A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age
Summary
The main purpose of Part A of this study is to evaluate the safety and tolerability of mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo from 14 days postinjection through 12 months. The main purpose of Part B of this study is to evaluate the safety, tolerability and immunogenicity of a booster dose (BD) of mRNA-1345 administered 24 months after the primary dose.
Timeline
- Start
- 2021-11-17
- Primary completion
- 2025-07-28
- Completion
- 2025-07-28
Outcome
Met primary endpoint
paper Vaccine efficacy was 83.7% (95.88% confidence interval [CI], 66.0 to 92.2) against RSV-associated lower respiratory tract disease with at least two signs or symptoms PMID 38091530 ↗
paper and 82.4% (96.36% CI, 34.8 to 95.3) against the disease with at least three signs or symptoms. PMID 38091530 ↗
Publications
- Desai M, Jimenez G, Wijewardane P, Lan L, Wilson L, Mehta S, Priddy F. Safety, Tolerability, and Immunogenicity of Revaccination With mRNA-1345 RSV Vaccine Administered 24 Months Following a Primary Dose in Adults >/=60 Years of Age. J Infect Dis. 2026 Jul 9:jiag350. doi: 10.1093/infdis/jiag350. Online ahead of print.
- Goswami J, Baqui AH, Doreski PA, Perez Marc G, Jimenez G, Ahmed S, Zaman K, Duncan CJA, Ujiie M, Ramet M, Perez-Breva L, Lan L, Du J, Kapoor A, Mehta S, Tomassini JE, Huang W, Zhou H, Stoszek SK, Priddy F, Lin N, Le Cam N, Shaw CA, Slobod K, Wilson E, Miller JM, Das R. Humoral Immunogenicity of mRNA-1345 RSV Vaccine in Older Adults. J Infect Dis. 2024 Nov 15;230(5):e996-e1006. doi: 10.1093/infdis/jiae316.
- Wilson E, Goswami J, Baqui AH, Doreski PA, Perez-Marc G, Zaman K, Monroy J, Duncan CJA, Ujiie M, Ramet M, Perez-Breva L, Falsey AR, Walsh EE, Dhar R, Wilson L, Du J, Ghaswalla P, Kapoor A, Lan L, Mehta S, Mithani R, Panozzo CA, Simorellis AK, Kuter BJ, Schodel F, Huang W, Reuter C, Slobod K, Stoszek SK, Shaw CA, Miller JM, Das R, Chen GL; ConquerRSV Study Group. Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults. N Engl J Med. 2023 Dec 14;389(24):2233-2244. doi: 10.1056/NEJMoa2307079.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mRNA-1345 | Messenger RNA (mRNA) | 50 ug | — |