drugset / Trial / NCT06932523

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

NCT06932523

Phase 1/2 Recruiting 645 enrolled Shanghai Institute Of Biological Products
RandomizedParallel-groupQuadruple-blindPrevention

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).

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Recombinant herpes zoster vaccine with high-dose adjuvant Vaccine Intramuscular
Subject Recombinant herpes zoster vaccine with low-dose adjuvant Vaccine Intramuscular
Comparator VARICELLA ZOSTER VIRUS ENVELOPE GLYCOPROTEIN E Vaccine Intramuscular

Indications