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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-12

Study Completion Date

2022-03-13

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.

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Detailed Description

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Conditions

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Autoimmune Diseases Inflammatory Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with auto-immune or autoinflammatory diseases

Patients with auto-immune or autoinflammatory diseases treated with immunosuppressants and/or biologics

Blood sample

Intervention Type BIOLOGICAL

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

Patients without auto-immune or autoinflammatory diseases

Patients without auto-immune or autoinflammatory diseases and not treated with immunosuppressants and/or biologics

Blood sample

Intervention Type BIOLOGICAL

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

Interventions

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Blood sample

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

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No