Autoimmune Diseases, Inflammatory Disorder
Conditions
Keywords
Covid-19, vaccine, SARS-CoV2, autoimmune diseases, immunosuppressants
Brief summary
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.
Interventions
BIOLOGICALBlood sample
Humoral and cellular immune response. Sample before vaccination, 1 month, 3 months, 6 months and 12 months post-vaccination
Sponsors
Immunov
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with neutralizing antibody | 1 month after vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with anti-SARS-CoV2 specific T lymphocytes | 1 month after vaccination |
| Proportion of patients with symptomatic infection by Covid 19 during follow-up | 1 month after vaccination |
| Proportion of patients with neutralizing antibody | 3 months after vaccination |
| Proportion of patients with flair of autoimmune disease | 1 month after vaccination |
| Proportion of patients with treatment-related adverse events grade 3 or 4 | 1 month 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 |
Countries
France
Outcome results
None listed