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Immunogenicity and Safety of SYS6017 in the Participants Aged 40 Years and Above

NCT07354659 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2026-01-21

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. We are conducting a study entitled "A Randomized, Blinded, Placebo- and Active-Controlled, Adaptive Phase 2 Clinical Trial to Evaluate the Immunogenicity and Safety of SYS6017 (a Herpes Zoster mRNA Vaccine) in Healthy Participants Aged 40 Years and Above".

Conditions

  • Herpes Zoster

Interventions

BIOLOGICAL

A zoster mRNA vaccine SYS6017

SYS6017，two-dose vaccination schedule (Month 0, 2)

OTHER

Placebo

0.9% saline，two-dose vaccination schedule (Month 0, 2)

BIOLOGICAL

Active Comparator Vaccine

Recombinant Zoster Vaccine (CHO cell)，two-dose vaccination schedule (Month 0, 2)

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
2026-01-10
Primary Completion
2027-03-10
Completion
2027-05-31

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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 NCT07354659 on ClinicalTrials.gov