Britain plans to be the first country to vaccinate healthy volunteers with COVID-19 vaccine candidates, then deliberately infect them with the virus, the government said on Oct. 20.
The “human challenge” vaccine trials will then compare the effects of different virus candidates on the volunteers and pinpoint any side effects, the government said in a statement.
The trials will use vaccines that have “proven to be safe in initial trials”; if approved by regulators, they will begin in January 2021. Results will be expected in May 2021, the government said.
The up to 90 volunteers expected to initially take part will be healthy 18- to 30-year olds who will be paid for their participation, it said.
The government is investing 36.6 million pounds ($47.4 million) in the research, which is to be carried out by Imperial College London, the Royal Free London NHS Foundation Trust, and private company hVIVO, a subsidiary of the pharmaceutical services company Open Orphan.
Open Orphan said in a statement that hVIVO’s “ highly trained scientists and medics” will oversee the “Virus Characterisation Study” in The Royal Free Hospital’s specialist research unit.
They said human challenge studies usually are only carried out when effective disease treatments are already available; the absence of such treatments makes it “ethically complex” to infect healthy people with the virus.
“But BEIS [Department for Business, Energy & Industrial Strategy] is backing the partnership and a human challenge model because COVID-19 poses an extraordinary threat to public health and the socioeconomic stability of the UK,” it said.
“The safety of volunteers in any clinical study is always paramount.”
“No study is completely risk-free,” said professor Chris Chiu, of the Department of Infectious Disease at Imperial College London and lead researcher on the human challenge study.
“But the Human Challenge Programme partners will be working hard to ensure we make the risks as low as we possibly can,” he added.
Meanwhile, 1Day Sooner, a group based in the United States pressing for COVID-19 vaccine trials, has attracted more than 38,500 volunteers from 166 countries saying they are willing to take part in a human challenge trial.
The human challenge trials announcement comes following a pause earlier this month in a Johnson & Johnson COVID-19 vaccine trial due to an unexplained illness in a study participant. It also follows the interruption in September of clinical trials for a vaccine being developed by AstraZeneca and Oxford University after a study subject fell ill.
Participants in Britain’s trial will be monitored for up to a year following the trials.
Tom Ozimek contributed to this report.