Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT03962816
Status:
UNKNOWN
Last Update Posted:
2019-05-24
First Post:
2019-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunogenicity and Persistence of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-05-26', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-23', 'studyFirstSubmitDate': '2019-05-23', 'studyFirstSubmitQcDate': '2019-05-23', 'lastUpdatePostDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-HBs Seroconversion Rate at Month 7', 'timeFrame': 'Month 7', 'description': 'Anti-HBs Seroconversion Rate at month 7 as measured by CMIA'}], 'secondaryOutcomes': [{'measure': 'Anti-HBs concentration at month 7', 'timeFrame': 'Month 7', 'description': 'Anti-HBs concentration at month 7 as measured by CMIA'}, {'measure': 'Occurrence of Adverse Events After Vaccination', 'timeFrame': 'Within 7 days after the vaccination', 'description': 'Occurrence of adverse reactions within 7 days after vaccination with the hepatitis'}, {'measure': 'Anti-HBs Seroconversion Rate at month 12', 'timeFrame': 'Month 12', 'description': 'Anti-HBs Seroconversion Rate at month 12 as measured by CMIA'}, {'measure': 'Anti-HBs concentration at month 12', 'timeFrame': 'Month 12', 'description': 'Anti-HBs concentration at month 12 as measured by CMIA'}, {'measure': 'Anti-HBs Seroconversion Rate at month 18', 'timeFrame': 'Month 18', 'description': 'Anti-HBs Seroconversion Rate at month 18 as measured by CMIA'}, {'measure': 'Anti-HBs concentration at month 18', 'timeFrame': 'Month 18', 'description': 'Anti-HBs concentration at month 18 as measured by CMIA'}, {'measure': 'Anti-HBs Seroconversion Rate at month 30', 'timeFrame': 'Month 30', 'description': 'Anti-HBs Seroconversion Rate at month 30 as measured by CMIA'}, {'measure': 'Anti-HBs concentration at month 30', 'timeFrame': 'Month 30', 'description': 'Anti-HBs concentration at month 30 as measured by CMIA'}, {'measure': 'Anti-HBs Seroconversion Rate at month 42', 'timeFrame': 'Month 42', 'description': 'Anti-HBs Seroconversion Rate at month 42 as measured by CMIA'}, {'measure': 'Anti-HBs concentration at month 42', 'timeFrame': 'Month 42', 'description': 'Anti-HBs concentration at month 42 as measured by CMIA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatitis B Vaccine', 'Randomized Controlled Trial', 'Methadone Maintenance Treatment Patients', 'Immunogenicity', 'Long-term Immune Response'], 'conditions': ['Hepatitis B Vaccine']}, 'referencesModule': {'references': [{'pmid': '39819251', 'type': 'DERIVED', 'citation': 'Mo X, Men Z, Gao L, Gao Y, Yao T, Liu Y, Yuan Y, Xue T, Wang F, Wang S, Wang K, Liang X, Feng Y. Immunogenicity persistence after four intramuscular triple-dose or standard-dose hepatitis B vaccine in patients receiving methadone maintenance treatment: A 1-year follow-up study in China. Hum Vaccin Immunother. 2025 Dec;21(1):2447108. doi: 10.1080/21645515.2024.2447108. Epub 2025 Jan 17.'}, {'pmid': '34503367', 'type': 'DERIVED', 'citation': 'Feng Y, Yao T, Gao Y, Li H, Dong S, Wu Y, Liu Y, Li J, Liu C, Liu J, Xue T, Yuan Y, Wu J, Wang F, Liang X, Wang S. Immunogenicity, safety, and compliance of high- and standard-strength four-dose hepatitis B vaccination regimens in patients receiving methadone maintenance therapy in China: a randomized, parallel-arm controlled trial. Expert Rev Vaccines. 2021 Dec;20(12):1629-1635. doi: 10.1080/14760584.2021.1977629. Epub 2021 Sep 16.'}]}, 'descriptionModule': {'briefSummary': 'At present, Methadone Maintenance Treatment Patients of Hepatitis B Vaccination in are vaccinated with hepatitis B vaccine according to the standard three-dose schedule immunization program, and the effect of preventing HBV infection is not ideal.\n\nThis is a randomized, controlled trial. The study will evaluate the immunogenicity and persistence of 20 µg and 60 µg recombinant hepatitis B vaccine with three or four injections at months 0, 1, and 6 or 0, 1,2, and 6 in Methadone Maintenance Treatment Patients', 'detailedDescription': 'Participants are randomized in a ratio of 1:1:1 into 20 µg recombinant hepatitis B vaccine group at months 0, 1, and 6 or 20µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6 or 60µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) and hepatitis B core antibody (anti-HBc) at enrollment\n* Sign informed consent, willing to participate in this study\n\nExclusion Criteria:\n\n* Being pregnant\n* Intolerance or allergy to any component of the vaccine\n* Any vaccination during the month preceding enrollment\n* Patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever\n* Patient with HIV Infection\n* The use of immunosuppressive agents in patients with nearly three months'}, 'identificationModule': {'nctId': 'NCT03962816', 'briefTitle': 'Immunogenicity and Persistence of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shanxi Medical University'}, 'officialTitle': 'A Prospective Study on the Immunogenicity and Persistence of Hepatitis B Vaccine in Methadone Maintenance Treatment Patients', 'orgStudyIdInfo': {'id': '2018ZX10721202001002002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '20 µg at months 0, 1, and 6', 'description': '20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6', 'interventionNames': ['Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6']}, {'type': 'EXPERIMENTAL', 'label': '20 µg at months 0, 1, 2,and 6', 'description': '20 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6', 'interventionNames': ['Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6']}, {'type': 'EXPERIMENTAL', 'label': '60 µg at months 0, 1, 2,and 6', 'description': '60 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6', 'interventionNames': ['Biological: 60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6']}], 'interventions': [{'name': '20 µg recombinant hepatitis B vaccine at months 0, 1, and 6', 'type': 'BIOLOGICAL', 'description': 'three-dose, 20 µg per dose', 'armGroupLabels': ['20 µg at months 0, 1, and 6']}, {'name': '20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6', 'type': 'BIOLOGICAL', 'description': 'four-dose, 20 µg per dose', 'armGroupLabels': ['20 µg at months 0, 1, 2,and 6']}, {'name': '60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6', 'type': 'BIOLOGICAL', 'description': 'four-dose, 60 µg per dose', 'armGroupLabels': ['60 µg at months 0, 1, 2,and 6']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taiyuan', 'country': 'China', 'contacts': [{'name': 'Yongliang Feng, PhD', 'role': 'CONTACT', 'email': 'fengyongliang048@163.com', 'phone': '#86-351-4135362'}], 'facility': 'Xinghualing Methadone Drug Point', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}], 'centralContacts': [{'name': 'Suping Wang, PhD', 'role': 'CONTACT', 'email': 'spwang88@163.com', 'phone': '#86-351-4135103'}, {'name': 'Yongliang Feng, PhD', 'role': 'CONTACT', 'email': 'fengyongliang048@163.com', 'phone': '#86-351-4135362'}], 'overallOfficials': [{'name': 'Suping Wang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanxi Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanxi Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention, China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Suping Wang', 'investigatorAffiliation': 'Shanxi Medical University'}}}}