Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-31 @ 1:54 AM
Study NCT ID:
NCT01686503
Status:
COMPLETED
Last Update Posted:
2015-02-05
First Post:
2012-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intradermal Versus Intramuscular Polio Vaccine Booster in HIV-Infected Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011054', 'term': 'Poliovirus Vaccine, Inactivated'}], 'ancestors': [{'id': 'D015164', 'term': 'Vaccines, Inactivated'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D023321', 'term': 'Poliovirus Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'troysb@evms.edu', 'phone': '757-446-8999', 'title': 'Dr. Stephanie Troy', 'organization': 'Eastern Virginia Medical School'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Higher baseline antibody titers than expected making it more difficult to detect differences between the study groups.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '2/5 Dose Intradermal IPV', 'description': 'Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device\n\nIPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.', 'otherNumAtRisk': 66, 'otherNumAffected': 33, 'seriousNumAtRisk': 66, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '1/5 Dose Intadermal IPV', 'description': 'Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.\n\nIPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.', 'otherNumAtRisk': 66, 'otherNumAffected': 29, 'seriousNumAtRisk': 66, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Full Dose Intramuscular IPV', 'description': 'Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.\n\nIPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.', 'otherNumAtRisk': 66, 'otherNumAffected': 18, 'seriousNumAtRisk': 66, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '2/5 Dose Intramuscular IPV', 'description': 'Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.\n\nIPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.', 'otherNumAtRisk': 33, 'otherNumAffected': 10, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Redness at Injection Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Swelling at Injection Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Tenderness at Injection Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders'}, {'term': 'Itching at injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'seriousEvents': [{'term': 'Hospitalization for electrolyte imbalances secondary to alcohol withdrawal', 'notes': 'Occured one month after receiving the vaccine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Post Booster Polio Neutralizing Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '2/5 Dose Intradermal IPV', 'description': 'Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device\n\nIPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.'}, {'id': 'OG001', 'title': '1/5 Dose Intadermal IPV', 'description': 'Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.\n\nIPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.'}, {'id': 'OG002', 'title': 'Full Dose Intramuscular IPV', 'description': 'Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.\n\nIPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.'}, {'id': 'OG003', 'title': '2/5 Dose Intramuscular IPV', 'description': 'Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.\n\nIPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.'}], 'classes': [{'title': 'Serotype 1', 'categories': [{'measurements': [{'value': '1715', 'groupId': 'OG000', 'lowerLimit': '1174', 'upperLimit': '2504'}, {'value': '976', 'groupId': 'OG001', 'lowerLimit': '730', 'upperLimit': '1304'}, {'value': '1249', 'groupId': 'OG002', 'lowerLimit': '916', 'upperLimit': '1705'}, {'value': '1328', 'groupId': 'OG003', 'lowerLimit': '795', 'upperLimit': '2219'}]}]}, {'title': 'Serotype 2', 'categories': [{'measurements': [{'value': '2188', 'groupId': 'OG000', 'lowerLimit': '1507', 'upperLimit': '3178'}, {'value': '1438', 'groupId': 'OG001', 'lowerLimit': '984', 'upperLimit': '2101'}, {'value': '1489', 'groupId': 'OG002', 'lowerLimit': '1041', 'upperLimit': '2128'}, {'value': '1938', 'groupId': 'OG003', 'lowerLimit': '1232', 'upperLimit': '3047'}]}]}, {'title': 'Serotype 3', 'categories': [{'measurements': [{'value': '2375', 'groupId': 'OG000', 'lowerLimit': '1423', 'upperLimit': '3963'}, {'value': '1698', 'groupId': 'OG001', 'lowerLimit': '1114', 'upperLimit': '2588'}, {'value': '1792', 'groupId': 'OG002', 'lowerLimit': '1133', 'upperLimit': '2835'}, {'value': '2075', 'groupId': 'OG003', 'lowerLimit': '1225', 'upperLimit': '3514'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '4-6 weeks after receiving the vaccine', 'description': 'Blood will be drawn at baseline and 4-6 weeks after receiving the vaccine booster dose. It will be spun down, and the serum frozen and stored at -80 degrees celsius. After all the participants have completed the study, all of the serum will be tested for polio neutralizing antibody titers.', 'unitOfMeasure': 'antibody titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Baseline Polio Neutralizing Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '2/5 Dose Intradermal IPV', 'description': 'Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device\n\nIPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.'}, {'id': 'OG001', 'title': '1/5 Dose Intadermal IPV', 'description': 'Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.\n\nIPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.'}, {'id': 'OG002', 'title': 'Full Dose Intramuscular IPV', 'description': 'Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.\n\nIPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.'}, {'id': 'OG003', 'title': '2/5 Dose Intramuscular IPV', 'description': 'Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.\n\nIPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.'}], 'classes': [{'title': 'Serotype 1', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000', 'lowerLimit': '31', 'upperLimit': '64'}, {'value': '42', 'groupId': 'OG001', 'lowerLimit': '29', 'upperLimit': '59'}, {'value': '42', 'groupId': 'OG002', 'lowerLimit': '30', 'upperLimit': '58'}, {'value': '34', 'groupId': 'OG003', 'lowerLimit': '20', 'upperLimit': '56'}]}]}, {'title': 'Serotype 2', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '44'}, {'value': '53', 'groupId': 'OG001', 'lowerLimit': '37', 'upperLimit': '76'}, {'value': '36', 'groupId': 'OG002', 'lowerLimit': '26', 'upperLimit': '51'}, {'value': '44', 'groupId': 'OG003', 'lowerLimit': '29', 'upperLimit': '66'}]}]}, {'title': 'Serotype 3', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '20'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '28'}, {'value': '16', 'groupId': 'OG002', 'lowerLimit': '11', 'upperLimit': '21'}, {'value': '11', 'groupId': 'OG003', 'lowerLimit': '7', 'upperLimit': '16'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'first visit', 'description': 'serum polio neutralizing antibody titers prior to the vaccine booster', 'unitOfMeasure': 'antibody titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '2/5 Dose Intradermal IPV', 'description': 'Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device\n\nIPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.'}, {'id': 'FG001', 'title': '1/5 Dose Intadermal IPV', 'description': 'Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.\n\nIPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.'}, {'id': 'FG002', 'title': 'Full Dose Intramuscular IPV', 'description': 'Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.\n\nIPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.'}, {'id': 'FG003', 'title': '2/5 Dose Intramuscular IPV', 'description': 'Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.\n\nIPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '66'}, {'groupId': 'FG003', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '64'}, {'groupId': 'FG003', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '231', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '2/5 Dose Intradermal IPV', 'description': 'Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device\n\nIPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.'}, {'id': 'BG001', 'title': '1/5 Dose Intadermal IPV', 'description': 'Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.\n\nIPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.'}, {'id': 'BG002', 'title': 'Full Dose Intramuscular IPV', 'description': 'Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.\n\nIPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.'}, {'id': 'BG003', 'title': '2/5 Dose Intramuscular IPV', 'description': 'Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.\n\nIPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45', 'spread': '10', 'groupId': 'BG000'}, {'value': '45', 'spread': '11', 'groupId': 'BG001'}, {'value': '46', 'spread': '11', 'groupId': 'BG002'}, {'value': '46', 'spread': '11', 'groupId': 'BG003'}, {'value': '46', 'spread': '11', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '76', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '155', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '221', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '163', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '66', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Most recent CD4 count', 'classes': [{'categories': [{'measurements': [{'value': '669', 'spread': '361', 'groupId': 'BG000'}, {'value': '630', 'spread': '331', 'groupId': 'BG001'}, {'value': '676', 'spread': '354', 'groupId': 'BG002'}, {'value': '569', 'spread': '260', 'groupId': 'BG003'}, {'value': '645', 'spread': '338', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Currently on antiretroviral therapy', 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '227', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diagnosis of AIDS in the record', 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '127', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Year diagnosed with HIV', 'classes': [{'categories': [{'measurements': [{'value': '2001', 'spread': '8', 'groupId': 'BG000'}, {'value': '2002', 'spread': '8', 'groupId': 'BG001'}, {'value': '2001', 'spread': '8', 'groupId': 'BG002'}, {'value': '2001', 'spread': '9', 'groupId': 'BG003'}, {'value': '2002', 'spread': '8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'calendar year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Born in the United States', 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '219', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Lived or traveled internationally', 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '78', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Reported receiving all childhood vaccines', 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '219', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Current smoker', 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '105', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Coinfected with hepatitis C', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Coinfected with hepatitis B', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 231}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-22', 'studyFirstSubmitDate': '2012-09-13', 'resultsFirstSubmitDate': '2015-01-13', 'studyFirstSubmitQcDate': '2012-09-17', 'lastUpdatePostDateStruct': {'date': '2015-02-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-01-22', 'studyFirstPostDateStruct': {'date': '2012-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post Booster Polio Neutralizing Antibody Titers', 'timeFrame': '4-6 weeks after receiving the vaccine', 'description': 'Blood will be drawn at baseline and 4-6 weeks after receiving the vaccine booster dose. It will be spun down, and the serum frozen and stored at -80 degrees celsius. After all the participants have completed the study, all of the serum will be tested for polio neutralizing antibody titers.'}], 'secondaryOutcomes': [{'measure': 'Baseline Polio Neutralizing Antibody Titers', 'timeFrame': 'first visit', 'description': 'serum polio neutralizing antibody titers prior to the vaccine booster'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Polio Immunity']}, 'referencesModule': {'references': [{'pmid': '25567841', 'type': 'RESULT', 'citation': 'Troy SB, Kouiavskaia D, Siik J, Kochba E, Beydoun H, Mirochnitchenko O, Levin Y, Khardori N, Chumakov K, Maldonado Y. Comparison of the Immunogenicity of Various Booster Doses of Inactivated Polio Vaccine Delivered Intradermally Versus Intramuscularly to HIV-Infected Adults. J Infect Dis. 2015 Jun 15;211(12):1969-76. doi: 10.1093/infdis/jiu841. Epub 2015 Jan 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a lower dose of inactivated polio vaccine (IPV) injected into the skin (intradermal administration) can work equally well or better than the standard dose injected into the muscle (intramuscular administration). There are more immune cells in the skin than in the muscle, and other vaccines have been shown to require a lower dose when administered intradermally. The study is being done in participants infected with HIV because HIV-infected people are known to respond less well to vaccines than other groups, so it is particularly important to know if IPV might work better in HIV-infected people if administered intradermally.\n\nIf it is possible to lower the dose of IPV by intradermal administration, this would make inactivated polio vaccine more affordable in the developing countries where it is most needed', 'detailedDescription': 'Oral polio vaccine (OPV) will not be sufficient to eradicate polio. OPV has failed to provide adequate polio immunity in certain immunocompromised populations, such as people with AIDS. Also, OPV can mutate and form neurovirulent strains capable of causing polio outbreaks. Inactivated polio vaccine (IPV), which cannot mutate into neurovirulent strains and which is more effective in populations that have failed to respond to OPV, will be needed globally to eradicate polio, but it is unaffordable for many developing countries. Because there are more immune cells in the skin than in the muscle, intradermal administration of IPV may be a way to increase the efficacy and reduce the dose (and thus the cost) of IPV. We plan to conduct a clinical trial randomizing 231 HIV-infected adults to receive a booster of two-fifths dose intradermal IPV, one-fifth dose intradermal IPV, full dose intramuscular IPV, or two-fifths dose intramuscular IPV. We will measure polio immunity before and after vaccine administration. Through this study, we will determine the optimal booster dose of intradermal IPV, whether intradermal works better than intramuscular IPV administration, and whether intradermal IPV is effective in an immunocompromised population. The data from this trial could contribute to global polio eradication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* documented HIV infection\n* age of at least 18 years old\n* HIV viral load \\<400 on the most recent test\n\nExclusion Criteria:\n\n* current acute moderate to severe illness (demonstrated by fever over 100.4 Fahrenheit, shortness of breath, altered mental status, or by judgment of the primary clinician)\n* current pregnancy\n* history of allergic reaction to a polio shot,\n* history of a life-threatening allergic reaction to neomycin, streptomycin, or polymyxin B'}, 'identificationModule': {'nctId': 'NCT01686503', 'acronym': 'IDIPV', 'briefTitle': 'Intradermal Versus Intramuscular Polio Vaccine Booster in HIV-Infected Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Virginia Medical School'}, 'officialTitle': 'Comparison of the Immunogenicity of Various Inactivated Polio Vaccine Booster Doses by Intradermal vs. Intramuscular Routes in HIV-Infected Subjects', 'orgStudyIdInfo': {'id': 'Doris Duke CF-2012061'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2/5 dose intradermal IPV', 'description': 'Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device', 'interventionNames': ['Drug: IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose']}, {'type': 'EXPERIMENTAL', 'label': '1/5 dose intradermal IPV', 'description': 'Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.', 'interventionNames': ['Drug: IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'full dose intramuscular IPV', 'description': 'Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.', 'interventionNames': ['Drug: IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2/5 dose intramuscular IPV', 'description': 'Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.', 'interventionNames': ['Drug: IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose']}], 'interventions': [{'name': 'IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose', 'type': 'DRUG', 'otherNames': ['IPOL (Sanofi Pasteur)'], 'description': 'Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.', 'armGroupLabels': ['1/5 dose intradermal IPV', '2/5 dose intradermal IPV', '2/5 dose intramuscular IPV', 'full dose intramuscular IPV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'C3ID Clinic, Eastern Virginia Medical School', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Stephanie B Troy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastern Virginia Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Virginia Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'NanoPass Technologies Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Stephanie Troy', 'investigatorAffiliation': 'Eastern Virginia Medical School'}}}}