Study of the Immune Response to SARS-CoV-2 Vaccination in Patients With Systemic Lupus
Overview
- Phase
- Not Applicable
- Intervention
- SRAS-CoV-2 vaccination immunological response
- Conditions
- Systemic Lupus
- Sponsor
- University Hospital, Strasbourg, France
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Investigation of the immune response following vaccination against SARS-CoV-2
- Status
- Terminated
- Last Updated
- 4 months ago
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.
Investigators
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
Arms & Interventions
Single group of 30 patients with systemic lupus
Intervention: SRAS-CoV-2 vaccination immunological response
Outcomes
Primary Outcomes
Investigation of the immune response following vaccination against SARS-CoV-2
Time Frame: 18 months
Collection of clinical data and correlation with immunological analyzes of the biological samples
Secondary Outcomes
- Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response(18 months)