As of Wednesday morning, the 1 Day Sooner project had over 26,000 volunteers from over 100 countries who are willing to be exposed to the novel coronavirus as part of a push to speed up vaccine research in what’s known as a “challenge trial.”
“It’s truly a remarkable outpouring,” said communications lead Abie Rohrig.
“It makes me, to be honest, optimistic about human nature and our ability to come together during times of crisis.”
1 Day Sooner, a grassroots group of scientists and researchers, describes a challenge trial as a study that deliberately exposes “participants to infection, in order to study diseases and test vaccines or treatments.”
Typically, testing involves giving human volunteers a vaccine or a placebo and then waiting for them to potentially be exposed to the virus on their own through their everyday life.
The organization notes that “[m]any people will try to be careful in this outbreak — by practicing self-isolation, for example — so it may take a very long time and a large number of subjects” to produce statistically significant results.
“If, instead, all of the study participants are exposed to the pathogen under highly controlled conditions, we could rely on a much lower number of volunteers and, with luck, develop a safe, effective and broadly available vaccine in a much shorter period of time,” the group’s website reads.
No challenge trial is currently planned, but if or when it comes to pass, Rohrig says roughly 100 or so volunteers would come to a bio-contained facility where they would be given a coronavirus vaccine or a placebo as part of a phase II trial (the first phase normally involves testing on animals).
Scientists would then wait the appropriate amount of time for the vaccine to take effect, and then the volunteers would be exposed to the novel coronavirus.
“That experiment can tell us something about the efficacy of a vaccine much sooner than normal trials, it is increasingly thought,” Rohrig said.
“Experts will probably choose people who are least vulnerable to the coronavirus. So that means people who are young and healthy because, again, those are the people who have the lowest mortality rate and face the lowest risks from the coronavirus.”
Over 1,000 Canadians are among the volunteers, including Conor Barnes, a Torontonian who now lives in British Columbia.
“I did a lot of research when I heard about it, when I heard about even just the idea of a human challenge trial and I thought, ‘what is that?’ and ‘is that something I could do to help?’ So, I just researched what the possible benefits are, what the risks are, particularly — I mean, there are some very particular risks with COVID — and decided that the benefits outweigh the cost,” he said.
“I think for some people it’s a lot more personal, but for me, it was a lot of just maths and going, okay, this checks out. This is a good [thing] on net.”
Barnes says family and friends have been “very supportive” though some have expressed a bit of worry about his decision, but he notes there hasn’t been much discussion since there is no challenge trial currently planned.
“It’s not a sign-up yet for a challenge trial, so I keep saying ‘pre-volunteer’ to people. It’s like me and the like thousands of other people have said ‘if there’s a trial in the future, come to me and then we can start seeing if I actually qualify.’”
On May 6, the World Health Organization (WHO) outlined the guidelines for “the ethical acceptability of COVID-19 human challenge studies.”
Western University professor Dr. Charles Weijer was among 13 members of the working group that developed those guidelines. He says human challenge studies in general are fairly uncommon and being tasked with contributing to the report was difficult.
“It’s an enormously challenging problem. I’ve been working as a bioethicist and specifically on problems in research ethics for 24 years now and I have to say, this is the most difficult question I’ve ever faced,” he said.
“On the one hand, you’ve got the potential of saving tens of thousands or even hundreds of thousands of lives by virtue of developing a vaccine earlier. But at the same time, even if we focus just on young, healthy adults, there’s still going to be a risk of death something on the order of three in 10,000.”
Weijer says the idea of human challenge trials for a COVID-19 vaccine gained traction in March when ethicist Nir Eyal at Rutgers University, along with a vaccine scientist at Harvard and a vaccine scientist at Oxford, published a paper in the Journal of Infectious Diseases arguing that routine vaccine development for COVID-19 could take years.
However, human challenge trials could accelerate vaccine development and save lives, they wrote.
“I have to say, our working group was pretty divided on the question. We came up with ethical guidance that was issued on May 6 of this year and in it we set out eight key criteria that a study would need to fulfill in order to be ethically acceptable.”
The criteria are:
- scientific justification,
- assessment of risks and potential benefits,
- consultation and engagement,
- site selection,
- participant selection,
- expert review, and
- informed consent.
“There’d need to be a clear case for social value, so researchers would have to explain and provide evidence for why it is this particular challenge study would speed the development of a COVID-19 vaccine. Secondly, the study could only include persons at the lowest risk,” he explained.
“Those individuals should be taken from communities, regions or countries where COVID-19 is circulating. So in other words, there’s a chance that even if they didn’t participate in the study, they could have become infected with COVID-19 anyway.”
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