Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-31 @ 8:17 PM
Study NCT ID:
NCT00100633
Status:
COMPLETED
Last Update Posted:
2008-10-01
First Post:
2005-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of and Immune Response to a Hepatitis B Virus Vaccine Given With a Booster (CpG7909 ODN) in HIV Infected and HIV Uninfected People
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'}], 'ancestors': [{'id': 'D014761', 'term': 'Viral Hepatitis Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-29', 'studyFirstSubmitDate': '2005-01-04', 'studyFirstSubmitQcDate': '2005-01-04', 'lastUpdatePostDateStruct': {'date': '2008-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of HIV peptides to which HIV infected patients respond using ELISPOT (CpG vs. no CpG in HIV infected participants)'}, {'measure': 'total number of CD8+ lymphocytes responding after HIV-peptide stimulation using ELISPOT (CpG vs. no CpG in HIV infected participants)'}, {'measure': 'safety'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients who develop protective hepatitis B (HB) antibody concentration (CpG vs. no CpG in HIV infected participants)'}, {'measure': 'percentage of patients who develop HB specific CD8+ lymphocyte responses using ELISPOT (CpG vs. no CpG in HIV infected participants)'}, {'measure': 'percentage of patients who develop HB specific CD8+ lymphocyte responses using ELISPOT (CpG vs. no CpG in all participants)'}, {'measure': 'percentage of patients who develop CD8+ lymphocyte proliferative responses as measured using CFSE (CpG vs. no CpG in HIV infected participants)'}, {'measure': 'percentage of patients who develop CD8+ lymphocyte proliferative responses as measured using CFSE (CpG vs. no CpG in all participants)'}, {'measure': 'expression of costimulatory molecules on B-cells in peripheral blood (CpG vs. no CpG in HIV infected participants)'}, {'measure': 'expression of costimulatory molecules on B-cells in peripheral blood (CpG recipients, HIV infected vs. uninfected participants)'}, {'measure': 'spontaneous IFN-gamma production in peripheral blood (CpG recipients, HIV infected vs. uninfected participants)'}]}, 'conditionsModule': {'keywords': ['Hepatitis B Vaccine', 'Treatment Experienced', 'Treatment Naive'], 'conditions': ['HIV Infections', 'Hepatitis B']}, 'referencesModule': {'references': [{'pmid': '15596832', 'type': 'BACKGROUND', 'citation': 'Jiang JQ, Patrick A, Moss RB, Rosenthal KL. CD8+ T-cell-mediated cross-clade protection in the genital tract following intranasal immunization with inactivated human immunodeficiency virus antigen plus CpG oligodeoxynucleotides. J Virol. 2005 Jan;79(1):393-400. doi: 10.1128/JVI.79.1.393-400.2005.'}, {'pmid': '15507621', 'type': 'BACKGROUND', 'citation': 'Schlaepfer E, Audige A, von Beust B, Manolova V, Weber M, Joller H, Bachmann MF, Kundig TM, Speck RF. CpG oligodeoxynucleotides block human immunodeficiency virus type 1 replication in human lymphoid tissue infected ex vivo. J Virol. 2004 Nov;78(22):12344-54. doi: 10.1128/JVI.78.22.12344-12354.2004.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the safety of and immune response to a hepatitis B virus vaccine series given with a boosting agent, CpG7909 oligodeoxynucleotides (ODN), in HIV infected and HIV uninfected individuals who previously failed to develop a response to hepatitis B vaccine.\n\nStudy hypothesis: Administration of CpG7909 ODN together with recombinant hepatitis B vaccine will result in increased frequency and magnitude of response to vaccine in individuals who have previously failed to mount a response to vaccination, and that in HIV infected subjects with detectable plasma viremia, it will lead to the enhancement of HIV-specific responses.', 'detailedDescription': 'As HIV disease progresses in HIV infected people, their immune responses to infectious and other foreign invaders becomes weaker; in particular, the cellular (T-cell) immune response is particularly affected by HIV. A boosting agent called CpG7909 ODN may be an ideal adjuvant for vaccines given to HIV infected people, because it may help elicit an increased CD8 T-cell response. This study will evaluate the safety of and immune response to a hepatitis B virus vaccine series given with CpG7909 ODN in HIV infected and uninfected people.\n\nThere will be three groups in this study; participants will be stratified by baseline CD4 counts and viral load. Within each group, participants will be randomly assigned to receive 3 injections of hepatitis B vaccine with CpG7909 ODN or 3 injections of hepatitis B vaccine alone. Injections will be given at study entry and Months 1 and 6. There will be 10 study visits; a physical exam and blood collection will occur at each visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for HIV Infected Participants:\n\n* HIV-1 infection\n* If receiving combination antiretroviral therapy (ART), must have been on ART for at least 3 months prior to study entry. Patients who anticipate a change in treatment (either initiating ART or stopping ART) in the next 7 months are not eligible.\n* CD4 count of 250 cells/mm3 or greater\n* Negative HBsAb, HBsAg, and HBcAb\n* Willing to use acceptable forms of contraception while on study treatment and for 24 weeks after study treatment has ended\n\nInclusion Criteria for HIV Uninfected Participants:\n\n* HIV uninfected\n* Negative HBsAb, HBsAg, and HBcAb\n* Willing to use acceptable forms of contraception while on study treatment and for 24 weeks after study treatment has ended\n\nExclusion Criteria for All Participants:\n\n* Cancer. Participants with squamous cell or basal cell skin cancer are not excluded.\n* Autoimmune disease\n* Immunosuppressive medications. People who use or have used corticosteroid nasal sprays are not excluded. People who have received fewer than 2 weeks of systemic corticosteroids with the last dose over a month prior to study entry are not excluded.\n* Any medical or psychiatric condition or occupational responsibilities that may interfere with the study\n* Immunomodulator or investigational agent therapy within 30 days prior to study entry\n* Allergy/sensitivity to study drugs or their formulations, including thimerosal\n* Current drug or alcohol use that, in the opinion of the investigator, would interfere with the study\n* Active hepatitis C virus infection, as indicated by serum antibodies to HCV AND detectable HCV RNA in plasma\n* Blood clotting abnormalities\n* Any other condition that, in the opinion of the investigator, might interfere with the study\n* Pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT00100633', 'briefTitle': 'Safety of and Immune Response to a Hepatitis B Virus Vaccine Given With a Booster (CpG7909 ODN) in HIV Infected and HIV Uninfected People', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Immunologic Effects of CpG ODN Administration to HIV Uninfected and HIV Infected Patients', 'orgStudyIdInfo': {'id': 'P01AI055793', 'link': 'https://reporter.nih.gov/quickSearch/P01AI055793', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'P01AI055793', 'link': 'https://reporter.nih.gov/quickSearch/P01AI055793', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'CpG7909 oligodeoxynucleotides (ODN)', 'type': 'DRUG'}, {'name': 'Hepatitis B virus vaccine', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals of Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Michael M. Lederman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'oldNameTitle': 'Michael M. Lederman/Professor of Medicine', 'oldOrganization': 'Case Western Reserve University'}}}}