Clinical trial evaluating Moderna’s variant vaccine begins

April 1, 2021

An investigational vaccine designed to protect against the B.1.351 SARS-CoV-2 variant has been administered as part of a new Phase 1 clinical trial evaluating the vaccine candidate's safety and immunogenicity in adult volunteers, according to a news release from the National Institutes of Health (NIH).

The vaccine, known as mRNA-1273.351, was developed by the biotechnology company Moderna. The trial is led and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH.

The trial will enroll approximately 210 healthy adult volunteers at four clinical research sites in the United States that are part of the NIAID-funded Infectious Diseases Clinical Research Consortium (IDCRC).

"The B.1.351 SARS-CoV-2 variant, first identified in the Republic of South Africa, has been detected in at least nine states in the United States," said NIAID Director Anthony S. Fauci, MD. "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. 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."

Investigators from NIAID and Moderna co-developed the mRNA-1273 vaccine, which is currently authorized by the U.S. Food and Drug Administration (FDA) for emergency use in the United States for the prevention of COVID-19 in adults 18 years of age and older. The vaccine is administered as two 100-microgram (mcg) doses 28 days apart.

The trial will enroll people ages 18 years and older who already have received the mRNA-1273 vaccine, as well as people ages 18 through 55 years who have not received any COVID-19 vaccine. Approximately 60 volunteers who previously received mRNA-1273 as a participant in NIAID's Phase 1 trial of mRNA-1273 (which began in March 2020) will enroll in the new variant Phase 1 trial. Approximately one year ago, these volunteers received two vaccinations of mRNA-1273 28 days apart at varying doses: 50 mcg, 100 mcg or 250 mcg.

The Phase 1 variant vaccine trial also will enroll approximately 150 volunteers ages 18 through 55 years who have not received any COVID-19 vaccine, have no known history of COVID-19 or SARS-CoV-2 infection, and do not have health conditions that are associated with an increased risk of severe illness from SARS-CoV-2 infection, such as cancer, heart conditions, type 2 diabetes mellitus, severe obesity or chronic kidney disease.

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