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More than 20,000 people have signed up to voluntarily be exposed to the novel coronavirus in a yet-to-be formulated “human classified trial.” The trial, being led by a group called 1Day Sooner, is meant to speed up vaccine development, but has no ties to companies currently working on one.
The group is looking for healthy volunteers between the ages of 20 and 45 who have no underlying conditions.
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“We want to recruit as many people as possible who want to do this, and pre-qualify them as likely to be able to participate in challenge trials should they occur,” Josh Morrison, 1Day Sooner co-founder, previously told Nature. “At the same time, we feel that the public policy decisions around challenge trials will be better informed if they highlight the voice of people interested in participating in such trials.”
Human challenge trials deliberately expose volunteers to infection in order to study diseases and possible vaccines or treatments. Similar trials are conducted each year with the seasonal flu. In one instance, St. Louis University’s Center for Vaccine Development offered $3,500 to volunteers who are willing to expose themselves to the influenza virus after receiving either the vaccine or a placebo.
“It is currently uncertain how many people COVID-19 will affect worldwide and at what speed its impacts will be felt,” the 1Day Sooner website said. “Possible outcomes are shaped by interventions like social distancing, the capacity of health systems, potential drug treatments and many other factors. A vaccine may come after the infection has peaked or once effective pharmaceutical treatments have blunted COVID-19’s impact. But it is clear that COVID-19 will continue to alter daily life until an effective vaccine is fully deployed.”
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As of Thursday, over 20,000 people from 102 countries had signed up to volunteer for the hypothetical trial. Human challenge trials for coronavirus have the support of 35 members of the House of Representatives who wrote to the Food and Drug Administration and the Department of Health and Human Services arguing that they should be allowed.
According to the group’s website, the trial, which has no potential start date and could by some estimates take up to two years to formulate, is aiming to enroll volunteers who are already likely to have been exposed to COVID-19, and they would be isolated in “highly controlled environments under constant observation.” The participants would receive the vaccine candidate or placebo and then be exposed to live coronavirus so that researchers could determine the vaccine candidate’s efficacy.
“If infection is detected, they would be provided with excellent medical treatment,” the group said. “Hopefully pharmaceutical treatments will also be available by the time a study is conducted.”
However, Anna Durbin, a vaccine researcher at Johns Hopkins University, who was involved in an unsuccessful push for a human challenge trial involving the Zika virus, said one problem for the COVID-19 challenge could be determining how much of the virus to expose participants to in order to develop a detectable illness.
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“What are your endpoints going to be?” she said, speaking to Stat News. “You know, do you want to give people pneumonia? I hope not. You want people who feel crappy to some extent, who definitely know they’re sick. And what that balance is or what that line is between just feeling crappy and then developing pneumonia, I think one of the scary things is we really don’t know what that is.”
Morrison told Nature that volunteers typically “recognize the risk but believe the benefits of vaccine acceleration are so tremendous that it is worth it to them.”
