UK Authorizes COVID-19 Human Challenge Trial

The British government has entered into a contract to conduct human challenge trials in which participants will be deliberately infected with COVID-19 to bolster development of a vaccine.

The UK government’s contract is with CRO OpenOrphan subsidiary hVIVO to conduct the study, which is being sponsored by the Imperial College London and Royal Free London NHS Foundation Trust.

Researchers will administer doses of the coronavirus to determine the smallest amount needed to trigger an infection in healthy young people between the ages of 18 and 30. The initial trial will enroll up to 90 paid volunteers, and subsequent stages will include participants who have been inoculated with a vaccine.

The UK’s announcement did not disclose which vaccine or vaccine candidates will be evaluated. AstraZeneca, Pfizer and BioNTech, Sanofi and GlaxoSmithKline, Johnson & Johnson, Novavax, and Valneva all have vaccines in late-stage development.

“This research will improve understanding of the virus, the biology of the disease, the signs that a person is protected from infection or developing the disease,” said Kate Bingham, chair of the government’s Vaccine Taskforce. “There is much we can learn in terms of immunity, the length of vaccine protection and reinfection.”

The government is eyeing a January start date and hopes to see results by May 2021.

In the U.S., the National Institutes of Health (NIH) has not approved any human challenge trials, but the NIH’s National Institute of Allergy and Infectious Diseases said it is looking into the “technical and ethical considerations.”

NIAID said it anticipates that toward the end of 2020 preliminary — and potentially final — data from candidate vaccine trials will be available and “will be used to assess future SARS-CoV-2 human challenge studies, should they be needed and deemed safe and ethical to employ.” — Jason Scott