NCT06932523 A Study to Evaluate the Safety of Recombinant Herpes Zoster Vaccine for Healthy Individuals
| NCT ID | NCT06932523 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shanghai Institute Of Biological Products |
| Condition | Herpes Zoster (HZ) |
| Study Type | INTERVENTIONAL |
| Enrollment | 645 participants |
| Start Date | 2025-04-04 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 645 participants in total. It began in 2025-04-04 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * Age ≥ 40 years old on the day of enrollment, gender not limited. * Can provide legal proof of identity. * Be able to understand the experimental procedure and sign a written informed consent form, expressing agreement to participate in the experiment. * Be able to participate in all planned follow-up visits and comply with all trial procedures. * On the day of enrollment, the body temperature was less than 37.3 ℃ (axillary temperature). * Chronic disease patients need to be in a stable period of chronic disease. * Female and male participants of childbearing age agreed to adopt strict and effective contraceptive measures from the start of the trial to 6 months after full exemption. Exclusion Criteria: * Individuals with a history of herpes zoster in the past. * Individuals with a history of vaccination against chickenpox or shingles. * Individuals who have had close contact with patients with chickenpox or shingles in the past 2 years. * Women of childbearing age who have a positive urine pregnancy test, are breastfeeding, pregnant, or plan to become pregnant within 6 months after the start of the test and the full exemption period. * Individuals who are allergic to any component of the vaccine or have a history of other severe allergies. * Use immunoglobulin and/or any blood products within 3 months prior to administering the trial vaccine, or plan to use them during the trial period. * Have taken antipyretic, analgesic, or anti allergic drugs within 72 hours prior to receiving the experimental vaccine. * Any experimental or unregistered product (drug, vaccine, biological product or device) other than the experimental vaccine has been used within one month prior to vaccination, or is planned to be used during the trial period. * Administer non live vaccines within 7 days prior to administering the experimental vaccine or live vaccines within 14 days prior to administering the experimental vaccine. * Suffering from a serious illness that prevents the completion of the entire experiment. * Received immunosuppressive therapy or other immunomodulatory drugs, monoclonal antibodies, thymosin, interferon, etc. within 6 months prior to vaccination with the experimental vaccine, or planned to receive such treatment within 1 month after the first dose to full immunization, but local medication is allowed. * Chemotherapy, radiotherapy, and organ and bone marrow transplantation related treatments for cancer or other diseases. * Diseases or medical measures that lead to immune dysfunction * Individuals currently suffering from serious infectious diseases such as active tuberculosis and active viral hepatitis. * Moderate or severe acute illness/infection, or febrile illness within 72 hours prior to vaccination. * Known to have a history of thrombocytopenia, any coagulation dysfunction, or being treated with anticoagulants. * Suffering from serious cardiovascular disease, pulmonary edema, serious liver and kidney disease, and diabetes that cannot be controlled by drugs. * Previous history of mental and neurological disorders or family history of mental illness. * Currently suffering from various severe infectious, suppurative, and allergic skin diseases. * Plan to move before the end of the trial or leave the local area for a long time during the scheduled trial visit. * (Phase I ) Abnormal blood routine, blood biochemistry, coagulation, and urine routine indicators before vaccination (excluding those judged by doctors to have no clinical significance). * Any situation that the researcher believes may affect the evaluation of the experiment.
Contact & Investigator
Yeqing Tong
PRINCIPAL INVESTIGATOR
Hubei Provincial Center for Disease Control and Prevention
Frequently Asked Questions
Who can join the NCT06932523 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Herpes Zoster (HZ). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06932523 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06932523 currently recruiting?
Yes, NCT06932523 is actively recruiting participants. Contact the research team at xuchaorong@sinopharm.com for enrollment information.
Where is the NCT06932523 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06932523 clinical trial?
NCT06932523 is sponsored by Shanghai Institute Of Biological Products. The principal investigator is Yeqing Tong at Hubei Provincial Center for Disease Control and Prevention. The trial plans to enroll 645 participants.