Long-term Effectiveness of a Recombinant Hepatitis E Vaccine
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| HE group Subjects who has been diagnosed as HE. |
Diagnostic Test: serology 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.
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| Control group Subjects who didn't meet the diagnosis criteria of HE. |
Diagnostic Test: serology 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.
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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From 11 townships（Anfeng、Fuan、Tangyang、Hougang、Liangduo、Qingdong、Shiyan、Shenzao、Wulie、Xuhe、Xin jie）
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ALT ≥ 2.5 ULN
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Born between 1941 and 1991
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dongtai Center for Disease Control and Prevention | Dongtai | Jiangsu | China | 224200 |
Sponsors and Collaborators
- Xiamen University
- Dongtai Center for Disease Control and Prevention
- Dongtai Hospital of Traditional Chinese Medicine
- Dongtai People's Hospital
Investigators
- Study Director: Zhang Jun, M.D., National Institute of Diagnostics and Vaccine Development in infectious disease, Xiamen University
Study Documents (Full-Text)
None provided.More Information
Publications
- Zhang J, Zhang XF, Huang SJ, Wu T, Hu YM, Wang ZZ, Wang H, Jiang HM, Wang YJ, Yan Q, Guo M, Liu XH, Li JX, Yang CL, Tang Q, Jiang RJ, Pan HR, Li YM, Shih JW, Ng MH, Zhu FC, Xia NS. Long-term efficacy of a hepatitis E vaccine. N Engl J Med. 2015 Mar 5;372(10):914-22. doi: 10.1056/NEJMoa1406011. Erratum In: N Engl J Med. 2015 Apr 9;372(15):1478.
- Zhu FC, Zhang J, Zhang XF, Zhou C, Wang ZZ, Huang SJ, Wang H, Yang CL, Jiang HM, Cai JP, Wang YJ, Ai X, Hu YM, Tang Q, Yao X, Yan Q, Xian YL, Wu T, Li YM, Miao J, Ng MH, Shih JW, Xia NS. Efficacy and safety of a recombinant hepatitis E vaccine in healthy adults: a large-scale, randomised, double-blind placebo-controlled, phase 3 trial. Lancet. 2010 Sep 11;376(9744):895-902. doi: 10.1016/S0140-6736(10)61030-6. Epub 2010 Aug 20.
- PRO-HE-004-2