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

Autoimmune Diseases Clinical Trial

— COVADIS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04870411
• Other study ID #: APHP210167
• Secondary ID: 2021-A00181-40
• Status: Terminated
• Start date: May 12, 2021
• Est. completion date: March 13, 2022

Study information

• Verified date: November 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 78
• Est. completion date: March 13, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• COVID-19
• 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

Locations

Country	Name	City	State
France	Internal medicine Service - Cochin Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Immunov

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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