Actively Recruiting
Randomized, Blinded, Controlled Phase I/II Trial Evaluating Safety and Immune Response of Recombinant Herpes Zoster Vaccine in Healthy Adults Aged 40 and Older
Led by Shanghai Institute Of Biological Products · Updated on 2026-01-07
645
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and immune response of two doses of a recombinant herpes zoster vaccine (RHZV) in healthy adults aged 40 and older. The study includes two parts: Substudy A (Phase I) and Substudy B (Phase II). It aims to assess different vaccine candidates, including dose levels, compared with the approved shingles vaccine and controls, to better understand their effects in various age groups. In Substudy A, participants aged 40-49 and 50+ will receive one of two RHZV candidates, the approved shingles vaccine, adjuvant controls, or saline via intramuscular injection on days 0 and 60. This phase includes a 12-month safety follow-up, totaling about 14 months of involvement. Substudy B includes age groups 40-49, 50-69, and 70+, using similar vaccination schedules and treatments. Some groups will continue to be monitored for up to 2 years to study the persistence of immunity. Participants will undergo regular safety assessments including monitoring immediate, solicited, unsolicited, and serious adverse events after vaccination. Researchers will measure antibody levels and immune response at multiple timepoints up to two years, using blood tests for specific antibodies. Study visits will include vaccinations, follow-ups, and immune response evaluations, helping to understand the vaccine's safety and the body's lasting immune reaction.
CONDITIONS
Brief 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 at enrollment, any gender
- Ability to provide legal proof of identity
- Ability to understand the study procedures and sign informed consent
- Willingness and ability to attend all follow-up visits and comply with study requirements
- Body temperature below 37.3°C on enrollment day
- Stable chronic disease if applicable
- Agreement to use effective contraceptive methods from study start to 6 months after full exemption for participants of childbearing potential
You will not qualify if you...
- History of herpes zoster (shingles)
- Previous 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 for women of childbearing age
- Allergy to vaccine components or history of severe allergies
- Use of immunoglobulin or blood products within 3 months prior or planned during study
- Use of antipyretic, analgesic, or anti-allergic drugs within 72 hours before vaccination
- Use of other experimental or unregistered products within 1 month before or during study
- Vaccination with non-live vaccines within 7 days or live vaccines within 14 days before study vaccine
- Serious illness preventing study completion
- Immunosuppressive therapy or immunomodulatory drugs within 6 months prior or planned during study period
- Chemotherapy, radiotherapy, or organ/bone marrow transplant treatments
- Medical conditions causing immune dysfunction
- Active serious infections such as tuberculosis or viral hepatitis
- Moderate or severe acute illness or fever within 72 hours before vaccination
- History of thrombocytopenia, coagulation disorders, or anticoagulant treatment
- Serious cardiovascular, pulmonary, liver, kidney disease, or uncontrolled diabetes
- History or family history of mental or neurological disorders
- Severe infectious, suppurative, or allergic skin diseases
- Planning to move or leave area during study
- (Phase I) Abnormal blood routine, biochemistry, coagulation, or urine tests before vaccination unless clinically insignificant
- Any condition affecting study evaluation as judged by researchers
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 months
Participants receive vaccinations intramuscularly on days 0 and 60 with one of the study vaccines or controls.
2 vaccination visits (in-person)
Duration - 12 months
Participants are followed for safety monitoring for 12 months after the second vaccination dose.
Multiple visits over 12 months for safety assessments
Duration - Up to 2 years
Some participants continue in long-term follow-up to assess persistence of immune response up to 2 years after vaccination.
Scheduled visits at 6, 12, and 24 months after last dose
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
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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