drugset / Trial / NCT05397223
A Study of Modified mRNA Vaccines in Healthy Adults
RandomizedParallel-groupOpen-labelPrevention
Summary
The main goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of study vaccines.
Timeline
- Start
- 2022-05-24
- Primary completion
- 2026-02-27
- Completion
- 2026-02-27
Publications
- Henry C, Makrinos D, Liu R, Cavallaro M, Fenderson B, Sun Y, Chang X, Astley E, Girard B, Yu WH, Oostendorp J, DiPiazza A, Paris R. An mRNA influenza vaccine induces immunity comparable to an adjuvanted vaccine in a randomized trial. NPJ Vaccines. 2026 Jan 14;11(1):50. doi: 10.1038/s41541-026-01370-7.
- Kaplonek P, Vargas R, Lee JS, Bertera H, Astley E, Girard B, Oostendorp J, Henry C, Paris R, Yu WH, Alter G. mRNA-1010 influenza vaccine elicits distinct and enhanced humoral immunity compared to adjuvanted inactivated vaccines. NPJ Vaccines. 2025 Dec 15;11(1):19. doi: 10.1038/s41541-025-01340-5.
- Fierro C, Sanchez-Crespo N, Makrinos D, Zhang W, Sun Y, Rohilla P, Girard B, Adeniji A, DiPiazza A, Paris R. Shared clinical and immunologic features of mRNA vaccines: preliminary results from a comparative clinical study. Front Immunol. 2025 Apr 10;16:1501275. doi: 10.3389/fimmu.2025.1501275. eCollection 2025.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elasomeran | Messenger RNA (mRNA) | — | Intramuscular |
| Comparator | Fluad | Vaccine | — | Intramuscular |
| Subject | Quadrivalent influenza vaccine | Vaccine | — | — |
| Subject | mRNA-1345 | Messenger RNA (mRNA) | — | Intramuscular |
| Subject | mRNA-1647 | Messenger RNA (mRNA) | — | Intramuscular |