Immune response to COVID-19 vaccination in patients with autoimmune disorders on various types of immunosuppressive treatments

Not Applicable

Completed

• Conditions: Immune response to COVID-19 (SARS-CoV-2 infection) vaccination in patients on immunosuppressive therapy; Infections and Infestations

• Registration Number: ISRCTN68832164
• Lead Sponsor: Charles University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-18
• Study Completion: 2022-04-01
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 199

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Observational
• Study Design: Not specified