Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2026-01-02 @ 9:21 AM
Study NCT ID:
NCT00706550
Status:
COMPLETED
Last Update Posted:
2014-04-24
First Post:
2008-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immune Responses to Pneumococcal Vaccination Among HIV-infected Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'C414006', 'term': '23-valent pneumococcal capsular polysaccharide vaccine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Maria.Rodriguez-Barradas2@va.gov', 'phone': '713-794-7384', 'title': 'Dr. Maria C. Rodriguez-Barradas', 'organization': 'Michael E. DeBakey Veterans Affairs Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Arm 1: PV Before Starting Antiretroviral Therapy', 'description': 'Arm 1 received PV prior to starting antiretroviral treatment.\n\nPV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine', 'otherNumAtRisk': 43, 'otherNumAffected': 2, 'seriousNumAtRisk': 43, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Arm 2: PV After >6 Months of Antiretroviral Therapy', 'description': 'Arm 2 received PV after at least 6 months of antiretroviral treatment.\n\nPV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine', 'otherNumAtRisk': 64, 'otherNumAffected': 1, 'seriousNumAtRisk': 64, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'CHF, arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration, electrolite abnormalities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elective surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal infections and other disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mental health related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Immunoglobulin G (IgG) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate: PV Before Starting Antiretroviral Therapy', 'description': 'Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.\n\nPV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine'}, {'id': 'OG001', 'title': 'Delayed: PV After >6 Months of Antiretroviral Therapy', 'description': 'Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment\n\nPV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine.'}], 'classes': [{'title': 'IgG levels against CPS 6B', 'categories': [{'measurements': [{'value': '5.12', 'spread': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.71', 'upperLimit': '27.60'}, {'value': '5.17', 'spread': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.10', 'upperLimit': '22.87'}]}]}, {'title': 'IgG levels against CPS 23F', 'categories': [{'measurements': [{'value': '1.80', 'spread': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.44', 'upperLimit': '9.35'}, {'value': '1.83', 'spread': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.74', 'upperLimit': '4.71'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline', 'description': 'Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.', 'unitOfMeasure': 'Micrograms/ml', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'IgG Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate: PV Before Starting Antiretroviral Therapy', 'description': 'Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.\n\nPV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine.'}, {'id': 'OG001', 'title': 'Delayed: PV After >6 Months of Antiretroviral Therapy', 'description': 'Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment\n\nPV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine.'}], 'classes': [{'title': 'IgG levels against CPS 6B', 'categories': [{'measurements': [{'value': '7.85', 'spread': '1.0', 'groupId': 'OG000', 'lowerLimit': '2.94', 'upperLimit': '43.58'}, {'value': '5.79', 'spread': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.23', 'upperLimit': '21.42'}]}]}, {'title': 'IgG levels against CPS 23F', 'categories': [{'measurements': [{'value': '2.50', 'spread': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.62', 'upperLimit': '23.37'}, {'value': '2.41', 'spread': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.80', 'upperLimit': '7.94'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One-month post-vaccine', 'description': "Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine.", 'unitOfMeasure': 'Micrograms/ml', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Immunoglobulin M (IgM) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate: PV Before Starting Antiretroviral Therapy', 'description': 'Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.\n\nPV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine.'}, {'id': 'OG001', 'title': 'Delayed: PV After >6 Months of Antiretroviral Therapy', 'description': 'Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment\n\nPV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine.'}], 'classes': [{'title': 'IgM levels against CPS 6B', 'categories': [{'measurements': [{'value': '1.89', 'groupId': 'OG000', 'lowerLimit': '0.40', 'upperLimit': '7.56'}, {'value': '1.85', 'groupId': 'OG001', 'lowerLimit': '0.39', 'upperLimit': '4.86'}]}]}, {'title': 'IgM levels against CPS 23F', 'categories': [{'measurements': [{'value': '0.59', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '4.29'}, {'value': '0.78', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '3.18'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline', 'description': 'Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.', 'unitOfMeasure': 'Micrograms/ml', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'IgM Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate: PV Before Starting Antiretroviral Therapy', 'description': 'Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.\n\nPV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine.'}, {'id': 'OG001', 'title': 'Delayed: PV After >6 Months of Antiretroviral Therapy', 'description': 'Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment\n\nPV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine.'}], 'classes': [{'title': 'IgM levels against CPS 6B', 'categories': [{'measurements': [{'value': '2.18', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '9.00'}, {'value': '2.26', 'groupId': 'OG001', 'lowerLimit': '0.59', 'upperLimit': '6.29'}]}]}, {'title': 'IgM levels against CPS 23F', 'categories': [{'measurements': [{'value': '0.65', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '3.20'}, {'value': '0.84', 'groupId': 'OG001', 'lowerLimit': '0.23', 'upperLimit': '2.86'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One-month post-vaccine', 'description': "Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine.", 'unitOfMeasure': 'Micrograms/ml', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Opsonophagocytic Killing Activity (OPA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate: PV Before Starting Antiretroviral Therapy', 'description': 'Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.\n\nPV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine.'}, {'id': 'OG001', 'title': 'Delayed: PV After >6 Months of Antiretroviral Therapy', 'description': 'Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment\n\nPV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine.'}], 'classes': [{'title': 'OPA titers against CPS 6B', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '512'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '512'}]}]}, {'title': 'OPA titers against CPS 23F', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '32'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '256'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline', 'description': "This assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. As explained previously for the immunoglobulins' assays, we measure the baseline point to be able to determine the increase after the vaccine is administered.", 'unitOfMeasure': 'Titers', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Opsonophagocytic Killing Activity (OPA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate: PV Before Starting Antiretroviral Therapy', 'description': 'Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.\n\nPV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine.'}, {'id': 'OG001', 'title': 'Delayed: PV After >6 Months of Antiretroviral Therapy', 'description': 'Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment\n\nPV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine.'}], 'classes': [{'title': 'OPA titers against CPS 6B', 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '512'}, {'value': '13.7', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '512'}]}]}, {'title': 'OPA titers against CPS 23F', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '128'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '64'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One-month post-vaccine', 'description': 'This assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. This point of time (one-month after vaccine), gives the information about how much the killing activity increased 1 month after the vaccine was administered.', 'unitOfMeasure': 'Titers', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Immediate: PV Before Starting Antiretroviral Therapy', 'description': 'Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.\n\nPV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine.'}, {'id': 'FG001', 'title': 'Delayed: PV After >6 Months of Antiretroviral Therapy', 'description': 'Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment\n\nPV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '28'}]}]}], 'recruitmentDetails': 'A total of 107 patients were enrolled on the study (11/2008-2/2011 at the Michael E. DeBakey VA Medical Center, at Thomas Street Clinic and at Legacy Clinic, in Houston, TX. Only the patients that completed the 1 month post-PV visit are included in the analysis (N=36 for each arm for a total of 72 out of the 107 initially enrolled).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1: PV Before Starting Antiretroviral Therapy', 'description': 'Arm 1 received PV prior to starting antiretroviral treatment.\n\nPV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine'}, {'id': 'BG001', 'title': 'Arm 2: PV After >6 Months of Antiretroviral Therapy', 'description': 'Arm 2 received PV after at least 6 months of antiretroviral treatment.\n\nPV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.4', 'spread': '12.9', 'groupId': 'BG000'}, {'value': '40.8', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '41.8', 'spread': '12.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-27', 'studyFirstSubmitDate': '2008-06-24', 'resultsFirstSubmitDate': '2013-09-26', 'studyFirstSubmitQcDate': '2008-06-26', 'lastUpdatePostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-09-26', 'studyFirstPostDateStruct': {'date': '2008-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunoglobulin G (IgG) Levels', 'timeFrame': 'Baseline', 'description': 'Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.'}, {'measure': 'IgG Levels', 'timeFrame': 'One-month post-vaccine', 'description': "Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine."}, {'measure': 'Immunoglobulin M (IgM) Levels', 'timeFrame': 'Baseline', 'description': 'Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.'}, {'measure': 'IgM Levels', 'timeFrame': 'One-month post-vaccine', 'description': "Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine."}, {'measure': 'Opsonophagocytic Killing Activity (OPA)', 'timeFrame': 'Baseline', 'description': "This assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. As explained previously for the immunoglobulins' assays, we measure the baseline point to be able to determine the increase after the vaccine is administered."}, {'measure': 'Opsonophagocytic Killing Activity (OPA)', 'timeFrame': 'One-month post-vaccine', 'description': 'This assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. This point of time (one-month after vaccine), gives the information about how much the killing activity increased 1 month after the vaccine was administered.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pneumococcal polysaccharide vaccine'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the best timing for administering pneumococcal vaccine (PV) to HIV-infected adults that have CD4 cell counts of more than 200 and are not yet receiving combination antiretroviral treatment (ART). Participants in this study will be assigned by chance to receive vaccination with PV prior to starting ART or after at least 6 months of ART. Antibody levels to components of the PV will be measured at 6 months and 12 months after vaccination. The results will tell us if patients that receive PV after 6 months of ART have better response to the vaccine than those that get vaccinated prior to treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV infected\n* CD4 count \\>200\n* no acute illness\n* no pneumococcal vaccination within 3 years\n* naive to treatment or if previously on treatment, no antiretroviral treatment for at least 6 months\n* willingness to start antiretroviral treatment as recommended by current guidelines\n\nExclusion Criteria:\n\n* prior pneumococcal vaccination within 3 years\n* prior AIDS diagnosis based on opportunistic disease\n* acute illness'}, 'identificationModule': {'nctId': 'NCT00706550', 'briefTitle': 'Immune Responses to Pneumococcal Vaccination Among HIV-infected Subjects', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Immune Responses to Pneumococcal Vaccination Among HIV-Infected Subjects', 'orgStudyIdInfo': {'id': 'INDA-002-08S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Immediate', 'description': 'Arm 1 will receive PV (23-valent pneumococcal polysaccharide vaccine) prior to starting antiretroviral treatment and will receive PLACEBO after at least 6 months of starting antiretroviral treatment.\n\nPV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine', 'interventionNames': ['Biological: (PV) 23-valent pneumococcal polysaccharide vaccine', 'Biological: Placebo']}, {'type': 'OTHER', 'label': 'Delayed', 'description': 'Arm 2 will receive PLACEBO prior to starting antiretroviral treatment and will receive PV (23-valent pneumococcal polysaccharide vaccine) after at least 6 months of starting antiretroviral treatment.\n\nPV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine', 'interventionNames': ['Biological: (PV) 23-valent pneumococcal polysaccharide vaccine', 'Biological: Placebo']}], 'interventions': [{'name': '(PV) 23-valent pneumococcal polysaccharide vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Pneumovax 23'], 'description': 'Currently commercially available pneumococcal polysaccharide vaccine', 'armGroupLabels': ['Delayed', 'Immediate']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Placebo', 'armGroupLabels': ['Delayed', 'Immediate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Michael E DeBakey VA Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Maria Rodriguez-Barradas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Michael E. DeBakey VA Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'collaborators': [{'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, {'name': 'Montefiore Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}