Humoral and cellular immune REsponse to SARS-CoV-2 vaccination in adult Patients with stable inflammatOry bowel disease or autoimmuNe hepatitis treated with different immunoSuppressive regimens: observational, prospectivE, controlled, single-center study

Charles University0 个研究点目标入组 199 人开始时间: 2021年3月18日最近更新: 2024年5月27日

适应症

试验速览

暂无简介。

•Group A: Patients with inflammatory bowel disease without immunosuppressant in maintenance therapy (50 patients)
•Group B: Patients with inflammatory bowel disease on maintenance therapy with azathioprine (50 patients)
•Group C: Patients with inflammatory bowel disease on biologic therapy (50 patients) (combination with azathioprine possible)
•Group D: Patients with autoimmune hepatitis on low-dose corticosteroid maintenance therapy with or without azathioprine (50 patients)
•Group E: Healthy volunteers (30)
•Inclusion criteria common in all groups:
•1. Interest in SARS-CoV-2 vaccination conducted by the national vaccination program (vaccination is not part of the study)
•2. Signed informed consent
•3. Age 18 years and above
•4. No symptoms or positive test for SARS-CoV-2 infection in the last 2 months
•Group-specific inclusion criteria:
•Group A: Diagnosis of inflammatory bowel disease, no immunosuppressant in maintenance therapy
•Group B: Diagnosis of inflammatory bowel disease, immunosuppressive therapy with azathioprine
•Group C: Diagnosis of inflammatory bowel disease, biologic therapy with anti-TNF alpha (infliximab, adalimumab) with or without concomitant azathioprine
•Group D: Diagnosis of autoimmune hepatitis, maintenance therapy with low-dose corticosteroid with or without azathioprine
•Group E: No history of major chronic diseases, no chronic medication

•1. Contraindication to SARS-CoV-2 vaccination
•2. Serious comorbidities (e.g. active oncological disease, terminal organ failure, severely limited life expectancy)
•3. Any other immunosuppressive or immunomodulatory treatment of comorbidities
•4. Moderate or severe activity of IBD or autoimmune hepatitis/exacerbation of disease (Crohn's disease - Harvey-Bradshaw index > 5, ulcerative colitis - partial Mayo score > 4, autoimmune hepatitis – ALT activity > 1.5 x ULN)

发起方

Charles University