Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 11:44 PM
Study NCT ID:
NCT01072734
Status:
COMPLETED
Last Update Posted:
2010-10-13
First Post:
2010-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Auto-immunity in Lupus Patients After Influenza Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2013-10-11', 'releaseDate': '2013-08-02'}, {'resetDate': '2016-05-20', 'releaseDate': '2016-04-14'}, {'resetDate': '2021-10-19', 'releaseDate': '2021-09-22'}, {'resetDate': '2025-12-04', 'releaseDate': '2025-11-17'}], 'estimatedResultsFirstSubmitDate': '2013-08-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'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'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014765', 'term': 'Viral Vaccines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-11', 'studyFirstSubmitDate': '2010-02-19', 'studyFirstSubmitQcDate': '2010-02-19', 'lastUpdatePostDateStruct': {'date': '2010-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The expression of CXCR4 on B cells, T cells, monocytes and granulocytes by FACS on LES patients will be measured the day of the vaccination and then 7 and 30 days post-vaccination', 'timeFrame': '7 and 30 days post-vaccination'}], 'secondaryOutcomes': [{'measure': 'The biological signs of autoimmunity will be followed using the routine laboratory tests such as the complement exploration and the detection of total anti-nuclear antibodies detection', 'timeFrame': 'one year after'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lupus', 'CXCR4 on leucocytes of patients with SLE', 'Influenza vaccine'], 'conditions': ['Systemic Lupus Erythematosus (SLE)']}, 'referencesModule': {'references': [{'pmid': '23764537', 'type': 'DERIVED', 'citation': 'Launay O, Paul S, Servettaz A, Roguet G, Rozenberg F, Lucht F, Lambert C, Presles E, Goulvestre C, Meritet JF, Galtier F, Dubray C, Lebon P, Weill B, Batteux F. Control of humoral immunity and auto-immunity by the CXCR4/CXCL12 axis in lupus patients following influenza vaccine. Vaccine. 2013 Aug 2;31(35):3492-501. doi: 10.1016/j.vaccine.2013.05.095. Epub 2013 Jun 11.'}]}, 'descriptionModule': {'briefSummary': 'Annual influenza vaccination is recommended in patients with systemic lupus erythematosus (SLE). However some concerns remain about vaccination and the risk of lupus flare', 'detailedDescription': 'SLE is a chronic autoimmune disease associated with the production of pathogenic anti-nuclear autoantibodies (ANAs) and characterized by the loss of self tolerance and the overexpression of B cells, leading to a high immunoglobulin production, 90% being autoantibodies.\n\nThere have been concerns about the safety of vaccination in patients with autoimmune diseases as it has been hypothesised that stimulation of the immune system via vaccination may lead to an increase in disease activity. Furthermore, SLE patients display a variety of immune dysfunctions which may influence their response to influenza vaccination.\n\nStudies indicate that, although influenza vaccination in SLE may generate autoimmune phenomena, no clinically significant increase in SLE disease activity can be expected. Therefore, influenza vaccination can be considered safe in quiescent SLE, in accordance with previous reviews on this subject\n\nThe aim of this study is to evaluate if the level of CXCR4 on leucocytes of patients with SLE could be a good prognostic marker for the efficacy and the safety of influenza vaccine in SLE patients. For that purpose, we will assay in lupus patients the cellular level of CXCR4 before and after administration of influenza vaccine and correlate the expression levels of CXCR4 with: 1) the evolution of clinical and biological signs of autoimmunity and 2) the humoral immune response towards influenza. If influenza vaccine has not been associated so far with increased risk of lupus flare, it is important to determine if patients with elevated leucocytes levels of CXCR4, (due to the impact of this molecule in humoral immunity), are more at risk of vaccine side effects particularly of autoimmune origin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria :\n\n* 18 years of age and older\n* informed consent signed\n* LES patients who meet the American College of Rheumatology (ACR) diagnostic criteria of SLE\n* Patient able to attend all visit schedule during the month following influenza vaccine administration\n* Clinical examination performed prior final inclusion with results communicated to the patient\n\nExclusion criteria :\n\n* For women, being pregnant or positive pregnancy test\n* Positive for HCV, HIV and HBV\n* Patient treated with rituximab (anti-CD20) or stopped for less than a year.\n* Patient for whom a treatment majorization is suspected within the month following influenza vaccine administration.\n* Hypersensitivity to active substances, eggs and to one of the vaccine components\n* Other vaccinations within the last 30 days before the inclusion at J0\n* Administration of blood products such as immunoglobulins within the last 90 days before J0\n* Progressive cancer, cirrhoses\n* Acute severe illness within the last 30 days before inclusion at J0\n* Patient non affiliated to a health social security system\n* Planned participation to another clinical study during the present study period\n* patient deprived of freedom by an administrative or court order'}, 'identificationModule': {'nctId': 'NCT01072734', 'acronym': 'GRIPLUP', 'briefTitle': 'Auto-immunity in Lupus Patients After Influenza Vaccine', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Role of CXCR4/CXCL12 Axis on the Control of Humoral Immunity and Auto-immunity in Lupus Patients After Influenza Vaccine Challenge', 'orgStudyIdInfo': {'id': 'P090104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaccine group', 'description': 'single group: all included patients will receive the vaccine', 'interventionNames': ['Drug: Vaccine']}], 'interventions': [{'name': 'Vaccine', 'type': 'DRUG', 'otherNames': ['Influenza vaccine'], 'description': 'Influenza vaccine', 'armGroupLabels': ['Vaccine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'CIC Vaccinologie Hopital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Odile Launay, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Valerie Millul', 'oldOrganization': 'Department Clinical Reseach of Developpement'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-08-02', 'type': 'RELEASE'}, {'date': '2013-10-11', 'type': 'RESET'}, {'date': '2016-04-14', 'type': 'RELEASE'}, {'date': '2016-05-20', 'type': 'RESET'}, {'date': '2021-09-22', 'type': 'RELEASE'}, {'date': '2021-10-19', 'type': 'RESET'}, {'date': '2025-11-17', 'type': 'RELEASE'}, {'date': '2025-12-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Assistance Publique - Hôpitaux de Paris'}}}}