Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT03405805
Status:
UNKNOWN
Last Update Posted:
2018-01-23
First Post:
2018-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunological Memory Against Pneumococcus Induced by 3 Infant PCV 13 Vaccination Schedules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C538862', 'term': '13-valent pneumococcal vaccine'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-15', 'studyFirstSubmitDate': '2018-01-15', 'studyFirstSubmitQcDate': '2018-01-15', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'immunoglobulin G (IgG) antibody serum titers (measured by ELISA)', 'timeFrame': '28 days post last vaccine dose', 'description': 'measurement of IgG antibody titers in serum pre- and post- last dose of PCV13'}, {'measure': 'switched immunoglobulin G (swIgG) B memory cell response (measured by flow cytometry)', 'timeFrame': '28 days post last vaccine dose', 'description': 'phenotype characterisation of swIgG memory B cells pre- and post- last dose of PCV13'}, {'measure': 'immunoglobulin M (IgM) B memory cell response (measured by flow cytometry)', 'timeFrame': '28 days post last vaccine dose', 'description': 'phenotype characterisation of IgM memory B cells pre- and post- last dose of PCV13'}], 'secondaryOutcomes': [{'measure': 'Transcriptional profile of Peripheral Blood Mononuclear Cells (PBMC) in response to PCV13 (measured by RNA-Sequencing)', 'timeFrame': '7 days post last vaccine dose', 'description': 'transcriptome analysis of PBMCs pre- and post last dose of PCV13 on a cohort of patients'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Immunogenicity, Vaccine', 'Immunologic Memory']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the establishment of immunological memory between the 3 different infant vaccination schedules with the 13-valent pneumococcal conjugate vaccine (PCV13) currently in use. We aim to determine the optimal schedule for the establishment of antigen-specific memory B-cell pool, which may serve as a correlate for longevity of immunological memory against vaccine serotypes. Moreover, we will study the transcriptome profiles expressed by peripheral lymphocytes during each immune response in an attempt to reveal immunological mechanisms beyond the antibody and circulating B cells level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Months', 'minimumAge': '2 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy infants 2-15 months of age living in Athens, Greece', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 2-15 months of age\n\nExclusion Criteria:\n\n* previously recorded allergy to PCV\n* intravenous immunoglobulin (IVIG) given within the previous 6 months\n* primary or secondary immunodeficiency\n* any chronic medical condition'}, 'identificationModule': {'nctId': 'NCT03405805', 'briefTitle': 'Immunological Memory Against Pneumococcus Induced by 3 Infant PCV 13 Vaccination Schedules', 'organization': {'class': 'OTHER', 'fullName': "Aghia Sophia Children's Hospital of Athens"}, 'officialTitle': 'The Establishment of Serotype-specific Immunological Memory Against Pneumococcus by a 3+1 Versus a 2+1 or 3+0 Infant PCV13 Vaccination Schedule', 'orgStudyIdInfo': {'id': 'isppd2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': '3+1', 'description': 'Healthy infants will receive 4 doses of the 13-valent pneumococcal conjugate vaccine (PCV13) at 2,4,6 and 12 months of age and blood and serum collection pre- dose, 7 days post- (only blood) and 28 days post- last dose.', 'interventionNames': ['Biological: 13-valent pneumococcal conjugate vaccine (PCV13)']}, {'label': '3+0', 'description': 'Healthy infants will receive 3 doses of the 13-valent pneumococcal conjugate vaccine (PCV13) at 2,4 and 6 months of age and blood and serum collection pre- dose, 7 days post- (only blood) and 28 days post- last dose.', 'interventionNames': ['Biological: 13-valent pneumococcal conjugate vaccine (PCV13)']}, {'label': '2+1', 'description': 'Healthy infants will receive 3 doses of the 13-valent pneumococcal conjugate vaccine (PCV13) at 2,4 and 12 months of age and blood and serum collection pre- dose, 7 days post- (only blood) and 28 days post- last dose.', 'interventionNames': ['Biological: 13-valent pneumococcal conjugate vaccine (PCV13)']}], 'interventions': [{'name': '13-valent pneumococcal conjugate vaccine (PCV13)', 'type': 'BIOLOGICAL', 'otherNames': ['Prevenar13'], 'description': 'Vaccination with PCV13', 'armGroupLabels': ['2+1', '3+0', '3+1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11527', 'city': 'Athens', 'state': 'Attica', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Vana Spoulou', 'role': 'CONTACT', 'phone': '00302107467620'}, {'name': 'Irene Tzovara, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ioanna Papadatou, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "'Aghia Sophia' Children's Hospital", 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Irene Tzovara, MD', 'role': 'CONTACT', 'email': 'itzovara@med.uoa.gr', 'phone': '0030 2107467620'}], 'overallOfficials': [{'name': 'Vana Spoulou, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': '"Aghia Sophia" Children\'s Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Aghia Sophia Children's Hospital of Athens", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Paediatrics', 'investigatorFullName': 'Vana Spoulou', 'investigatorAffiliation': "Aghia Sophia Children's Hospital of Athens"}}}}