Immunological Response to COVID-19 Vaccine in Patients With Autoimmune and Inflammatory Diseases Treated With Immunosuppressants and/or Biologics

Study Overview
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Brief Summary
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Vaccination against the new coronavirus (SARS-CoV-2) was extended to patients at risk of severe forms of Covid-19, including in particular patients with autoimmune and inflammatory diseases treated by immunosuppressants and/or biologics. In this particular population, the effectiveness of vaccines, in particular influenza and pneumococcal vaccinations, is often reduced, especially in case of treatment with rituximab and / or methotrexate. Regarding the SARS-CoV-2 vaccine, the studies that allowed the marketing authorization of the available vaccines did not include patients treated with immunosuppressants or immunomodulators. Thus, the impact of treatments on the production of neutralizing antibodies and specific T lymphocytes is not known. The goal of this study is to assess the immune response to the SARS-CoV-2 vaccine in patients with autoimmune and inflammatory diseases treated with immunosuppressants or immunomodulators.

Official Title
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Immunological Response to COVID-19 Vaccine in Patients With Autoimmune and Inflammatory Diseases Treated With Immunosuppressants and/or Biologics

Conditions
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Autoimmune Diseases, Inflammatory Disorder

Intervention / Treatment
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* Biological: Blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Group 1 : Patient over 18 years old, Patient informed and not opposed to participate Patient followed for an autoimmune or inflammatory disease (vasculitis, systemic lupus, systemic sclerosis, non-infectious uveitis) Treatment with immunosuppressant and / or immunomodulator Group 2 : Patient over 18 years old, Patient informed and not opposed to participate Patient not followed for an autoimmune or inflammatory disease (vasculitis, systemic lupus, systemic sclerosis, non-infectious uveitis) Absence of treatment with immunosuppressant and / or immunomodulator Exclusion Criteria: Contraindication to vaccination Progressive cancer Pregnant or breastfeeding woman Current infection less than 3 weeks old Weight less than 40 kg Patient under tutor- or curator-ship Patient without health insurance

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with auto-immune or autoinflammatory diseases<br>Patients with auto-immune or autoinflammatory diseases treated with immunosuppressants and/or biologics | Biological: Blood sample<br>* Humoral and cellular immune response. Sample before vaccination, 1 month, 3 months, 6 months and 12 months post-vaccination<br>|
| Patients without auto-immune or autoinflammatory diseases<br>Patients without auto-immune or autoinflammatory diseases and not treated with immunosuppressants and/or biologics | Biological: Blood sample<br>* Humoral and cellular immune response. Sample before vaccination, 1 month, 3 months, 6 months and 12 months post-vaccination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with neutralizing antibody |  | 1 month after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with neutralizing antibody |  | 3 months after vaccination | 
| Proportion of patients with neutralizing antibody |  | 6 months after vaccination | 
| Proportion of patients with neutralizing antibody |  | 12 months after vaccination | 
| Proportion of patients with anti-SARS-CoV2 specific T lymphocytes |  | 1 month after vaccination | 
| Proportion of patients with anti-SARS-CoV2 specific T lymphocytes |  | 3 months after vaccination | 
| Proportion of patients with anti-SARS-CoV2 specific T lymphocytes |  | 6 months after vaccination | 
| Proportion of patients with anti-SARS-CoV2 specific T lymphocytes |  | 12 months after vaccination | 
| Proportion of patients with symptomatic infection by Covid 19 during follow-up |  | 1 month after vaccination | 
| Proportion of patients with symptomatic infection by Covid 19 during follow-up |  | 3 months after vaccination | 
| Proportion of patients with symptomatic infection by Covid 19 during follow-up |  | 6 months after vaccination | 
| Proportion of patients with symptomatic infection by Covid 19 during follow-up |  | 12 months after vaccination | 
| Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment |  | 1 month after vaccination | 
| Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment |  | 3 months after vaccination | 
| Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment |  | 6 months after vaccination | 
| Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment |  | 12 months after vaccination | 
| Proportion of patients with flair of autoimmune disease |  | 1 month after vaccination | 
| Proportion of patients with flair of autoimmune disease |  | 3 months after vaccination | 
| Proportion of patients with flair of autoimmune disease |  | 6 months after vaccination | 
| Proportion of patients with flair of autoimmune disease |  | 12 months after vaccination | 
| Proportion of patients with treatment-related adverse events grade 3 or 4 |  | 1 month after vaccination | 
| Proportion of patients with treatment-related adverse events grade 3 or 4 |  | 3 months after vaccination | 
| Proportion of patients with treatment-related adverse events grade 3 or 4 |  | 6 months after vaccination | 
| Proportion of patients with treatment-related adverse events grade 3 or 4 |  | 12 months after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid-19, vaccine, SARS-CoV2, autoimmune diseases, immunosuppressants