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
← catalyst calendarSponsored by ModernaTX, Inc. (industry) · MRNA — their whole pipeline →.
Phase
Phase 1/2
Status
Completed
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
303actual
Sites
23
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-09-06 | actual | When the study began enrolling |
| Primary completion | 2025-04-25 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-04-25 | actual | The whole study's end, after follow-up |
| First posted | 2023-09-13 | actual | When this record first appeared on the registry |
| Results posted | 2026-05-08 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-05-08 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Genital Herpes
Interventions
- Biological: mRNA-1608
- Biological: BEXSERO
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants With Solicited Local and Systemic ARs
measured Up to Day 64 (Within 7 days after study vaccination)
Number of Participants With Unsolicited Adverse Events (AEs)
measured Up to Day 85 (Up to 28 days after study vaccination)
Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Study Discontinuation
measured Day 1 through Day 393
Number of Participants With Medically Attended AEs (MAAEs)
measured Day 1 through Day 393
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2023-08-16 · 1.4 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-09-04 · 2.0 MB · SAP_001.pdf
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