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

No results posted yet for this study

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07330440 on ClinicalTrials.gov