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NCT06033261 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by ModernaTX.
- Completed
- Registry status
- Phase 1
- Development phase
- 303
- Enrollment target
NCT06033261: Completed Phase 1 study, sponsored by ModernaTX.
NCT06033261 is a Phase 1 study that has completed, run by ModernaTX. The registered enrollment target is 303 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (405% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06033261, a Phase 1 study, has completed, sponsored by ModernaTX.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 303 participants
- Enrollment target
Study 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.
Primary Outcome
Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs)
Interventions
- BIOLOGICAL mRNA-1608
- BIOLOGICAL BEXSERO
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 303 participants |
| Start Date | 2023-09-06 |
| Est. Completion | 2025-04-25 |
| Phase | Phase 1 |
What the finished NCT06033261 record still lists
NCT06033261 is an interventional study that assigns participants to a tested intervention. The registered 303 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (405% higher).
The record links to 0 conditions, and to 2 interventions - of which mRNA-1608 is the first listed.
NCT06033261 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06033261 about?
NCT06033261 is a clinical study titled "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". 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.
What is the current status of trial NCT06033261?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 303 participants. The study started on 2023-09-06. Estimated completion is 2025-04-25.
What interventions are being tested in trial NCT06033261?
The interventions under investigation include: mRNA-1608 (BIOLOGICAL), BEXSERO (BIOLOGICAL).
Who is sponsoring clinical trial NCT06033261?
This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06033261's enrollment target sits among peer trials
303 124th of 2000 higher than 1,877 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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