NCT06335849

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Guangzhou Patronus Biotech Co., Ltd. · Industry
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

A randomized, observer-blinded, positive-controlled, dose escalation trial will be conducted to observe the safety and immunogenicity of LYB004 in adults 50 to 70 years of age. A total of 48 healthy subjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:1) to receive LYB004 or SHINGRIX. Two dose levels of LYB004 will be provided, low dose 25 μg and high dose 50 μg. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60, respectively.

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-27
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2024-03-28
• Last updated: 2025-03-13

Locations

1 site across 1 country: Australia