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

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.

Study Overview

• Status: Terminated
• Conditions: Autoimmune Diseases; Inflammatory Disorder
• Intervention / Treatment: Biological: Blood sample

• Study Type: Observational
• Enrollment (Actual): 78

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Internal medicine Service - Cochin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with neutralizing antibody	1 month after vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with neutralizing antibody	3 months after vaccination
Proportion of patients with neutralizing antibody	6 months after vaccination
Proportion of patients with neutralizing antibody	12 months after vaccination
Proportion of patients with anti-SARS-CoV2 specific T lymphocytes	1 month after vaccination
Proportion of patients with anti-SARS-CoV2 specific T lymphocytes	3 months after vaccination
Proportion of patients with anti-SARS-CoV2 specific T lymphocytes	6 months after vaccination
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	1 month after vaccination
Proportion of patients with symptomatic infection by Covid 19 during follow-up	3 months after vaccination
Proportion of patients with symptomatic infection by Covid 19 during follow-up	6 months after vaccination
Proportion of patients with symptomatic infection by Covid 19 during follow-up	12 months after vaccination
Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment	1 month after vaccination
Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment	3 months after vaccination
Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment	6 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	1 month after vaccination
Proportion of patients with flair of autoimmune disease	3 months after vaccination
Proportion of patients with flair of autoimmune disease	6 months after vaccination
Proportion of patients with flair of autoimmune disease	12 months after vaccination
Proportion of patients with treatment-related adverse events grade 3 or 4	1 month after vaccination
Proportion of patients with treatment-related adverse events grade 3 or 4	3 months after vaccination
Proportion of patients with treatment-related adverse events grade 3 or 4	6 months after vaccination
Proportion of patients with treatment-related adverse events grade 3 or 4	12 months after vaccination

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Immunov; URC Necker Cochin, France

Publications and helpful links

General Publications

• Welzel D, Roskamm N, Samek L, Sturzenhofecker P. Pindolol postmyocardial infarction study: evaluation of the drug's antiarrhythmic and antianginal activity. Am Heart J. 1982 Aug;104(2 Pt 2):512-5. doi: 10.1016/0002-8703(82)90148-x.
• Cameron MM, Milligan PJ, Llanos-Cuentas A, Davies CR. An association between phlebotomine sandflies and aphids in the Peruvian Andes. Med Vet Entomol. 1995 Apr;9(2):127-32. doi: 10.1111/j.1365-2915.1995.tb00168.x.
• Scholes J, Freeman M. The reflective dialogue and repertory grid: a research approach to identify the unique contribution of nursing, midwifery or health visiting to the therapeutic milieu. J Adv Nurs. 1994 Nov;20(5):885-93. doi: 10.1046/j.1365-2648.1994.20050885.x.
• Sacre K, Goulenok T, Bahuaud M, Francois C, Van der Haegen MC, Alexandra JF, Aucouturier P, Hurtado-Nedelec M, Moins-Teisserenc H, Batteux F, Papo T. Impaired long-term immune protection following pneumococcal 13-valent/23-valent polysaccharide vaccine in systemic lupus erythematosus (SLE). Ann Rheum Dis. 2018 Oct;77(10):1540-1542. doi: 10.1136/annrheumdis-2017-212789. Epub 2018 Feb 14. No abstract available.
• Hadjadj J, Planas D, Ouedrani A, Buffier S, Delage L, Nguyen Y, Bruel T, Stolzenberg MC, Staropoli I, Ermak N, Macraigne L, Morbieu C, Henriquez S, Veyer D, Pere H, Casadevall M, Mouthon L, Rieux-Laucat F, Chatenoud L, Schwartz O, Terrier B. Immunogenicity of BNT162b2 vaccine against the Alpha and Delta variants in immunocompromised patients with systemic inflammatory diseases. Ann Rheum Dis. 2022 May;81(5):720-728. doi: 10.1136/annrheumdis-2021-221508. Epub 2022 Jan 12.

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2021
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): March 13, 2022

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: vaccine; Covid-19; SARS-CoV2; autoimmune diseases; immunosuppressants
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Autoimmune Diseases; Investigative Techniques; Therapeutics; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection; Phlebotomy
• Other Study ID Numbers: APHP210167; 2021-A00181-40 (Other Identifier: France : ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No