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RecruitingPhase 1Phase 2NCT06932523

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

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

Sponsor

Shanghai Institute Of Biological Products

Enrollment

645 participants

Start Date

Apr 4, 2025

Study Type

INTERVENTIONAL

Conditions

Herpes Zoster (HZ)

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).

Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called High-dose adjuvant, a biological treatment called Low-dose adjuvant, and others for people with herpes zoster (hz). The study is currently recruiting participants at 1 location. People eligible for this study include aged 40 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALRecombinant herpes zoster vaccine with low-dose adjuvant

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

BIOLOGICALRecombinant herpes zoster vaccine with high-dose adjuvant

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

BIOLOGICALLow-dose adjuvant

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

BIOLOGICALHigh-dose adjuvant

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

BIOLOGICALShingrix (GSK)

Positive control, Intramuscular injection, 0, 2 months schedule

BIOLOGICALNormal Saline

Placebo control, Intramuscular injection, 0, 2 months schedule

Locations(1)

Hubei Provincial Center for Disease Control and Prevention

Wuhan, Hubei, China

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NCT06932523

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