Auto-immunity in Lupus Patients After Influenza Vaccine

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Institut National de la Santé Et de la Recherche Médicale, France
• Treatments: Vaccines

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