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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

March 27, 2024

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2025

Conditions
Herpes Zoster
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.

Trial Locations (1)

3004

Nucleus Network Pty Ltd, Melbourne

All Listed Sponsors
collaborator

Yantai Patronus Biotech Co., Ltd.

INDUSTRY

lead

Guangzhou Patronus Biotech Co., Ltd.

INDUSTRY

NCT06335849 - A Safety and Immunogenicity Trial of the Recombinant Zoster Vaccine (CHO Cell), LYB004 in Adults Aged 50 to 70 Years | Biotech Hunter | Biotech Hunter