A draft core protocol for COVID-19 vaccine trials was recently published by the World Health Organization (WHO) R&D Working Group, whose members include a number of researchers from the University of Washington School of Public Health and the Fred Hutchinson Cancer Research Center.
The innovative core protocol approach provides consistency, efficiency, and reliability in the process for evaluating vaccines to prevent the spread of COVID-19. Participants receiving experimental vaccines administered at different times and across broad populations in different countries can be merged into one overarching clinical trial. This enables concurrent evaluation of the benefits and risks of each promising vaccine and provides timely feedback to public health officials and clinicians.
UW Professor of Biostatistics Thomas Fleming, a member of the Working Group, expressed hope that enrollment of trials in the core protocol would begin soon. “My current best sense is that enrollment could begin within a few months and will occur on an international basis, eventually engaging more than a hundred sites worldwide. Likely, a large number of vaccines will be evaluated in this international CORE trial, each within three to six months from the time of their initiation, with potentially 200,000 participants being randomized by the time we have completed evaluation of the first ten candidates.”
As to enrollment of Seattle-area participants in the protocol, Fleming says the level of involvement by the local community has not yet been determined.
Other UW School of Public Health faculty who have made substantive contributions to the WHO R&D Working Group efforts include:
- Peter Gilbert, Research Professor; Member, Vaccine and Infectious Disease Division and Public Health Sciences Divisions, Fred Hutchinson Cancer Research Center
- M. Elizabeth “Betz” Halloran, Professor of Biostatistics; Director, Center for Inference and Dynamics of Infectious Diseases, Fred Hutchinson Cancer Research Center
- Yunda Huang, Affiliate Associate Professor of Global Health, Fred Hutchinson Cancer Research Center
- Holly Janes, Affiliate Associate Professor of Biostatistics; Member Infectious Disease Division and Public Health Sciences Divisions at Fred Hutchinson Cancer Research Center
Deb Nelson, Biostatistics communications and event manager