Herpes ZosterNCT07585370
Long-term Effectiveness of the Live Attenuated Herpes Zoster Vaccine
An observational study of Herpes Zoster, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Attenuated Zoster Vaccine, Live
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24,740 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2026to 30 Jun 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jiangsu Provincial Center for Diseases Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine)
Nanjing, Jiangsu
Pengfei Jin, #86-25-83759913, jpf19891103@163.com
About this study
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
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.
- Conditions
- Herpes Zoster
- Being tested
- Attenuated Zoster Vaccine, Live, Matched Placebo Without Live Virus
- Keywords
- Virus Diseases, Infections, DNA Virus Infections, Herpesviridae Infections, Varicella Zoster Virus Infection, Herpes Zoster
- Medical subject headings
- Herpes Zoster, Virus Diseases, Infections, DNA Virus Infections, Herpesviridae Infections, Varicella Zoster Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attenuated Zoster Vaccine, LiveBiological
This vaccine was produced by Changchun BCHT Biotechnology Co.
Matched Placebo Without Live VirusBiological
This placebo was produced by Changchun BCHT Biotechnology Co. for use in the Phase III Clinical Trial.
Attenuated Zoster Vaccine, LiveBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| The vaccine group. | Not described Receives: Biological: Attenuated Zoster Vaccine, Live | |
| The placebo group. | Not described Receives: Biological: Matched Placebo Without Live Virus; Biological: Attenuated Zoster Vaccine, Live |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Herpes Zoster comparing participants originally assigned to the vaccine group and participants originally assigned to the placebo group
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start6 Mar 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 24,740 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Collaborators
- Zhejiang Provincial Center for Disease Control and Prevention, 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)
- Responsible party
- Sponsor
- Investigators
- Pengfei Jin, Principal investigator, Jiangsu Provincial Center for Diseases Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585370
- Sponsor's protocol ID
- JSIIT006
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No