Immune response to COVID-19 (SARS-CoV-2 infection) vaccination in patients on immunosuppressive therapy Infections and Infestations
Conditions
Interventions
This study involves no intervention. The study team does not provide SARS-CoV-2 vaccination. The researchers only observe the immune response to SARS-CoV-2 vaccination. The vaccination itself is carri
Sponsors
Charles University
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Demographic parameters measured using a questionnaire: 1.1. Age (Visit 1) 1.2. Sex (Visit 1) 1.3. BMI (Visit 1, 2, 3) 2. Evaluation of IBD (not in healthy controls): 2.2. Cohn’s disease - disease form and location derived from medical record, disease activity assessed by Harvey Bradshaw index (Visit 1, 2, 3) 2.3. Ulcerative colitis – extent derived from medical record, disease activity assessed by Partial Mayo score (Visit 1, 2, 3) 2.3. Autoimmune hepatitis - activity derived from ALT level (remission defined as ALT no higher than 1.5 x ULN) (Visit 1, 2, 3) 3. Treatment of disease (Visit 1, 2, 3): 3.1 IBD groups A-C: 3.1.1. Mesalazine dose (g/d) derived from medical record 3.1.2. Azathioprine dose (mg/d) derived from medical record 3.1.3. Infliximab dose 5 mg/kg or 10 mg/kg, dosing interval, BT/vaccine interval for the first and second dose of the vaccine, derived from medical record 3.1.4. Adalimumab dose 40 mg/2 w or 80 mg/2 w, dosing interval, BT/vaccine interval for the first and second dose of the vaccine, derived from medical record 3.2. AIH group D (Visit 1, 2, 3): 3.2.1. Corticosteroid dose (mg/d) derived from medical record 3.2.2. Azathioprine dose (mg/d) derived from medical record 4. Laboratory parameters (group A-E): 4.1. Initial blood collection up to 1 month before the start of vaccination (Visit 1): 4.1.1. Complete blood count incl. white blood cell differential, assessed by standard hematologic measurement 4.1.2. Biochemistry: total bilirubin, AST, ALT, GGT, ALP, albumin, CRP, Fe; assessed by standard biochemistry measurement 4.1.3. Immunology and special tests: total IgG measured by nephelometry; SARS-CoV-2 IgG antibodies measured by ELISA; CD45, CD4, CD3, interferon-gamma, CD8, CD107, TNF-alpha, CD69, CD3, Ki67, CD137, CD27, CD45RO measured by flow cytometry 4.2. Blood collection 1 month after the second vaccination dose (Visit 2): 4.2.1. Total IgG measured by nephelometry; SARS-CoV-2 IgG antibodies measured by ELISA; CD45, CD4, CD3, interfero | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 25OH vitamin D measured by immunochemistry at Visit 1 2. History of previous influenza vaccination derived from questionnaire 1 at Visit 1 | — |
Countries
Czech Republic
Outcome results
None listed