UK researchers are set to explore a human challenge study with SARS-CoV-2, the first such study anywhere in the world.
The Human Challenge Programme is a partnership between Imperial College London (ICL), the Department for Business, Energy and Industrial Strategy (BEIS), hVIVO (a clinical company with expertise in viral human challenge models) and the Royal Free London NHS Foundation Trust.
The first stage of the project will explore the feasibility of exposing healthy volunteers to SARS-CoV-2. The study would recruit volunteers between the ages of 18 and 30 years 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.
In this initial phase, the aim will be to discover the smallest amount of virus it takes to cause a person to develop COVID-19; this is known as a virus characterisation study. Once 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.
The human challenge study will be reviewed by a specially convened ethics committee before any volunteers are enrolled, and the Medicines and Healthcare products Regulatory Agency (MHRA) will be asked to approve the study before it is conducted.
While no specific vaccine candidates for the human challenge trials have been confirmed yet, the study is expected to begin early next year, with further details of volunteer recruitment and the study design to be published in the coming months.
ICL's Dr Chris Chiu, lead researcher, said: “Our number one priority is the safety of the volunteers. My team has been safely running human challenge studies with other respiratory viruses for over 10 years.”
Those interested in registering should visitwww.UKCovidChallenge.com.
