NCT06801509

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

A Randomized, Double-blind, Controlled Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the Recombinant Herpes Zoster Vaccine in Healthy Adults

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: Sinocelltech Ltd. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

The purposes of the study are to evaluate the Safety, Tolerability, and Immunogenicity of different dose levels of recombinant herpes zoster vaccine with 2 doses 60 days apart in healthy subjects aged 40 years and older.

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
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；

Timeline

• Start date: 2025-02-15
• Primary completion: 2025-11-10
• Completion: 2027-10-10
• First posted: 2025-01-30
• Last updated: 2025-01-30

Locations

1 site across 1 country: China