NCT06932523

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 645 (estimated)
• Sponsor: Shanghai Institute Of Biological Products · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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).

Detailed description

There are two parts of the study. Substudy A: This substudy is the Phase I portion of the study. In this substudy, participants will receive 1 of 2 RHZV candidates (different dose levels) or the approved shingles vaccine (positive control) or adjuvant controls or normal saline intramuscularly. Participants will be divided into 2 age groups: 40-49 years old and ≥ 50 years old. Participants will receive vaccinations on days 0 and 60. Participants will complete a 12-month safety follow-up after two doses of vaccination, and they will take part in this study for about 14 months. Substudy B: This substudy is the Phase Ⅱ portion of the study. In this part of the study, participants will also receive 1 of 2 RHZV candidates (different dose levels) or the approved shingles vaccine (positive control) or normal saline intramuscularly. Participants will be divided into 3 age groups: 40-49 years old, 50-69 years old and ≥ 70 years old. Participants will receive vaccinations on days 0 and 60. Some group(s) will continue into persistence-of-immunity (overtime assessment of effect of vaccine) portion of the study. Those participants will be involved in this study for up to 2 years.

Conditions

• Herpes Zoster (HZ)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-04-04
• Primary completion: 2026-06-30
• Completion: 2027-12-31
• First posted: 2025-04-17
• Last updated: 2026-01-07

Locations

1 site across 1 country: China