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

Overview

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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 31, 2021

Interventions

  • Biological: Blood sample
    • Humoral and cellular immune response. Sample before vaccination, 1 month, 3 months, 6 months and 12 months post-vaccination

Arms, Groups and Cohorts

  • Patients with auto-immune or autoinflammatory diseases
    • Patients with auto-immune or autoinflammatory diseases treated with immunosuppressants and/or biologics
  • Patients without auto-immune or autoinflammatory diseases
    • Patients without auto-immune or autoinflammatory diseases and not treated with immunosuppressants and/or biologics

Clinical Trial Outcome Measures

Primary Measures

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

Secondary 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Collaborator
    • Immunov
  • Provider of Information About this Clinical Study
    • Sponsor

References

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.