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ACTIVE NOT RECRUITING
NCT06335849
PHASE1

A Safety and Immunogenicity Trial of the Recombinant Zoster Vaccine (CHO Cell), LYB004 in Adults Aged 50 to 70 Years

Sponsor: Guangzhou Patronus Biotech Co., Ltd.

View on ClinicalTrials.gov

Summary

This phase 1 study in Australia will evaluate the safety and immunogenicity of the Recombinant Zoster Vaccine (CHO Cell), LYB004 in Adults Aged 50 to 70 Years.

Official title: A Phase I, Randomized, Observer-blinded, Positive-Controlled, Dose Escalation Clinical Trial to Assess the Safety and Immunogenicity of the Recombinant Zoster Vaccine (CHO Cell), LYB004 in Adults Aged 50 to 70 Years

Key Details

Gender

All

Age Range

50 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2024-03-27

Completion Date

2025-09-30

Last Updated

2025-03-13

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

LYB004 25µg

Subjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:2:1) to receive 25 μg LYB004, 50 μg LYB004 or SHINGRIX. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60.

BIOLOGICAL

LYB004 50µg

Subjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:2:1) to receive 25 μg LYB004, 50 μg LYB004 or SHINGRIX. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60.

BIOLOGICAL

SHINGRIX

Subjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:2:1) to receive 25 μg LYB004, 50 μg LYB004 or SHINGRIX. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60.

Locations (1)

Nucleus Network Pty Ltd

Melbourne, Victoria, Australia