Hepatitis E
Conditions
Keywords
Hepatitis E, Test-Negative Design, Effectiveness, Vaccine, Rat hepatitis E virus infection
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTserology and virology detection of hepatitis E virus
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.
Sponsors
Dongtai Center for Disease Control and Prevention
Dongtai Hospital of Traditional Chinese Medicine
Dongtai People's Hospital
Xiamen University
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
32 Years to 82 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of hepatitis E infection | Two months after sampling | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of rat hepatitis E infection | Two months after sampling | 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. |
Countries
China
Contacts
Primary ContactZhang Jun, PhD
Outcome results
None listed