By Jonathan Springston, Editor, Relias Media
The United Kingdom this week approved the first COVID-19 human challenge trial, during which subjects will be infected with the virus so researchers can understand symptoms better and help with effective vaccine development.
In a few weeks, 90 healthy volunteers age 18-30 years will be recruited and infected with a small amount of COVID-19. Researchers will use a strain that has been circulating in the United Kingdom for the past year and is considered low risk in young people. Medical professionals and scientists will be monitoring subjects 24 hours a day, noting pathology, symptomology, immune system reactions, and how the virus spreads. Participants will be paid.
The research team says by learning more about COVID-19 this way, they and other investigators can find out which vaccines work best. “We have secured a number of safe and effective vaccines for the U.K., but it is essential that we continue to develop new vaccines and treatments for COVID-19. We expect these studies to offer unique insights into how the virus works and help us understand which promising vaccines offer the best chance of preventing the infection,” Interim Chair of the U.K. Vaccines Taskforce Clive Dix said in a statement.
To some, deliberately infecting a person with a virus may sound controversial — even shocking, but human challenge trials are not unprecedented. Before the government announced this COVID-19 challenge trial would proceed, a committee of the U.K.’s Research Ethics Service reviewed the proposal and subsequently gave the green light to move forward.
In the early weeks of the pandemic and related vaccine research, the World Health Organization released guidelines regarding the ethical acceptability of COVID-19 human challenge studies. “It is a standard research ethics requirement that, on balance, benefits should outweigh risks. Given the ethically sensitive nature of SARS-CoV-2 challenge studies, assessment of their potential benefits and risks should be especially rigorous,” the agency wrote.
The cover story of the July 2020 issue of IRB Advisor went into detail about the ethical issues of challenge trials. In a companion article, research ethicists outlined tips for those who are considering creating these trials.