A Study to Evaluate the Safety of Recombinant Herpes Zoster Vaccine for Healthy Individuals

Last updated: January 5, 2026
Sponsor: Shanghai Institute Of Biological Products
Overall Status: Active - Recruiting

Phase

1/2

Condition

Shingles

Chickenpox (Varicella Zoster Infection)

Rash

Treatment

Recombinant herpes zoster vaccine with high-dose adjuvant

Recombinant herpes zoster vaccine with low-dose adjuvant

High-dose adjuvant

Clinical Study ID

NCT06932523
SIBP-V04-Ⅰ/Ⅱ
  • Ages > 40
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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 consentform, expressing agreement to participate in the experiment.

  • Be able to participate in all planned follow-up visits and comply with all trialprocedures.

  • On the day of enrollment, the body temperature was less than 37.3 ℃ (axillarytemperature).

  • Chronic disease patients need to be in a stable period of chronic disease.

  • Female and male participants of childbearing age agreed to adopt strict andeffective contraceptive measures from the start of the trial to 6 months after fullexemption.

Exclusion

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 inthe past 2 years.

  • Women of childbearing age who have a positive urine pregnancy test, arebreastfeeding, pregnant, or plan to become pregnant within 6 months after the startof the test and the full exemption period.

  • Individuals who are allergic to any component of the vaccine or have a history ofother severe allergies.

  • Use immunoglobulin and/or any blood products within 3 months prior to administeringthe trial vaccine, or plan to use them during the trial period.

  • Have taken antipyretic, analgesic, or anti allergic drugs within 72 hours prior toreceiving the experimental vaccine.

  • Any experimental or unregistered product (drug, vaccine, biological product ordevice) other than the experimental vaccine has been used within one month prior tovaccination, or is planned to be used during the trial period.

  • Administer non live vaccines within 7 days prior to administering the experimentalvaccine or live vaccines within 14 days prior to administering the experimentalvaccine.

  • Suffering from a serious illness that prevents the completion of the entireexperiment.

  • Received immunosuppressive therapy or other immunomodulatory drugs, monoclonalantibodies, thymosin, interferon, etc. within 6 months prior to vaccination with theexperimental vaccine, or planned to receive such treatment within 1 month after thefirst dose to full immunization, but local medication is allowed.

  • Chemotherapy, radiotherapy, and organ and bone marrow transplantation relatedtreatments for cancer or other diseases.

  • Diseases or medical measures that lead to immune dysfunction

  • Individuals currently suffering from serious infectious diseases such as activetuberculosis and active viral hepatitis.

  • Moderate or severe acute illness/infection, or febrile illness within 72 hours priorto vaccination.

  • Known to have a history of thrombocytopenia, any coagulation dysfunction, or beingtreated with anticoagulants.

  • Suffering from serious cardiovascular disease, pulmonary edema, serious liver andkidney disease, and diabetes that cannot be controlled by drugs.

  • Previous history of mental and neurological disorders or family history of mentalillness.

  • Currently suffering from various severe infectious, suppurative, and allergic skindiseases.

  • Plan to move before the end of the trial or leave the local area for a long timeduring the scheduled trial visit.

  • (Phase I ) Abnormal blood routine, blood biochemistry, coagulation, and urineroutine indicators before vaccination (excluding those judged by doctors to have noclinical significance).

  • Any situation that the researcher believes may affect the evaluation of theexperiment.

Study Design

Total Participants: 645
Treatment Group(s): 6
Primary Treatment: Recombinant herpes zoster vaccine with high-dose adjuvant
Phase: 1/2
Study Start date:
April 04, 2025
Estimated Completion Date:
December 31, 2027

Study Description

There are two parts of the study.

Substudy A:

This substudy is the Phase I portion of the study. In this substudy, participants will receive 1 of 2 RHZV candidates (different dose levels) or the approved shingles vaccine (positive control) or adjuvant controls or normal saline intramuscularly. Participants will be divided into 2 age groups: 40-49 years old and ≥ 50 years old. Participants will receive vaccinations on days 0 and 60. Participants will complete a 12-month safety follow-up after two doses of vaccination, and they will take part in this study for about 14 months.

Substudy B:

This substudy is the Phase Ⅱ portion of the study. In this part of the study, participants will also receive 1 of 2 RHZV candidates (different dose levels) or the approved shingles vaccine (positive control) or normal saline intramuscularly. Participants will be divided into 3 age groups: 40-49 years old, 50-69 years old and ≥ 70 years old. Participants will receive vaccinations on days 0 and 60. Some group(s) will continue into persistence-of-immunity (overtime assessment of effect of vaccine) portion of the study. Those participants will be involved in this study for up to 2 years.

Connect with a study center

  • Hubei Provincial Center for Disease Control and Prevention

    Wuhan 1791247, Hubei 1806949
    China

    Active - Recruiting

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