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
NCT07330440 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144
Last updated 2026-01-09
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
- 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
- BIOLOGICAL
-
Low-Dose Cohort
Each human dose is 0.25 mL
- BIOLOGICAL
-
Mid-Dose Cohort
Each human dose is 0.5 mL
Sponsors & Collaborators
-
Changchun BCHT Biotechnology Co.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-10-13
- Primary Completion
- 2027-03-04
- Completion
- 2027-06-30
Countries
- China
Study Locations
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