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U.K. Approved Study Will Infect Volunteers With Covid

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LONDON — In the coming weeks, a small, carefully selected group of volunteers is expected to arrive on the 11th floor of a London hospital to be given what the rest of the world’s 7.8 billion people have been trying to avoid: a coronavirus infection.

They will be administered tiny droplets of the virus into their nostrils as part of a plan authorized by British regulators on Wednesday to deliberately infect unvaccinated volunteers with the coronavirus.

The scientists hope to eventually expose vaccinated people to the virus as a way of comparing the effectiveness of different vaccines. But before that, the project’s backers have to expose unvaccinated volunteers in order to determine the lowest dose of the virus that will reliably infect them.

As many as 90 people could be part of the trial, but the number could be lower if researchers can determine the right dose with fewer volunteers.

By controlling the amount of the virus people are subjected to and monitoring them from the moment they are infected, scientists are hoping to discover things about how the immune system responds to the coronavirus that would be impossible outside a lab — and to develop ways of directly comparing the efficacy of treatments and vaccines.

“We are going to learn an awful lot about the immunology of the virus,” Peter Openshaw, an Imperial College London professor involved in the study, said on Wednesday. He added that the study would be able “to accelerate not only understanding of diseases caused by infection, but also to accelerate the discovery of new treatments and of vaccines.”

The idea of such a study, called a human challenge trial, has been hotly debated since the early months of the pandemic.

In the past, scientists have deliberately exposed volunteers to diseases like typhoid and cholera to test vaccines. But infected people could be cured of those diseases; Covid-19 has no known cure, putting the scientists in charge of the British study in largely uncharted ethical territory.

In order to try to ensure that participants do not become seriously ill, the British study will be restricted to young, healthy volunteers, in an 18 to 30 age range.

But there have been severe Covid-19 cases even in those types of patients, and the long-term consequences of an infection are also largely unknown. The age restrictions also may make it difficult to translate the findings to older adults or people with pre-existing conditions, whose immune responses might be different and who are the target group for treatments and vaccines.

“It will be a limited study,” said Ian Jones, a professor of virology at the University of Reading who is not part of the study. “And you could argue that, by definition, it’s not going to study those in whom it’s most important to know what’s going on.”

For now, the only part of the study to be formally authorized by British regulators is the experiment to determine the lowest dose of virus needed to infect people.

After being exposed to the virus, the participants will be isolated for two weeks in the hospital. For that and the year’s worth of follow-up appointments that are planned, they will be paid 4,500 pounds, or about $6,200. The researchers said that would compensate people for time away from jobs or families without creating too large an economic incentive for people to participate.

When the idea of human challenge trials was first floated last year, some scientists saw it as a way of shaving off crucial time in the race to identify a vaccine. Unlike in large clinical trials, in which scientists wait for vaccinated people to encounter the virus in their communities, researchers in this project would eventually purposely infect vaccinated people.

Now that several vaccines have been authorized, the goals of this human challenge trial are somewhat different.

For now, the researchers will be exposing people to the version of the virus that has been circulating in Britain since last spring, and not the more contagious and potentially deadlier variant that has taken hold more recently. But eventually, they said, they could give people experimental vaccines designed to address the effect of new, worrisome variants and then subject them to those versions of the virus.

They could also directly compare different vaccine doses and dosing intervals for the same vaccine.



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