectively target either the small or large intestine for immunization and accordingly revealed a regionalized immune system in the gut. Future applications and research endeavors suggested by the findings are discussed. PMID:23493163

Zhu, Qing; Berzofsky, Jay A.

2013-01-01

399

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.

400

Typhoid Vaccine  

MedlinePLUS

... serious disease. It is caused by bacteria called Salmonella Typhi. Typhoid causes a high fever, fatigue, weakness, ... a typhoid carrier. • Laboratory workers who work with Salmonella Typhi bacteria. Inactivated typhoid vaccine (shot) • One dose ...

401

What controls biological productivity in coastal upwelling systems? Insights from a comparative modeling study  

NASA Astrophysics Data System (ADS)

The magnitude of the biological productivity in Eastern Boundary Upwelling Systems (EBUS) is traditionally viewed as directly reflecting the upwelling intensity. Yet, different EBUS show different sensitivities of productivity to upwelling-favorable winds (Carr and Kearns, 2003). Here, using a comparative modeling study of the California Current System (California CS) and Canary Current System (Canary CS), we show how physical and environmental factors, such as light, temperature and cross-shore circulation modulate the response of biological productivity to upwelling strength. To this end, we made a series of eddy-resolving simulations of the California CS and Canary CS using the Regional Ocean Modeling System (ROMS), coupled to a nitrogen based Nutrient-Phytoplankton-Zooplankton-Detritus (NPZD) ecosystem model. We find the nutrient content of the euphotic zone to be 20 % smaller in the Canary CS relative to the California CS. Yet, the biological productivity is 50 % smaller in the latter. This is due to: (1) a faster nutrient-replete growth in the Canary CS relative to the California CS, related to a more favorable light and temperature conditions in the Canary CS, and (2) the longer nearshore water residence times in the Canary CS which lead to larger buildup of biomass in the upwelling zone, thereby enhancing the productivity. The longer residence times in the Canary CS appear to be associated with the wider continental shelves and the lower eddy activity characterizing this upwelling system. This results in a weaker offshore export of nutrients and organic matter, thereby increasing local nutrient recycling and enhancing the coupling between new and export production in the Northwest African system. Our results suggest that climate change induced perturbations such as upwelling favorable wind intensification might lead to contrasting biological responses in the California CS and the Canary CS, with major implications for the biogeochemical cycles and fisheries in these two ecosystems.

Lachkar, Z.; Gruber, N.

2011-06-01

402

Advanced concepts in biomass production and biological pretreatment. Annual report, April 1988 to March 1989  

SciTech Connect

The overall objective of the research is to investigate fundamental processes for enhancing the efficiency of methane from sorghum systems. The report provides specifics of research activities in the Texas A and M biomass and biological pretreatment program sponsored by Gas Research Institute and co-funded by Texas Agricultural Experiment Station. Four research groups, each with specific tasks, are involved in the project: biomass production, quantity and quality, biological pretreatment and processing, long-term effects of land application of digester effluent, and systems modeling and analysis.

Hiler, E.A.

1989-04-01

403

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

404

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

405

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.

406

Novel linear DNA vaccines induce protective immune responses against lethal infection with influenza virus type A/H5N1  

PubMed Central

Vaccine development for possible influenza pandemics has been challenging. Conventional vaccines such as inactivated and live attenuated virus preparations are limited in terms of production speed and capacity. DNA vaccination has emerged as a potential alternative to conventional vaccines against influenza pandemics. In this study, we use a novel, cell-free DNA manufacturing process (synDNA™) to produce prototype linear DNA vaccines against the influenza virus type A/H5N1. This synDNA™ process does not require bacterial fermentation, so it avoids the use of antibiotic resistance genes and other nucleic acid sequences unrelated to the antigen gene expression in the actual therapeutic DNA construct. The efficacy of various vaccines expressing the hemagglutinin and neuraminidase proteins (H5N1 synDNA™), hemagglutinin alone (H5 synDNA™) or neuraminidase alone (N1 synDNA™) was evaluated in mice. Two of the constructs (H5 synDNA™ and H5N1 synDNA™) induced a robust protective immune response with up to 93% of treated mice surviving a lethal challenge of a virulent influenza A/Vietnam/1203/04 H5N1 isolate. In combination with a potent biological activity and simplified production footprint, these characteristics make DNA vaccines prepared with our synDNA™ process highly suitable as alternatives to other vaccine preparations. PMID:18443425

Kendirgi, Frédéric; Yun, Nadezda E.; Linde, Nathaniel S.; Zacks, Michele A.; Smith, Jeanon N.; Smith, Jennifer K.; McMicken, Harilyn; Chen, Yin; Paessler, Slobodan

2008-01-01

407

Meat Production in a Feedlot System of Zebu—Holstein Steers and Heifers with Dairy Genetics: Productive and Biological Analyses  

PubMed Central

The aim of this study was to evaluate the productive and biological efficiency of steers and heifers from dairy genetics in a feedlot system in terms of meat production. Twenty-four steers and 24 heifers at 10 monthes of age, (3/4) Zebu × (1/4) Holstein were utilized. They were distributed over four feedlot times, 30, 60, 90, and 120 days with four replications for each sex, and were slaughtered at the end of each period. The productive and biological analyses were performed through comparative slaughter to determine the body composition. Heifers presented with greater intakes (P < 0.05) of dry matter in grams per kg of body weight. Steers presented with a greater (P < 0.05) final empty body weight, carcass gain, cold carcass weight, and meat proportion in the carcass; however, heifers presented with a greater subcutaneous fat thickness (P < 0.05) and, consequently, a greater (P < 0.05) fat proportion in the carcass. We conclude that steers are more efficient in their productive performance than heifers in a feedlot. For the finishing carcass fat cover, heifers need 90 days in the feedlot. The net energy requirements for maintenance are 67?kcal/EBW0.75/d, and the net requirements of energy (NEg) and protein (NPg) for gain can be estimated by the following equations: NEg(Mcal/d) = 0.067 × EBW0.75 × EBG1.095 and NPg = 162 × EBG ? 5.62 × RE for the two sexes. PMID:25574483

Menezes, Gustavo Chamon de Castro; Valadares Filho, Sebastião de Campos; Ruas, José Reinaldo Mendes; Detmann, Edenio; Menezes, Arismar de Castro; Zanett, Diego; Mariz, Lays Débora Silva; Rennó, Luciana Navajas; da Silva Junior, Jarbas Miguel

2014-01-01

408

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

409

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...

410

Therapeutic vaccination to treat chronic infectious diseases: current clinical developments using MVA-based vaccines.  

PubMed

A famous milestone in the vaccine field has been the first successful vaccination against smallpox, in 1798, by Edward Jenner. Using the vaccinia cowpox virus, Jenner was able to protect vaccinees from variola or smallpox. The Modified Virus Ankara (MVA) poxvirus strain has been one of the vaccines subsequently developed to prevent smallpox infection and was selected by the US government in their Biodefense strategy. Progress in molecular biology and immunology associated with MVA infection has led to the development of MVA as vaccine platform, both in the field of preventive and therapeutic vaccines. This later class of therapeutics has witnessed growing interest that has translated into an increasing number of vaccine candidates reaching the clinics. Among those, MVA-based therapeutic vaccines have addressed four major chronic infections including viral hepatitis, AIDS, human papillomavirus-linked pathologies and tuberculosis. Clinical trials encompass phase 1 and 2 and have started to show significant results and promises. PMID:22894957

Boukhebza, Houda; Bellon, Nadine; Limacher, Jean Marc; Inchauspé, Geneviève

2012-12-01

411

The double-edged sword: How evolution can make or break a live-attenuated virus vaccine  

PubMed Central

Even students who reject evolution are often willing to consider cases in which evolutionary biology contributes to, or undermines, biomedical interventions. Moreover the intersection of evolutionary biology and biomedicine is fascinating in its own right. This review offers an overview of the ways in which evolution has impacted the design and deployment of live-attenuated virus vaccines, with subsections that may be useful as lecture material or as the basis for case studies in classes at a variety of levels. Live- attenuated virus vaccines have been modified in ways that restrain their replication in a host, so that infection (vaccination) produces immunity but not disease. Applied evolution, in the form of serial passage in novel host cells, is a “classical” method to generate live-attenuated viruses. However many live-attenuated vaccines exhibit reversion to virulence through back-mutation of attenuating mutations, compensatory mutations elsewhere in the genome, recombination or reassortment, or changes in quasispecies diversity. Additionally the combination of multiple live-attenuated strains may result in competition or facilitation between individual vaccine viruses, resulting in undesirable increases in virulence or decreases in immunogenicity. Genetic engineering informed by evolutionary thinking has led to a number of novel approaches to generate live-attenuated virus vaccines that contain substantial safeguards against reversion to virulence and that ameliorate interference among multiple vaccine strains. Finally, vaccines have the potential to shape the evolution of their wild type counterparts in counter-productive ways; at the extreme vaccine-driven eradication of a virus may create an empty niche that promotes the emergence of new viral pathogens. PMID:22468165

Hanley, Kathryn A.

2012-01-01

412

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

413

Vaccination against bacterial kidney disease: Chapter 22  

USGS Publications Warehouse

Bacterial kidney disease (BKD) of salmonid fishes, caused by Renibacterium salmoninarum, has been recognized as a serious disease in salmonid fishes since the 1930s. This chapter discusses the occurrence and significance, etiology, and pathogenesis of vibriosis. It then describes the different vaccination procedures and the effects and side-effects of vaccination. Despite years of research, however, only a single vaccine has been licensed for prevention of BKD, and has demonstrated variable efficacy. Therefore, in addition to a presentation of the current status of BKD vaccination, a discussion of potential future directions for BKD vaccine development is included in the chapter. This discussion is focused on the unique characteristics of R. salmoninarum and its biology, as well as aspects of the salmonid immune system that might be explored specifically to develop more effective vaccines for BKD prevention.

Elliott, Diane G.; Wiens, Gregory D.; Hammell, K. Larry; Rhodes, Linda D.

2014-01-01

414

Enhancing Specific-Antibody Production to the ragB Vaccine with GITRL That Expand Tfh, IFN-?+ T Cells and Attenuates Porphyromonas gingivalis Infection in Mice  

PubMed Central

The outer membrane protein RagB is one of the major virulence factors of the periodontal pathogen Porphyromonas gingivalis (P. gingivalis). In order to induce protective immune response against P. gingivalis infection, an mGITRL gene-linked ragB DNA vaccine (pIRES-ragB-mGITRL ) was constructed. Six-week-old female BALB/c mice were immunized with pIRES-ragB-mGITRL through intramuscular injection and then challenged by subcutaneous injection in the abdomen with P. gingivalis. RagB-specific antibody-forming cells were evaluated by an Enzyme-linked immunosorbent spot, and specific antibody was determined by enzyme-linked immunosorbent assay. In addition, the frequencies of Tfh and IFN-?+ T cells in spleen were measured using flow cytometer, and the levels of IL-21 and IFN-? mRNA or proteins were detected by real time RT-PCR or ELISA. The data showed that the mGITRL-linked ragB DNA vaccine induced higher levels of RagB-specific IgG in serum and RagB-specific antibody-forming cells in spleen. The frequencies of Tfh and IFN-?+ T cells were obviously expanded in mice immunized by pIRES-ragB-mGITRL compared with other groups (pIRES or pIRES-ragB ). The levels of Tfh and IFN-?+ T cells associated cytokines were also significantly increased in pIRES-ragB-mGITRL group. Therefore, the mice immunized with ragB plus mGITRL showed the stronger resistant to P. gingivalis infection and a significant reduction of the lesion size caused by P. gingivalis infection comparing with other groups. Taken together, our findings demonstrated that intramuscular injection of DNA vaccine ragB together with mGITRL induced protective immune response dramatically by increasing Tfh and IFN-?+ T cells and antibody production to P. gingivalis. PMID:23560053

Su, Zhaoliang; Kong, Fanzhi; Shi, Xiaoju; Tong, Jia; Shen, Pei; Peng, Tianqing; Wang, Shengjun; Xu, Huaxi

2013-01-01

415

Vaccine adjuvants revisited.  

PubMed

The development of new adjuvants for human vaccines has become an expanding field of research in the last thirty years, for generating stronger vaccines capable of inducing protective and long-lasting immunity in humans. Instead of such efforts, with several adjuvant strategies approaching to requirements for their clinical application, limitations like adjuvant toxicity remain to be fully surpassed. Here we summarize the current status of adjuvant development, including regulatory recommendations, adjuvant requirements, and adjuvant categories like mineral salts, tensoactive compounds, microorganism-derived adjuvants, emulsions, cytokines, polysaccharides, nucleic acid-based adjuvants, and a section dedicated to particulate antigen delivery systems. The mechanisms of adjuvanticity are also discussed in the light of recent findings on Toll-like receptors' biology and their involvement on immune activation. PMID:17336431

Aguilar, J C; Rodríguez, E G

2007-05-10

416

[Influenza vaccination present and future].  

PubMed

In healthy adults younger than 65 years the effectiveness of influenza vaccination is up to 90% for laboratory confirmed influenza, but is far less in elderly individuals over 65 years and those with comorbidities. However the vaccination in elderly people is effective in preventing complications of influenza infection: pneumonia, hospital admission and death from influenza or pneumonia. This effect is larger for elderly individuals living in nursing homes than in those living in the community. Recommendations at present include vaccination of all people over the age of 65, of high-risk groups, and of those who can transmit influenza to high-risk individuals (healthcare workers). Since 2005 it is recommended that people with occupational contact with wild or domestic birds should be vaccinated to reduce the risk of simultaneous infection with a human and an avian influenza virus. Influenza vaccination is considered to be safe: side effects are reversible within 1-2 days, severe complications are exceedingly rare. Most frequently inactivated vaccines are used, but in the USA there is also an attenuated live vaccine available. They all contain surface antigens of two influenza A strains and one influenza B strain. The world health organization (WHO) selects every year the strains to be included in the vaccine and the viruses are then grown on embryonated chicken eggs. This process requires detailed planning up to 6 months. Because a pandemic event cannot be predicted, this period is too long and there is an urgent need to develop techniques to reduce the vaccine production time and enhance its efficacy. Additionally, several researchers are exploring the possibility of generating a universal vaccine against influenza A virus that does not require reformulation on an annual basis. PMID:18581910

Eich, G

2007-11-01

417

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

418

9 CFR 113.210 - Feline Calicivirus Vaccine, Killed Virus.  

Code of Federal Regulations, 2010 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...

2010-01-01

419

9 CFR 113.208 - Avian Encephalomyelitis Vaccine, Killed Virus.  

Code of Federal Regulations, 2013 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...

2013-01-01

420

9 CFR 113.316 - Canine Parainfluenza Vaccine.  

Code of Federal Regulations, 2013 CFR

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

2013-01-01

421

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

422

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

423

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

424

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

425

9 CFR 113.314 - Feline Calicivirus Vaccine.  

Code of Federal Regulations, 2011 CFR

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

2011-01-01

426

9 CFR 113.304 - Feline Panleukopenia Vaccine.  

Code of Federal Regulations, 2014 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.304 Feline Panleukopenia...Panleukopenia Vaccine shall be prepared from virus-bearing cell culture fluids. Only...

2014-01-01

427

9 CFR 113.304 - Feline Panleukopenia Vaccine.  

Code of Federal Regulations, 2013 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.304 Feline Panleukopenia...Panleukopenia Vaccine shall be prepared from virus-bearing cell culture fluids. Only...

2013-01-01

428

9 CFR 113.315 - Feline Rhinotracheitis Vaccine.  

Code of Federal Regulations, 2013 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.315 Feline Rhinotracheitis...Rhinotracheitis Vaccine shall be prepared from virus-bearing cell culture fluids. Only...

2013-01-01

429

9 CFR 113.315 - Feline 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 § 113.315 Feline Rhinotracheitis...Rhinotracheitis Vaccine shall be prepared from virus-bearing cell culture fluids. Only...

2010-01-01

430

9 CFR 113.330 - Marek's Disease Vaccines.  

Code of Federal Regulations, 2011 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.330 Marek's Disease...disease vaccine shall be prepared from virus-bearing tissue culture cells....

2011-01-01

431

9 CFR 113.304 - Feline Panleukopenia Vaccine.  

Code of Federal Regulations, 2012 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.304 Feline Panleukopenia...Panleukopenia Vaccine shall be prepared from virus-bearing cell culture fluids. Only...

2012-01-01

432

9 CFR 113.317 - Parvovirus Vaccine (Canine).  

Code of Federal Regulations, 2012 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....

2012-01-01

433

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

434

9 CFR 113.316 - Canine Parainfluenza Vaccine.  

Code of Federal Regulations, 2014 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....

2014-01-01

435

9 CFR 113.210 - Feline Calicivirus Vaccine, Killed Virus.  

Code of Federal Regulations, 2014 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...

2014-01-01

436

9 CFR 113.315 - Feline Rhinotracheitis Vaccine.  

Code of Federal Regulations, 2014 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.315 Feline Rhinotracheitis...Rhinotracheitis Vaccine shall be prepared from virus-bearing cell culture fluids. Only...

2014-01-01

437

9 CFR 113.317 - Parvovirus Vaccine (Canine).  

Code of Federal Regulations, 2010 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....

2010-01-01

438

9 CFR 113.306 - Canine Distemper Vaccine.  

Code of Federal Regulations, 2010 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.306 Canine Distemper...Distemper Vaccine shall be prepared from virus-bearing cell culture fluids or...

2010-01-01

439

9 CFR 113.206 - Wart Vaccine, Killed Virus.  

Code of Federal Regulations, 2011 CFR

...2011-01-01 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...

2011-01-01

440

9 CFR 113.306 - Canine Distemper Vaccine.  

Code of Federal Regulations, 2011 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.306 Canine Distemper...Distemper Vaccine shall be prepared from virus-bearing cell culture fluids or...

2011-01-01

441

9 CFR 113.211 - Feline Rhinotracheitis Vaccine, Killed Virus.  

Code of Federal Regulations, 2011 CFR

...Feline Rhinotracheitis Vaccine, Killed Virus. 113.211 Section 113.211 Animals...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Killed Virus Vaccines § 113.211 Feline...

2011-01-01