Overview

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