Dosing officially began last week in a Phase 2 trial of Moderna’s COVID-19 Omicron variant-specific, bivalent booster vaccine candidate.
Known currently as mRNA-1273.214, the candidate combines another Omicron booster candidate with Moderna’s official COVID-19 vaccine, mRNA-1273.
“We are pleased to begin this study of our bivalent booster candidate that includes our Omicron-specific candidate and the Moderna COVID-19 vaccine,” Stéphane Bancel, CEO of Moderna, said. “Our mRNA platform allows us to pivot with speed and flexibility to create a bespoke vaccine to target new variants as they arise. Our goal has been to remain ahead of the virus, and we are committed to generating and sharing data with public health authorities as they prepare for the fall booster season.”
Approximately 374 U.S. participants are expected to be enrolled in the trial at about 20 sites. All participants will be at least 18 years old and must have previously received the two-dose primary series of mRNA-1273, along with a 50 µg booster dose at least three months before beginning the trial. All will be evaluated for immunogenicity, safety, and reactogenicity of mRNA-1273.214 as a single booster dose.
Separately, the other booster rolled into this vaccine candidate is being concurrently evaluated in a Phase 2 U.S. study and a Phase 3 U.K. study in collaboration with the National Institute for Health Research.