World’s First Human Challenge COVID-19 Study to Infect Healthy Young Volunteers with SARS-CoV-2 Virus

Researchers are set to explore a human challenge study with the virus that causes COVID-19, the first such study 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. The researchers hope that the work will ultimately help to 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 previous 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. The researchers will assess what amount of virus is needed to cause infection and elicit an immune response by slowly increasing the viral dose to which small groups of volunteers are exposed. The proportion of participants becoming infected and the amount of virus that they subsequently shed will be tracked to better understand the course of infection. As higher viral doses may be linked to more severe outcomes, the researchers are aiming to infect volunteers with the lowest possible dose to trigger viral replication but minimize symptoms. Once this first phase is completed, clinical researchers aim to use this human challenge model to study how vaccines work in the body to stop or prevent COVID-19, to look at potential treatments and study the immune response.

“Deliberately infecting volunteers with a known human pathogen is never undertaken lightly. However, such studies are enormously informative about a disease, even one so well studied as COVID-19,” said Professor Peter Openshaw, co-investigator on the study and Director of the MRC-funded Human Challenge Consortium (HIC-Vac) at Imperial College London. “It is really vital that we move as fast as possible towards getting effective vaccines and other treatments for COVID-19, and challenge studies have the potential to accelerate and de-risk the development of novel drugs and vaccines.”

Related Links:
Imperial College London
hVIVO