Enrolling begins for second-generation booster COVID-19 vaccine trial

Investigators at the Baylor College of Medicine Vaccine and Treatment Evaluation Unit are recruiting participants for a multicenter Phase 1 clinical trial to examine the safety, tolerability and immune responses following booster immunization with different doses of two investigational COVID-19 vaccines developed by Gritstone bio, Inc. The investigational vaccines encode for the spike protein, similar to that used in the current COVID-19 vaccines given under FDA Emergency Use Authorization, and portions of additional SARS-CoV-2 proteins.

“Gritstone bio’s COVID-19 vaccine candidates have been designed to broaden the immune response to SARS-CoV-2, the virus that causes COVID-19, with the goal of generating immune responses to provide protection against emerging variants of SARS-CoV-2,” said Dr. Jennifer Whitaker, assistant professor of medicine and molecular virology and microbiology at Baylor and principal investigator of the trial at Baylor.

Participants must be age 18 and older, healthy, with no known history of SARS-CoV-2 infection, and have completed their COVID-19 vaccination dosing with a vaccine under FDA Emergency Use Authorization (e.g., Pfizer, Moderna or Johnson & Johnson) at least four months ago.

Participants will be asked to:

• Commit to eight or more in-person clinic visits and one or two telephone visits over 13 to 14 months.
• Receive one or two injections of study vaccine (depending on which previous vaccine was received).
• Have several blood draws for safety monitoring and to see whether vaccines stimulate immune responses to the vaccine components.
• Keep track of how they’re feeling after each injection. The study staff also will be in contact with each participant.

Interested participants should email COVID-VAX@bcm.edu or call 713-798-4912. Visit ClinicalTrials.gov for more information, clinical trials identifier: NCT04776317.
The study is sponsored and funded by the U.S. National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and is being conducted through the NIAID-supported Infectious Diseases Clinical Research Consortium.

These second-generation COVID-19 vaccine candidates were developed by Gritstone bio, a U.S.-based clinical-stage biotechnology company, under its “CORAL” COVID-19 program. The project is supported by the NIH, the Bill & Melinda Gates Foundation, and a license agreement with La Jolla Institute for Immunology.