The human viral challenge model: accelerating the evaluation of respiratory antivirals, vaccines and novel diagnostics.

ABSTRACT: The Human Viral Challenge (HVC) model has, for many decades, helped in the understanding of respiratory viruses and their role in disease pathogenesis. In a controlled setting using small numbers of volunteers removed from community exposure to other infections, this experimental model enables proof of concept work to be undertaken on novel therapeutics, including vaccines, immunomodulators and antivirals, as well as new diagnostics.Crucially, unlike conventional phase 1 studies, challenge studies include evaluable efficacy endpoints that then guide decisions on how to optimise subsequent field studies, as recommended by the FDA and thus licensing studies that follow. Such a strategy optimises the benefit of the studies and identifies possible threats early on, minimising the risk to subse

SUBMITTER: Lambkin-Williams R 

PROVIDER: S-EPMC6013893 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature