By InvitationPhase 1

A Phase I Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell)

China120 participantsStarted 2026-05-28

Plain-language summary

To evaluate the safety and tolerability of different dosages of recombinant zoster vaccine (CHO cell) when administered to adults 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: * Participants are aged ≥40 years on the day of enrollment and can provide legal identity documents; * The participant voluntarily agrees to take part in the trial and is capable of fully understanding and signing the informed consent form; * The participant is able to comply with the requirements specified in the clinical trial protocol. Exclusion Criteria: * Axillary body temperature \>37.3°C on the day of enrollment\*; * Subjects with a prior history of herpes zoster, or having had close contact with patients with chickenpox/herpes zoster within 30 days prior to enrollment; * Subjects with previous vaccination history of chickenpox or herpes zoster vaccine; * Subjects allergic to any component of the investigational vaccine (Varicella-Zoster Virus glycoprotein E, BK-02 adjuvant, dipotassium hydrogen phosphate trihydrate, sodium dihydrogen phosphate monohydrate, sucrose, Polysorbate 80), or with a history of severe hypersensitivity to any drugs or vaccines; * Confirmed or suspected immunosuppression or immunodeficiency disorders induced by underlying diseases or immunosuppressive/cytotoxic therapies, including but not limited to subjects diagnosed with immunodeficiency diseases, malignant tumors, HIV infection, leukemia, lymphoma, Hodgkin's disease, or compromised immunity resulting from organ and bone marrow transplantation; * Subjects with asplenia or functional asplenia, or autoimmune diseases such as Hashimoto's thyroiditis, vitiligo, rheumatoid a…

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

Adverse Events/Reactions

Timeframe: 14/30 days after injection

Incidence of adverse events/reactions after administration

Timeframe: 14days and 30 days after administration

Trial details

NCT IDNCT07633197

SponsorChangchun BCHT Biotechnology Co.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-28

View on ClinicalTrials.gov More Herpes trials

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.