Research Explores Enhanced Vaccine Dose to Bolster Immune Response, Anticipate Subsequent Outbreaks of COVID-19
In the ongoing battle against COVID-19, updated boosters have been approved and are being rolled out, targeting newly dominant and emerging coronavirus variants. The FDA has given the green light to updated COVID-19 shots from Pfizer, Moderna, and Novavax, aiming to improve protection against evolving strains.
This move reflects ongoing efforts to adapt vaccines as the virus evolves, with the primary focus on maintaining effective immunity, especially against severe disease, hospitalization, and death, which remain significant risks for vulnerable populations such as seniors and people with underlying health conditions.
However, vaccination uptake remains a challenge, partly due to complexity in vaccine recommendations and hesitancy.
Amidst this, a new national COVID vaccine study is being led by the University of Rochester Medical Center. Known as the COVAIL trial, this Phase 2 clinical trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The trial is being conducted at 24 medical centers across the U.S., including the Infectious Diseases Clinical Research Consortium and the University of Rochester Medical Center's Vaccine Treatment and Evaluation Unit (VTEU).
Angela Branche, an associate professor of Infectious Diseases and co-director of the University of Rochester Medical Center's Vaccine Treatment and Evaluation Unit (VTEU), is co-chair of the COVAIL trial along with Nadine Rouphael, M.D., with Emory University. The goal of the COVAIL trial is to determine which vaccine regime offers the broadest immune response, potentially providing protection against current and future variants.
The trial is open to volunteers 18 years and older who have received a primary COVID vaccination series and booster shot. Moderna will supply the vaccines for the first stage of the COVAIL trial, with the trial expanding over time to include vaccines produced by other manufacturers. The study will compare immune responses to two Pfizer/BioNTech boosters, one targeting the original SARS-CoV-2 virus and BA.1 Omicron variant, the other the original virus and BA.4/BA.5 Omicron variants.
The COVAIL trial aims to recruit up to 600 volunteers at 24 sites across the U.S., including Rochester. Participants will be randomly assigned to receive a second booster dose of either the original vaccine, doses engineered against the Beta, Delta, and Omicron variants, or doses that combine variants.
The latest update related to COVID-19 boosters also includes insights from the COVIAL trial results, published in Clinical Infectious Diseases, which suggest the need for continuous updates to COVID boosters to combat emerging viral variants. The BA.4/BA.5 booster, for instance, outperformed the BA.1 booster in eliciting an immune response to the BA.4/BA.5 variants.
As the virus continues to evolve, potentially leading to new variants causing periods of higher incidence of symptomatic disease, the COVAIL trial is a significant step towards moving from responsiveness to preparedness in dealing with COVID variants.
For more information about the COVAIL trial, volunteers can visit covidresearch.urmc.edu or call 585 273-3990.
References: 1. COVID-19 Vaccine Hesitancy: A Review of the Current State and Future Directions 2. COVIAL trial results 3. FDA authorizes updated COVID-19 boosters 4. COVID-19: Who is at higher risk?
