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NCT Number: NCT06961721

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of a Live Attenuated Herpes Zoster Vaccine in Adults Aged 40 Years and Older

To evaluate the immunogenicity 42 days after vaccination with the live attenuated herpes zoster vaccine.

To evaluate the safety of the live attenuated herpes zoster vaccine.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥40 years on enrollment day;
  • The informed consent of the subject can be obtained and signed;
  • The subjects themselves were able to complete the trial in accordance with the requirements of the clinical trial protocol;
  • Armpit body temperature ≤37.0℃ on the day of enrollment.

Exclusion criteria

  • People who are immune deficient or immunosuppressed due to certain diseases or treatments. Causes of immunodeficiency or immunosuppression may include, but are not limited to, primary or acquired immunodeficiency conditions, such as AIDS or other diseases caused by viral infection; Leukemia, lymphoma, or other malignancies affecting the bone marrow or lymphatic system; Being treated for immunosuppression; Being treated with radiation/chemotherapy for a tumor;
  • Do not use in persons with a history of allergic reaction to any of the components contained in this product;
  • Those who are in the acute stage of acute infection and chronic infection should postpone the vaccination of this product;
  • Premenopausal women who tested positive for pregnancy, pregnant women, breastfeeding women, or those who planned to have a baby within 6 months;
  • If this product and other injectable live attenuated vaccines are not administered at the same time, the interval should be at least 28 days;
  • Treatment with whole blood, plasma, or immunoglobulin is given within 5 months or 3 weeks prior to vaccination;
  • Received another investigational drug within 1 month prior to receiving the investigational vaccine/placebo, or is participating in another clinical trial, or plans to use it during the study;
  • Taking or about to take salicylate drugs, including aspirin and difluorosalicylic acid;
  • Patients with abnormal blood pressure that cannot be controlled by medication (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg);
  • Previous vaccinations against chickenpox or shingles (including use of registered products or participation in clinical trials of chickenpox or shingles vaccine);
  • Any situation that the investigator considers likely to affect the evaluation of the trial。

Treatment and study plan

Herpes Zoster Vaccine, Live

Biological

assigned to the vaccine group and placebo group in a 2:1 ratio.

Placebo

Biological

assigned to the vaccine group and placebo group in a 2:1 ratio.

Primary outcomes

  1. Immunogenicity:

    Time frame: Day 0 and Day 42

    Geometric mean titer (GMT)at Day 0 and Day 42.

  2. Immunogenicity:

    Time frame: Day 0 and Day 42

    geometric mean concentration (GMC) at Day 0 and Day 42.

  3. Immunogenicity:

    Time frame: Day 0 and Day 42

    geometric mean fold increase (GMFI)at Day 0 and Day 42

  4. Immunogenicity:

    Time frame: Day 0 and Day 42

    seroconversion/seroresponse rate (4-fold increase) at Day 0 and Day 42.

Secondary outcomes

  1. Adverse Events

    Time frame: 42 days

    • Incidence, severity, and causality of solicited local,systemic adverse events within 14 days post-vaccination;
    • The incidence and severity of unsolicited adverse events within 42 days after vaccination and their association with vaccination;
    • Incidence of Serious Adverse events (SAE) within 42 days after vaccination。

Study contacts

Contact information is provided by the study sponsor or research team.

shaohong yan, Undergraduate degree

CONTACT

[email protected]

13015018766

Sponsors and collaborators

Lead sponsor

Changchun BCHT Biotechnology Co.

Industry

Collaborators

  • Center for Disease Control and Prevention, Fujian
  • Inner Mongolia Center for Disease Control and Prevention

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 8, 2025
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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