LONDON—U.K. medical-ethics authorities gave the go-ahead Wednesday to controversial trials that will deliberately infect young, healthy volunteers with coronavirus with the aim of better understanding the virus’s impact on the human body and speeding vaccine development.
The trials, called human challenge trials, will be the first in the world targeting Covid-19 and will initially involve up to 90 volunteers between 18 and 30 years old, the government said Wednesday. They are set to begin in London by March, backed by $47 million in U.K. government funding initially announced in October.
With medics and scientists standing by 24 hours a day, researchers will inject closely controlled doses of coronavirus into the noses of quarantined volunteers. This set of volunteers won’t have received vaccines. The idea is to start with the smallest possible amount that allows researchers to gauge infection levels, symptoms and transmission methods while trying to ensure the volunteers’ safety.
If that goes well, a second stage of the trials is planned to include the use of vaccines—researchers haven’t specified which ones—to test how well they protect against symptoms and possibly transmission. Vaccines would be administered to healthy volunteers, who would then be purposely infected with coronavirus, again in closed-off quarters to contain the virus.
Scientific and medical-ethics views about the proposed trials have been mixed since the U.K. revealed its plans in October, with this week’s green light making the U.K. a pandemic outlier. Previous challenge trials have focused on malaria, typhoid, cholera and flu.
Some public-health experts argue that high infection rates negate the need for such trials, because there is ample opportunity to study the virus in people who contract it naturally without risking the health of more people. Others say there is no substitute for tightly controlled studies to help fast-track vaccine development so that shots reach more people around the world quickly.
But young, healthy people sometimes suffer extreme Covid symptoms, and there is no proven, blanket treatment for subjects who fall seriously ill.
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“Given that current treatment options for Covid-19 are limited, it is important that volunteers are being sourced from the lowest-risk groups and are closely monitored throughout the course of the study,” Dr.
head of vaccines at the Wellcome Trust, said Wednesday. He said that properly done, a challenge trial could provide valuable insights into the virus’s impact from the moment of infection, leading to new treatments as well as vaccines.
The debate over inoculating humans with live, potent viruses has gone on for centuries. In a now-famous experiment in the late 1700s, British doctor
injected a child with material from a smallpox lesion, then recorded details of the boy’s reaction.
Researchers from Imperial College London and the state-run National Health Service are working with a private U.K.-based drug-testing company called hVIVO Services Ltd. with experience in challenge trials, to manufacture the virus, screen volunteers and make other arrangements. London’s Royal Free Hospital, which has clinical-testing rooms designed to contain viruses, will host trial volunteers, who will be paid for their time in quarantine. The U.K.’s Vaccines Taskforce, created last year to coordinate the government’s buying and distribution of Covid-19 vaccines, is also a partner.
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The virus used in the trials will be an earlier version circulating in the U.K. since early 2020, not a more-transmissible variant that emerged in the country later in the year, the government said. That is because the earlier version is shown to be low-risk for young, healthy adults.
A U.S. nonprofit that was created early in the pandemic to recruit people for challenge trials had 3,500 volunteers sign up in the U.K., according to
spokesman for the nonprofit, called 1Day Sooner. Only a small number will qualify, he said. U.K. researchers on Wednesday asked for more volunteers.
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Appeared in the February 18, 2021, print edition as ‘U.K. Trials Will Infect Young With Virus.’