NCT06375512

A Study to Describe the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants

A Phase 1, Randomized, Multicenter, Double-blind, Dose-ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants 50 to 69 Years Old

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Shenzhen Shenxin Biotechnology Co., Ltd · Industry
• Sex: All
• Age: 50 Years – 69 Years
• Healthy volunteers: Accepted

Summary

The study will evaluate the safety, tolerability, and immunogenicity (your immune system's reaction) of the study vaccine called Herpes Zoster IN001 mRNA Vaccine (IN001) in healthy participants who are between 50 and 69 years of age

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
BIOLOGICAL	HZ Vaccine (IN001)	Formulation for injection
BIOLOGICAL	Placebo	0.9% sodium chloride (normal saline) for injection
BIOLOGICAL	Shingrix	Sterile suspension for injection

Timeline

• Start date: 2024-07-05
• Primary completion: 2026-02-20
• Completion: 2026-02-20
• First posted: 2024-04-19
• Last updated: 2026-03-31

Locations

3 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study