Britain to infect healthy individuals with coronavirus for vaccine trials
British scientists on Tuesday announced plans to launch the first COVID-19 human challenge trials in which researchers will intentionally infect a sample of healthy volunteers with the virus in order to speed up the testing of potential vaccines.
According to The Washington Post, the research, scheduled to begin in January, will be led by scientists at Imperial College London and funded by the British government.
Fewer than 100 volunteers between the ages of 18 and 30 will have a laboratory-grown strain of COVID-19 blown into their noses and will be quarantined in a private unit at the Royal Free Hospital in London, where they will undergo regular testing over a two- to three-week period.
According to the Post, the study aims to determine the minimal amount of virus necessary to cause an active infection in the volunteers’ upper respiratory system.
Later in the spring, the scientists hope to add more volunteers, who will be treated with candidate vaccines and then exposed to the virus to see how well the vaccines protect them.
Andrew Catchpole, chief science officer for hVIVO, a commercial pharmaceutical company that will coordinate the human challenge trial research, said the study will be reviewed by a specially convened ethics committee and Britain’s Medicines and Healthcare products Regulatory Agency, its version of the U.S. Food and Drug Administration (FDA).
Challenge trials have not received as much widespread support in the U.S. due to the ethical concerns associated with deliberately infecting people with a virus that has already killed more than 1.1 million people globally, according to The New York Times coronavirus database.
However, the idea of using challenge trials to speed up the process of vaccine testing has increasingly gained more ground.
In April, a group of 35 House lawmakers, led by Reps. Bill Foster (D-Ill.) and Donna Shalala (D-Fla.), a former secretary of the Department of Health and Human Services, wrote to the FDA to vocalize their support.
“Our situation in this pandemic is analogous to war, in which there is a long tradition of volunteers risking their health and lives on dangerous missions for which they understand the risks and are willing to do so in order to help save the lives of others,” they wrote in the letter.
In August, Reuters reported that federal health officials had begun initial work to establish protocols of a challenge trial of a COVID-19 vaccine, including manufacturing a strain of the virus that could be used.
The National Institute of Allergy and Infectious Diseases (NIAID) told Reuters at the time that multiple clinical studies of different vaccines were already underway, and a challenge trial was not likely to replace them.
Reuters said in August that NIAID was prioritizing large-scale field trials to evaluate COVID-19 vaccine candidates while also being open to the possibility of using challenge trials for future generations of vaccines or treatments.
Challenge trials could help a vaccine be approved for public use faster than a traditional clinical trial would, as a conventional one would require that researchers wait for some of the participants to become infected in the course of their daily lives.