The University of California San Diego is one of 24 academic medical centers that will enroll residents in the COVID-19 Variant Immunologic Landscape Trial (COVAIL) in a national effort to test combinations of COVID-19 vaccines that target variants.
Fully vaccinated and boosted San Diego County residents may participate in the clinical trial funded through a contract to Frederick National Laboratory for Cancer Research, operated by Leidos Biomedical Research in Frederick, Maryland. The study is funded by the National Institute of Allergy and Infectious Diseases.
Academic medical centers involved in the trial will enroll 600 participants to be randomly assigned one of six vaccines developed by Moderna. The trial is slated to run for four years and can expand to enroll 1,500 participants nationwide.
“The emergence of SARS-CoV-2 variants has challenged the efficacy of available preventive vaccines. It’s clear that we need to learn more about how we might adapt vaccines to match circulating variants and expand and optimize immune coverage to existing and emerging variants,” said Susan Little, MD, professor of medicine at UC San Diego School of Medicine and principal investigator of the UC San Diego trial site.
According to Little, the COVAIL study will evaluate the safety and immunogenicity of additional doses of prototype and variant vaccine candidates in previously vaccinated participants regardless of their history of COVID-19 exposure.
“It will evaluate innate, cellular, and humoral (the presence of antibodies in the blood) immune responses to inform on how to shift the immune response to cover new variants as they emerge,” Little wrote in a statement.
Researchers at the Emory Vaccine Center in Atlanta and the University of Rochester Medical Center in New York are leading the trial. Participants must be at least 18 and fully vaccinated, with evidence that they also have received a booster shot.
Enrollment will be targeted toward specific age groups but will skew toward older age groups that are at higher risk of complications when infected by COVID-19. About 45 percent of COVAIL participants will be 65 or older.
Participants will be monitored for symptoms and adverse events following vaccination and will be asked to return to the clinic during set times for 12 to 14 months to provide blood samples.
For more information about the trial, visit clinicaltrials.gov
