February 17, 2021

ethical approval and the start of virus characterisation study for Human Challenge Trials

The first question that needs to be addressed when carrying out human challenge trials is to work out the minimum amount of virus necessary to cause infection in healthy participants. This is called a virus characterisation study. The protocol for a virus characterisation study for COVID-19 has today received ethical approval from the Health Research Authority (HRA) to go ahead (https://www.gov.uk/government/news/worlds-first-coronavirus-human-challenge-study-receives-ethics-approval-in-the-uk).

Since the Human Challenge Programme team briefed journalists last October about their plans for this work, we’ve had multiple vaccines licensed for use against COVID-19 and seen the emergence of new variants of the virus, some of which appear to partially evade current vaccines. We invited journalists to hear from the team about how their work fits into this rapidly changing vaccine landscape, what this first stage of the programme will look like, and how this study can pave the way to more rapidly and effectively evaluate new COVID-19 vaccines.

Speakers included:

Prof Peter Openshaw, Professor of Experimental Medicine at Imperial College London

Dr Andrew Catchpole, Chief Scientific Officer at hVIVO

Dr Chris Chiu, Chief Investigator, and Clinical Reader and Honorary Consultant in Infectious Diseases at Imperial College London, and Lead at the Imperial Network for Vaccine Research

Prof Sir Terence Stephenson, Chair, Health Research Authority 

Prof Robert Read, Head of Clinical and Experimental Sciences within Medicine at the University of Southampton, and Director of the NIHR Southampton Biomedical Research centre

This Briefing was accompanied by an SMC Roundup of Comments.