Trials / Active Not Recruiting
Active Not RecruitingNCT07311148
A Immunogenicity and Safety Trial of the Recombinant Zoster Vaccine （CHO Cell）, LYB004 in Adults Aged 40 Years and Older
A Phase Ⅱ, Randomized, Observer-blinded, Parallel-Controlled Clinical Trial to Assess the Immunogenicity and Safety of the Recombinant Zoster Vaccine, LYB004 in Adults Aged 40 Years and Older
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 840 (estimated)
- Sponsor
- Guangzhou Patronus Biotech Co., Ltd. · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Accepted
Summary
This phase 2 study in China will evaluate the immunogenicity and safety of the Recombinant Zoster Vaccine, LYB004 in adults aged 40 years and older.
Detailed description
A randomized, observer-blinded, parallel-controlled trial will be conducted to observe the immunogenicity and safety of LYB004 in adults aged 40 years and older. A total of 840 participants aged 40 years and older will be enrolled. Four formulations of LYB004 will be provided: two dose levels of antigen and two dose levels of adjuvant. Participants aged 40-49 years old will randomly receive four investigational vaccines and the placebo in a 2:2:2:2:1 ratio. Participants aged 50 years and older will randomly receive four investigational vaccines, positive control and the placebo in a 2:2:2:2:2:1 ratio.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Low dose antigen and low dose adjuvant of LYB004 | 0.5 mL per dose, containing 25 μg VZV-gEM adjuvanted with A01C. |
| BIOLOGICAL | Low dose antigen and high dose adjuvant of LYB004 | 0.5 mL per dose, containing 25 μg VZV-gEM adjuvanted with A01B. |
| BIOLOGICAL | High dose antigen and low dose adjuvant of LYB004 | 0.5 mL per dose, containing 50 μg VZV-gEM adjuvanted with A01C. |
| BIOLOGICAL | High dose antigen and high dose adjuvant of LYB004 | 0.5 mL per dose, containing 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
- 2025-10-23
- Primary completion
- 2026-01-01
- Completion
- 2026-12-01
- First posted
- 2025-12-30
- Last updated
- 2025-12-30
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07311148. Inclusion in this directory is not an endorsement.