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ACTIVE NOT RECRUITING
NCT07311148
PHASE2

A Immunogenicity and Safety Trial of the Recombinant Zoster Vaccine (CHO Cell), LYB004 in Adults Aged 40 Years and Older

Sponsor: Guangzhou Patronus Biotech Co., Ltd.

View on ClinicalTrials.gov

Summary

This phase 2 study in China will evaluate the immunogenicity and safety of the Recombinant Zoster Vaccine, LYB004 in adults aged 40 years and older.

Official title: A Phase Ⅱ, Randomized, Observer-blinded, Parallel-Controlled Clinical Trial to Assess the Immunogenicity and Safety of the Recombinant Zoster Vaccine, LYB004 in Adults Aged 40 Years and Older

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

840

Start Date

2025-10-23

Completion Date

2026-12

Last Updated

2025-12-30

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Low dose antigen and low dose adjuvant of LYB004

0.5 mL per dose, containing 25 μg VZV-gEM adjuvanted with A01C.

BIOLOGICAL

Low dose antigen and high dose adjuvant of LYB004

0.5 mL per dose, containing 25 μg VZV-gEM adjuvanted with A01B.

BIOLOGICAL

High dose antigen and low dose adjuvant of LYB004

0.5 mL per dose, containing 50 μg VZV-gEM adjuvanted with A01C.

BIOLOGICAL

High dose antigen and high dose adjuvant of LYB004

0.5 mL per dose, containing 50 μg VZV-gEM adjuvanted with A01B.

BIOLOGICAL

Placebo

0.5 mL per dose, without antigen and adjuvant.

BIOLOGICAL

Positive control

0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B.

Locations (1)

Hengnan County Center for Disease Control and Prevention

Hengyang, Hunan, China