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

• ClinicalTrials.gov Identifier: NCT04870411
• Recruitment Status: Terminated
• First Posted: May 3, 2021
• Last Update Posted: December 9, 2022
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Immunov
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Tracking Information

• First Submitted Date: March 26, 2021
• First Posted Date: May 3, 2021
• Last Update Posted Date: December 9, 2022
• Actual Study Start Date: May 12, 2021
• Actual Primary Completion Date: August 31, 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 29, 2021): Proportion of patients with neutralizing antibody [ Time Frame: 1 month after vaccination ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 29, 2021)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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 Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

Serum and cells

• 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

Condition

• Autoimmune Diseases
• Inflammatory Disorder

Intervention

Biological: Blood sample

Humoral and cellular immune response. Sample before vaccination, 1 month, 3 months, 6 months and 12 months post-vaccination

Study Groups/Cohorts

• Patients with auto-immune or autoinflammatory diseases
  Patients with auto-immune or autoinflammatory diseases treated with immunosuppressants and/or biologics
  Intervention: Biological: Blood sample
• Patients without auto-immune or autoinflammatory diseases
  Patients without auto-immune or autoinflammatory diseases and not treated with immunosuppressants and/or biologics
  Intervention: Biological: Blood sample

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.
• 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.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: December 7, 2022): 78
• Original Estimated Enrollment (submitted: April 29, 2021): 200
• Actual Study Completion Date: March 13, 2022
• Actual Primary Completion Date: August 31, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04870411
• Other Study ID Numbers: APHP210167; 2021-A00181-40 ( Other Identifier: France : ANSM )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Assistance Publique - Hôpitaux de Paris
• Original Responsible Party: Same as current
• Current Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Original Study Sponsor: Same as current
• Collaborators: Immunov
• Investigators: Not Provided
• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: November 2022