Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06874842
PHASE1

Safety and Immunogenicity of the Recombinant Zoster Vaccine, LYB004 in Adults Aged 40 Years and Older

Sponsor: Guangzhou Patronus Biotech Co., Ltd.

View on ClinicalTrials.gov

Summary

This phase 1 study in China will evaluate the safety and immunogenicity of the Recombinant Zoster Vaccine, LYB004 in adults aged 40 years and older.

Official title: A Phase I, Randomized, Observer-blinded, Parallel-Controlled, Dose Escalation Clinical Trial to Assess the Safety and Immunogenicity 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

92

Start Date

2025-03-13

Completion Date

2026-10

Last Updated

2025-04-01

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Low dose antigen and low dose adjuvant of LYB004

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

BIOLOGICAL

Low dose antigen and high dose adjuvant of LYB004

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

BIOLOGICAL

High dose antigen and low dose adjuvant of LYB004

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

BIOLOGICAL

High dose antigen and high dose adjuvant of LYB004

0.5 mL per dose, containing a total of 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)

Guangdong Provincial Center for Disease Control and Prevention

Meizhou, China