Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-01-13 @ 8:50 PM
Study NCT ID:
NCT02547493
Status:
COMPLETED
Last Update Posted:
2022-01-03
First Post:
2015-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022242', 'term': 'Pneumococcal Vaccines'}, {'id': 'C538862', 'term': '13-valent pneumococcal vaccine'}, {'id': 'D000069594', 'term': 'Abatacept'}], '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'}, {'id': 'D018796', 'term': 'Immunoconjugates'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-30', 'studyFirstSubmitDate': '2015-09-07', 'studyFirstSubmitQcDate': '2015-09-09', 'lastUpdatePostDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Humoral response comparison after vaccination (number of patient with at least a two-fold increase of the antibody titer for at least 3 of the 5 serotypes of interest : 1,3 14, 7F, 19A)', 'timeFrame': '1 month after vaccination', 'description': 'To compare the rate of responders, at one month after vaccination, between patients vaccinated with PCV and patient vaccinated with PPSV.'}], 'secondaryOutcomes': [{'measure': "Side Effect frequency (number of side effect at each patient's visit for both groups)", 'timeFrame': '1, 2,6 ans 12 months after inclusion', 'description': 'Comparison of the frequency of side effects between the 2 groups at 1, 2, 6 and 12 months'}, {'measure': 'Prime boost strategy efficacity evaluation (number of responder in the PCV group)', 'timeFrame': '6 months after inclusion', 'description': 'Calculation of the rate of responders, in the PCV group, at 4 month after re-vaccination by a dose of PPSV'}, {'measure': 'Long term immune response after vaccination', 'timeFrame': '6 and 12 months after vaccination', 'description': 'Comparison between the 2 groups of the rate of responders at 6 and 12 months after vaccination'}, {'measure': 'Comparison between the 2 groups of the opsonophagocytosis activity of the antibodies produced', 'timeFrame': '1, 2, 6 and 12 months after vaccination', 'description': 'Comparison between the 2 groups of the opsonophagocytic titers (OPA) at 1, 2, 6 and 12 months after vaccination'}, {'measure': 'Pneumococcal vaccination predictive factor identification', 'timeFrame': '12 month after last patient inclusion', 'description': 'Analysis of the collected date to search for predictive factors of immune response after pneumococcal vaccination by comparison of the rates of responders within each group, according to age, gender, RA activity, MTX dosage, corticosteroid, dosage, therapeutical history'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Vaccination against Pneumococcal', 'Naïve Abatacept patients'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'Is pneumococcal conjugate vaccine (which induces a T-dependent humoral response) more efficient than pneumococcal polysaccharide vaccine (which induces a T-independent humoral response) in RA patients treated with abatacept, biotherapy targeting T-cells? The investigator propose to conduct a prospective, multicenter (11 centers), randomized, open-label study.\n\nThe patients are going to be randomized in 2 groups: patients of the first group will be vaccinated with the polysaccharide pneumococcal vaccine (Pneumo23®/Pneumovax®) whereas patients of the second group will be vaccinated with conjugate pneumococcal vaccine (Prevenar13®).', 'detailedDescription': 'The study population will be all the RA patients between 18 and 85 years with instauration of a treatment by sub-cutaneous abatacept in association with methotrexate who agreed to participate to the study.\n\nAt the time of their inclusion, patients will be randomized for receiving either pneumococcal polysaccharide vaccine (PPSV) or pneumococcal conjugate vaccine (PCV).\n\nThe primary endpoint will be evaluated at one month after vaccination. The total of follow-up will be of 12 months.\n\nFor the patients of the group PCV, the prime-boost strategy will be applied in order to be in accordance with the current French recommendation and a revaccination at 2 months after the initial vaccine will be realized with PPSV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* RA according to American College of Rheumatology (ACR)/European League Against rheumatism (EULAR) 2010 criteria\n* Disease Activity Score (DAS) 28 ≥ 3.2\n* Initiation of a treatment by sub-cutaneous abatacept in combination with methotrexate (MTX), whatever treatment they were receiving before (apart from rituximab (RTX) in the last year)\n* Patient has signed study consent form\n\nExclusion Criteria:\n\n* age \\< 18 or \\> 85 year\n* dementia\n* patients subjects to legal protection measures\n* Corticosteroids ≥ 10mg/d the day of inclusion\n* Patient who had a pneumococcal vaccination in the previous 3 years\n* Last pneumococcal vaccination \\< 3 year\n* rituximab in the last year\n* History of anaphylactic response to a vaccination\n* Contraindications to abatacept or methotrexate\n* Pregnancy or pregnancy wish\n* Breast feeding\n* Patient who currently abuse drugs or alcohol\n* Subject who have received any live vaccines within 3 months of the anticipated first dose of study medication.\n* Subject who have receive any vaccine within 1 month of the anticipated first dose of the study medication and for all the duration of the study\n* Patient with contraindication to intramuscular injections\n* Subject with respiratory insufficiency\n* Subject at risk for Tuberculosis.\n* Blood transfusion within the 3 months previous to the study and for all the duration of the study.\n* Concomitant biologic disease-modifying antirheumatic drug (DMARD)\n* Within 4 weeks of receiving treatment with any investigational drug.\n* Patient positive for hepatitis B surface antigen\n* Patient who are positive for hepatitis C antibody if the presence of hepatitis C virus was also shown with polymerase chain reaction or recombinant immunoblot assay.'}, 'identificationModule': {'nctId': 'NCT02547493', 'acronym': 'VACINA', 'briefTitle': 'Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Comparison of Humoral Response to Conjugate Pneumococcal Vaccine and Polysaccharide Pneumococcal Vaccine in Rheumatoid Arthritis (RA) Patients Treated With Abatacept', 'orgStudyIdInfo': {'id': '9419'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'pneumococcal polysaccharide vaccine', 'description': 'Patients are vaccinated vith Peumo23/Pneumovax on the first day. Abatacept started on frst day.', 'interventionNames': ['Biological: pneumococcal polysaccharide vaccine', 'Drug: Abatacept']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pneumococcal conjugate vaccine', 'description': 'Patients are vaccinated with Prevenar13 on the first day, and with Pneumo23/Pneumovax two months later.\n\nAbatacept started on frst day.', 'interventionNames': ['Biological: pneumococcal conjugate vaccine', 'Drug: Abatacept']}], 'interventions': [{'name': 'pneumococcal polysaccharide vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Pneumo23/Pneumovax'], 'description': 'Vaccination with PPSV on first day. NB : PPSV vaccine Pneumo23 has been replaced in September 2017 by the equivalent vaccine Pneumovax because of the stop of commercialization of Pneumo23 in France by the pharmaceutical company.', 'armGroupLabels': ['pneumococcal polysaccharide vaccine']}, {'name': 'pneumococcal conjugate vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Prevenar13'], 'description': 'Patients are vaccinated with Prevenar13 on the first day, and with Pneumo23/Pneumovax two months later.', 'armGroupLabels': ['pneumococcal conjugate vaccine']}, {'name': 'Abatacept', 'type': 'DRUG', 'otherNames': ['Orencia'], 'description': 'Abatacept started on frst day', 'armGroupLabels': ['pneumococcal conjugate vaccine', 'pneumococcal polysaccharide vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'state': 'Hérault', 'country': 'France', 'facility': 'CHRU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Nord', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Montpied', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'CHU Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU Roger Salengro', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '45000', 'city': 'Orléans', 'country': 'France', 'facility': 'CHU Orléans', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '78013', 'city': 'Paris', 'country': 'France', 'facility': 'CHU La pitié salpétriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '67200', 'city': 'Strasbourg', 'country': 'France', 'facility': 'CHU Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '98012', 'city': 'Monaco', 'country': 'Monaco', 'facility': 'CHPG Monaco', 'geoPoint': {'lat': 43.73718, 'lon': 7.42145}}], 'overallOfficials': [{'name': 'Jacques Morel, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU de Montpellier'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}