A Phase 2 clinical trial evaluating second COVID-19 booster shots and various variant-targeted vaccines has begun enrolling adult participants at Emory.
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, and Emory has received funding support under NIH contract number 75N91019D00024 to Leidos Biomedical Research in Frederick, Maryland.
The COVAIL trial aims to understand if the vaccine regimens being tested — 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.
"The COVAIL study is addressing an important public health need by testing different potential booster shots of variant vaccines to expand and optimize immune coverage to existing and emerging antigenic variants," says Nadine Rouphael, MD, MSc, study co-chair and executive director of the Hope Clinic at Emory Vaccine Center.
The study includes both the currently authorized mRNA-1273 vaccine from Moderna, Inc. as well as three different investigational vaccines targeting the Beta, Delta or Omicron variants, sometimes given at the same time. More detailed information about the study is available at clinicaltrials.gov (NCT05289037).
Despite waning protection against mild infections during the Omicron wave, COVID-19 vaccines available in the United States so far have maintained durable protection against severe disease. But predicting if, when and where new COVID-19 variants will emerge and how they will affect the population remains challenging.
"The SARS-CoV-2 virus will continue to evolve over time, leading potentially to new variants and the possibility of periods of higher incidence of symptomatic disease," says Angela Branche, MD, study co-chair and associate professor of medicine at the University of Rochester. "Our hope with the COVAIL study is to move from responsiveness to preparedness."
NIAID and its partners are preparing for the possibility of future variants evading protection against currently available COVID-19 vaccines. Study vaccines included in this first stage of the trial come from Moderna, Inc., but researchers plan to enroll more participants to evaluate additional vaccine platforms and variant vaccines from other manufacturers as needed to further inform public health decisions.
At Emory, the Hope Clinic, led by Rouphael, is participating in COVAIL, as well as the Emory Children's Center Vaccine Research Clinic led by Evan Anderson, MD. Those interested in participating in the trial at the Hope Clinic, located in Decatur, can contact the Hope Clinic
