Auto-immunity in Lupus Patients After Influenza Vaccine
NCT ID: NCT01072734
Last Updated: 2010-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
28 participants
INTERVENTIONAL
2009-09-30
2010-02-28
Brief Summary
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Detailed Description
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There 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.
Studies 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
The 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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vaccine group
single group: all included patients will receive the vaccine
Vaccine
Influenza vaccine
Interventions
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Vaccine
Influenza vaccine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* informed consent signed
* LES patients who meet the American College of Rheumatology (ACR) diagnostic criteria of SLE
* Patient able to attend all visit schedule during the month following influenza vaccine administration
* Clinical examination performed prior final inclusion with results communicated to the patient
Exclusion Criteria
* Positive for HCV, HIV and HBV
* Patient treated with rituximab (anti-CD20) or stopped for less than a year.
* Patient for whom a treatment majorization is suspected within the month following influenza vaccine administration.
* Hypersensitivity to active substances, eggs and to one of the vaccine components
* Other vaccinations within the last 30 days before the inclusion at J0
* Administration of blood products such as immunoglobulins within the last 90 days before J0
* Progressive cancer, cirrhoses
* Acute severe illness within the last 30 days before inclusion at J0
* Patient non affiliated to a health social security system
* Planned participation to another clinical study during the present study period
* patient deprived of freedom by an administrative or court order
18 Years
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Department Clinical Reseach of Developpement
Principal Investigators
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Odile Launay, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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CIC Vaccinologie Hopital Cochin
Paris, , France
Countries
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References
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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.
Other Identifiers
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P090104
Identifier Type: -
Identifier Source: org_study_id