The Model Explained

This text is adapted from Lambkin-Williams et al 2018, the original manuscript is open source and available here along with the citation details.

In contemporary HVC trials, healthy volunteers are administered an investigational therapeutic either before (prophylaxis trials) or after (treatment trials) inoculation with the specific challenge strain of the virus. The viruses used in the HVC model are not attenuated and produce symptoms consistent with clinically observed ARI. Each virus is propagated under GMP conditions, with a minimal number of passages from the isolates to the challenge stocks. The few mutations that occur within the virus are rapidly selected out due to a genetic bottleneck, with the consequence that the virus in the human host is considered wild-type [143]. The similarity between virus recovered from the inoculated host and the originator reference virus strain provides assurance that the model disease process is closely aligned with the reference virus strain and is not altered nor attenuated.

There are limited licensed therapeutic options against respiratory viruses, highlighting a significant unmet medical need. A model such as the HVC allows the rapid evaluation of novel therapeutics. The model shortens both preclinical and early clinical development phases by providing a better understanding of the host and pathogen’s initial interaction and has the potential to make the necessary vaccines and medicines more rapidly available than traditional development approaches otherwise might.