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RECRUITING
NCT06932523
PHASE1/PHASE2

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

Sponsor: Shanghai Institute Of Biological Products

View on ClinicalTrials.gov

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).

Official title: Randomized, Blinded, Controlled Phase I/Ⅱ Clinical Trial Evaluating the Safety and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) for Healthy Individuals Aged 40 Years and Above

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

645

Start Date

2025-04-04

Completion Date

2027-12-31

Last Updated

2026-01-07

Healthy Volunteers

Yes

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

Locations (1)

Hubei Provincial Center for Disease Control and Prevention

Wuhan, Hubei, China