Vanderbilt University Medical Center (VUMC) is participating in a national phase 1 clinical trial in healthy adults of an investigational vaccine against the B.1.351 variant of the COVID-19 virus that was first identified in South Africa.

The multicenter trial, which began this week <March 31>, is evaluating the safety and immunogenicity of the mRNA-1273.351vaccine developed by the Cambridge, Massachusetts-based biotechnology company ModernaTX, Inc. The trial is led and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

Approximately 210 healthy adult volunteers at VUMC and three other clinical research sites in the NIAID-funded Infectious Diseases Clinical Research Consortium (IDCRC) will receive the vaccine. Lisa A. Jackson, MD, MPH, senior investigator at the Kaiser Permanente Washington Health Research Institute in Seattle, is the study's principal investigator.

"There is an 'arms race' right now between the vaccine and these variants," said Buddy Creech, MD, MPH, director of the Vanderbilt Vaccine Research Program who will lead the VUMC trial. "We need to put maximum pressure on the virus as fast as we can so that those variants can't take hold."

On March 4 the Tennessee Department of Health confirmed the state's first case of the B.1.351 variant, which appears to spread more readily than the original strain of the COVID-19 virus, SARS-CoV-2.

"Preliminary data show that the COVID-19 vaccines currently available in the United States should provide an adequate degree of protection against SARS-CoV-2 variants," NIAID Director Anthony S. Fauci, MD, said in a news release announcing the phase 1 trial.

"However, out of an abundance of caution, NIAID has continued its partnership with Moderna to evaluate this variant vaccine candidate should there be a need for an updated vaccine," Fauci said.

VUMC's participation in the phase 1 trial of the mRNA-1273.351 vaccine will involve healthy adults who have not previously been vaccinated against or infected by SARS-CoV-2, Creech said.

The volunteers will be randomly assigned to receive different combinations of Moderna vaccines made against the original and variant strains of SARS-CoV-2. The ability of each combination to trigger an immune response that can neutralize both strains will be assessed. Preliminary findings from the study are expected in May.

At this time, the research sites anticipate they will have an adequate number of volunteers for this study. For more information, visit clinicaltrials.gov and search for trial identifier NCT04785144.

Investigators from NIAID and Moderna co-developed the mRNA-1273 vaccine, currently one of three vaccines authorized by the U.S. Food and Drug Administration for emergency use for prevention of COVID-19 in adults 18 years old and older.

Creech led phase 3 testing at VUMC of the first Moderna vaccine and another COVID-19 vaccine developed by Janssen Biotech Inc., a pharmaceutical company of Johnson & Johnson. Last month the Johnson & Johnson vaccine became the third COVID-19 vaccine authorized for emergency use.

Creech is principal investigator of the NIH-funded Vanderbilt Vaccine and Treatment Evaluation Unit (VTEU), which as part of the IDCRC works to develop and test vaccine and other therapies to combat infectious diseases.

The mRNA-1273.351 vaccine trial at VUMC is funded in whole or in part by the NIAID, U.S. Department of Health and Human Services and VTEU Cooperative Agreement/Grant number UM1AI148452.