Evaluating the long-term effectiveness of a hepatitis E vaccine
Long-term Effectiveness of a Recombinant Hepatitis E Vaccine: a Test-negative Design Study
This study is testing how well the hepatitis E vaccine works over time in people from Dongtai City who have high liver enzyme levels.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2900 (estimated) |
| Ages | 32 Years to 82 Years |
| Sex | All |
| Sponsor | Xiamen University Academic / other |
| Locations | 1 site (Dongtai, Jiangsu) |
| Trial ID | NCT05976594 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the long-term effectiveness of the hepatitis E vaccine (Hecolin®) by collecting residual clinical serum from patients in Dongtai City who have elevated ALT levels. The study will involve patients born between 1941 and 1991 from 11 townships, and will utilize serological and virological tests to diagnose hepatitis E and analyze the prevalence of rat hepatitis E infection. Data on vaccination history will also be collected to evaluate the vaccine's effectiveness over time.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals born between 1941 and 1991 from specific townships in Dongtai who have elevated ALT levels.
Not a fit: Patients who do not meet the age or ALT criteria, or those not residing in the specified townships, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term protection offered by the hepatitis E vaccine, potentially improving vaccination strategies.
How similar studies have performed: While there have been studies on hepatitis E vaccines, this specific approach focusing on long-term effectiveness and prevalence in a defined population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. From 11 townships（Anfeng、Fuan、Tangyang、Hougang、Liangduo、Qingdong、Shiyan、Shenzao、Wulie、Xuhe、Xinjie） 2. ALT ≥ 2.5 ULN 3. Born between 1941 and 1991
Where this trial is running
Dongtai, Jiangsu
- Dongtai Center for Disease Control and Prevention — Dongtai, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Zhang Jun, PhD
- Email: zhangj@xmu.edu.cn
- Phone: 0592-2184110
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.