Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-01-04 @ 7:56 AM
Study NCT ID:
NCT00480792
Status:
COMPLETED
Last Update Posted:
2013-07-23
First Post:
2007-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV Infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C075656', 'term': 'GenHevac B Pasteur'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 437}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-22', 'studyFirstSubmitDate': '2007-05-30', 'studyFirstSubmitQcDate': '2007-05-30', 'lastUpdatePostDateStruct': {'date': '2013-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HIV-infected patients who seroconvert in the first two months after the last vaccination. Seroconversion is defined as antibodies AbHBs titers equal or above 10 mUI per ml.', 'timeFrame': 'two months after the last injection;week 28, month 18, month 30 and month 42'}], 'secondaryOutcomes': [{'measure': 'According to the vaccine administration (IM or ID) comparison of AbHBs titers,permanence of the humoral response,intensity of clinical and biological events and predicting factors related to seroconversion', 'timeFrame': 'two months after the last injection; week 28, month 18, month 30 and month 42'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatitis B vaccination', 'GenHevac-B Pasteur', 'HIV Infections'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '27064975', 'type': 'DERIVED', 'citation': 'Launay O, Rosenberg AR, Rey D, Pouget N, Michel ML, Reynes J, Neau D, Raffi F, Piroth L, Carrat F; ANRS HB03 VIHVAC-B (Trial Comparing 3 Strategies of Vaccination Against the Virus of Hepatitis B in HIV-Infected Patients) Group. Long-term Immune Response to Hepatitis B Virus Vaccination Regimens in Adults With Human Immunodeficiency Virus 1: Secondary Analysis of a Randomized Clinical Trial. JAMA Intern Med. 2016 May 1;176(5):603-10. doi: 10.1001/jamainternmed.2016.0741.'}, {'pmid': '21486976', 'type': 'DERIVED', 'citation': 'Launay O, van der Vliet D, Rosenberg AR, Michel ML, Piroth L, Rey D, Colin de Verdiere N, Slama L, Martin K, Lortholary O, Carrat F; ANRS HB03 VIHVAC-B Trial. Safety and immunogenicity of 4 intramuscular double doses and 4 intradermal low doses vs standard hepatitis B vaccine regimen in adults with HIV-1: a randomized controlled trial. JAMA. 2011 Apr 13;305(14):1432-40. doi: 10.1001/jama.2011.351.'}]}, 'descriptionModule': {'briefSummary': 'In HIV infected patients, individuals exposed to the virus of Hepatitis B are more susceptible to develop a chronic and severe liver disease with a major risk of cirrhosis and liver cancer.\n\nHowever, the existing protocol of vaccination against Hepatitis B is less efficient in HIV-infected patients than in non HIV-infected-patients, and, in case of response, its longevity has to be followed up carefully. This study compares the efficacy of the standard protocol vaccination with GenHevac-B and 2 other protocols, a double-dose of GenHevac-B and a set of intradermal injections of Genhevac-B, in HIV-infected patients with lymphocytes T CD4 level above 200 permm3.', 'detailedDescription': 'Comparison of 3 vaccination strategy against Hepatitis B in patients with HIV infection T CD4 above 200 per mm3\n\nIntervention:\n\n1. Arm A: GenHevac-B 20 microgramme Intramuscular use at M0, M1, M6\n2. Arm B: GenHevac-B 40 microgramme Intramuscular use at M0, M1, M2, M6\n3. Arm C: GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge Eligible for Study: 18 years - NA, Genders Eligible for Study: Both\n\nCriteria\n\nInclusion criteria:\n\n* HIV infection\n* T CD4 count cell level above 200 per mm3\n* Serology Hepatitis B negative (AgHBs, AbHBs and AbHBc negative)\n* unchanged ARV for the last 3 months for patients who are receiving ARV at the screening visit\n* Undetectable for the last 6 months with ARV for any patient with T CD4 level below 350 per mm3\n* Pregnancy test negative at the screening and inclusion visits\n\nExclusion Criteria:\n\n* Any injection of the vaccine against Hepatitis B in the medical history\n* Acute cytolysis in the last 3 months with transaminases equal or above 5 times the upper normal range for HIV-HCV coinfected patients, or transaminases equal or above 2 times the upper normal for non coinfected patients\n* Any vaccine received one month before the inclusion\n* History of intolerance to any component of GenHevac-B\n* Evolutive opportunistic infection treated the month before the screening visit\n* Severe and acute pyretic infection or unexplained fever the week before inclusion\n* Evolutive hemopathy or solid-organ cancer\n* Prothrombin factor equal or below 50 percent and/or platelets equal or below 50 000 per mm3\n* Immunosuppressive treatment or general corticotherapy (equal or above 0,5 mg per kg per day during above 7 days) in the last 6 months before the screening visit\n* Previous Immunomodulating treatment (interferon, interleukin-2,etc) or plan in the next 6 months\n* Splenectomy\n* Decompensated cirrhosis (Child Pugh B or C)\n* Kidney deficient function (creatinine clearance below 50 ml per mn)\n* Other immunocompromised condition not related to HIV infection (solid-organ transplantation, chemotherapy in the last 6 months)\n* Any participation to another clinical trial plan until Week 28'}, 'identificationModule': {'nctId': 'NCT00480792', 'acronym': 'VIHVAC-B', 'briefTitle': 'Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV Infected Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'Open-label, Randomized, and Multicentric Phase III Clinical Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV-1-infected Patients With CD4-positive T-lymphocytes Counts Above 200 permm3 ANRS HB 03 VIHVAC-B', 'orgStudyIdInfo': {'id': '2006-003940-50'}, 'secondaryIdInfos': [{'id': 'ANRS HB 03 VIHVAC-B'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'GenHevac-B 20 microgramme Intramuscular use at M0, M1, M6', 'interventionNames': ['Biological: GenHevac B Pasteur']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'GenHevac-B 40 microgramme Intramuscular use at M0, M1, M2, M6', 'interventionNames': ['Biological: GenHevac B Pasteur']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': 'GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6', 'interventionNames': ['Biological: GenHevac B Pasteur']}], 'interventions': [{'name': 'GenHevac B Pasteur', 'type': 'BIOLOGICAL', 'otherNames': ['Sanofi Pasteur MSD'], 'description': 'Intra-muscular injection 20 microgramme Intramuscular use at M0, M1, M6', 'armGroupLabels': ['A']}, {'name': 'GenHevac B Pasteur', 'type': 'BIOLOGICAL', 'otherNames': ['Sanofi Pasteur MSD'], 'description': 'Intra-muscular injection 40 microgramme intramuscular use at M0, M1,M2, M6', 'armGroupLabels': ['B']}, {'name': 'GenHevac B Pasteur', 'type': 'BIOLOGICAL', 'otherNames': ['Sanofi Pasteur MSD'], 'description': 'GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Cochin CIC de vaccinologie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Odile Launay, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CIC de vaccinologie Cochin-Pasteur 27, rue du Fb Saint Jacques 75014 Paris Fr'}, {'name': 'Fabrice Carrat, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Inserm U707 27, rue de Chaligny 75571 Paris cedex 12 Fr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'MCM Vaccines B.V.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}