Vaccine preclinical studies 2

Published on December 31, 2015   20 min

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Other Talks in the Series: Vaccines

Now we're going to move from the vaccine's safety aspects or toxicology, to the pharmacology aspects, or proof-of-concept. This is the flip side of safety. So safety is the way we try to identify risks and assess risks, and the proof-of-concept studies or mode-of-action studies, are how we try to assess the potential for benefit. So for drugs, pharmacology encompasses the concepts of pharmacokinetics and pharmacodynamics. But in fact for vaccines, those concepts don't really readily apply and what we're really trying to address is the immunological mechanism for protection. So we look at immunogenicity in animals and if there's a relevant animal model, then we try to do studies of challenge-protection. And I'll explain those in more detail in a moment. Often these types of studies are research studies. And in fact, they're rarely, if ever, performed in compliance with good laboratory practices. So even though they're intended to support regulatory decision making about potential for benefit, in fact, the fact that they're not required to meet these good laboratory practice regulations reflects the fact that, in fact, in the US, Phase 1 studies can only be placed on clinical hold for safety. And so really the regulatory decision making, the precision around that has to be on the basis of risk assessment or safety aspects.