NCT07354659

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

A Randomized, Blinded, Placebo- and Active-Controlled, Adaptive Phase 2 Study to Evaluate the Immunogenicity and Safety of SYS6017 (a Herpes Zoster mRNA Vaccine) in Healthy Participants Aged 40 Years and Above

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 800 (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. 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

Type	Name	Description
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)

Timeline

• Start date: 2026-01-10
• Primary completion: 2027-03-10
• Completion: 2027-05-31
• First posted: 2026-01-21
• Last updated: 2026-01-21