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Clinical Trial
. 2025 May;31(5):1484-1493.
doi: 10.1038/s41591-025-03591-0. Epub 2025 Mar 18.

mRNA-based seasonal influenza and SARS-CoV-2 multicomponent vaccine in healthy adults: a phase 1/2 trial

Amanda K Rudman Spergel  1 , Jintanat Ananworanich  1 , Ruiting Guo  1 , Weiping Deng  1 , Lizbeth Carmona  2 , Kristin Schaefers  1 , Yamuna D Paila  1 , Boris Kandinov  1 , Charles H Eger  3 , Melissa Sinkiewicz  1 , Sarah Shao  1 , Carole Henry  1 , Christine A Shaw  4
Affiliations
Clinical Trial

mRNA-based seasonal influenza and SARS-CoV-2 multicomponent vaccine in healthy adults: a phase 1/2 trial

Amanda K Rudman Spergel et al. Nat Med. 2025 May.

Abstract

A multicomponent vaccine targeting several seasonal respiratory pathogens may provide simultaneous protection in a single-injection regimen. We present interim (28 days) findings from a phase 1/2 study of an mRNA-based multicomponent vaccine (mRNA-1083), encoding seasonal influenza and SARS-CoV-2 antigens. Adults (18-79 years) were randomly assigned to receive different compositions of mRNA-1083 at varying dose levels on day 1. The primary study objectives were reactogenicity through 7 days and safety through 28 days postvaccination, and the secondary study objective was immunogenicity against vaccine-matched influenza and SARS-CoV-2 strains at day 29 assessed by hemagglutination inhibition and pseudovirus neutralization assays, respectively. The multicomponent mRNA-1083 vaccine was generally well-tolerated, with most solicited adverse reactions being Grade 1 or 2 in severity. The incidence of unsolicited adverse events was similar across vaccine groups. mRNA-1083 induced immune responses against influenza and SARS-CoV-2 that were, in general, similar to or higher than those achieved with licensed quadrivalent influenza (standard or high dose) and SARS-CoV-2 (bivalent mRNA-1273) vaccines. These data support ongoing phase 3 evaluation of the mRNA-1083 vaccine. ClinicalTrials.gov registration: NCT05827926 .

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Conflict of interest statement

Competing interests: A.K.R.S., J.A., R.G., W.D., L.C., K.S., Y.D.P., B.K., M.S., S.S., C.H. and C.A.S. are employees of Moderna, Inc., and may hold stock/stock options in the company. The remaining author declares no competing interests.

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