How long the live shingles vaccine protects you
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 will see if the live attenuated shingles vaccine keeps adults from the original Phase III trial protected against herpes zoster for up to six years after vaccination.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 24740 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Jiangsu Province Centers for Disease Control and Prevention Research network |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT07585370 on ClinicalTrials.gov |
What this trial studies
This multicenter retrospective cohort study will include 24,740 participants who were non-herpes zoster cases in the modified full analysis set (E-mFAS) from the Phase III trial (NCT04334577) conducted in 2020–2021. Individuals originally randomized 1:1 to receive one dose of the live attenuated zoster vaccine (≥4.3 lg PFU per 0.5 mL) or matched placebo will be compared using a stage-based design to measure cumulative incidence of herpes zoster within six years after vaccination. Stage 1 will compare outcomes between the originally vaccinated and placebo groups using data collected at participating provincial and county CDC sites. People who developed herpes zoster during the original trial or who died before the retrospective follow-up are excluded from this analysis.
Who should consider this trial
Good fit: Ideal candidates are adults who were enrolled in the Phase III trial (NCT04334577), remained herpes zoster–free during that trial (E-mFAS), and can provide verbal informed consent for retrospective follow-up.
Not a fit: Individuals who developed herpes zoster during the original trial, who died before the retrospective study, or who were not part of the original Phase III cohort are not eligible and will not benefit from this analysis.
Why it matters
Potential benefit: If successful, the results could clarify how long this vaccine protects and inform booster or vaccination policy decisions.
How similar studies have performed: Previous long-term studies of live zoster vaccines (for example Zostavax) have shown initial protection with waning immunity over several years, so the approach is established but long-term effectiveness varies by vaccine and population.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Nanjing, Jiangsu
- Jiangsu Provincial Center for Diseases Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine) — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Pengfei Jin — Jiangsu Provincial Center for Diseases Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine)
- Study coordinator: Pengfei Jin
- Email: jpf19891103@163.com
- Phone: #86-25-83759913
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.