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inclusion difficulties
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single group of 30 patients with systemic lupus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SRAS-CoV-2 vaccination immunological response | Biological | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Patient treated by:
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
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Patients with systemic lupus, monitored and vaccinated at the national reference center for "rare systemic autoimmune diseases" of the University Hospitals of Strasbourg.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Hautepierre | Strasbourg | Bas-Rhin | 67000 | France |
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Whole blood with subsequent extraction of:
|
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 |