A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥50 Years of Age
Summary
The main purposes of Part A of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with a seasonal influenza vaccine (Afluria® Quadrivalent); to evaluate the impact of coadministered influenza vaccine on the immune response to RSV-A; and to evaluate the impact of coadministered RSV vaccine on the immune response to influenza. The main purposes of Part B of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with mRNA-1273.214; to evaluate the effect of coadministered mRNA-1273.214 on the immune response to RSV-A; and to evaluate the effect of coadministered RSV vaccine on the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The main purposes of Part C (single arm, open-label) of this study are to evaluate the safety and tolerability of a booster dose (BD) of mRNA-1345 administered at 1 Year following a primary dose; to evaluate the immune response to RSV-A of a BD of mRNA 1345 administered at 1 Year following a primary dose; and to evaluate the immune response to RSV-B of a BD of mRNA-1345 administered at 1 Year following a primary dose.
Timeline
- Start
- 2022-04-01
- Primary completion
- 2024-11-08
- Completion
- 2024-11-08
Outcome
Mixed primary results
paper Non-inferiority was declared when the lower bound of the 95% CI for GMRs was greater than 0·667 and for seroresponse rate differences was greater than -10%. PMID 39608389 ↗
paper GMR of nAbs against RSV-A in the mRNA-1345 plus SIIV4 group versus the mRNA-1345 alone group was 0·81 (95% CI 0·67 to 0·97) PMID 39608389 ↗
paper seroresponse rate difference in nAbs against RSV-A between the groups was -11·2% (95% CI -17·9 to -4·1). PMID 39608389 ↗
paper only the seroresponse rate difference in nAbs against RSV-A in part A did not meet the non-inferiority criterion. PMID 39608389 ↗
Publications
- Goswami J, Cardona JF, Caso J, Hsu DC, Simorellis AK, Wilson L, Dhar R, Wang X, Kapoor A, Collins A, Righi V, Lan L, Du J, Zhou H, Stoszek SK, Shaw CA, Reuter C, Wilson E, Das R. Safety, Tolerability, and Immunogenicity of Revaccination With mRNA-1345, an mRNA Vaccine Against Respiratory Syncytial Virus, Administered 12 Months Following a Primary Dose in Adults Aged >/=50 Years. Clin Infect Dis. 2026 Apr 30;82(4):e855-e862. doi: 10.1093/cid/ciaf515.
- Goswami J, Cardona JF, Hsu DC, Simorellis AK, Wilson L, Dhar R, Tomassini JE, Wang X, Kapoor A, Collins A, Righi V, Lan L, Du J, Zhou H, Stoszek SK, Shaw CA, Reuter C, Wilson E, Miller JM, Das R; study investigators. Safety and immunogenicity of mRNA-1345 RSV vaccine coadministered with an influenza or COVID-19 vaccine in adults aged 50 years or older: an observer-blinded, placebo-controlled, randomised, phase 3 trial. Lancet Infect Dis. 2025 Apr;25(4):411-423. doi: 10.1016/S1473-3099(24)00589-9. Epub 2024 Nov 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Afluria® Quadrivalent | Vaccine | 60 ug | Intramuscular |
| Subject | mRNA-1273.214 | Messenger RNA (mRNA) | 50 ug | Intramuscular |
| Subject | mRNA-1345 | Messenger RNA (mRNA) | 50 ug | Intramuscular |