Clinical trial NCT04870411: Immunological Response to COVID-19 Vaccine in Patients With Autoimmune and Inflammatory Diseases Treated With Immunosuppressants and/or Biologics
Official title: Immunological Response to COVID-19 Vaccine in Patients With Autoimmune and Inflammatory Diseases Treated With Immunosuppressants and/or Biologics
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Autoimmune Diseases
Inflammatory Disorder
Keywords: Covid-19
vaccine
SARS-CoV2
autoimmune diseases
immunosuppressants
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Immunov
First posted: 2021-05-03
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with auto-immune or autoinflammatory diseases treated with immunosuppressants and/or biologics = 170 patients Patients without auto-immune or autoinflammatory diseases and not treated with immunosuppressants and/or biologics = 30 patients

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with neutralizing antibody
timeFrame: 1 month after vaccination
Secondary outcomes:
measure: Proportion of patients with neutralizing antibody
timeFrame: 3 months after vaccination
measure: Proportion of patients with neutralizing antibody
timeFrame: 6 months after vaccination
measure: Proportion of patients with neutralizing antibody
timeFrame: 12 months after vaccination
measure: Proportion of patients with anti-SARS-CoV2 specific T lymphocytes
timeFrame: 1 month after vaccination
measure: Proportion of patients with anti-SARS-CoV2 specific T lymphocytes
timeFrame: 3 months after vaccination
measure: Proportion of patients with anti-SARS-CoV2 specific T lymphocytes
timeFrame: 6 months after vaccination
measure: Proportion of patients with anti-SARS-CoV2 specific T lymphocytes
timeFrame: 12 months after vaccination
measure: Proportion of patients with symptomatic infection by Covid 19 during follow-up
timeFrame: 1 month after vaccination
measure: Proportion of patients with symptomatic infection by Covid 19 during follow-up
timeFrame: 3 months after vaccination
measure: Proportion of patients with symptomatic infection by Covid 19 during follow-up
timeFrame: 6 months after vaccination
measure: Proportion of patients with symptomatic infection by Covid 19 during follow-up
timeFrame: 12 months after vaccination
measure: Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment
timeFrame: 1 month after vaccination
measure: Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment
timeFrame: 3 months after vaccination
measure: Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment
timeFrame: 6 months after vaccination
measure: Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment
timeFrame: 12 months after vaccination
measure: Proportion of patients with flair of autoimmune disease
timeFrame: 1 month after vaccination
measure: Proportion of patients with flair of autoimmune disease
timeFrame: 3 months after vaccination
measure: Proportion of patients with flair of autoimmune disease
timeFrame: 6 months after vaccination
measure: Proportion of patients with flair of autoimmune disease
timeFrame: 12 months after vaccination
measure: Proportion of patients with treatment-related adverse events grade 3 or 4
timeFrame: 1 month after vaccination
measure: Proportion of patients with treatment-related adverse events grade 3 or 4
timeFrame: 3 months after vaccination
measure: Proportion of patients with treatment-related adverse events grade 3 or 4
timeFrame: 6 months after vaccination
measure: Proportion of patients with treatment-related adverse events grade 3 or 4
timeFrame: 12 months after vaccination
Other outcomes:
Locations:
city: Paris
country: France
facility: Internal medicine Service - Cochin Hospital
Study officials:
References:
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