UK to Start World’s First COVID-19 Human Challenge Trial

A specially convened UK clinical trial ethics committee has given the go-ahead for a COVID-19 human challenge study that is slated to start within weeks to help inform further vaccine and treatment research.

The UK government previously drew up an agreement in October with hVIVO, a subsidiary of contract research organization OpenOrphan, to conduct the study (DID, Oct. 21, 2020), but it has now received the ethical approval needed for the trial to get under way.

The small-scale trial will include up to 90 healthy adult volunteers age 18 to 30 years who will be exposed to the virus in a controlled setting. It looks to establish a model to use for COVID-19 challenge studies and determine the lowest dose of virus that causes infection, according to Andrew Catchpole, hVIVO’s chief scientific officer.

“Data from this study will immediately facilitate the challenge model to be used for vaccine efficacy testing as well as to answer a wide range of fundamental scientific questions that are not feasible with traditional field trials, such as exactly what type of immunological response is required to confer protection from re-infection,” he said.

Although human challenge trials present ethical dilemmas because their participants are intentionally infected with a pathogen, challenge trials over many decades have helped speed up treatments for diseases including malaria, typhoid, cholera, norovirus and influenza, and they have also helped researchers select vaccine candidates that show the most promise for phase 3 trials, the UK government said.

Human challenge trials can also help researchers better understand how COVID-19 affects people as soon as they are infected, which could serve to inform research on new treatments, said Charlie Weller, head of vaccines at Wellcome Trust.

“Human infection studies have real potential to improve our understanding of COVID-19, which is crucial to the long-term pandemic response. These studies provide controlled, highly regulated environments that complement late-stage vaccine development by testing the effectiveness of current and new vaccines,” she said. — James Miessler