NCT06447779

Efficacy, Safety and Immunogenicity Study of Recombinant Zoster Vaccine(CHO Cell) in Adults Aged 40 Years and Older

A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Phase III Clinical Trial to Evaluate Efficacy, Safety and Immunogenicity of Recombinant Zoster Vaccine (CHO Cell) in Adults Aged 40 Years and Above

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25,000 (estimated)
• Sponsor: MAXVAX Biotechnology Limited Liability Company · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of the sutdy is to evaluate efficacy, safety and immunogenicity of Recombinant Zoster Vaccine (CHO Cell) with 2 doses at 2-month interval in adults aged 40 years and older.

Detailed description

A total of 25000 adults aged 40 years and older will be enrolled, stratified into 40-49, 50-59, 60-69 and ≥70 years of age. All subjects will randomly receive investigational vaccine or placebo at a ratio of 1:1. Efficacy and safety will be assessed in all subjects, while immunogenicity will be assessed in a subset of 1250 subjests in a selected trial site.

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Zoster Vaccine (CHO Cell)	0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with MA105. Intramuscular injection
BIOLOGICAL	NaCl solution Placebo	0.5 mL per dose, containing 4.5 mg sodium chloride. Intramuscular injection

Timeline

• Start date: 2024-07-13
• Primary completion: 2025-09-01
• Completion: 2027-09-01
• First posted: 2024-06-07
• Last updated: 2024-10-24

Locations

4 sites across 1 country: China