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

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ClinicalTrials.gov Identifier: NCT04870411
Recruitment Status : Recruiting
First Posted : May 3, 2021
Last Update Posted : May 24, 2021
Sponsor:
Collaborator:
Immunov
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Autoimmune Diseases Inflammatory Disorder Biological: Blood sample

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Immunological Response to COVID-19 Vaccine in Patients With Autoimmune and Inflammatory Diseases Treated With Immunosuppressants and/or Biologics
Actual Study Start Date : May 12, 2021
Estimated Primary Completion Date : November 12, 2021
Estimated Study Completion Date : November 12, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with auto-immune or autoinflammatory diseases
Patients with auto-immune or autoinflammatory diseases treated with immunosuppressants and/or biologics
Biological: Blood sample
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
Biological: Blood sample
Humoral and cellular immune response. Sample before vaccination, 1 month, 3 months, 6 months and 12 months post-vaccination




Primary Outcome Measures :
  1. Proportion of patients with neutralizing antibody [ Time Frame: 1 month after vaccination ]

Secondary Outcome Measures :
  1. Proportion of patients with neutralizing antibody [ Time Frame: 3 months after vaccination ]
  2. Proportion of patients with neutralizing antibody [ Time Frame: 6 months after vaccination ]
  3. Proportion of patients with neutralizing antibody [ Time Frame: 12 months after vaccination ]
  4. Proportion of patients with anti-SARS-CoV2 specific T lymphocytes [ Time Frame: 1 month after vaccination ]
  5. Proportion of patients with anti-SARS-CoV2 specific T lymphocytes [ Time Frame: 3 months after vaccination ]
  6. Proportion of patients with anti-SARS-CoV2 specific T lymphocytes [ Time Frame: 6 months after vaccination ]
  7. Proportion of patients with anti-SARS-CoV2 specific T lymphocytes [ Time Frame: 12 months after vaccination ]
  8. Proportion of patients with symptomatic infection by Covid 19 during follow-up [ Time Frame: 1 month after vaccination ]
  9. Proportion of patients with symptomatic infection by Covid 19 during follow-up [ Time Frame: 3 months after vaccination ]
  10. Proportion of patients with symptomatic infection by Covid 19 during follow-up [ Time Frame: 6 months after vaccination ]
  11. Proportion of patients with symptomatic infection by Covid 19 during follow-up [ Time Frame: 12 months after vaccination ]
  12. Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment [ Time Frame: 1 month after vaccination ]
  13. Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment [ Time Frame: 3 months after vaccination ]
  14. Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment [ Time Frame: 6 months after vaccination ]
  15. Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment [ Time Frame: 12 months after vaccination ]
  16. Proportion of patients with flair of autoimmune disease [ Time Frame: 1 month after vaccination ]
  17. Proportion of patients with flair of autoimmune disease [ Time Frame: 3 months after vaccination ]
  18. Proportion of patients with flair of autoimmune disease [ Time Frame: 6 months after vaccination ]
  19. Proportion of patients with flair of autoimmune disease [ Time Frame: 12 months after vaccination ]
  20. Proportion of patients with treatment-related adverse events grade 3 or 4 [ Time Frame: 1 month after vaccination ]
  21. Proportion of patients with treatment-related adverse events grade 3 or 4 [ Time Frame: 3 months after vaccination ]
  22. Proportion of patients with treatment-related adverse events grade 3 or 4 [ Time Frame: 6 months after vaccination ]
  23. Proportion of patients with treatment-related adverse events grade 3 or 4 [ Time Frame: 12 months after vaccination ]

Biospecimen Retention:   Samples Without DNA
Serum and cells


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04870411


Contacts
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Contact: Jérôme HADJADJ 00 33 1 58 41 41 18 jerome.hadjadj@aphp.fr
Contact: Marie BENHAMMANI-GODARD 00 33 1 58 41 11 90 marie.godard@aphp.fr

Locations
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France
Internal medicine Service - Cochin Hospital Recruiting
Paris, France, 75014
Contact: Jérôme HADJADJ    00 33 1 58 41 41 18    jerome.hadjadj@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Immunov
Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04870411    
Other Study ID Numbers: APHP210167
2021-A00181-40 ( Other Identifier: France : ANSM )
First Posted: May 3, 2021    Key Record Dates
Last Update Posted: May 24, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Covid-19
vaccine
SARS-CoV2
autoimmune diseases
immunosuppressants
Additional relevant MeSH terms:
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Autoimmune Diseases
Immune System Diseases