Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-02-20 @ 6:01 PM
Study NCT ID:
NCT02003703
Status:
COMPLETED
Last Update Posted:
2019-01-31
First Post:
2013-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV .
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C075654', 'term': 'Engerix-B'}, {'id': 'C023768', 'term': 'halofantrine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-29', 'studyFirstSubmitDate': '2013-12-02', 'studyFirstSubmitQcDate': '2013-12-05', 'lastUpdatePostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serologic Response', 'timeFrame': '4-8 weeks After Exposure', 'description': 'Number of participants with positive hepatitis B surface antigen (HBsAg) antibodies 4 to 8 weeks after completion of the vaccination schemes.'}], 'secondaryOutcomes': [{'measure': 'Local Reactions to Vaccine', 'timeFrame': 'One Week after Exposure', 'description': 'Number of participants presenting dermatologic reactions to the vaccine up to one week after exposure.'}, {'measure': 'Systemic Reactions to the Vaccine', 'timeFrame': 'One Week after Exposure', 'description': 'Number of participants presenting any systemic adverse reaction attributable to vaccination.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vaccine', 'Primary Prevention', 'Immunogenicity'], 'conditions': ['Hepatitis B', 'HIV']}, 'referencesModule': {'references': [{'pmid': '34424307', 'type': 'DERIVED', 'citation': 'Vargas JI, Jensen D, Martinez F, Sarmiento V, Peirano F, Acuna P, Provoste F, Bustos V, Cornejo F, Fuster A, Acuna M, Fuster F, Soto S, Estay D, Jensen W, Ahumada R, Arab JP, Soza A, Fuster F. Comparative Efficacy of a High-Dose vs Standard-Dose Hepatitis B Revaccination Schedule Among Patients With HIV: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2120929. doi: 10.1001/jamanetworkopen.2021.20929.'}]}, 'descriptionModule': {'briefSummary': "Hepatitis B virus infection is a common occurrence among patients with HIV. Effective vaccines are available, but there's some uncertainty regarding specific dosages, specially among those who have not responded to an initial vaccination. The purpose of this study is to determine the effectiveness of a simplified immunization schedule compared to a high-dose one."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 18 years of age.\n* Patients infected with Human Immunodeficiency Virus (HIV)\n* Failed previous vaccination with a standard dose scheme of recombinant hepatitis B vaccine (20mcg at 0, 1 and 6 months). Nonresponders will be considered as those patients presenting a hepatitis B surface antigen antibody titer lower than 10UI/mL 4 to 8 weeks after the last dose of the vaccine.\n* Provision of informed consent.\n\nExclusion Criteria:\n\n* Proven Hepatitis B virus infection (acute or chronic).\n* Proven hypersensitivity to the vaccine or any of its components.'}, 'identificationModule': {'nctId': 'NCT02003703', 'acronym': 'CORE-HIV', 'briefTitle': 'Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV .', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Valparaiso'}, 'officialTitle': 'Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV : A Randomised Trial', 'orgStudyIdInfo': {'id': '45/2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Recombinant Hepatitis B Virus Vaccine (High Dose)', 'description': 'Patients allocated to this arm will receive three doses of 40mcg each of recombinant hepatitis B vaccine (Engerix-B (R)). Doses will be administered at 0, 1 and 2 months.', 'interventionNames': ['Biological: Recombinant Hepatitis B Virus Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Recombinant Hepatitis B Virus Vaccine (Standard Dose)', 'description': 'Patients allocated to this arm will receive three doses of 20mcg each of recombinant hepatitis B vaccine (Engerix-B (R)). Doses will be administered at 0, 1 and 2 months.', 'interventionNames': ['Biological: Recombinant Hepatitis B Virus Vaccine']}], 'interventions': [{'name': 'Recombinant Hepatitis B Virus Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Engerix B (GlaxoSmithKline)'], 'armGroupLabels': ['Recombinant Hepatitis B Virus Vaccine (High Dose)', 'Recombinant Hepatitis B Virus Vaccine (Standard Dose)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Viña del Mar', 'state': 'Región de Valparaíso', 'country': 'Chile', 'facility': 'Hospital Gustavo Fricke', 'geoPoint': {'lat': -33.02457, 'lon': -71.55183}}], 'overallOfficials': [{'name': 'Francisco Fuster, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Gustavo Fricke, Viña del Mar, Chile'}, {'name': 'Jose I Vargas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Escuela de Medicina, Universidad de Valparaíso, Chile'}, {'name': 'Daniela Jensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Escuela de Medicina, Universidad de Valparaíso'}, {'name': 'Felipe T Martinez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro de Investigaciones Biomédicas, Escuela de Medicina, Universidad de Valparaíso'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Valparaiso', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}, {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, {'name': 'Aclin Laboratory', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Felipe Martinez', 'investigatorAffiliation': 'Universidad de Valparaiso'}}}}