Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-29 @ 9:58 AM
Study NCT ID:
NCT03962803
Status:
UNKNOWN
Last Update Posted:
2019-05-24
First Post:
2019-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Persistence of Hepatitis B Vaccination in HIV-Infected 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': '2019-06-05', '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', 'HIV-Infected Patients', 'Immunogenicity', 'Long-term Immune Response'], 'conditions': ['Hepatitis B Vaccine']}, 'referencesModule': {'references': [{'pmid': '35312441', 'type': 'DERIVED', 'citation': 'Feng Y, Chen Z, Xie R, Yao T, Wu Y, Yang F, Yuan C, Nie X, Wang F, Liang X, Wang S. Immunogenicity and safety of 4 intramuscular standard-dose and high-dose hepatitis B vaccine in people living with HIV: a randomized, parallel-controlled trial. Expert Rev Vaccines. 2022 Jun;21(6):861-868. doi: 10.1080/14760584.2022.2056024. Epub 2022 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'At present, HIV-Infected 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 HIV-Infected 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': '18 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* CD4 cell count ≤ 200 cells/µL\n* Patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever\n* The use of immunosuppressive agents in patients with nearly three months'}, 'identificationModule': {'nctId': 'NCT03962803', 'briefTitle': 'Immunogenicity and Persistence of Hepatitis B Vaccination in HIV-Infected Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shanxi Medical University'}, 'officialTitle': 'A Prospective Study on the Immunogenicity and Persistence of Hepatitis B Vaccine in HIV-Infected Patients', 'orgStudyIdInfo': {'id': '2018ZX10721202001002001'}}, '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', 'facility': 'Shanxi Center for Disease Control and Prevention', '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'}}}}