Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-04-23 @ 1:03 PM
Study NCT ID:
NCT03041051
Status:
UNKNOWN
Last Update Posted:
2017-02-02
First Post:
2017-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunological Memory Induced by the 13valent Pneumococcal Conjugate(PCV13) and 23valent Plain Polysaccharide Vaccine(PPV23) in HIV-infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-01', 'studyFirstSubmitDate': '2017-02-01', 'studyFirstSubmitQcDate': '2017-02-01', 'lastUpdatePostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by flow cytometry)', 'timeFrame': 'One month post-PCV13, PPV23', 'description': 'immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by flow cytometry)'}, {'measure': 'immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by flow cytometry)', 'timeFrame': 'One month post-PCV13, PPV23', 'description': 'immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by flow cytometry)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['HIV Infection']}, 'referencesModule': {'references': [{'pmid': '29722823', 'type': 'DERIVED', 'citation': 'Farmaki PF, Chini MC, Mangafas NM, Tzanoudaki MT, Piperi CP, Lazanas MZ, Spoulou VS. Immunogenicity and Immunological Memory Induced by the 13-Valent Pneumococcal Conjugate Followed by the 23-Valent Polysaccharide Vaccine in HIV-Infected Adults. J Infect Dis. 2018 Jun 5;218(1):26-34. doi: 10.1093/infdis/jiy135.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of a combined vaccination schedule of the 13-valent pneumococcal conjugate (PCV13) and 23valent plain polysaccharide vaccine (PPV23) on the establishment of immunological memory in HIV-infected adults on ART.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CD4 T cell count \\>200cells/μl\n* on ART\n\nExclusion Criteria:\n\n* no previously recorded allergy to PCV, PPV23\n* no intravenous immunoglobulin (IVIG) given within the previous 6 months\n* no other vaccine given within the previous 6 months'}, 'identificationModule': {'nctId': 'NCT03041051', 'briefTitle': 'Immunological Memory Induced by the 13valent Pneumococcal Conjugate(PCV13) and 23valent Plain Polysaccharide Vaccine(PPV23) in HIV-infected Patients', 'organization': {'class': 'OTHER', 'fullName': "Aghia Sophia Children's Hospital of Athens"}, 'officialTitle': 'Study of the Immunogenicity and Immunological Memory Induced by the 13valent Pneumococcal Conjugate(PCV13) and 23valent Plain Polysaccharide Vaccine(PPV23) in HIV-infected Adults', 'orgStudyIdInfo': {'id': '51198eAS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PCV13', 'interventionNames': ['Biological: PCV13']}, {'type': 'EXPERIMENTAL', 'label': 'PPV23', 'interventionNames': ['Biological: PPV23']}], 'interventions': [{'name': 'PCV13', 'type': 'BIOLOGICAL', 'armGroupLabels': ['PCV13']}, {'name': 'PPV23', 'type': 'BIOLOGICAL', 'armGroupLabels': ['PPV23']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Vana Spoulou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Greece 'Aghia Sophia' Children's Hospital Athens, Attiki, Greece, 11527"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Aghia Sophia Children's Hospital of Athens", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatric Infectious Diseases', 'investigatorFullName': 'Vana Spoulou', 'investigatorAffiliation': "Aghia Sophia Children's Hospital of Athens"}}}}