The UK government has signed a contract to develop a COVID-19 human challenge study model, which would be the first of its kind in the world if it goes ahead.
The contract, signed with Open Orphan subsidiary hVIVO, starts immediately and could be worth around £10m depending on the final number of volunteers included in the characterisation study.
The study will be sponsored by Imperial College London and conducted by hVIVO at The Royal Free Hospital’s specialist research unit in London.
The government has already secured the first three slots to test vaccine using the challenge study, which hVIVO said is expected to start in 2021. Each slot reservation has been secured at a respective cost of £2.5m each for a total of £7.5m, although it has not been yet disclosed which candidates have been selected.
If approved by regulators and an ethics committee in the UK, young and healthy volunteers will be purposely infected with the SARS-CoV-2 virus, which causes COVID-19.
“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 ten years,” said Chris Chiu from the department of infectious disease at Imperial College London and lead researcher on the human challenge study.
“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,” he added.
Initially, researchers will aim to discover the smallest amount of the virus it takes to cause COVID-19 infection in small groups of healthy young people aged between 18-30 years old who are at a low risk of harm.
Medics and scientists will closely monitor the participants following exposure to the virus, carefully recording the effect in volunteers for 24 hours per day.
In a statement, the government said that it will invest £33.6m at this initial stage, otherwise known as a virus characterisation study.
Following the virus characterisation stage, a vaccine candidate that has been proven to be safe in initial trials will be given to a small number of healthy adult volunteers who are then exposed to the virus in a safe and controlled environment.
“The funding announced today for these ground-breaking but carefully controlled studies marks an important next step in building on our understanding of the virus and accelerating the development of our most promising vaccines which will ultimately help in beginning our return to normal life,” said Business Secretary Alok Sharma.