More than £30m of UK government money is to be funded for the world’s first Covid-19 “challenge trials”, in which healthy young volunteers are intentionally infected with the virus to hasten the development of a vaccine.
The trials have the potential to yield results more quickly than conventional vaccine field trials in which researchers must wait for participants to get infected in the real world.
Curing a Virus by exposing to another virus
Studies have also been used to compare multiple vaccine candidates, develop treatments, and gather data about the immediate aftermath of infection that would not be possible to procure otherwise.
The use of such trials dates back to the end of the 18th century when the English physician Edward Jenner inoculated a young boy with cowpox virus and then exposed him to smallpox as part of an effort that led to the world’s first vaccine. Since then, the method has also been used to develop vaccines for typhoid, cholera, and malaria.
The government has announced it is investing £33.6m to back the studies in partnership with Imperial College London, hVIVO, and the Royal Free London NHS foundation trust. The funding includes a contract worth up to £10m signed with Vivo, a subsidiary of Dublin-based pharmaceutical services company Open Orphan, to develop the model for the trial.
This characterization study, sponsored by Imperial College London, is pending regulatory and ethical review.
Helping The Subject
“We’re not trying to make these subjects really sick. In fact, quite the reverse. We’re religiously trying to get just enough that we can detect [the] virus,” said Andrew Catchpole, the chief scientific officer of Vivo. “We could achieve the goal with as much as only 10, 20, maybe even 30 people … and then we can move on to vaccine testing.”
Apart from ensuring volunteers’ immune systems are not overburdened, one key component of the study is choosing the appropriate strain of the virus. The company isolated the strain about four months ago, said Catchpole, emphasizing that it continues to represent the strain circulating in the UK population.
Increasing investment for the Program
The company will get up to £10m to conduct the characterization study, depending on the number of volunteers used. The government has also secured the first three slots to test vaccines, with each reservation valued at £2.5m, hVivo said.
On the relative risks of human challenge trials, Katharine Wright, assistant director at the Nuffield Council on Bioethics, noted that they take place to test flu vaccines without there being an effective
treatment and all “first in human” trials similarly present unknown risks.
Increment in the Subjects
Despite the uncertainty, volunteers are lining up. More than 2,500 UK volunteers have signed up to the 1Day Sooner movement, which has been petitioning parliament to support human challenge trials and fund a challenge study center to quarantine between 100 and 200 volunteers. Globally, the non-profit organization advocating for human challenge study volunteers has attracted over 38,500 willing participants.
But people were volunteering for altruistic reasons, said Wright. “People are publicly coming forward to volunteer for challenge trials because they want to help everyone return to ordinary life as soon as possible,” she said. “It’s a very impressive … but they will have to understand that nothing is certain in research.”