Actively Recruiting
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Protective Efficacy, Safety, and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) in Subjects Aged 40 Years and Older
Led by Beijing Luzhu Biotechnology Co., Ltd. · Updated on 2023-10-18
4
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the protective efficacy and safety of a recombinant herpes zoster vaccine called LZ901 in healthy adults aged 40 years and older. This phase 3, randomized, double-blind, placebo-controlled trial aims to protect participants against shingles caused by the varicella zoster virus. The vaccine contains a tetramer of VZV glycoprotein E combined with an aluminum hydroxide adjuvant known to enhance immune response and widely used in vaccines worldwide. Participants will receive two doses of either the LZ901 vaccine or a placebo (aluminum hydroxide adjuvant) injected into the upper arm on day 0 and day 29. Around 26,000 participants will be enrolled, including a subgroup of about 3,000 to assess the consistency of immune response across three vaccine batches and monitor persistence of immunity up to 36 months. The study includes four groups: treatment main, placebo main, treatment immunization, and placebo immunization groups. Participants will undergo up to 24 visits depending on their group, including on-site and in-person visits for screening, vaccination, and follow-up assessments. Researchers will monitor vaccine efficacy 30 days after full immunization, track adverse events from immediate to 12 months post-vaccination, and evaluate immune response through antibody tests at multiple time points. The study also explores the vaccine's impact on reducing the severity and occurrence of postherpetic neuralgia in adults 40 years and older.
CONDITIONS
Brief Title
A Phase Ⅲ Clinical Study to Evaluate Protective Efficacy and Safety of a Recombinant Herpes Zoster Vaccine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 40 years or older at the time of consent
- Able to provide legal identity certificate
- Able to understand study procedures and voluntarily agree to participate
- Female participants are not pregnant or lactating
- Female participants with childbearing potential must use reliable contraception and have no pregnancy or fertility plans within 7 months
- Axillary temperature 37.06C or below on enrollment day
- Able to attend all scheduled follow-up visits and comply with protocol requirements
You will not qualify if you...
- History of herpes zoster within the previous 5 years
- Previous vaccination against varicella or shingles, including any clinical trial vaccine
- Hypersensitivity to any vaccine components or prior severe allergic reactions to similar vaccines
- Immunodeficiency diseases or recent immunosuppressive/cytotoxic treatments
- Receiving immunosuppressive therapy within 3 months prior to vaccination or 1 month after full immunization
- Received certain vaccines within 14 to 28 days before vaccination
- Suffering from acute illness or exacerbation of chronic disease within 3 days prior to vaccination
- History of asplenia or splenectomy
- Treatment with blood products or globulins within 3 months before enrollment or planned within 2 months after vaccination
- Participation in other clinical studies of investigational products during this trial
- Significant medical conditions that may prevent trial completion or limit survival to less than 4 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 month
Participants receive two doses of either the recombinant herpes zoster vaccine or placebo on Day 0 and Day 29.
2 on-site visits for dosing plus additional visits depending on subgroup assignment
Duration - 12 months
Participants complete safety follow-up visits to monitor adverse events and vaccine efficacy for up to 12 months after full immunization.
Up to 16 visits including on-site and in-person visits depending on subgroup
Duration - Up to 36 months
Participants in the immunization subgroup have extended monitoring for immunogenicity persistence and batch-to-batch consistency up to 36 months after full immunization.
Up to 24 visits including on-site and in-person visits
Trial Site Locations
Total: 1 location
1
Jiangsu Province Center for Disease Control and Prevention (China)
Zhenjiang, Jiangsu, China, 210009
Actively Recruiting
Research Team
F
Fengcai Zhu, MM
P
Pengfei Jin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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