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Recruiting NCT07585370

Long-term Effectiveness of the Live Attenuated Herpes Zoster Vaccine

— Observational Herpes Zoster

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Attenuated Zoster Vaccine, Live, Matched Placebo Without Live Virus, Attenuated Zoster Vaccine, Live.
Who it may be relevant to
Registry conditions: Herpes Zoster. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Biological Attenuated Zoster Vaccine, Live
    This vaccine was 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.
  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (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 [Time frame: 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Jiangsu Provincial Center for Diseases Control and Prevention (Jiangsu Provincial Academy — Nanjing

Identifiers

NCT: NCT07585370 · JSIIT006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗