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 announced in a media outlet last month, was disclosed publicly on Tuesday morning with an initial £33.6 million of government funding.
The aim is to speed up vaccine development by contaminating 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 occurs in conventional clinical trials.
Before that, healthy recruits aged 18 to 30 years old will take part in a virus characterisation study at the Royal Free Hospital’s special biocontainment suite to learn how people react 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 approximately three months.
Andrew Catchpole, scientific director of hVivo, a company specialising in human challenge studies, which will be running the project in partnership with academic partners led by the Imperial College London said that they want to find the lowest dose of the virus that will reproducibly deliver an infection.
hVivo is a spinout from the 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 United Kingdom, to be manufactured at Great Ormond Street Hospital’s Zayed Centre for Research.
When the scientists have determined the most suitable doses to use, they will start to test COVID 19 vaccine candidates selected 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 determine which vaccines to test.
Chris Chiu of Imperial, the study’s lead researcher said that human challenge studies can increase their knowledge of COVID 19 in extraordinary ways and accelerate the development of the many possible new COVID 19 treatments and vaccines.
He added that their number one priority is the safety of the volunteers and that his team has been safely conducting human challenge studies with other respiratory viruses for over 10 years and that no study is entirely risk-free but the human challenge programme partners will be working hard to guarantee that they make the risks as low as they conceivably can.
