Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT05976594
Status:
UNKNOWN
Last Update Posted:
2023-08-15
First Post:
2023-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Effectiveness of a Recombinant Hepatitis E Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016751', 'term': 'Hepatitis E'}], 'ancestors': [{'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Clinical residual serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2900}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-12', 'studyFirstSubmitDate': '2023-07-19', 'studyFirstSubmitQcDate': '2023-07-28', 'lastUpdatePostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of hepatitis E infection', 'timeFrame': 'Two months after sampling', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Rate of rat hepatitis E infection', 'timeFrame': 'Two months after sampling', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatitis E', 'Test-Negative Design', 'Effectiveness', 'Vaccine', 'Rat hepatitis E virus infection'], 'conditions': ['Hepatitis E']}, 'referencesModule': {'references': [{'pmid': '20728932', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25738667', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '82 Years', 'minimumAge': '32 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from the designated township who met the criteria of "ALT ≥ 2.5 ULN" and born between 1941 and 1991 will be enrolled in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. From 11 townships（Anfeng、Fuan、Tangyang、Hougang、Liangduo、Qingdong、Shiyan、Shenzao、Wulie、Xuhe、Xinjie）\n2. ALT ≥ 2.5 ULN\n3. Born between 1941 and 1991'}, 'identificationModule': {'nctId': 'NCT05976594', 'briefTitle': 'Long-term Effectiveness of a Recombinant Hepatitis E Vaccine', 'organization': {'class': 'OTHER', 'fullName': 'Xiamen University'}, 'officialTitle': 'Long-term Effectiveness of a Recombinant Hepatitis E Vaccine: a Test-negative Design Study', 'orgStudyIdInfo': {'id': 'PRO-HE-004-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HE group', 'description': 'Subjects who has been diagnosed as HE.', 'interventionNames': ['Diagnostic Test: serology and virology detection of hepatitis E virus']}, {'label': 'Control group', 'description': "Subjects who didn't meet the diagnosis criteria of HE.", 'interventionNames': ['Diagnostic Test: serology and virology detection of hepatitis E virus']}], 'interventions': [{'name': 'serology and virology detection of hepatitis E virus', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Control group', 'HE group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '224200', 'city': 'Dongtai', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yang Changlin', 'role': 'CONTACT', 'email': '759106863@qq.com', 'phone': '0515-85212669'}], 'facility': 'Dongtai Center for Disease Control and Prevention', 'geoPoint': {'lat': 32.85231, 'lon': 120.30947}}], 'centralContacts': [{'name': 'Zhang Jun, PhD', 'role': 'CONTACT', 'email': 'zhangj@xmu.edu.cn', 'phone': '0592-2184110'}], 'overallOfficials': [{'name': 'Zhang Jun, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Institute of Diagnostics and Vaccine Development in infectious disease, Xiamen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data sharing requires investigator consent'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiamen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dongtai Center for Disease Control and Prevention', 'class': 'UNKNOWN'}, {'name': 'Dongtai Hospital of Traditional Chinese Medicine', 'class': 'UNKNOWN'}, {'name': "Dongtai People's Hospital", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Jun Zhang', 'investigatorAffiliation': 'Xiamen University'}}}}