Long-term Effectiveness of the Live Attenuated Herpes Zoster Vaccine
1 other identifier
observational
24,740
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2026
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 6, 2026
CompletedFirst Submitted
Initial submission to the registry
May 7, 2026
CompletedFirst Posted
Study publicly available on registry
May 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
May 13, 2026
May 1, 2026
4 months
May 7, 2026
May 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Herpes Zoster comparing participants originally assigned to the vaccine group and participants originally assigned to the placebo group
From the end of the Phase III Clinical Trial in July 2021 to June 2023, before catch-up vaccination among placebo participants
Secondary Outcomes (2)
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
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
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 Outcomes (7)
Incidence of Herpes Zoster stratified by sex
From July 2021 to the survey date in 2026
Incidence of Herpes Zoster stratified by age group
From July 2021 to the survey date in 2026
Incidence of Herpes Zoster stratified by chronic disease history
From July 2021 to the survey date in 2026
- +4 more other outcomes
Study Arms (2)
The vaccine group.
The placebo group.
Interventions
This vaccine was produced by Changchun BCHT Biotechnology Co.
This placebo was produced by Changchun BCHT Biotechnology Co. for use in the Phase III Clinical Trial.
Eligibility Criteria
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.
You may qualify if:
- 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.
- Individuals who were able to complete the study with verbal informed consent.
You may not qualify if:
- Individuals who developed herpes zoster during the original Phase III Clinical Trial follow-up period.
- Individuals who were known to have died before the retrospective study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jiangsu Province Centers for Disease Control and Preventionlead
- Changxing County Center for Disease Control and Prevention (Changxing County Health Supervision Institute)collaborator
- Guanyun County Center for Disease Control and Prevention (Guanyun County Health Supervision Institute)collaborator
- Pizhou City Center for Disease Control and Prevention (Health Supervision Institute)collaborator
- Pei County Center for Disease Control and Prevention (Pei County Health Supervision Institute)collaborator
- Binhai County Center for Disease Control and Prevention (Binhai County Health Supervision Institute)collaborator
- Zhejiang Provincial Center for Disease Control and Prevention (Zhejiang Provincial Academy of Preventive Medicine)collaborator
Study Sites (1)
Jiangsu Provincial Center for Diseases Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine)
Nanjing, Jiangsu, China
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Pengfei Jin
Jiangsu Provincial Center for Diseases Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2026
First Posted
May 13, 2026
Study Start
March 6, 2026
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
May 13, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share