Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:03 AM
Study NCT ID:
NCT00589394
Status:
COMPLETED
Last Update Posted:
2016-01-11
First Post:
2007-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of the Mechanisms of Protective Humoral Immunity in Response to the Pneumococcal Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022242', 'term': 'Pneumococcal Vaccines'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-08', 'studyFirstSubmitDate': '2007-12-28', 'studyFirstSubmitQcDate': '2008-01-08', 'lastUpdatePostDateStruct': {'date': '2016-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess IgG antibodies to pneumococcus pre- and post-pneumococcal immunization in healthy controls', 'timeFrame': '4-6 wks'}], 'secondaryOutcomes': [{'measure': 'Analysis of B cell subsets in blood of healthy controls pre-and post-pneumococcal immunization to identify changes in memory B cell, class switched and activated B cells.', 'timeFrame': '4-6 wks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pneumococcal vaccine', 'normal response', 'immunodeficiency', 'Healthy patients', 'Healthy Volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The lack of clear guidelines and studies addressing the proper response to the pneumococcal vaccine (Pneumovax ®) has hampered our ability to diagnosis and care for our immunodeficiency patients. Should an age matched normal response range to the Pneumovax ® be established, it would have a profound impact in the diagnosis, safety and care of immunodeficiency patients. Moreover, characterizing the B cell compartments response to the Pneumovax ® may better delineate the mechanism of protective immunity from Pneumovax ® and provide an additional tool for the diagnosis and care for immunodeficiency patients.', 'detailedDescription': 'The ability to respond to a polysaccharide vaccine antigen is an integral part of evaluating a patient with immunodeficiency. The pneumococcal vaccine (Pneumovax ®) remains the only readily available and the most widely used unconjugated polysaccharide vaccine. Although the pneumococcal vaccine is widely used test the immune systems response to a polysaccharide antigen, no clear guidelines or studies exist to what is considered a proper response to the Pneumovax ®. Immunoglobulin M (IgM) memory B cells are thought to play an important role in protection against pneumococcal disease. It is not known to what extent the ability of B cells to be activated in response to pneumococcal vaccination contributes to protective immunity. To address these issues, the following two specific aims are proposed:\n\nSpecific Aim 1. Assess Immunoglobulin G (IgG) antibodies to pneumococcus pre- and post-pneumococcal immunization in healthy controls Specific Aim 2. Analysis of B cell subsets in blood of healthy controls pre-and post-pneumococcal immunization to identify changes in memory B cell, class switched and activated B cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients from 20 to 70 years of age\n\nExclusion Criteria:\n\n* Previous or current diagnosis of an immunodeficiency (primary and secondary)\n* Previous or current diagnosis of a rheumatological disorders (Rheumatoid arthritis, Lupus, Sjögren, vasculitis), cancer, diabetes, active infection and/or other chronic diseases (multiple sclerosis, etc)\n* Current or previous use (within that last 6 months) of systemic/inhaled corticosteroids, sulfasalazine, and other immunosuppressive agents (cyclosporin, methotrexate, CellCept) anti-convulsants (phenytoin, carbamazepine), gold, d-penicillamine, and anti-malarials (quinine, chloroquine, hydroxychloroquine)\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00589394', 'briefTitle': 'Analysis of the Mechanisms of Protective Humoral Immunity in Response to the Pneumococcal Vaccine', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Analysis of the Mechanisms of Protective Humoral Immunity in Response to the Pneumococcal Vaccine', 'orgStudyIdInfo': {'id': '06-005905'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'pneumococcal vaccination (Pneumovax)', 'description': 'Intervention:\n\nPatients receive one dose of the Pneumovax vaccine. The 23 pneumococcal serotypes are measured before and after vaccination in order to measure response in a healthy population.', 'interventionNames': ['Biological: pneumococcal vaccination (Pneumovax)']}], 'interventions': [{'name': 'pneumococcal vaccination (Pneumovax)', 'type': 'BIOLOGICAL', 'description': 'pneumovax was given', 'armGroupLabels': ['pneumococcal vaccination (Pneumovax)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55902', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Miguel A. Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Miguel Park', 'investigatorAffiliation': 'Mayo Clinic'}}}}