Long-term Effectiveness of the Live Attenuated Herpes Zoster Vaccine

Официальное название

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

Обзор

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.

Вмешательства

• Биопрепарат Attenuated Zoster Vaccine, Live
  This vaccine was produced by Changchun BCHT Biotechnology Co.
• Биопрепарат Matched Placebo Without Live Virus
  This placebo was produced by Changchun BCHT Biotechnology Co. for use in the Phase III Clinical Trial.
• Биопрепарат 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.

Первичные конечные точки

• Incidence of Herpes Zoster comparing participants originally assigned to the vaccine group and participants originally assigned to the placebo group [Срок оценки: From the end of the Phase III Clinical Trial in July 2021 to June 2023, before catch-up vaccination among placebo participants]

Вторичные конечные точки (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 [Срок оценки: 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 [Срок оценки: 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]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Jiangsu Provincial Center for Diseases Control and Prevention (Jiangsu Provincial Academy — Нанкин

Идентификаторы

NCT: NCT07585370 · JSIIT006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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