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

Completed Phase 1, PHASE2 Last updated 8 May 2025

What this trial tests

Phase 1, PHASE2 trial testing mRNA-1608 in Genital Herpes in 365 participants. Completed in 25 April 2025.

Timeline

6 September 2023

Primary endpoint
25 April 2025

25 April 2025

Quick facts

Lead sponsor	ModernaTX, Inc.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	365
Start date	6 September 2023
Primary completion	25 April 2025
Estimated completion	25 April 2025
Sites	23 locations across United States

Drugs / interventions tested

• mRNA-1608 — full drug profile →
• BEXSERO — full drug profile →

Conditions studied

• Genital Herpes — all drugs for Genital Herpes →

Sponsor

ModernaTX, Inc. — full company profile →

Who can join

Adults 18 to 55, any sex, with Genital Herpes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. mRNA vaccines for infectious diseases - advances, challenges and opportunities.
   Pardi N, Krammer F. · · 2024 · cited 111× · PMID 39367276 · DOI 10.1038/s41573-024-01042-y
2. A review of HSV pathogenesis, vaccine development, and advanced applications.
   Bai L, Xu J, Zeng L, Zhang L, et al · · 2024 · cited 30× · PMID 39207577 · DOI 10.1186/s43556-024-00199-7
3. Clinical development of therapeutic mRNA applications.
   Żak MM, Zangi L. · · 2025 · cited 28× · PMID 40143545 · DOI 10.1016/j.ymthe.2025.03.034
4. Therapeutic vaccines for herpesviruses.
   Cohen JI. · · 2024 · cited 24× · PMID 38690731 · DOI 10.1172/jci179483
5. Toward the Eradication of Herpes Simplex Virus: Vaccination and Beyond.
   Chang JY, Balch C, Oh HS. · · 2024 · cited 12× · PMID 39339952 · DOI 10.3390/v16091476
6. Current development of therapeutic vaccines for the treatment of chronic infectious diseases.
   Park PG, Fatima M, An T, Moon YE, et al · · 2024 · cited 5× · PMID 38362373 · DOI 10.7774/cevr.2024.13.1.21
7. Tackling cutaneous herpes simplex virus disease with topical immunomodulators-a call to action.
   Duarte LF, Carbone-Schellman J, Bueno SM, Kalergis AM, et al · · 2025 · cited 4× · PMID 39982077 · DOI 10.1128/cmr.00147-24
8. The Path Towards Effective Long-Lasting Tissue-Targeted Prime/Pull/Keep Herpes Simplex Therapeutic Vaccines.
   Quadiri A, Lekbach Y, Elfatimi E, Prakash S, et al · · 2025 · cited 2× · PMID 41012114 · DOI 10.3390/vaccines13090908