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Researchers are ready to explore a human challenge study with the virus that causes COVID-19, the first study of its kind anywhere in the world.
The Human Challenge Program is a partnership between Imperial College London (London, UK) and hVIVO (London, UK), a clinical company with expertise in viral human challenge models. The study will also involve the Department for Business, Energy and Industrial Strategy (BEIS) and the Royal Free London NHS Foundation Trust. Researchers hope that the work will finally help reduce the spread of the coronavirus, mitigate its impact, and reduce deaths from COVID-19.
The first stage of the project will explore the feasibility of exposing healthy volunteers to the SARS-CoV-2 coronavirus. The study would recruit volunteers between the ages of 18 and 30 with no history or symptoms of COVID-19, no underlying health conditions, and no known adverse risk factors for COVID-19, such as heart disease, diabetes, or obesity. Researchers will assess how much virus it takes to cause an infection and elicit an immune response by slowly increasing the viral dose to which small groups of volunteers are exposed. The proportion of participants who will be infected and the amount of virus they subsequently shed will be monitored to better understand the course of infection. Since higher viral doses may be linked to more severe outcomes, the researchers aim to infect volunteers with the lowest dose possible to trigger viral replication but minimize symptoms. Once this first phase is complete, clinical researchers intend to use this human challenge model to study how vaccines work in the body to stop or prevent COVID-19, to look at possible treatments, and to study the immune response.
“Deliberate infection of volunteers with a known human pathogen is never taken lightly. Yet such studies are enormously informative about a disease, even one as well-studied as COVID-19, ”said Professor Peter Openshaw, study co-investigator and director of the MRC-funded Human Challenge Consortium (HIC-Vac) at Imperial College London. “It is really vital that we move as quickly as possible toward obtaining vaccines and other effective treatments for COVID-19, and challenge studies have the potential to accelerate and de-risk the development of new drugs and vaccines.”
Related links:
Imperial College London
hLIVE
