UK to Run Challenge Trials for COVID-19 Vaccines: Report
The UK government will fund challenge trials that are expected to begin in January to assess the effectiveness of experimental coronavirus vaccines, the Financial Times reported Wednesday, citing people familiar with the project. According to the report, researchers said the studies will help winnow the “large field” of COVID-19 vaccines slated to enter clinical testing early next year, although AstraZeneca and Sanofi have already come out saying neither they nor their respective vaccine candidates will be involved.
A final decision about the site of the initial challenge trials has not been made, although the report indicated they will take place at a secure quarantine facility in east London where volunteers will first be inoculated with a vaccine, and then receive a challenge dose of SARS-CoV-2 about a month later under controlled conditions. The report said the trials would initially use Gilead Sciences’ antiviral Veklury (remdesivir) as a potential “rescue remedy” to prevent serious illness in participants.
Faster road to vaccine?
Roughly 2000 potential volunteers have signed up for challenge studies in the UK through the US-based advocacy group 1Day Sooner, the Financial Times said. Earlier this year, the group’s co-founder Josh Morrison suggested that challenge trials may offer a potentially “speedier route” to an effective coronavirus vaccine than traditional studies. The Financial Times report said 1Day Sooner is kicking off a campaign this week with a petition to the UK parliament seeking public funding of a biocontainment facility with enough room to quarantine 100 to 200 volunteers.
The report added that the project’s academic leader is Imperial College London, and that it will be run by hVivo, which was bought earlier this year by pharmaceutical research organization Open Orphan. In March, Open Orphan said it had started working on the world’s first human coronavirus challenge study model, noting that it had a 24-bedroom quarantine clinic where the challenge model would be developed and used.
Open Orphan also indicated at the time that it would use common coronavirus strains such as OC43 and 229E that are from the same family as SARS-CoV-2, but that unlike the novel coronavirus, these strains have been widespread in the community for many years and cause only a mild cold-like respiratory illness. “Consequently, these common coronaviruses, while closely related to the COVID-19 strain can safely be administered to volunteers in hVIVO’s highly controlled quarantine clinic,” it said.
Volunteer safety ‘top priority’
Meanwhile, the UK Medicines and Healthcare products Regulatory Agency (MHRA), which would have to sign off on the human challenge trials, stated that these types of studies “can be helpful for the development of vaccines and can provide early evidence of clinical efficacy, particularly when there are low rates of infection of the virus in the population.” However, the agency said the safety of participants would be a “top priority” and that any proposal from a developer to include a human infection challenge as part of a clinical trial for a vaccine “would be considered on a benefit-risk basis, with risks monitored for and minimised in the proposed trial design.”
Last month, the US National Institute of Allergy and Infectious Diseases said it had started looking into the technical and ethical considerations of conducting human challenge studies, with government scientists doing preliminary work on manufacturing a strain of SARS-CoV-2 that could be used in such studies of potential vaccines.