World’s first trial of deliberate coronavirus infection is approved

The world’s first Covid-19 “human challenge” trial — infecting healthy young adults with coronavirus — will begin in London within a month, to analyse the virus and how the immune system responds.

The UK government announced on Wednesday that the study at the Royal Free Hospital had received the required approval from a specially convened research ethics committee.

Up to 90 volunteers aged 18 to 30 will be inoculated with a version of the virus that has been circulating in the UK since last March — not a new variant.

“This has been shown to be of low risk in healthy young adults,” said a statement by the trial partnership which includes Imperial College London, the Royal Free, the government’s vaccines task force and hVivo, a company experienced in running human challenge trials in other infectious diseases.

The initial “virus characterisation study” will help scientists work out the smallest amount of coronavirus that will cause infection and examine how the immune system responds.

Analysis of these initial results will take several months. Then vaccines in clinical development will be given to small numbers of volunteers who have been deliberately exposed to the Covid-19 virus, helping to identify the most effective vaccine candidates and accelerate their development.

A challenge trial will achieve guaranteed exposure to the virus under controlled conditions. All Covid-19 vaccine trials so far have been in the community where the researchers have to wait for volunteers to be exposed naturally — a random and uncertain process.

The government has provided the project with £33.6m in funding. Human challenge studies have already played an important role in developing treatments or vaccines for several other diseases, including malaria, typhoid, cholera and flu.

Chris Chiu of Imperial College, the trial’s chief investigator, said: “We are asking for volunteers aged between 18 and 30 to join this research endeavour and help us to understand how the virus infects people and how it passes so successfully between us.

“Our eventual aim is to establish which vaccines and treatments work best in beating this disease, but we need volunteers to support us in this work.”

Participants, who must not have been infected previously with the Sars-Cov-2 virus, will be screened intensively to check they are healthy.

After two days of observation, the virus will be introduced in droplets up their nose and they will then spend at least two weeks quarantined in a special suite, while doctors and scientists monitor every aspect of their immune response.

Participants will be allowed to go home only when extensive testing shows they are not infectious, said Chiu.

Financial compensation depends on how long they have to spend in isolation but is likely to be around £4,500, which would also cover follow-up tests over the course of a year or more.

The international campaign group 1Day Sooner, which is lobbying for coronavirus challenge trials, said: “We have great confidence that Imperial College will plan and execute this trial with an abundance of respect for the rights and interests of research subjects.”

Alistair Fraser-Urquhart, a 1Day Sooner supporter who wants to take part in the trial, said: “I’ve spent a long time dwelling on these risks, but I’m still ready to take them on for the benefit of others.”