NCT06033261

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 1/2, Randomized, Observer-Blind, Controlled, Dose-Ranging Study of mRNA-1608, an HSV-2 Therapeutic Candidate Vaccine, in Healthy Adults 18 to 55 Years of Age With Recurrent HSV-2 Genital Herpes

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 365 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

Participants with a history of recurrent genital herpes will be randomly assigned in a 1:1:1:1 ratio to receive mRNA-1608 at 1 of the 3 dose levels or control (BEXSERO) administered as 2 doses at 0 and 2 months (Day 1 and Day 57).

Conditions

• Genital Herpes

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-1608	Sterile liquid for injection
BIOLOGICAL	BEXSERO	A vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B.

Timeline

• Start date: 2023-09-06
• Primary completion: 2025-04-25
• Completion: 2025-04-25
• First posted: 2023-09-13
• Last updated: 2025-05-08

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study