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ENROLLING BY INVITATION
NCT07330440
PHASE1

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

Sponsor: Changchun BCHT Biotechnology Co.

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2025-10-13

Completion Date

2027-06

Last Updated

2026-01-09

Healthy Volunteers

Yes

Conditions

Interventions

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

Locations (1)

Beijing Jishuitan Hospital

Beijing, China