A Study of mRNA-1608, a Herpes Simplex Virus -2 (HSV-2) Therapeutic Candidate Vaccine, in Healthy Adults 18 to 55 Years of Age With Recurrent HSV-2 Genital Herpes
Phase 1/2
Completed
NCT06033261
| Condition | Genital Herpes |
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| Phase | Phase 1/2 |
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| Sponsor | ModernaTX, Inc. |
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| Status | Completed |
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| Enrollment | 303 participants |
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| Interventions | mRNA-1608, BEXSERO |
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| Start date | Sep 6, 2023 |
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| Completion date | Apr 25, 2025 |
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| Results posted | May 8, 2026 |
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Summary
The purpose of this study is to generate safety and immunogenicity data and establish a proof-of-concept of clinical benefit of the mRNA-1608 vaccine candidate.
Number of Participants With Solicited Local and Systemic ARs
Up to Day 64 (Within 7 days after study vaccination) · Participants
| BEXSERO | 74 Participants |
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| mRNA-1608 Dose Level 1 | 75 Participants |
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| mRNA-1608 Dose Level 2 | 75 Participants |
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| mRNA-1608 Dose Level 3 | 74 Participants |
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Number of Participants With Unsolicited Adverse Events (AEs)
Up to Day 85 (Up to 28 days after study vaccination) · Participants
| BEXSERO | 22 Participants |
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| mRNA-1608 Dose Level 1 | 18 Participants |
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| mRNA-1608 Dose Level 2 | 18 Participants |
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| mRNA-1608 Dose Level 3 | 21 Participants |
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Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Study Discontinuation
Day 1 through Day 393 · Participants
| BEXSERO | 0 Participants |
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| mRNA-1608 Dose Level 1 | 2 Participants |
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| mRNA-1608 Dose Level 2 | 2 Participants |
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| mRNA-1608 Dose Level 3 | 2 Participants |
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| BEXSERO | 0 Participants |
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| mRNA-1608 Dose Level 1 | 0 Participants |
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Open in BENITIONS
View on ClinicalTrials.gov
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