Long-term Effectiveness of a Recombinant Hepatitis E Vaccine

Study Overview
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Brief Summary
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This test-negative study is designed to evaluate the long-term effectiveness of hepatitis E vaccine (Hecolin®) and to explore the prevalence of rat hepatitis E in Dongtai City.

Detailed Description
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In this negative test study, residual clinical serum will be collected from 13 hospitals in Dongtai, if it was from patients born between 1941-1991 from 11 towns in Dongtai, who tested positive for ALT levels higher than 2.5 times the upper limit of normal (ULN). Detection of HEV IgM, IgG, antigen, RNA will be performed to diagnose hepatitis E (HE) in each individual. In addition, HE vaccination history will be collect. All the information above will be used to evaluate the long-term effectiveness of HE vaccine. Based on the study design, virological and serological detection (IgM, IgG, antigen, and RNA) of hepatitis E virus species C (HEV-C) will be performed to analyze the prevalence of rat hepatitis E infection in Dongtai.

Official Title
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Long-term Effectiveness of a Recombinant Hepatitis E Vaccine: a Test-negative Design Study

Conditions
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Hepatitis E

Intervention / Treatment
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* Diagnostic Test: serology and virology detection of hepatitis E virus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: From 11 townships（Anfeng、Fuan、Tangyang、Hougang、Liangduo、Qingdong、Shiyan、Shenzao、Wulie、Xuhe、Xinjie） ALT ≥ 2.5 ULN Born between 1941 and 1991

Ages Eligible for Study
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Minimum Age: 32 Years
Maximum Age: 82 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HE group<br>Subjects who has been diagnosed as HE. | Diagnostic Test: serology and virology detection of hepatitis E virus<br>* Serum will be tested for HEV serology and virology, including HEV-IgM, HEV-IgG, HEV-antigen, and HEV-RNA for HEV species A (HEV-A) and HEV species C (HEV-C)，and further HEV genotyping for those positive for HEV-RNA.<br>|
| Control group<br>Subjects who didn't meet the diagnosis criteria of HE. | Diagnostic Test: serology and virology detection of hepatitis E virus<br>* Serum will be tested for HEV serology and virology, including HEV-IgM, HEV-IgG, HEV-antigen, and HEV-RNA for HEV species A (HEV-A) and HEV species C (HEV-C)，and further HEV genotyping for those positive for HEV-RNA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of hepatitis E infection | In patients with ALT > 2.5 ULN, HEV infection is diagnosed as positive when two of the following indicators are positive: (1) HEV-IgM; (2) Seroconversion or four-fold increase of HEV-IgG；(3) HEV-RNA; (4) HEV-antigen. | Two months after sampling | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of rat hepatitis E infection | In patients with ALT > 2.5 ULN, rat hepatitis E infection is diagnosed as positive when two of the following virologic or serological tests are positive: (1) IgM anti-HEV-C-; (2) IgG anti-HEV-C- seroconversion or four-fold increase；(3) HEV-C-RNA; (4) HEV-C-antigen. | Two months after sampling | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis E, Test-Negative Design, Effectiveness, Vaccine, Rat hepatitis E virus infection