NCT06874842

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Guangzhou Patronus Biotech Co., Ltd. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

A randomized, observer-blinded, positive-controlled, dose escalation trial will be conducted to observe the safety and immunogenicity of LYB004 in adults aged 40 years and older. A total of 92 healthy subjects will be enrolled and stratified by age (40-49，50-59 years and ≥60 years in a 5:6:8 ratio). Four formulations of LYB004 will be provided, two dose levels of antigen and two dose levels of adjuvant. A sentinel and escalating dosing approach will be used for close monitoring of safety to minimize risk to participants. Participants will be enrolled in one of six cohorts, including Cohort 1 (40-49 years, low dose, n=10), Cohort 2 (50-59 years, low dose, n=12), Cohort 3 (≥60 years, low dose, n=24), Cohort 4 (40-49 years, high dose, n=10), Cohort 5 (50-59 years, high dose, n=12), and Cohort 6 (≥60 years, high dose, n=24). In Cohort 1 and Cohort 4, three sentinels each were set up, and they were randomly vaccinated with the investigational vaccine (low dose adjuvant), the investigational vaccine (high dose adjuvant), or a placebo in a 1:1:1 ratio. The remaining participants were randomly vaccinated in a 3:3:1 ratio with the low dose investigational vaccine (low dose adjuvant), the low dose investigational vaccine (high dose adjuvant), or a placebo. In Cohort 2 and Cohort 5, four sentinels each were set up, and they were randomly vaccinated with the investigational vaccine (low dose adjuvant), the investigational vaccine (high dose adjuvant), a positive control/Shingrix®, or a placebo in a 1:1:1:1 ratio. The remaining participants were randomly vaccinated in a 3:3:1:1 ratio with the same options. In Cohort 3 and Cohort 6, four sentinels each were also set up, and they were randomly vaccinated in a 1:1:1:1 ratio with the investigational vaccine (low dose adjuvant), the investigational vaccine (high dose adjuvant), a positive control/Shingrix®, or a placebo. The remaining participants were randomly vaccinated in a 7:7:3:3 ratio with the same options. The two-dose immunization schedule will be adopted, that is, LYB004 or Shingrix® or placebo will be intramuscularly injected on Day 0 and Day 60, respectively.

Conditions

• Herpes Zoster (HZ)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-13
• Primary completion: 2026-02-01
• Completion: 2026-10-01
• First posted: 2025-03-13
• Last updated: 2025-04-01

Locations

1 site across 1 country: China