Actively Recruiting
A Study to Evaluate the Safety of Recombinant Herpes Zoster Vaccine for Healthy Individuals
Led by Shanghai Institute Of Biological Products · Updated on 2026-01-07
645
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this clinical study is to evaluate the safety and immunogenicity of receiving two doses of recombinant herpes zoster vaccine (CHO cells) (RHZV) in healthy individuals aged 40 years and above. This study will be conducted in 2 substudies: Substudy A (Phase I) and Substudy B (Phase Ⅱ).
CONDITIONS
Official Title
A Study to Evaluate the Safety of Recombinant Herpes Zoster Vaccine for Healthy Individuals
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 years or older on the day of enrollment
- Any gender
- Able to provide legal proof of identity
- Able to understand the study procedures and sign informed consent
- Able to attend all follow-up visits and comply with study procedures
- Body temperature below 37.3 6C on enrollment day
- Stable chronic disease if present
- Agree to use effective contraception from the start of the study until 6 months after last dose (if of childbearing potential)
You will not qualify if you...
- History of herpes zoster infection
- History of vaccination against chickenpox or shingles
- Close contact with chickenpox or shingles patients in past 2 years
- Positive pregnancy test, breastfeeding, pregnant, or planning pregnancy within 6 months (if of childbearing potential)
- Allergy to any vaccine components or history of severe allergies
- Use of immunoglobulin or blood products within 3 months before vaccination or planned use during study
- Use of antipyretic, analgesic, or anti-allergic drugs within 72 hours before vaccination
- Use of any experimental or unregistered products within 1 month before or planned during study
- Receipt of non-live vaccines within 7 days or live vaccines within 14 days before vaccination
- Serious illness preventing study completion
- Immunosuppressive therapy or immunomodulatory drugs within 6 months before or planned 1 month after first dose
- Cancer treatments such as chemotherapy, radiotherapy, organ or bone marrow transplant
- Conditions causing immune dysfunction
- Serious infectious diseases like active tuberculosis or viral hepatitis
- Moderate or severe acute or febrile illness within 72 hours before vaccination
- History of thrombocytopenia, coagulation disorders, or anticoagulant treatment
- Severe cardiovascular, pulmonary edema, serious liver or kidney disease, or uncontrolled diabetes
- Mental or neurological disorders or family history of mental illness
- Severe infectious, suppurative, or allergic skin diseases
- Planning to move or leave area during study
- Abnormal lab tests before vaccination in Phase I (unless deemed not clinically significant)
- Any condition the researcher believes affects study evaluation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, China
Actively Recruiting
Research Team
C
Chaorong Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
10
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