Scientists in the UK are moving towards what are being referred to as “challenge trials”, which will involve healthy volunteers being deliberately infected with the novel coronavirus to test whether a vaccine offers any protection, according to a media report.
In the first trial of its kind expected to be formally announced next week, participants will be injected with an unnamed experimental vaccine and around a month later exposed to Sars-Cov-2, the virus that causes COVID-19, The Financial Times reported.
The government-funded study is expected to begin in January, with the trials likely to take place in a large secure facility in Whitechapel in east London or nearby.
Around 2,000 potential volunteers have signed up for challenge studies in the UK through the US-based group 1Day Sooner, campaigning for COVID-19 trials, and are expected to be paid a few thousand pounds for signing up to the upcoming trials, according to the newspaper.
The project’s academic leader is Imperial College London, and it will be run by hVivo, a spinout from Queen Mary University of London that was bought earlier this year by Open Orphan, a Ireland-based pharmaceutical research organisation.
Oxford University is also believed to be considering a similar “challenge trial” to test whether people have protective immunity from COVID-19 if they have been previously infected.
A government spokesperson said it is looking into collaborating on the potential development of a vaccine through human challenge studies.
Any trial that involves exposing people to the virus would need the approval of the UK Medicines and Healthcare products Regulatory Agency (MHRA), as well as an independent research committee.
“The safety of trial participants is our top priority and any proposal from a developer to include a human infection challenge as part of a clinical trial for development of a vaccine would be considered on a benefit-risk basis, with risks monitored for and minimised in the proposed trial design,” the MHRA said.
Dr Claire Waddington, clinical lecturer in infectious diseases at the University of Cambridge, said challenge trials are “well established as a way to accelerate the development of vaccines”.
She pointed to similar trials being used for typhoid vaccines, which are now being rolled out in affected countries.
