TerminatedNot Applicable

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

Stopped: Most of the patients were already vaccinated

France78 participantsStarted 2021-05-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Proportion of patients with neutralizing antibody

Timeframe: 1 month after vaccination

Trial details

NCT IDNCT04870411

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-08-31