Second-generation COVID-19 vaccine clinical trial starts at BCM

Baylor College of Medicine investigators are recruiting volunteers for a multicenter Phase 1 clinical trial to examine the safety, tolerability and immune response for different doses of a two-part, investigational COVID-19 vaccine regimen.

“Gritstone Oncology’s COVID-19 vaccine candidate has 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 Baylor’s trial site.

Participants must be age 18 and older, healthy, with no known history of SARS-CoV-2 infection, no prior receipt of COVID-19 vaccines, and at low risk for SARS-CoV-2 infection.

Participants will be asked to:

• Commit to eight or more study in-person clinic visits and participate in four telephone visits over 13 to 16 months, receiving two injections of vaccine, and having several blood draws for safety monitoring and to see whether the vaccine resulted in an immune response.
   
• Keep track of how they’re feeling after each injection. The study staff also will be in contact with each participant. The results of the immune tests in each vaccinated group will be shared with the participants a few months after the second vaccine.
   

The second stage of the study will include examining the effectiveness of the investigational vaccine encoding for portions of multiple SARS-CoV-2 proteins, in addition to the components of spike protein used in the current COVID-19 vaccines given under FDA Emergency Use Authorization.

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.

This second-generation COVID-19 vaccine candidate was developed by Gritstone, a U.S.-based clinical-stage biotechnology company, under its “CORAL” COVID-19 program with support from departments within the NIH, the Bill & Melinda Gates Foundation and a license agreement with La Jolla Institute for Immunology.