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NOT YET RECRUITING
NCT07892989
PHASE1/PHASE2

Immunogenicity and Safety of SYS6052 in the Participants Aged 40 Years and Above

Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

View on ClinicalTrials.gov

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, Controlled, Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of SYS6052 (Recombinant Herpes Zoster Vaccine (CHO Cell)) Administered to Participants Aged 40 Years and Above".

Official title: A Randomized, Blinded, Controlled, Phase 1/2 Clinical Trial to Evaluate the Safety and Immunogenicity of SYS6052 (Recombinant Herpes Zoster Vaccine (CHO Cell)) Administered to Participants Aged 40 Years and Above

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

496

Start Date

2026-10-31

Completion Date

2028-06-30

Last Updated

2026-10-23

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

Recombinant Zoster Vaccine (CHO cell) SYS6052

SYS6052 is a recombinant herpes zoster vaccine (CHO cell) developed by CSPC Megalith Biopharmaceutical Co., Ltd . Its active ingredient is the VZV glycoprotein E (gE) recombinantly expressed in CHO cells, and it is intended for clinical use in the prevention of herpes zoster.

BIOLOGICAL

Placebo: 0.9% sodium chloride injection

Placebo: 0.9% sodium chloride injection

BIOLOGICAL

Active Comparator Vaccine

Active Comparator Vaccine