Auto-immunity in Lupus Patients After Influenza Vaccine (GRIPLUP)

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 2

Conditions

Systemic Lupus Erythematosus (SLE)

Treatments

Drug: Vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT01072734

P090104

Details and patient eligibility

About

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

Full 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.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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