drugset / Trial / NCT06067230
A Study to Investigate the Immunogenicity and Safety of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in High-risk Adults
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The study is divided into 2 parts (Part A and Part B). Part A of the study will evaluate the safety and immune response to mRNA-1345 in high-risk adults aged ≥18 to \<60 years. Part B of the study will evaluate the safety and immune response to mRNA-1345 in adults who received solid organ transplant (SOT).
Timeline
- Start
- 2023-10-06
- Primary completion
- 2026-07-30
- Completion
- 2026-07-30
Outcome
Met primary endpoint
paper Day 29 nAb GMTs in the 50-µg group met noninferiority criteria: RSV-A GMT ratio (GMR), 1.2 (95% confidence interval [CI], 1.1-1.3); PMID 40464662 ↗
paper Noninferiority was also demonstrated for seroresponse rate differences: RSV-A, 11.8% (95% CI, 7.8-15.5); RSV-B, 10.8% (95% CI, 5.9-15.6). PMID 40464662 ↗
Publications
- Mayer EF, Falsey AR, Wolfe CR, Herc E, Burns F, Kabbani D, Kumar D, Mannan A, She F, Lan L, McGrath S, Kapoor A, Priddy F. Respiratory Syncytial Virus Vaccination in Solid Organ Transplant Recipients: Interim Findings From a Phase 3 Trial of mRNA-1345. Clin Infect Dis. 2026 May 20;82(5):e1112-e1121. doi: 10.1093/cid/ciag108.
- Mayer EF, Falsey AR, Clark R, Ferguson M, Cardona J, She F, Jones B, Reuter C, Collins A, Mannan A, Kapoor A, Slobod K, Stoszek SK, Du J, Mou J, Lan L, Zhou H, Wilson E, Goswami J, Das R, Priddy F. Safety, Tolerability, and Immunogenicity of mRNA-1345 in Adults at Increased Risk for Respiratory Syncytial Virus Disease Aged 18-59 Years. Clin Infect Dis. 2026 Feb 4;81(6):e708-e716. doi: 10.1093/cid/ciaf292.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mRNA-1345 | Messenger RNA (mRNA) | 30 ug | Intramuscular |
| Subject | mRNA-1345 | Messenger RNA (mRNA) | 50 ug | Intramuscular |