NCT06954818

Safety and Immunogenicity of SYS6017 in Healthy Participants Aged 40 Years or More

A Randomized, Observer-blind, Placebo-controlled, Adaptive Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of SYS6017(a Zoster mRNA Vaccine) in Healthy Participants Aged 40 Years or More

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

Herpes zoster is caused by the reactivation of latent varicella-zoster virus (VZV) which stays in latency after its primary infection. Immunosenescence contributes significantly to elevating morbidity associated with aging. Vaccination plays a key role in reducing the disease burden of zoster and the associated complications. This randomized, observer-blind, placebo-controlled, adaptive phase 1 trial aims to evaluate the safety and immunogenicity of an investigational zoster mRNA vaccine in healthy participants aged 40 years or more.

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
BIOLOGICAL	A zoster mRNA vaccine SYS6017	SYS6017 is an investigational lipid nanoparticle (LNP)-coated mRNA vaccine encoding the glycoprotein E (gE) of VZV, and indicated for active immunization for the prevention of zoster caused by the reactivation of latent VZV.
OTHER	Placebo	saline solution

Timeline

• Start date: 2025-05-10
• Primary completion: 2025-12-10
• Completion: 2026-11-10
• First posted: 2025-05-02
• Last updated: 2025-05-08