Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-03-24 @ 9:46 PM
Study NCT ID:
NCT00230061
Status:
COMPLETED
Last Update Posted:
2010-06-02
First Post:
2005-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatitis B Vaccination in HIV-infected Persons
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D006509', 'term': 'Hepatitis B'}], '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'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017325', 'term': 'Hepatitis B Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}], 'ancestors': [{'id': 'D014761', 'term': 'Viral Hepatitis Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-01', 'studyFirstSubmitDate': '2005-09-28', 'studyFirstSubmitQcDate': '2005-09-28', 'lastUpdatePostDateStruct': {'date': '2010-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of anti-Hbs titer after completing hepatitis B vaccination.'}], 'secondaryOutcomes': [{'measure': 'To compare response and compliance between two vaccination schedules: short and standard'}]}, 'conditionsModule': {'keywords': ['HIV'], 'conditions': ['HIV Infections', 'Hepatitis B']}, 'referencesModule': {'references': [{'pmid': '2019762', 'type': 'BACKGROUND', 'citation': 'Bodsworth NJ, Cooper DA, Donovan B. The influence of human immunodeficiency virus type 1 infection on the development of the hepatitis B virus carrier state. J Infect Dis. 1991 May;163(5):1138-40. doi: 10.1093/infdis/163.5.1138.'}, {'pmid': '9181644', 'type': 'BACKGROUND', 'citation': 'Sinicco A, Raiteri R, Sciandra M, Bertone C, Lingua A, Salassa B, Gioannini P. Coinfection and superinfection of hepatitis B virus in patients infected with human immunodeficiency virus: no evidence of faster progression to AIDS. Scand J Infect Dis. 1997;29(2):111-5. doi: 10.3109/00365549709035869.'}, {'pmid': '9252068', 'type': 'BACKGROUND', 'citation': 'Ockenga J, Tillmann HL, Trautwein C, Stoll M, Manns MP, Schmidt RE. Hepatitis B and C in HIV-infected patients. Prevalence and prognostic value. J Hepatol. 1997 Jul;27(1):18-24. doi: 10.1016/s0168-8278(97)80274-7.'}, {'pmid': '8988900', 'type': 'BACKGROUND', 'citation': 'Lemon SM, Thomas DL. Vaccines to prevent viral hepatitis. N Engl J Med. 1997 Jan 16;336(3):196-204. doi: 10.1056/NEJM199701163360307. No abstract available.'}, {'pmid': '3105779', 'type': 'BACKGROUND', 'citation': 'Carne CA, Weller IV, Waite J, Briggs M, Pearce F, Adler MW, Tedder RS. Impaired responsiveness of homosexual men with HIV antibodies to plasma derived hepatitis B vaccine. Br Med J (Clin Res Ed). 1987 Apr 4;294(6576):866-8. doi: 10.1136/bmj.294.6576.866.'}, {'pmid': '1535502', 'type': 'BACKGROUND', 'citation': 'Keet IP, van Doornum G, Safary A, Coutinho RA. Insufficient response to hepatitis B vaccination in HIV-positive homosexual men. AIDS. 1992 May;6(5):509-10. No abstract available.'}, {'pmid': '9116065', 'type': 'BACKGROUND', 'citation': 'Wong EK, Bodsworth NJ, Slade MA, Mulhall BP, Donovan B. Response to hepatitis B vaccination in a primary care setting: influence of HIV infection, CD4+ lymphocyte count and vaccination schedule. Int J STD AIDS. 1996 Nov-Dec;7(7):490-4. doi: 10.1258/0956462961918563.'}, {'pmid': '1532609', 'type': 'BACKGROUND', 'citation': 'Bruguera M, Cremades M, Salinas R, Costa J, Grau M, Sans J. Impaired response to recombinant hepatitis B vaccine in HIV-infected persons. J Clin Gastroenterol. 1992 Jan;14(1):27-30. doi: 10.1097/00004836-199201000-00007.'}, {'pmid': '10649616', 'type': 'BACKGROUND', 'citation': 'Rey D, Krantz V, Partisani M, Schmitt MP, Meyer P, Libbrecht E, Wendling MJ, Vetter D, Nicolle M, Kempf-Durepaire G, Lang JM. Increasing the number of hepatitis B vaccine injections augments anti-HBs response rate in HIV-infected patients. Effects on HIV-1 viral load. Vaccine. 2000 Jan 18;18(13):1161-5. doi: 10.1016/s0264-410x(99)00389-8.'}, {'pmid': '14575766', 'type': 'BACKGROUND', 'citation': 'Sasaki Md, Foccacia R, de Messias-Reason IJ. Efficacy of granulocyte-macrophage colony-stimulating factor (GM-CSF) as a vaccine adjuvant for hepatitis B virus in patients with HIV infection. Vaccine. 2003 Nov 7;21(31):4545-9. doi: 10.1016/s0264-410x(03)00500-0.'}, {'pmid': '11530313', 'type': 'BACKGROUND', 'citation': 'Wilson CM, Ellenberg JH, Sawyer MK, Belzer M, Crowley-Nowick PA, Puga A, Futterman DC, Peralta L; Adolescent Medicine HIV/AIDS Research Network. Serologic response to hepatitis B vaccine in HIV infected and high-risk HIV uninfected adolescents in the REACH cohort. Reaching for Excellence in Adolescent Care and Health. J Adolesc Health. 2001 Sep;29(3 Suppl):123-9. doi: 10.1016/s1054-139x(01)00278-6.'}, {'pmid': '7802981', 'type': 'BACKGROUND', 'citation': 'Rutstein RM, Rudy B, Codispoti C, Watson B. Response to hepatitis B immunization by infants exposed to HIV. AIDS. 1994 Sep;8(9):1281-4. doi: 10.1097/00002030-199409000-00010.'}, {'pmid': '8874636', 'type': 'BACKGROUND', 'citation': 'Scolfaro C, Fiammengo P, Balbo L, Madon E, Tovo PA. Hepatitis B vaccination in HIV-1-infected children: double efficacy doubling the paediatric dose. AIDS. 1996 Sep;10(10):1169-70. No abstract available.'}, {'pmid': '14622443', 'type': 'BACKGROUND', 'citation': 'Saltoglu N, Inal AS, Tasova Y, Kandemir O. Comparison of the accelerated and classic vaccination schedules against Hepatitis B: three-week Hepatitis B vaccination schedule provides immediate and protective immunity. Ann Clin Microbiol Antimicrob. 2003 Nov 17;2:10. doi: 10.1186/1476-0711-2-10.'}, {'pmid': '8310757', 'type': 'BACKGROUND', 'citation': 'Marchou B, Picot N, Chavanet P, Auvergnat JC, Armengaud M, Devilliers P, Cerisier JE, Marie FN, Excler JL. Three-week hepatitis B vaccination provides protective immunity. Vaccine. 1993 Nov;11(14):1383-5. doi: 10.1016/0264-410x(93)90165-t.'}, {'pmid': '11803077', 'type': 'BACKGROUND', 'citation': 'Nothdurft HD, Dietrich M, Zuckerman JN, Knobloch J, Kern P, Vollmar J, Sanger R. A new accelerated vaccination schedule for rapid protection against hepatitis A and B. Vaccine. 2002 Jan 15;20(7-8):1157-62. doi: 10.1016/s0264-410x(01)00432-7.'}, {'pmid': '12564251', 'type': 'BACKGROUND', 'citation': 'Wright NM, Campbell TL, Tompkins CN. Comparison of conventional and accelerated hepatitis B immunisation schedules for homeless drug users. Commun Dis Public Health. 2002 Dec;5(4):324-6.'}]}, 'descriptionModule': {'briefSummary': 'In this study we compare the efficacy of two different HBV-vaccination schedules in HIV-infected persons concerning immune response and compliance. Short schedule: t=0,1,3 weeks and standard schedule: t=0,1,6 months.', 'detailedDescription': 'It is known that HIV-infected persons are more prone to develop chronic hepatitis B infection when they get infected with this virus. After developing chronic hepatitis B these patients are more likely to get livercirrosis and hepatocellular carcinoma (Bodsworth et al.).\n\nHepatitis B vaccination is available and the vaccine is about 95% protective in preventing immunocompetent persons from developing chronic hepatitis B infection (Lemon). The response on this vaccin is less effective in HIV-infected persons (Carne et al.). Furthermore there is a compliance problem in the standard scheme.\n\nIn this study we compare the efficacy of two different HBV vaccination schedules in HIV-infected persons concerning immune response and compliance. A short schedule: t=0,1,3 weeks, in which there are good results concerning immune response and compliance in immunocompetent persons (Saltog et al.) and the standard schedule: t=0,1,6 months. Patients not immune at week 28 will be offered boostervaccination. This consists of double doses at t=0,1,2 months.\n\n800 persons are needed to show non-inferiority with lower margin of 10% of the short schedule in comparison with the control group. Powercalculation is 80%. Randomization is stratified according to CD4 count(CD4 \\<200, 200-500, \\>500).\n\nThe hypothesis of the study is a better compliance and a comparable immune response in the short schedule, through which persons will be protected against hepatitis B in an early stage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV positive\n* Negative for HBsAg and anti-HBc\n* 18 years or older\n\nExclusion Criteria:\n\n* previous Hepatitis B vaccination\n* current opportunistic infection'}, 'identificationModule': {'nctId': 'NCT00230061', 'briefTitle': 'Hepatitis B Vaccination in HIV-infected Persons', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Randomised Open Label Clinical Trial of the Immune Response to Hepatitis B Vaccination in HIV-infected Persons.', 'orgStudyIdInfo': {'id': 'SNO-T-07-102'}}, 'armsInterventionsModule': {'interventions': [{'name': 'HBVAXPRO, Hepatitis B (Recombinant) vaccine, 10 mcg/ml', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000 CA', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Theodora EM de Vries-Sluijs, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stichting Nuts Ohra', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Theodora EMS de Vries-Sluijs', 'oldOrganization': 'ErasmusMC'}}}}