Immune Response to SARS-CoV-2 Vaccination in Systemic Lupus

Study Overview
=================
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.

Official Title
-----------------
Study of the Immune Response to SARS-CoV-2 Vaccination in Patients With Systemic Lupus

Conditions
-----------------
Systemic Lupus

Intervention / Treatment
-----------------
* Biological: SRAS-CoV-2 vaccination immunological response


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single group of 30 patients with systemic lupus<br> | Biological: SRAS-CoV-2 vaccination immunological response<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigation of the immune response following vaccination against SARS-CoV-2 | Collection of clinical data and correlation with immunological analyzes of the biological samples | 3 or 4 weeks | 
| Investigation of the immune response following vaccination against SARS-CoV-2 | Collection of clinical data and correlation with immunological analyzes of the biological samples | 3 months | 
| Investigation of the immune response following vaccination against SARS-CoV-2 | Collection of clinical data and correlation with immunological analyzes of the biological samples | 6 months | 
| Investigation of the immune response following vaccination against SARS-CoV-2 | Collection of clinical data and correlation with immunological analyzes of the biological samples | 12 months | 
| Investigation of the immune response following vaccination against SARS-CoV-2 | Collection of clinical data and correlation with immunological analyzes of the biological samples | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response | Measurement of lupus disease activity by a validated score (SLEDAI) at the time of vaccination and follow-up. | 3 or 4 weeks | 
| Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response | Measurement of lupus disease activity by a validated score (SLEDAI) at the time of vaccination and follow-up. | 3 months | 
| Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response | Measurement of lupus disease activity by a validated score (SLEDAI) at the time of vaccination and follow-up. | 6 months | 
| Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response | Measurement of lupus disease activity by a validated score (SLEDAI) at the time of vaccination and follow-up. | 12 months | 
| Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response | Measurement of lupus disease activity by a validated score (SLEDAI) at the time of vaccination and follow-up. | 18 months |