A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Recombinant Herpes Zoster Vaccine

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

540

Participants

Timeline

Start Date

February 15, 2025

Primary Completion Date

November 10, 2025

Study Completion Date

October 10, 2027

Conditions
Herpes Zoster
Interventions
BIOLOGICAL

Recombinant Herpes Zoster Vaccine (SCTV04C) Low-Dose

Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Immunization procedure: 2 doses, 60 days apart;

BIOLOGICAL

Recombinant Herpes Zoster Vaccine (SCTV04C) High-Dose

Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Immunization procedure: 2 doses, 60 days apart;

BIOLOGICAL

Placebo control: Saline

The placebo in this study is 0.9% sodium chloride (normal saline) injection; Immunization procedure: 2 doses, 60 days apart;

BIOLOGICAL

Shingrix®

Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Dosage of vaccination: 50 μg; Immunization procedure: 2 doses, 60 days apart

BIOLOGICAL

Ganwei®

Route of vaccination: subcutaneous injection into the lateral deltoid of the upper arm; Dosage of vaccination: 0.5 mL; Immunization procedure: saline will be administered at Day 0, and Ganwei® will be administered at Day 60;

Trial Locations (1)

635100

Dazhu CDC, Dazhou

All Listed Sponsors
lead

Sinocelltech Ltd.

INDUSTRY