Infectious disease study design has changed
Every year, promising infectious disease programmes stall or fail — not because the science was wrong, but because the study design couldn't keep pace with where the field had moved. Getting this right requires more than a CRO. It requires BSL3-certified infrastructure, validated pathogen models, and a team that has run these challenges before. Today's teams are navigating:
- RSV programmes where a single serotype no longer covers the patient population
- Influenza trials where strain selection is misaligned with current circulating variants
- hMPV studies where the regulatory path and the challenge model are both still being defined
- Vaccine platforms where immunogenicity endpoints are scientifically compelling but not yet regulatory-ready
- Outpatient respiratory trial protocols where sample variability undermines the data before lock
Written by the team behind 5,000+ infectious disease challenge participants.
The perspectives in this guide are grounded in decades of hands-on human challenge trial experience. Dr Andrew Catchpole — DPhil in influenza replication from Oxford University, virologist, and Chief Scientific Officer at hVIVO — leads the company's infectious disease scientific strategy and has played a key role in developing challenge models for influenza, RSV, hMPV, HRV, and SARS-CoV-2. hVIVO supports seven of the world's ten largest biopharmaceutical companies, operating BSL2 and BSL3-certified clinical and laboratory facilities at its Canary Wharf quarantine unit alongside a specialist scientific team.
