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A Study to Evaluate the Safety of Recombinant Herpes Zoster Vaccine for Healthy Individuals

NCT06932523 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 645

Last updated 2026-01-07

No results posted yet for this study

Summary

The purpose of this clinical study is to evaluate the safety and immunogenicity of receiving two doses of recombinant herpes zoster vaccine (CHO cells) (RHZV) in healthy individuals aged 40 years and above. This study will be conducted in 2 substudies: Substudy A (Phase I) and Substudy B (Phase Ⅱ).

Conditions

  • Herpes Zoster (HZ)

Interventions

BIOLOGICAL

Recombinant herpes zoster vaccine with low-dose adjuvant

Candidate 1, Dose Level 1, Intramuscular injection, 0, 2 months schedule

BIOLOGICAL

Recombinant herpes zoster vaccine with high-dose adjuvant

Candidate 2, Dose Level 2, Intramuscular injection, 0, 2 months schedule

BIOLOGICAL

Low-dose adjuvant

Adjuvant control 1, Dose Level 1, Intramuscular injection, 0, 2 months schedule

BIOLOGICAL

High-dose adjuvant

Adjuvant control 2, Dose Level 2, Intramuscular injection, 0, 2 months schedule

BIOLOGICAL

Shingrix (GSK)

Positive control, Intramuscular injection, 0, 2 months schedule

BIOLOGICAL

Normal Saline

Placebo control, Intramuscular injection, 0, 2 months schedule

Sponsors & Collaborators

  • Shanghai Institute Of Biological Products

    lead INDUSTRY

Principal Investigators

  • Yeqing Tong · Hubei Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-04
Primary Completion
2026-06-30
Completion
2027-12-31

Countries

  • China

Study Locations

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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 NCT06932523 on ClinicalTrials.gov