Actively Recruiting
Study to Evaluate the Safety and Immunogenicity of a Lyophilized Herpes Zoster Virus mRNA Vaccine
Led by Sinovac Biotech Co., Ltd · Updated on 2026-02-10
519
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial included two parts, Part A and Part B. The goal of Part A is to evaluate the safety and preliminary immunogenicity of the lyophilized herpes zoster virus mRNA vaccine (HZ mRNA vaccine) in healthy populations aged 40 years and older. The goal of Part B is to select the optimal dosage and schedule in healthy populations aged 50 years and older to support next further study.
CONDITIONS
Official Title
Study to Evaluate the Safety and Immunogenicity of a Lyophilized Herpes Zoster Virus mRNA Vaccine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Phase I: Age 40 years or older; Phase II: Age 50 years or older
- Able to understand and voluntarily sign the informed consent form
- Able to provide legal identification
- Participants of childbearing potential and their partners agree to use effective contraception from consent signing until 6 months after last vaccine dose, with no plans for sperm or egg donation
- Agree to follow visit schedules, sample collection, vaccination, and other study procedures and remain accessible throughout the trial
You will not qualify if you...
- History of chickenpox or herpes zoster in adulthood
- Previous chickenpox or herpes zoster vaccination or participation in related clinical trials
- Close contact with chickenpox or herpes zoster patients within 30 days prior
- Significant abnormalities in lab tests before vaccination (for Phase I only), including blood counts, liver and kidney function, urine protein, coagulation tests, and ECG
- Poorly controlled chronic diseases or significant medical history including cardiovascular, metabolic, hematological, hepatic, renal, digestive, respiratory diseases, major organ transplant, or recent malignancy
- History or risk of myocarditis, pericarditis, or cardiomyopathy
- Autoimmune or immunodeficiency diseases or family history thereof
- Coagulation disorders
- Severe neurological or psychiatric disorders or family history
- Acute illness or worsening chronic disease within 7 days or active infection
- Current or recent immunosuppressive or cytotoxic therapy
- Recent use of immunoglobulins or blood products
- Participation in other clinical trials within 30 days
- Recent vaccination with live, nucleic acid, subunit, inactivated, or other vaccines
- Known allergy to vaccines or components
- Pregnancy, lactation, or positive pregnancy test
- Fever within 3 days before vaccination or recent use of antipyretics or related medications
- Unsatisfactory physical exam on vaccination day
- Skin conditions at injection site that may interfere
- Any other investigator-determined factors making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention
Xinjiang, China, 831100
Actively Recruiting
Research Team
N
Na Xie
CONTACT
J
Jiao Xue
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
5
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