Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged… (NCT06851832) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
China960 participantsStarted 2025-02-16
Plain-language summary
The objective of this study was to evaluate the safety, immunogenicity and immune persistence of recombinant herpes zoster vaccine (CHO cells) with different adjuvant doses in healthy people aged 40 years and older.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female participants aged 40 years or older at the time of enrollment.
* Voluntarily agrees to participate in the trial, fully understands, and signs the informed consent form.
* Able to attend all scheduled follow-ups and comply with the clinical trial protocol requirements to complete the trial.
* Female participants must meet the following criteria:1)Surgically sterilized or postmenopausal for ≥2 years, or women of childbearing potential (not menopausal or menopausal \<2 years) with a negative pregnancy test and willing to use effective physical contraception (e.g., condoms, intrauterine device) from enrollment until 6 months after full immunization. 2)Agree not to breastfeed from enrollment until 6 months after full immunization.
* Axillary temperature ≤37.0°C.
Exclusion Criteria:
a Exclusion criteria for the first dose:
* A history of herpes zoster.
* A history of varicella or herpes zoster vaccination.
* Close contact with a varicella/herpes zoster patient within the past year.
* Received immunoglobulin and/or any blood products within 3 months before vaccination.
* Received immunosuppressive treatment within 3 months prior to vaccination (e.g., systemic corticosteroids for ≥14 days, at a dose ≥2 mg/kg/day or ≥20 mg/day of prednisone, or an equivalent dose of prednisone) (excluding inhaled, intra-articular, and topical steroids).
* A history of severe allergic reactions to any vaccine or medication (e.g., anaphylactic shock, allergic lar…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of solicited local and systemic adverse events (AEs) within 0-14 days after each vaccine dose.
Timeframe: Within 14 days after each vaccine dose.
2
The incidence of unsolicited adverse events (AEs) within 0-30 days after each vaccine dose.
Timeframe: Within 30 days after each vaccine dose.
3
The incidence of laboratory abnormalities (including blood biochemistry, blood routine, urine routine and electrocardiogram) on Day 3 after each vaccine dose.
Timeframe: On Day 3 after each vaccine dose.(Applicable to Phase I only)
4
The incidence of serious adverse events (SAEs) and Adverse Events of Special Interest (AESI) from the vaccination of the first dose to 12 months after full immunization.
Timeframe: From the vaccination of the first dose to 12 months after full immunization.
5
The cell-mediated immune response rate of CD4+ T cells expressing at least two activation markers (IFN-γ, IL-2, TNF-α, CD40L) one month after full immunization.
Timeframe: One month after full immunization.(Applicable to Phase Ⅱ only)
6
The GMC/GMT, seroconversion rate, and GMI of anti-gE antibodies and anti-VZV antibodies one month after full immunization.