Long-term Effectiveness of the Live Attenuated Herpes Zoster Vaccine

May 7, 2026 updated by: Jiangsu Province Centers for Disease Control and Prevention

Long-term Effectiveness of the Live Attenuated Herpes Zoster Vaccine in Adults Aged 40 Years or Older: a Multicenter, Retrospective Cohort Study Based on Phase III Trial

This is a multicenter retrospective cohort study to evaluate the long-term effectiveness of the live attenuated herpes zoster vaccine within 6 years after vaccination. We plan to select 24,740 participants who were non-herpes zoster cases in the modified Full Analysis Set for Efficacy (E-mFAS) from the Phase III Clinical Trial (NCT04334577) of the live attenuated herpes zoster vaccine manufactured by Changchun BCHT Biotechnology Co. conducted during 2020-2021. In the original Phase III Clinical Trial, the participants were randomly assigned to the vaccine group and the placebo group at a 1:1 ratio to receive one dose of the live attenuated herpes zoster vaccine (with varicella-zoster virus >=4.3 lg PFU per 0.5 mL dose) or one dose of placebo (with no varicella-zoster virus component), respectively. This study uses a stage-based design. In Stage 1, participants originally assigned to the vaccine group and those originally assigned to the placebo group will be compared to assess the cumulative incidence of herpes zoster from the end of the original Phase III Clinical Trial in July 2021 to the marketing authorization of the vaccine in China in June 2023. In Stage 2, after marketing authorization of the vaccine in China in June 2023, a large proportion of the participants originally assigned to the placebo group received catch-up vaccination and thereby formed a catch-up vaccination group. These stage-specific groups will be compared to evaluate the relative waning of protection in participants who received catch-up vaccination compared with participants vaccinated in the original Phase III Clinical Trial. In addition, among participants originally assigned to the placebo group who received catch-up vaccination, the incidence of herpes zoster during the post-catch-up vaccination period will be compared with the incidence during their earlier placebo period before catch-up vaccination, in order to evaluate the relative risk of herpes zoster under vaccinated versus placebo exposure. For this study, telephone surveys will be conducted using a standardized questionnaire to collect data on herpes zoster occurrence from participants, with verbal informed consent obtained prior to the survey. Face-to-face interviews will also be conducted to verify reported herpes zoster cases. Moreover, their past medical history and lifestyle information will be collected.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

24740

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Provincial Center for Diseases Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

We plan to select 24,740 participants who were non-herpes zoster cases in the modified Full Analysis Set for Efficacy (E-mFAS) from the Phase III Clinical Trial (NCT04334577) of the live attenuated herpes zoster vaccine manufactured by Changchun BCHT Biotechnology Co. conducted during 2020-2021.

Description

Inclusion Criteria:

  1. Individuals included in the E-mFAS from the Phase III Clinical Trial (NCT04334577) of the live attenuated herpes zoster vaccine produced by Changchun BCHT biotechnology Co. conducted during 2020-2021.
  2. Individuals who were able to complete the study with verbal informed consent.

Exclusion Criteria:

  1. Individuals who developed herpes zoster during the original Phase III Clinical Trial follow-up period.
  2. Individuals who were known to have died before the retrospective study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
The vaccine group.
Biological: Attenuated Zoster Vaccine, Live
This vaccine was produced by Changchun BCHT Biotechnology Co.
Biological: Attenuated Zoster Vaccine, Live
After market authorization in June 2023, part of the participants originally assigned to placebo received catch-up vaccination with the marketed live attenuated herpes zoster vaccine produced by Changchun BCHT Biotechnology Co.
The placebo group.
Biological: Attenuated Zoster Vaccine, Live
This vaccine was produced by Changchun BCHT Biotechnology Co.
Biological: Attenuated Zoster Vaccine, Live
After market authorization in June 2023, part of the participants originally assigned to placebo received catch-up vaccination with the marketed live attenuated herpes zoster vaccine produced by Changchun BCHT Biotechnology Co.
Biological: Matched Placebo Without Live Virus
This placebo was produced by Changchun BCHT Biotechnology Co. for use in the Phase III Clinical Trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Herpes Zoster comparing participants originally assigned to the vaccine group and participants originally assigned to the placebo group
Time Frame: From the end of the Phase III Clinical Trial in July 2021 to June 2023, before catch-up vaccination among placebo participants
From the end of the Phase III Clinical Trial in July 2021 to June 2023, before catch-up vaccination among placebo participants

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of Herpes Zoster comparing participants in the original placebo group who received catch-up vaccination and participants originally assigned to the vaccine group under continued follow-up
Time Frame: From June 2023 to the survey date in 2026
From June 2023 to the survey date in 2026
Incidence of Herpes Zoster among participants originally assigned to the placebo group, comparing the post-catch-up vaccination period with their earlier placebo period before catch-up vaccination
Time Frame: From July 2021 to June 2023 for the earlier placebo period, and from June 2023 to the survey date in 2026 for the post-catch-up vaccination period
From July 2021 to June 2023 for the earlier placebo period, and from June 2023 to the survey date in 2026 for the post-catch-up vaccination period

Other Outcome Measures

Outcome Measure
Time Frame
Incidence of Herpes Zoster stratified by sex
Time Frame: From July 2021 to the survey date in 2026
From July 2021 to the survey date in 2026
Incidence of Herpes Zoster stratified by age group
Time Frame: From July 2021 to the survey date in 2026
From July 2021 to the survey date in 2026
Incidence of Herpes Zoster stratified by chronic disease history
Time Frame: From July 2021 to the survey date in 2026
From July 2021 to the survey date in 2026
Incidence of Herpes Zoster stratified by immunosuppressive treatment history
Time Frame: From July 2021 to the survey date in 2026
From July 2021 to the survey date in 2026
Incidence of Herpes Zoster stratified by alcohol use
Time Frame: From July 2021 to the survey date in 2026
From July 2021 to the survey date in 2026
Incidence of Herpes Zoster stratified by smoking status
Time Frame: From July 2021 to the survey date in 2026
From July 2021 to the survey date in 2026
Incidence of Herpes Zoster stratified by physical activity or physical labor
Time Frame: From July 2021 to the survey date in 2026
From July 2021 to the survey date in 2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

Collaborators

Zhejiang Provincial Center for Disease Control and Prevention (Zhejiang Provincial Academy of Preventive Medicine)
Changxing County Center for Disease Control and Prevention (Changxing County Health Supervision Institute)
Guanyun County Center for Disease Control and Prevention (Guanyun County Health Supervision Institute)
Pizhou City Center for Disease Control and Prevention (Health Supervision Institute)
Pei County Center for Disease Control and Prevention (Pei County Health Supervision Institute)
Binhai County Center for Disease Control and Prevention (Binhai County Health Supervision Institute)

Investigators

  • Principal Investigator: Pengfei Jin, Jiangsu Provincial Center for Diseases Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

May 7, 2026

First Submitted That Met QC Criteria

May 7, 2026

First Posted (Actual)

May 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JSIIT006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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