WASHINGTON (October 20 2022) — The GW School of Medicine and Health Sciences is recruiting participants for the final stage of a clinical trial to evaluate two Omicron-specific vaccines. The study, known as the COVID-19 Variant Immunologic Landscape (COVAIL) trial, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The George Washington University School of Medicine and Health Sciences has received funding support as an agreement under NIH contract number 75N91019D00024 to Leidos Biomedical Research in Frederick, Maryland.
Back in April, The GW School of Medicine and Health Sciences was selected to serve as one of 24 participating sites for the Phase 2 clinical trial to evaluate additional COVID-19 booster shots in adults, including multiple vaccines based on viral variants such as Delta and Omicron. The trial aims to understand if different vaccine regimens – prototype and variant vaccines alone and in combinations – can broaden immune responses in adults who already have received a primary vaccination series and a first booster shot.
Researchers at GW, led by David Diemert, MD, professor of Medicine and of Microbiology, Immunology, and Tropical Medicine at the GW School of Medicine and Health Sciences (SMHS) and a physician in the Division of Infectious Diseases at The GW Medical Faculty Associates (MFA), are conducting the clinical trial to help prepare for the possibility of future variants evading protection from currently available COVID-19 vaccines.
“We are excited to begin recruitment for this final stage,” said Diemert. “Omicron has become the dominant variant of this virus because of its ability to spread quickly. This trial will help us learn how to best protect against this variant and move us a step closer to stopping this deadly disease.”
The COVAIL trial will gather data on the immune responses induced by prototype vaccines and variant vaccine candidates—including bivalent vaccines, which target two SARS-CoV-2 variants—to inform booster shot recommendations.
Most participants will attend 8 or 9 in-person study visits, including an initial screening visit (which may be combined with the first study vaccination visit), one study vaccination visit, and 7 in-person follow-up visits. The participants will be in the study for up to approximately 13 months, if they have a separate screening visit, or 12 months, if the screening visit is combined with the first study vaccination visit.
The study is being conducted in collaboration with academic medical centers across the U.S. including GW, NIAID’s Infectious Diseases Clinical Research Consortium (IDCRC) and the NIAID SARS-CoV-2 Assessment of Viral Evolution (SAVE) Program.
For more information about the trial, including specific site locations, and for details on how to participate, please visit clinicaltrials.gov and search identifier NCT05289037.
GW School of Medicine and Health Science is recruiting volunteers who have been both vaccinated and boosted (with Pfizer, Moderna, or J&J vaccines) for a #COVID19 booster & variant-specific vaccine clinical trial. Visit the COVAIL Volunteer Survey for more information.
Much of this release was pulled from NIAID’s press release.