GRIPLUP: Auto-immunity in Lupus Patients After Influenza Vaccine

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT01072734

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Enrollment

Location

Arm

Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus (SLE)	Drug: Vaccine	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Role of CXCR4/CXCL12 Axis on the Control of Humoral Immunity and Auto-immunity in Lupus Patients After Influenza Vaccine Challenge

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vaccine group single group: all included patients will receive the vaccine	Drug: Vaccine Influenza vaccine Other Names: Influenza vaccine

Arm

Intervention/Treatment

Experimental: Vaccine group

single group: all included patients will receive the vaccine

Drug: Vaccine

Influenza vaccine

Other Names:

Influenza vaccine

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria :

18 years of age and older
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 :

For women, being pregnant or positive pregnancy test
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