The idea is to deliberately infect a group of volunteers with the coronavirus, then give half the group the vaccine and half the group a placebo, according to The Hill.
There is an alternative, and that entails giving volunteers the vaccine after they’ve contracted the virus on their own, but backers of the HCT say deliberate infections could trim months off the process, thereby saving thousands of lives.
Josh Morrison is the co-founder of a group called 1Day Sooner. It is not affiliated with groups or companies developing or funding coronavirus vaccines, however, they do advocate for using human challenge trials to test the effectiveness of vaccines.
“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,” says Morrison, who is also the executive director of organ donation advocacy group Waitlist Zero, according to Nature.com. “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.”
As of today, Morrison’s website shows they have 3,499 volunteers from 52 countries already signed up to participate in trials. To date, there has been no “go-ahead” for conducting a human challenge trial, although an FDA spokesperson said that all options are being considered.
Ethics and history of human challenge trials
Volunteering to be infected with a virus or bacteria is not something that many people would want to do, and there are ethical questions that need answering. We are talking about moral standards and what is considered acceptable by society as a whole.
Arthur Caplan, a New York University bioethicist, and Stanley Plotkin, who helped develop the rubella vaccine, have this to say about the ethics of doing human trials: “It might seem as though anybody volunteering to participate in such a study lacks the capacity for rational decision-making or must have misunderstood the informed-consent form, however, in this situation, “Acceleration of that standard process is necessary.”
Many vaccines and treatments for disease have been speeded up by using human challenge trials. Perhaps the most famous was the first-ever vaccine for smallpox. Edward Jenner created this early version of a vaccine in 1796 by taking samples from a cowpox sore and putting it into the skin of James Phipps—his gardener’s eight-year-old son. Jenner then intentionally exposed Phipps to smallpox, but the child did not become infected.
Everyone has heard of Tamiflu, right? In the 1980s and 1990s, the University of Virginia School of Medicine conducted challenge studies with influenza A and B which helped speed the development of oseltamivir (Tamiflu)— an antiviral medication that features on the World Health Organization’s List of Essential Medicines.
Charlie Weller, head of the vaccines program at Wellcome, a biomedical-research funder in London, says the charity has begun discussing the ethics and logistics of a human-challenge trial for a coronavirus vaccine. Weller says there is still a question of if a challenge trial would actually speed up the development of a vaccine for the coronavirus.
“I think there’s potential,” Weller adds, “but we’ve got so many questions to work through to understand whether it can help in the timelines we have.”
