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

Terminated

• Conditions: Inflammatory Disorder; Autoimmune Diseases
• Interventions: Biological: Blood sample

• Registration Number: NCT04870411
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-04-29
• Study First Posted: 2021-05-03
• Study Start: 2021-05-12
• Primary Completion: 2021-08-31
• Study Completion: 2022-03-13
• Status Verified: 2022-11
• Last Update Submitted: 2022-12-07
• Last Update Posted: 2022-12-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients without auto-immune or autoinflammatory diseases	Blood sample	Patients without auto-immune or autoinflammatory diseases and not treated with immunosuppressants and/or biologics
Patients with auto-immune or autoinflammatory diseases	Blood sample	Patients with auto-immune or autoinflammatory diseases treated with immunosuppressants and/or biologics

Primary Outcome Measures

Name	Time	Method
Proportion of patients with neutralizing antibody	1 month after vaccination

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with anti-SARS-CoV2 specific T lymphocytes	12 months after vaccination
Proportion of patients with symptomatic infection by Covid 19 during follow-up	12 months after vaccination
Proportion of patients with treatment-related adverse events grade 3 or 4	12 months after vaccination
Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment	12 months after vaccination
Proportion of patients with flair of autoimmune disease	12 months after vaccination
Proportion of patients with neutralizing antibody	12 months after vaccination

Trial Locations

Locations (1)

Internal medicine Service - Cochin Hospital; 🇫🇷 Paris, France