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The ‘human challenge trials’ would need to be approved by the U.K. health care regulator.
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The U.K. government is considering launching ‘human challenge trials’ where healthy volunteers are purposefully infected with the coronavirus that causes COVID-19 in a bid to speed up development of a vaccine.
The studies, set to be government-funded, could begin in January at a quarantine facility in London, the Financial Times reported. The trials will be run by Irish company Open Orphan’s ORPH, -6.66% hVivo unit, with Imperial College London as the academic lead, the report added. It could also test and compare multiple vaccine candidates, currently being developed around the world.
Human challenge studies, which have been successfully used in the past to develop vaccines for malaria and cholera, involve deliberately infecting volunteers to test the effectiveness of vaccines.
In this case, volunteers would be inoculated with a potential vaccine before receiving a dose of SARS-CoV-2, the coronavirus that causes COVID-19, under controlled conditions, according to reports.
In an emailed statement to MarketWatch, a government spokesperson said: “We are working with partners to understand how we might collaborate on the potential development of a COVID-19 vaccine through human challenge studies. These discussions are part of our work to research ways of treating, limiting and hopefully preventing the virus so we can end the pandemic sooner.”
Any such studies would need to be approved by the health care regulator — the Medicines and Healthcare products Regulatory Agency.
The World Health Organization issued ethical guidance in May on the use of COVID-19 human challenge studies. The WHO said the method can be “substantially faster” and requires far fewer participants to be exposed to experimental vaccines, while also being useful in comparing multiple vaccine candidates. The studies would have to meet eight strong criteria to be considered ethically acceptable. The WHO said that included selecting low-risk volunteers — healthy adults aged 18-30 — reducing the number of participants, close monitoring, and providing “high-quality supportive care.” It added that there could still be risks of infection, serious illness and death.
U.S.-based organization 1Day Sooner, which advocates on behalf of COVID-19 challenge trial volunteers, welcomed the news and said it would petition the government for a center to house 100-200 challenge participants at a time. The group said it has had input in the preparations for U.K. challenge trials, while 2,000 volunteers have reportedly signed up for the trials through 1Day Sooner.
Peter Horby, professor of emerging infectious diseases and global health at the University of Oxford, told BBC Radio the trials were a good idea.
“We now know the risk in a healthy young adult with no underlying conditions is extremely low. We suspected this before, but we really did not have the strength of evidence to go forward with challenging people with the virus — but now I think there is clear data.”
He added: “The second thing that has changed is there are now some treatments that have been shown to have a benefit, so in the likely event that a challenged person does become unwell, there are drugs that can be given very early to help control the disease.”
