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

Assistance Publique - Hôpitaux de Paris78 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Autoimmune Diseases Inflammatory Disorder

Interventions

Blood sample

Humoral and cellular immune response. Sample before vaccination, 1 month, 3 months, 6 months and 12 months post-vaccination

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Internal medicine Service - Cochin Hospital

Paris, France

Outcomes

Primary Outcomes

Proportion of patients with neutralizing antibody

Time frame: 1 month after vaccination

Secondary Outcomes

Proportion of patients with neutralizing antibody

Time frame: 3 months after vaccination

Proportion of patients with neutralizing antibody

Time frame: 6 months after vaccination

Proportion of patients with neutralizing antibody

Time frame: 12 months after vaccination

Proportion of patients with anti-SARS-CoV2 specific T lymphocytes

Time frame: 1 month after vaccination

Proportion of patients with anti-SARS-CoV2 specific T lymphocytes

Time frame: 3 months after vaccination

Proportion of patients with anti-SARS-CoV2 specific T lymphocytes

Time frame: 6 months after vaccination

Proportion of patients with anti-SARS-CoV2 specific T lymphocytes

Time frame: 12 months after vaccination

Proportion of patients with symptomatic infection by Covid 19 during follow-up

Time frame: 1 month after vaccination

Proportion of patients with symptomatic infection by Covid 19 during follow-up

Time frame: 3 months after vaccination

Proportion of patients with symptomatic infection by Covid 19 during follow-up

Time frame: 6 months after vaccination

Proportion of patients with symptomatic infection by Covid 19 during follow-up

Time frame: 12 months after vaccination

Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment

Time frame: 1 month after vaccination

Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment

Time frame: 3 months after vaccination

Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment

Time frame: 6 months after vaccination

Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment

Time frame: 12 months after vaccination

Proportion of patients with flair of autoimmune disease

Time frame: 1 month after vaccination

Proportion of patients with flair of autoimmune disease

Time frame: 3 months after vaccination

Proportion of patients with flair of autoimmune disease

Time frame: 6 months after vaccination

Proportion of patients with flair of autoimmune disease

Time frame: 12 months after vaccination

Proportion of patients with treatment-related adverse events grade 3 or 4

Time frame: 1 month after vaccination

Proportion of patients with treatment-related adverse events grade 3 or 4

Time frame: 3 months after vaccination

Proportion of patients with treatment-related adverse events grade 3 or 4

Time frame: 6 months after vaccination

Proportion of patients with treatment-related adverse events grade 3 or 4

Time frame: 12 months after vaccination

Data from ClinicalTrials.gov

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