A medical lab with Irish owners will be conducting unprecedented Covid-19 challenge trials using human volunteers.
Dublin-based Open Orphan acquired trial leaders hVivo this year.
The laboratory that has links with Imperial College and Queen Mary’s University is using a London-based quarantine site to test vaccines by inoculating young people and then giving them a “challenge” dose of Sars-Cov-2, which causes Covid-19.
Researchers told the Financial Times the trials should “narrow the large field of promising Covid-19 vaccines” that will be tested next year.
Challenge trials will reportedly commence in January.
Around 2,000 people have signed up as volunteers through campaign group 1Day sooner to help enlist the vast numbers of tests needed for a viable clinical trial.
Lead organiser of the campaign, 18-year-old Alastair Fraser-Urquhart, said, “By exposing just a few hundred carefully selected young, healthy people to coronavirus…we can test a huge range of vaccines very quickly”.
The trials will involve adopting a strain of the coronavirus that genetically represents Sars-CoV-2 that’s being spread among the population and selecting doses that won’t overburden volunteers’ immune system.
A “rescue remedy” will be on hand to prevent the occurrence of serious illness. Remedsevir will be used as the only drug that has worked against Covid-19.
Volunteers in the challenge will be compensated with up to £3,750 (around €4,100).
hVivo will use the 24-bed facility in the east end of London in the first instance but will look at other facilities as it tests further vaccines.
The trials must get approval from both an independent research ethics committee and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
“The safety of trial participants is our top priority”, said MHRA, speaking to the Financial Times. It stressed that any proposal for human infection challenge as part of a vaccine trial “would be considered on a benefit-risk basis, with risks monitored for and minimised in the proposed trial design”.
