NCT07330440

A Phase I Study to Evaluate the Safety, Tolerability, and Immunogenicity of an mRNA Vaccine Against Herpes Simplex Virus Type 2 (HSV-2) Post-Vaccination

A Phase I, Dose-escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of an mRNA Vaccine Against Herpes Simplex Virus Type 2 (HSV-2) in Healthy Participants Aged 18-55 Years, Stratified by Serostatus

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Changchun BCHT Biotechnology Co. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Preliminary Evaluation of the Safety and Immunogenicity Post-Vaccination with Different Doses of an mRNA Vaccine against Herpes Simplex Virus Type 2 (HSV-2) in Populations with Different Serostatus

Conditions

• Genital Herpes

Interventions

Type	Name	Description
BIOLOGICAL	Low-Dose Cohort	Each human dose is 0.25 mL
BIOLOGICAL	Mid-Dose Cohort	Each human dose is 0.5 mL
BIOLOGICAL	High-Dose Cohort	Each human dose is 1.0 mL
BIOLOGICAL	Placebo Group	Each human dose: 0.25 mL, 0.5 mL, or 1.0 mL

Timeline

• Start date: 2025-10-13
• Primary completion: 2027-03-04
• Completion: 2027-06-01
• First posted: 2026-01-09
• Last updated: 2026-01-09

Locations

1 site across 1 country: China