Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT00137605
Status:
COMPLETED
Last Update Posted:
2014-02-13
First Post:
2005-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Versus Delayed Pneumococcal Vaccination in HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011008', 'term': 'Pneumococcal Infections'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'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': 'D022242', 'term': 'Pneumococcal Vaccines'}, {'id': 'D000069443', 'term': 'Heptavalent Pneumococcal Conjugate Vaccine'}], 'ancestors': [{'id': 'D022541', 'term': 'Streptococcal Vaccines'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D017778', 'term': 'Vaccines, Combined'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-11', 'studyFirstSubmitDate': '2005-08-26', 'studyFirstSubmitQcDate': '2005-08-29', 'lastUpdatePostDateStruct': {'date': '2014-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of serotypes to which a response is found'}, {'measure': 'A response is defined as a doubling in antibody titer at 1 month compared to baseline.'}], 'secondaryOutcomes': [{'measure': 'Antibody response at 6 months and one year'}, {'measure': 'Changes in viral load 3 months post immunization'}, {'measure': 'Adverse events'}, {'measure': 'Overall incidence of invasive pneumococcal disease'}, {'measure': 'Incidence of invasive pneumococcal disease between vaccines'}]}, 'conditionsModule': {'keywords': ['HIV', 'HIV Infections'], 'conditions': ['Pneumococcal Infections']}, 'referencesModule': {'references': [{'pmid': '23535358', 'type': 'RESULT', 'citation': 'Slayter KL, Singer J, Lee TC, Kayhty H, Schlech WF. Immunization against pneumococcal disease in HIV-infected patients: conjugate versus polysaccharide vaccine before or after reconstitution of the immune system (CTN-147). Int J STD AIDS. 2013 Mar;24(3):227-31. doi: 10.1177/0956462412472450. Epub 2013 May 6.'}, {'pmid': '39883948', 'type': 'DERIVED', 'citation': 'Kimby E, Schar S, Pirosa MC, Vanazzi A, Mey UM, Rauch D, Wahlin BE, Hitz F, Hernberg M, Johansson AS, de Nully Brown P, Hagberg H, Ferreri AJM, Krasniqi F, Voegeli M, Novak U, Zander T, Bersvendsen H, Mamot C, Mingrone W, Stathis A, Dirnhofer S, Hayoz S, Ostenstad B, Zucca E. Six-month rituximab-lenalidomide regimen in advanced untreated follicular lymphoma: SAKK 35/10 trial 10-year update. Blood Adv. 2025 Apr 8;9(7):1712-1719. doi: 10.1182/bloodadvances.2024014840.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether people who are HIV-positive respond better to a vaccine for pneumonia-related disease when they are immunized immediately, or when immunization is delayed until the immune system has improved to a certain level. The study will also compare the effectiveness of polysaccharide and heptavalent vaccines.', 'detailedDescription': 'A multicentre, randomized controlled trial using a two factorial design. Eighty patients will be randomly assigned to receive either Pneumovax (or Pneumo23 according to standard use at site) or heptavalent pneumococcal conjugate vaccine (Prevnar) prior to reconstitution of the immune system or will have immunization delayed until their CD4 count is greater than 200 cells/mm3 after the introduction of antiretroviral therapy. Randomization will be stratified by study centre. Variable block sizes will be used to try to prevent study personnel from guessing the next allocation. Random allocation lists will be generated by computer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-positive\n* Between 18 and 65 years of age\n* Have a CD4 cell count below 200 cells/mm3\n* Willing to begin/change antiretroviral therapy\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Have had previous pneumococcal vaccination\n* Have had occurrence of pneumococcal infection (brain, blood or lung infections) in past 5 years\n* Have hypersensitivity to components of either vaccine\n* Have acute feverish illness at the time of vaccination\n* Have had splenectomy (removal of the spleen)\n* Have received treatment with IVIG within the last 6 months'}, 'identificationModule': {'nctId': 'NCT00137605', 'briefTitle': 'Early Versus Delayed Pneumococcal Vaccination in HIV', 'organization': {'class': 'NETWORK', 'fullName': 'CIHR Canadian HIV Trials Network'}, 'officialTitle': 'A Pilot Study Assessing the Efficacy of Pneumococcal Vaccine in HIV Patients: Delayed Versus Immediate Immunization', 'orgStudyIdInfo': {'id': 'CTN 147'}, 'secondaryIdInfos': [{'id': 'Control # 078760'}, {'id': 'File # 9427-C1574-34C'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pneumovax/immediate', 'interventionNames': ['Biological: Pneumovax']}, {'type': 'EXPERIMENTAL', 'label': 'Pneumovax/delayed', 'interventionNames': ['Biological: Pneumovax']}, {'type': 'EXPERIMENTAL', 'label': 'Prevnar/immediate', 'interventionNames': ['Biological: Prevnar']}, {'type': 'EXPERIMENTAL', 'label': 'Prevnar/delayed', 'interventionNames': ['Biological: Prevnar']}], 'interventions': [{'name': 'Pneumovax', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Pneumovax/delayed', 'Pneumovax/immediate']}, {'name': 'Prevnar', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Prevnar/delayed', 'Prevnar/immediate']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V1Y 1T2', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Medical Arts Health Research Group', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Downtown IDC', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St. Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'St. Boniface General Hospital', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'city': 'Windsor', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Moncton Hospital', 'geoPoint': {'lat': 46.39658, 'lon': -67.40896}}, {'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Victoria General', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Hospital", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto General', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Metropolitan Hospital', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Chest/Royal-Victoria', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'city': 'Ste-Foy', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Laval'}], 'overallOfficials': [{'name': 'Walter Schlech, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Victoria General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CIHR Canadian HIV Trials Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}]}}}