Baylor launches clinical trial for COVID-19 vaccine booster

Researchers at the Vaccine and Treatment Evaluation Unit at Baylor College of Medicine have launched a clinical trial to study the safety and efficacy of a booster dose of the Moderna-mRNA-1273 COVID-19 vaccine. The study is for people who already have received one of the vaccines approved under Emergency Use Authorization (EUA) by the FDA. A second part of the study will enroll participants who have never received a COVID-19 vaccine or had a prior SARS-CoV-2 infection to measure immune response to a booster vaccine after receiving the EUA Moderna vaccine.

The study is being conducted by the Infectious Disease Clinical Research Consortium in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

Individuals in the first group of the study must have received either the Pfizer, Moderna or J&J vaccines within the last 12 to 20 weeks. Researchers will aim to establish the safety of the Moderna vaccine given as a booster and determine if there is an antibody response to the original strain as well as variant strains of the virus. It also will look at whether individuals who received one vaccine initially will have an immune response to a different vaccine as the booster.

“It’s important to determine the magnitude of the immune response after a booster dose in persons who received different vaccines in their initial vaccine regimen. We will also be looking at the safety of a booster dose,” said Dr. Robert Atmar, professor of infectious diseases at Baylor and co-principal investigator of the national study.

The second group of individuals in the trial will be those who have not previously been vaccinated or had SARS-CoV-2 infection. They will receive the EUA Moderna vaccine, followed by a booster vaccine from Moderna or another vaccine manufacturer after at least 12 weeks.

Individuals interested in enrolling in the trial can call 713-798-4912 or email Covid-vax@bcm.edu.

This activity is supported by the Infectious Diseases Clinical Research Consortium (IDCRC) through the National Institute of Allergy and Infectious Diseases (NIAID) (UM1AI148684). The IDCRC, consisting of the Vaccine Treatment and Evaluation Units (VTEUs) and the IDCRC Leadership Group, was formed in 2019 to support the planning and implementation of infectious diseases clinical research that efficiently addresses the scientific priorities of NIAID.  The consortium includes infectious diseases leaders and clinical researchers from Emory University, University of Maryland School of Medicine, Baylor College of Medicine, Cincinnati Children’s Medical Center and University of Cincinnati, FHI360, Fred Hutchinson Cancer Research Center, Johns Hopkins University, Kaiser Permanente Washington Health Research Institute, New York University, Saint Louis University, Vanderbilt University Medical Center, University of Alabama at Birmingham, University of Rochester, University of Washington, and NIAID. For more information about the IDCRC, please visit www.IDCRC.org.