A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults

Summary

The study is divided into 2 parts: Part 1 and Part 2. The purpose of Part 1 of this study is to generate sufficient safety, reactogenicity, and immunogenicity data to enable selection of an mRNA-1083 vaccine composition and dose level to evaluate in a subsequent Phase 3 clinical trial in adults. The purpose of Part 2 of this study is to generate safety and immunogenicity data for additional mRNA-1083 compositions and dose levels in young adults ≥18 years and \<50 years of age.

Timeline

Start

2023-04-14

Primary completion

2024-12-03

Completion

2024-12-03

Publications

• Rudman Spergel AK, Ananworanich J, Guo R, Deng W, Carmona L, Schaefers K, Paila YD, Kandinov B, Eger CH, Sinkiewicz M, Shao S, Henry C, Shaw CA. mRNA-based seasonal influenza and SARS-CoV-2 multicomponent vaccine in healthy adults: a phase 1/2 trial. Nat Med. 2025 May;31(5):1484-1493. doi: 10.1038/s41591-025-03591-0. Epub 2025 Mar 18.

Drugs

Indications