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Lecture 5 - Regulatory Aspects of Vaccine Development

Lecture 5 - Regulatory Aspects of Vaccine Development -...

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EVO REGULATORY ASPECTS OF VACCINE DEVELOPMENT Edwin Oaks, Ph.D. George Mason University Fall 2008
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EVO Introduction Vaccines today consist of a variety of products Live viruses Live bacteria Killed viruses or bacteria Subcellular or acellular products Purified proteins Purified polysaccharides Conjugate vaccines Antigen is coupled to a carrier protein DNA vaccines
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EVO Vaccine Characterization All biologicals, including vaccines, must meet a set of standards before use in clinical trials (described in 21 CFR 610.11) Safety: The product must not contain extraneous toxic contaminants causing unexpected, unacceptable biological activity. (No weight loss or death over 7 days in two mice and two guinea pigs. This criteria is called the General Safety Test). Sterility: The product must not contain contaminating bacteria or yeast. (It must be evaluated in aerobic and anaerobic culture procedures). Important for killed and subunit vaccines For live vaccines the culture must be “pure” Purity: The product must not contain extraneous matter, such as pyrogens or chemicals (it should have a negative pyrogenicity test in rabbits)
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EVO Vaccine Characterization, cont. Potency: The biological (vaccine) can do what is claimed for it. For vaccines it must be immunogenic & efficacious in animal models Identity : The product must be defined biochemically DNA or amino acid sequence Antigens can be identified with defined antibodies If living product - must be identified by accepted culture methods Stability For live attenuated vaccines -reversion to virulence would be problem Persistence in environment after vaccination For subunit vaccines - what effects do environmental extremes have on the product’s potency.
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EVO Preclinical Assessment of Vaccine Candidates Where do vaccine candidates come from? Research labs Academia Government Private biotech and pharmaceutical industry Criteria for advancing to human trials Vaccine candidate must address a public health need Vaccine must be a logical means to control disease Example, controlling Shiga-toxin producing E. coli is best accomplished by meat inspection and proper cooking practices - not by mass vaccination of children
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EVO Preclinical Assessment of Vaccine Candidates Vaccine candidate is designed based on sound scientific rationale Contains known protective antigen eg: Hemophilus influenzae type b polysaccharide A live strain of a pathogen attenuated by genetic deletion of known virulence factors eg: Live cholera vaccine with mutated cholera toxin gene Expectation of Safety Risk of vaccine injury/benefit of vaccine ratio must be low Vaccines will be administered to healthy people who are at low risk to disease Safety must be demonstrated in an appropriate animal model » Use dose and route of administration that will be proposed for human use
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EVO Preclinical Assessment of Vaccine Candidates
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