Long-term Effectiveness of a Recombinant Hepatitis E Vaccine
NCT ID: NCT05976594
Last Updated: 2023-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2900 participants
OBSERVATIONAL
2023-08-12
2025-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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HE group
Subjects who has been diagnosed as HE.
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.
Control group
Subjects who didn't meet the diagnosis criteria of HE.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. ALT ≥ 2.5 ULN
3. Born between 1941 and 1991
32 Years
82 Years
ALL
No
Sponsors
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Dongtai Center for Disease Control and Prevention
UNKNOWN
Dongtai Hospital of Traditional Chinese Medicine
UNKNOWN
Dongtai People's Hospital
UNKNOWN
Xiamen University
OTHER
Responsible Party
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Jun Zhang
professor
Principal Investigators
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Zhang Jun, M.D.
Role: STUDY_DIRECTOR
National Institute of Diagnostics and Vaccine Development in infectious disease, Xiamen University
Locations
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Dongtai Center for Disease Control and Prevention
Dongtai, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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PRO-HE-004-2
Identifier Type: -
Identifier Source: org_study_id
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