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 : Terminated (Most of the patients were already vaccinated)

First Posted : May 3, 2021

Last Update Posted : December 9, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Immunov

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

Study Description

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

Study Design

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Study Type :	Observational
Actual Enrollment :	78 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
Actual Primary Completion Date :	August 31, 2021
Actual Study Completion Date :	March 13, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COVID-19 (Coronavirus Disease 2019) COVID-19 Vaccines Vaccines

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

Proportion of patients with neutralizing antibody [ Time Frame: 1 month after vaccination ]

Secondary Outcome Measures :

Proportion of patients with neutralizing antibody [ Time Frame: 3 months after vaccination ]
Proportion of patients with neutralizing antibody [ Time Frame: 6 months after vaccination ]
Proportion of patients with neutralizing antibody [ Time Frame: 12 months after vaccination ]
Proportion of patients with anti-SARS-CoV2 specific T lymphocytes [ Time Frame: 1 month after vaccination ]
Proportion of patients with anti-SARS-CoV2 specific T lymphocytes [ Time Frame: 3 months after vaccination ]
Proportion of patients with anti-SARS-CoV2 specific T lymphocytes [ Time Frame: 6 months after vaccination ]
Proportion of patients with anti-SARS-CoV2 specific T lymphocytes [ Time Frame: 12 months after vaccination ]
Proportion of patients with symptomatic infection by Covid 19 during follow-up [ Time Frame: 1 month after vaccination ]
Proportion of patients with symptomatic infection by Covid 19 during follow-up [ Time Frame: 3 months after vaccination ]
Proportion of patients with symptomatic infection by Covid 19 during follow-up [ Time Frame: 6 months after vaccination ]
Proportion of patients with symptomatic infection by Covid 19 during follow-up [ Time Frame: 12 months after vaccination ]
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 ]
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 ]
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 ]
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 ]
Proportion of patients with flair of autoimmune disease [ Time Frame: 1 month after vaccination ]
Proportion of patients with flair of autoimmune disease [ Time Frame: 3 months after vaccination ]
Proportion of patients with flair of autoimmune disease [ Time Frame: 6 months after vaccination ]
Proportion of patients with flair of autoimmune disease [ Time Frame: 12 months after vaccination ]
Proportion of patients with treatment-related adverse events grade 3 or 4 [ Time Frame: 1 month after vaccination ]
Proportion of patients with treatment-related adverse events grade 3 or 4 [ Time Frame: 3 months after vaccination ]
Proportion of patients with treatment-related adverse events grade 3 or 4 [ Time Frame: 6 months after vaccination ]
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

Eligibility Criteria

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

Contacts and Locations

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

Locations

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

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Immunov

More Information

Publications:

Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24. Erratum In: Lancet Respir Med. 2020 Apr;8(4):e26.

Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, McGettigan J, Khetan S, Segall N, Solis J, Brosz A, Fierro C, Schwartz H, Neuzil K, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Mascola J, Polakowski L, Ledgerwood J, Graham BS, Bennett H, Pajon R, Knightly C, Leav B, Deng W, Zhou H, Han S, Ivarsson M, Miller J, Zaks T; COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021 Feb 4;384(5):403-416. doi: 10.1056/NEJMoa2035389. Epub 2020 Dec 30.

Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Perez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Tureci O, Nell H, Schaefer A, Unal S, Tresnan DB, Mather S, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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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:	December 9, 2022
Last Verified:	November 2022
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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COVID-19 Autoimmune Diseases Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases	Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Immune System Diseases

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