Volunteer enrollment begins for Phase III clinical trial that will determine the efficacy of Novavax vaccine candidate.
UW Medicine investigators are starting volunteer enrollment for an investigational COVID-19 vaccine clinical trial. The Phase III study will examine whether the Novavax vaccine candidate can protect against SARS-CoV-2, the coronavirus responsible for COVID-19.
UW Medicine’s site for enrolling participants is the Virology Research Clinic at Harborview Medical Center’s Ninth and Jefferson Building. The site will enroll up to 1,000 volunteers. Investigators will make the trial accessible and equitable for populations disproportionately impacted by the COVID-19 pandemic; this would entail deploying mobile sites in other parts of the state.
Volunteers 18 and older can enroll with the Virology Research Clinic in several ways:
- Complete the volunteer screening registry and enter site code “UWVR”
- Email: email@example.com
- Call: 206.520.4212
- Visit: www.uwvteu.org for more information
Participants will be asked to:
- Commit to coming into the research site for eight or more visits over one to two years, receiving two injections of the vaccine and having several blood draws to discern whether the vaccine results in an immune response.
- Keep track of how they’re feeling following each injection. The study staff also will be in contact with each participant.
- Be aware that the study will be double blind and randomized, with two of every three participants receiving the trial vaccine and one of every three participants receiving a placebo (salt water).
“Rapid enrollment into the COVID-19 vaccine trials is critical, as the epidemic in the United States is currently worsening. However, these trials are designed to make sure that the vaccines are thoroughly evaluated for both safety and efficacy,” said Dr. Scott McClelland, professor of medicine, epidemiology and global health, who is the principal investigator at UW Medicine.
McClelland said there will be a concerted effort to reach out to underserved communities.
“It is important that we provide equitable access to the trial for people from the communities that have been hardest hit by COVID-19, particularly the Latinx, Black and Native American communities,” he said. “And because seniors are particularly at risk of serious infections, we aim to make sure at least a quarter of enrollees are age 65 or older.”
Dr. Anna Wald, professor of medicine, epidemiology and laboratory medicine and pathology, and director of the Virology Research Clinic, is working with McClelland on the trial. She noted that although this an investigational vaccine, it is based on technology similar to what’s been used to make vaccines for many years and is considered a very safe approach to vaccine design.
“Some people may have a sore arm or mild flu-like symptoms for a day or two after receiving the vaccine but in general these vaccines are well-tolerated,” Wald said. “The vaccine does not contain live SARS-CoV-2 and participants cannot develop COVID-19 as a result of participating in the study."
The trial is part of the National Institutes of Health’s newly established COVID-19 Prevention Network, formed by the National Institute of Allergy and Infectious Diseases to respond to the global pandemic. The network plans to enroll thousands of volunteers for Phase 3 efficacy trials for COVID-19 vaccines and monoclonal antibodies. The network is a part of “Operation Warp Speed,” a partnership led by the U.S. Department of Health and Human Services to invest in and coordinate the development, manufacturing and distribution of COVID-19 diagnostics, therapeutics and vaccines.
The U.S.-based late-stage biotechnology company Novavax is leading the trial as regulatory sponsor. The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority, part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, are providing funding support for the trial.
See original story on UW Medicine Newsroom.
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