Systemic Lupus
Conditions
Brief summary
The main objective is to study the impact of vaccination against Covid-19 on the specific humoral and cellular immune response (against SARS-CoV-2) and non-specific (evolution of the pathological immune system of the disease), in a lupus population. The secondary objective is to study the impact of lupus disease activity on the humoral and cellular response of patients following vaccination against SARS-CoV-2. The hypothesis is that disease activity and / or certain treatments used in lupus may interfere with the humoral and cellular immune response induced by vaccination against SARS-CoV-2.
Interventions
BIOLOGICALSRAS-CoV-2 vaccination immunological response
Follow for 18 months a single group of 30 patients with systemic lupus after their SRAS-CoV-2 vaccination. Intervention includes immunological analysis on additional volume of blood collected as part of routine care.
Sponsors
University Hospital, Strasbourg, France
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult subject (≥ 18 years old), male or female * Patient with systemic lupus according to ACR 1997 criteria * Patient followed by the National Reference Center Rare Systemic Autoimmune Diseases of the University Hospitals of Strasbourg * Patient who agreed to be vaccinated against SARS-CoV-2 * Subject having expressed his non-opposition to the research * Subject affiliated to a social health insurance protection scheme
Exclusion criteria
* Patient treated by: * Corticosteroids (\> = 10mg / day) * Immunosuppressant (azathioprine, mycophenolate mofetil, cyclophosphamide) to control lupus activity * A biomedicine targeting B cells (rituximab, belumimab). * Inability to provide informed information about the subject (subject in an emergency, difficulty in understanding the subject, etc.) * Subject under safeguard of justice * Subject under guardianship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigation of the immune response following vaccination against SARS-CoV-2 | 3 or 4 weeks | Collection of clinical data and correlation with immunological analyzes of the biological samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response | 3 or 4 weeks | Measurement of lupus disease activity by a validated score (SLEDAI) at the time of vaccination and follow-up. |
Countries
France
Outcome results
None listed