Volunteers in London are to be infected with coronavirus early next year, in the world’s first Covid-19 “human challenge trials”. The project, first disclosed in the Financial Times last month, was announced publicly on Tuesday morning with an initial £33.6m of government funding.
The aim is to speed up vaccine development by infecting participants with coronavirus in a secure clinic, a month or so after vaccination, rather than waiting for them to be exposed as they go about their normal lives in the community — as happens in conventional clinical trials.
Before that, healthy volunteers aged 18 to 30 will take part in a “virus characterisation study at the Royal Free Hospital’s special biocontainment suite to discover how people respond to infection.
Starting with a tiny dose of the virus, the scientists will gradually increase the amount given to the volunteers until they reach a level that reliably infects the upper respiratory tract. Up to 90 people will be involved at this stage, which is expected to last about three months.
“We want to find the lowest dose of the virus that will reproducibly deliver an infection,” said Andrew Catchpole, scientific director of hVivo, a company specialising in human challenge studies which will be running the project in collaboration with academic partners led by Imperial College London.
hVivo is a spinout from Queen Mary University of London that was bought earlier this year by Open Orphan, a Dublin-based pharmaceutical research company.
Dr Catchpole said the virus used would be a strain circulating in the UK, to be manufactured at Great Ormond Street Hospital’s Zayed Centre for Research.
When the scientists have decided the most appropriate doses to use, they will begin to test Covid-19 vaccine candidates chosen by the UK vaccines task force — probably beginning in late spring if the characterisation studies go well. The government has reserved the first three trial slots and will decide which vaccines to test.
“Human challenge studies can increase our understanding of Covid-19 in unique ways and accelerate development of the many potential new Covid-19 treatments and vaccines,” said Chris Chiu of Imperial, the study’s lead researcher.
“Our number one priority is the safety of the volunteers,” he added. “My team has been safely running human challenge studies with other respiratory viruses for over 10 years. No study is completely risk free but the human challenge programme partners will be working hard to ensure we make the risks as low as we possibly can.”
The study design will be reviewed by an expert ethics committee and will need approval from the Medicines and Healthcare products Regulatory Agency (MHRA) before any volunteers are enrolled. An independent board will monitor the trial when it gets under way.
The organisers will have an “intervention therapy” or “rescue remedy” at hand to prevent participants’ infection causing dangerous disease. The present plan is to use remdesivir, an antiviral drug that has given mixed results in clinical trials, unless something better emerges before the study begins.
The US-based advocacy group 1Day Sooner, which campaigns for Covid-19 infection trials, has signed up 38,500 people worldwide, including more than 2,000 in the UK, who said they would volunteer for a challenge study.
Dr Catchpole said the team would work with 1Day Sooner but is setting up its own website www.ukcovidchallenge.com for people to register interest in taking part. “We are looking for the fittest of the fit,” he said.
Volunteers’ payment, to be decided in consultation with the study’s ethics committee, is likely to be about £4,000 if people spend two to three weeks in quarantine during the study.
“Each volunteer is carefully informed of all the risks and they can withdraw at any time prior to infection with the virus,” said Peter Openshaw, professor of experimental medicine at Imperial. “Once they are infected they would be required to remain at the clinical facility under careful observation until they are no longer infectious and test negative for the presence of live coronavirus.