The government-funded trial will seek to interpret the virus' transmissibility and infection, in order to inform vaccination and treatment strategies.
The first human challenge study to assess coronavirus 2019 (COVID-19) is approved to begin in the UK in the coming month, according to the country’s Department for Business, Energy & Industrial Strategy.
The £33.6 million government-funded trial will break new ground by intentionally exposing 90 healthy young adult volunteers to the pandemic virus, in an effort to interpret the effect of SARS-CoV-2 infection, COVID-19 progression, and the immune system’s response to the virus.
Investigators also aim to interpret vaccine efficacy in this closely-monitored trial, in an extension of the original study that would include vaccine candidates being exposed to the virus.
Given the concerning risks associated with such an assessment, the trial will involve major institutions involved in the UK’s pandemic response: the government-designated Vaccines Taskforce, Imperial College London, the Royal Free London NHS Foundation Trust, and clinical company hVIVO, which in the past has led design of viral human challenge models.
The volunteers, aged 18-30 years old, exposed to a “minimal” amount of SARS-CoV-2 to cause infection, will be monitored closely at the Royal Free Hospital’s specialist and secure clinical research facilities in London—which according to the UK government, are designed specifically to contain the virus.
In fact, the virus being used in the trial was produced by investigators at Great Ormond Street Hospital for Children NHS Foundation Trust in London, hVIVO, and Imperial College London. The virus will represent the prominent strain circulating in the UK since March 2020, shown to be of lessened risk in young health adults such as the would-be volunteers.
Human challenge trials have been previously conducted in infectious diseases including malaria, influenza, typhoid, cholera, and norovirus, helping investigators to establish ideal therapies and vaccines.
This challenge study was granted approval following review from an independent ethics committee, a decision which hVIVO chief scientific officer Dr. Andrew Catchpole called a “very important milestone” in the pursuit of further challenge studies in the pandemic.
“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.
Trial chief investigator Dr. Chris Chiu, of the Department of Infectious Disease at Imperial College London, called on eligible volunteers to join the trial, which he said will contribute to understanding both SARS-CoV-2 infection and transmissibility.
“Our eventual aim is to establish which vaccines and treatments work best in beating this disease, but we need volunteers to support us in this work,” he said in a statement.