Auto-immunity in Lupus Patients After Influenza Vaccine

Phase 2

Completed

• Conditions: Systemic Lupus Erythematosus (SLE)
• Interventions: Drug: Vaccine

• Registration Number: NCT01072734
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Annual influenza vaccination is recommended in patients with systemic lupus erythematosus (SLE). However some concerns remain about vaccination and the risk of lupus flare

Detailed Description

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.

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.

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2010-01
• Study Completion: 2010-02
• Study First Submitted: 2010-02-19
• Study First Submitted QC: 2010-02-19
• Study First Posted: 2010-02-22
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-11
• Last Update Posted: 2010-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaccine group	Vaccine	single group: all included patients will receive the vaccine

Primary Outcome Measures

Name	Time	Method
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	7 and 30 days post-vaccination

Secondary Outcome Measures

Name	Time	Method
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	one year after

Trial Locations

Locations (1)

CIC Vaccinologie Hopital Cochin; 🇫🇷 Paris, France