NCT07400003

Study to Evaluate the Safety and Immunogenicity of a Lyophilized Herpes Zoster Virus mRNA Vaccine

A Randomized, Double-Blind, Controlled Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of Different Doses of a Lyophilized Herpes Zoster Virus mRNA Vaccine in Adults Aged 40 Years and Older

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 519 (estimated)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

This clinical trial included two parts, Part A and Part B. The goal of Part A is to evaluate the safety and preliminary immunogenicity of the lyophilized herpes zoster virus mRNA vaccine (HZ mRNA vaccine) in healthy populations aged 40 years and older. The goal of Part B is to select the optimal dosage and schedule in healthy populations aged 50 years and older to support next further study.

Detailed description

This is a randomized, double-blind, controlled study. Part A employed sequential enrollment by age and dosage. All participants received two doses of the study vaccine. Safety observation conducted throughout the study. Humoral and celluar immunity were evaluated. In Part B, participants randomly received either different dosage study vaccine or active controlled vaccine, with different immunization schedule. Safety observation conducted throughout the study. Humoral and celluar immunity were evaluated. Immune persistence was also evaluated at multiple timepoints after vaccination.

Conditions

• Herpes Zoster
• mRNA Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Low-dose experimental vaccine	Lyophilized herpes zoster virus mRNA vaccine
BIOLOGICAL	High-dose experimental vaccine	Lyophilized herpes zoster virus mRNA vaccine
BIOLOGICAL	Active-controlled vaccine A	herpes zoster attenuated live vaccine, lyophilized
BIOLOGICAL	Active-controlled vaccine B	Shingrix®
OTHER	Placebo group	Saline

Timeline

• Start date: 2026-01-06
• Primary completion: 2026-05-31
• Completion: 2027-04-30
• First posted: 2026-02-10
• Last updated: 2026-02-10

Locations

1 site across 1 country: China