A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and in Children Who Are Respiratory Syncytial Virus (RSV)-Seropositive

Summary

The primary objectives of this study are to evaluate the tolerability and reactogenicity of a single injection of up to 5 dose levels of mRNA-1345 in younger adults, women of child-bearing potential, and older adults including Japanese older adults; of 3 injections of the middle dose level of mRNA-1345 given 56 days apart in younger adults; of a booster injection of mRNA-1345 given approximately 12 and 24 months after the primary injection in older adults; and of 3 injections of 1 of 2 dose levels of mRNA-1345 given 56 days apart in children who are RSV-seropositive.

Timeline

Start

2020-09-30

Primary completion

2024-07-18

Completion

2024-07-18

Publications

• Schnyder Ghamloush S, Fanning S, Essink B, Eder F, Snape MD, Stoszek SK, Guo R, Dhar R, Righi V, Morsy L, Kapoor A, El Asmar L, Shaw CA. Safety and immunogenicity of an mRNA-based RSV vaccine in seropositive children aged 12-59 months. Hum Vaccin Immunother. 2025 Dec;21(1):2557676. doi: 10.1080/21645515.2025.2557676. Epub 2025 Sep 15.
• Fitz-Patrick D, Mihara H, Mills A, Mithani R, Kapoor A, Dhar R, Wilson L, Guo R, Simorellis AK, Panozzo CA, Reuter C, Wilson E, Chen GL, Stoszek SK, Shaw CA, Goswami J. Safety and immunogenicity of an mRNA-based RSV vaccine in Japanese older adults aged >/=60 years: A phase 1, randomized, observer-blind, placebo-controlled trial. Respir Investig. 2024 Nov;62(6):1037-1043. doi: 10.1016/j.resinv.2024.08.011. Epub 2024 Sep 9.
• Shaw CA, Essink B, Harper C, Mithani R, Kapoor A, Dhar R, Wilson L, Guo R, Panozzo CA, Wilson E, Simorellis AK, Reuter C, Stoszek SK, Chen GL, Das R, Goswami J. Safety and Immunogenicity of an mRNA-Based RSV Vaccine Including a 12-Month Booster in a Phase 1 Clinical Trial in Healthy Older Adults. J Infect Dis. 2024 Sep 23;230(3):e647-e656. doi: 10.1093/infdis/jiae081.
• Shaw CA, Mithani R, Kapoor A, Dhar R, Wilson L, El Asmar L, Schnyder-Ghamloush S, Schaefers K, August A, Stoszek SK, Chen GL. Safety, Tolerability, and Immunogenicity of an mRNA-Based Respiratory Syncytial Virus Vaccine in Healthy Young Adults in a Phase 1 Clinical Trial. J Infect Dis. 2024 Sep 23;230(3):e637-e646. doi: 10.1093/infdis/jiae035.

Drugs

Indications