A paper in the Journal for Infectious Diseases describes the option of a “Human Challenge Study” where participants could volunteer to become infected with the novel coronavirus.
The paper acknowledges the obvious risk of inflicting damage on said individuals should the goal of proving out a vaccine’s efficacy fall short.
The paper asserts such a drastic approach would take “months” off the lengthy timeline for vaccine development and phased safety research which normally takes 3-4 years.
Charlier Weller, head of vaccines at the Wellcome Trust commented on the conflicting approach saying, “It kind of goes against your natural inclination to intentionally infect someone with something...”
While the idea sounds drastic to some, the website 1 Day Sooner hopes to recruit as many people as possible to become infected for a challenge study. So far, the website reports 26 thousand volunteers across 102 countries.
The founder of 1 Day Sooner Josh Morrison is also the executive director of Waitlist Zero, an advocacy group for living organ donation.
“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, “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.”
Though a Human Challenge Study promises faster development, it is not without its complexity. A pool of uninflected individuals would need to be sourced and selected for those with low risk for mortality due to complications from infection with the virus.
The paper describes this as “young adults, without chronic health conditions, and not otherwise sick) and who are at substantial risk of natural exposure to SARS-CoV-2 (eg, resident in areas with high transmission rates).”
As studies go, a placebo group would also be measured. In this group, participants would still be infected by the virus but would not take the vaccine. This group’s data would serve to measure whether their infection is not worse than the infection of a naturally infected individual. This process alone could take several weeks.
At this point, participants would be split into either a placebo or non placebo. This means one group takes the risk of receiving an early, experimental vaccine, while the other the more serious risk of not taking one at all—for the purpose of comparative data.
There would be much complexity that follows this, including isolating the participants to keep the data clean. Participants would also need to be followed to monitor for symptoms.
The study asserts individuals infected, should they develop symptoms, would be given front of the line access to rationed life saving equipment.
All of this only describes the first phase of the testing. A similar process would need to be repeated in three phases just like a normal vaccine study. In each phase the number of participants increases.
In the United States, Human Challenge Studies are being seriously considered. 35 members of the US Congress, led by Bill Foster and Donna Shalala wrote to Department of Health and Human Services director Alex Azar in support of Human Challenge Studies due to the critical nature of the COVID-19 pandemic.