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

Assistance Publique - Hôpitaux de Paris

Status: Terminated

Conditions: Inflammatory Disorder; Autoimmune Diseases

Treatments: Biological: Blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT04870411

2021-A00181-40 (Other Identifier)

APHP210167

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

78 participants in 2 patient groups

Patients with auto-immune or autoinflammatory diseases

Description:

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

Treatment:

Biological: Blood sample

Patients without auto-immune or autoinflammatory diseases

Description:

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

Treatment:

Biological: Blood sample