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

NCT06801509 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2025-01-30

No results posted yet for this study

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

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；

Sponsors & Collaborators

  • Sinocelltech Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-15
Primary Completion
2025-11-10
Completion
2027-10-10

Countries

  • China

Study Locations

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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 NCT06801509 on ClinicalTrials.gov