Trials / Active Not Recruiting
Active Not RecruitingNCT05856084
Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 30 Years and Above
A Phase II, Single Center, Randomized, Blind, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 30 Years and Above
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 924 (estimated)
- Sponsor
- MAXVAX Biotechnology Limited Liability Company · Industry
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Accepted
Summary
The purposes of the study are to evaluate the immunogenicity and safety of different dose levels of recombinant herpes zoster vaccine (CHO Cells) with 2 doses at 2-month intervals in healthy subjects aged 30 years and older.
Detailed description
The clinical trial will be a single-center, randomized, blind, controlled study in which two dose levels of vaccine will be tested in healthy adults aged 30 to 49 years and 50 years and older. A total of 924 participants will be enrolled, including 396 participants aged 30 to 49 years and 528 participants aged 50 years and older. Participants aged 30 to 49 years will be randomized into three subgroups (low dose vaccine group, high dose vaccine group and placebo group) in a 1:1:1 ratio. Participants aged 50 years and older will be randomized into four subgroups (low dose vaccine group, high dose vaccine group, Shingrix® group and placebo group) in a 1:1:1:1 ratio.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Low dose Recombinant Herpes Zoster Vaccine (CHO cells) | 0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with low dose MA105. |
| BIOLOGICAL | High dose Recombinant Herpes Zoster Vaccine (CHO cells) | 0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with high dose MA105. |
| BIOLOGICAL | Positive control | 0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B. |
| BIOLOGICAL | Placebo | 0.5 mL per dose, containing 4.5 mg sodium chloride. |
Timeline
- Start date
- 2023-05-07
- Primary completion
- 2024-12-28
- Completion
- 2026-03-31
- First posted
- 2023-05-12
- Last updated
- 2024-11-20
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05856084. Inclusion in this directory is not an endorsement.