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

NCT06954818 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-05-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • CSPC Megalith Biopharmaceutical Co.,Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-10
Primary Completion
2025-12-10
Completion
2026-11-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06954818 on ClinicalTrials.gov