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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00181-40 | Other Identifier | France : ANSM |
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Most of the patients were already vaccinated
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| Name | Class |
|---|---|
| Immunov | UNKNOWN |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Biological | Humoral and cellular immune response. Sample before vaccination, 1 month, 3 months, 6 months and 12 months post-vaccination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with neutralizing antibody | 1 month after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with neutralizing antibody | 3 months after vaccination | |
| Proportion of patients with neutralizing antibody | 6 months after vaccination | |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Internal medicine Service - Cochin Hospital | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32105632 | Background | 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. | |
| 33378609 |
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Serum and cells
| 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 |
| 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. |
| 33301246 | Background | 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. |
| 29444908 | Background | 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. |
| 35022159 | Result | 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. |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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