LONDON, UK—Nature Medicine has published the results of the world’s first COVID human challenge study. The preprint became available as of February 2022, but the full publication also contains supplementary materials, including the study protocol. Imperial College London’s announcement of the results, including a summary of the findings of interest,
1Day Sooner began advocating on behalf of volunteers who wanted to participate in COVID challenge studies in April 2020. We called for greater transparency for these studies and an earlier release of the protocol (as published in the Guardian and the British Medical Journal), to ensure public trust and understanding.
We appreciate the research team’s boldness in being the first team to run COVID human challenge studies, and are grateful to the team and study participants. While 1Day had no role in running the study, a number of our volunteers (some quoted below) have spoken widely about their pride in their participation. In addition, 1Day Sooner worked hard to build the public conversation around challenge trials and engage interested parties, and continues to advocate that medical trial volunteers should be represented in medical ethics discussions.
In this infectious dosing study, participants were exposed to an early strain of SARS-CoV-2 and kept under medical observation so immune response data could be collected and analyzed. The preprint contains data describing participants’ viral load, symptoms, and period of contagiousness, as well as the sensitivity and specificity of lateral flow tests.
The results of this challenge trial are fascinating, and would have been even more useful early in the pandemic, when there was immense uncertainty about contagiousness and the use of lateral flow tests, among other items this study examined. These results demonstrate the importance of using challenge trials early in emergency situations and treating them with urgency once they are underway.
Now that the COVID challenge model has finally been established and better treatments exist, the model needs to be expanded to new strains and scaled up to test universal coronavirus vaccines, intranasal vaccine formulations, and new antiviral treatments. Dr. Fauci has endorsed the use of common cold coronavirus challenge models in developing universal vaccines, and Dr. Dean Smith, Section Head of the Combination Vaccines review division in Health Canada, suggested human challenge as a potentially important approach to authorizing universal coronavirus vaccines at a January WHO global consultation on the topic.
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