A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age
Summary
The main purpose of this study is to evaluate the efficacy of mRNA 1647 vaccine in CMV-seronegative female participants and to evaluate the safety and reactogenicity of mRNA-1647 vaccine in all participants. The purpose of the Phase 3 extension substudy is to extend the observation period of the main study and to assess the longer-term immunogenicity, efficacy, and safety of the mRNA-1647 vaccine against primary CMV infection in healthy females who were CMV-seronegative at Baseline of the mRNA-1647-P301 main study (including participants who remain CMV-seronegative upon entry into the extension substudy and participants who seroconverted during the main study). The extension substudy will also evaluate the immune persistence and safety of mRNA-1647 in a subset of female participants who were CMV-seropositive at Baseline of the main study. No interventional vaccine will be administered in the extension substudy.
Timeline
- Start
- 2021-10-26
- Primary completion
- 2025-11-04
- Completion
- 2025-11-04
Outcome
Missed primary endpoint
Stopped: “The Sponsor decided to terminate the study after it did not meet the primary efficacy endpoint at final analysis. The safety profile was consistent with prior studies, and no safety concerns were raised by the Data and Safety Monitoring Board.”
release “mRNA-1647, the Company's investigational cytomegalovirus (CMV) vaccine. The study did not meet its primary efficacy endpoint” q4web.com ↗
Publications
- Galiza EP, Khalil A, Heath PT. Update on Vaccines in Antenatal Care. Pediatr Infect Dis J. 2024 Feb 1;43(2):e60-e62. doi: 10.1097/INF.0000000000004183. Epub 2023 Dec 27. No abstract available.
- Stewart AG, Kotton CN. What's New: Updates on Cytomegalovirus in Solid Organ Transplantation. Transplantation. 2024 Apr 1;108(4):884-897. doi: 10.1097/TP.0000000000004855. Epub 2023 Oct 30.
- Kadambari S, Evans C, Lyall H. Congenital Infections: Priorities and Possibilities for Resource-limited Settings. Pediatr Infect Dis J. 2023 Feb 1;42(2):e45-e47. doi: 10.1097/INF.0000000000003710. Epub 2022 Sep 12. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mRNA-1647 | Messenger RNA (mRNA) | — | Intramuscular |