Autoimmune Hepatitis, Crohn Disease, Liver Transplant; Complications, Psoriatic Arthritis, Rheumatoid Arthritis, Spondyloarthritis, Ulcerative Colitis
Conditions
Brief summary
The purpose of this study is to assess the strength and duration of the immunological response to COVID-19 vaccines in patients treated with immunosuppressive and/or immunomodulating medication for immune-mediated inflammatory diseases in rheumatology and gastroenterology and after a liver transplantation.
Detailed description
Patients on long-term immunosuppressive and/or immunomodulating medication may be susceptible to serious COVID-19. Hence, it is important they get sufficient protection by a COVID-19 vaccine. However, these patients may also be at risk for a less robust vaccine response. There is an urgent need to assess the humoral and cellular immune response to COVID-19 vaccines in these patient groups. The clinical consequences could be to administer several re-vaccinations or to adjust medication. This prospective, observational study aims to assess the immune response after COVID vaccination in patients suffering from inflammatory diseases and using immunosuppressive medication. Also, liver transplanted patients on immunosuppressive medication will be included. Serum and whole blood samples will be obtained from all participants before and 1-4 weeks after the vaccination. Additionally, serum samples will be collected every 3-6 months for 5 years. If patients are allotted further vaccine doses , the patient response will be assessed by blood tests 2-4 weeks after any additional vaccine doses. In a subset of patients, samples will be drawn to study cellular immune responses. Demographic data and data regarding immunosuppressive medication will be recorded. Disease activity (clinical activity indices and biomarkers of inflammation) will be assessed. Blood samples will be obtained for biobank. Information regarding vaccination status and potential COVID-19 testing will be obtained from relevant registers.
Interventions
None listed
Sponsors
University Hospital, Akershus
Diakonhjemmet Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. An established clinical diagnosis of one of the following immune-mediated diseases: rheumatoid arthritis (RA), spondyloarthritis (SpA), psoriatic arthritis (PsA), ulcerative colitis (UC,) Crohns disease (CD), autoimmune hepatitis (AIH) or patients who have undergone a liver transplantation 2. Treatment with relevant immunosuppressive and/or immunomodulating medication \* 3. Adult patients (\> 18 years) 4. Patient intends to obtain vaccination against COVID-19 during the next 6 months * \* The following drugs are considered relevant immunosuppressants and/or immunomodulators and patients using them may be eligible for this study: Rituximab, infliximab, adalimumab, golimumab, certolizumab, etanercept, tocilizumab, abatacept, secukinumab, vedolizumab, ustekinumab, risankizumab, methotrexate, sulfasalazine, leflunomide, azathioprine, 6-mercaptopurine, tofacitinib, filgotinib, baricitinib, upadacitinib, tacrolimus, mycophenolate, prednisolone
Exclusion criteria
1\) Allergy or intolerance to elements of the COVID-19 vaccines \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serological response | 4 weeks after vaccination, then at 3 month intervals during the first year and 6 month intervals for up to a total of 5 years | Change from baseline in serum levels of anti-SARS-CoV-2 antibodies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Reported by patient for the first 48 hours following each vaccine dose | Occurence of patient-reported adverse events related to vaccination against COVID-19 |
| BASDAI | Within 4 weeks of the patient receiving the final dose of vaccine | BASDAI questionnaire to assess disease activity in spondyloarthritis |
| Cellular response | 7-10 days after vaccination, then at 3 month intervals during the first year and 6 month intervals for up to a total of 5 years | Change from baseline in T cell reactivity to SARS-CoV-2 |
| Harvey-Bradshaw index (HBI) | Every 3 months for the first year of study, every 6 months thereafter until study completion | Harvey-Bradshaw index to assess disease activity in Crohn disease |
| DAS28 | Within 4 weeks of the patient receiving the final dose of vaccine | Disease Activity Score 28 to assess disease activity in RA and PsA |
| Partial Mayo score | Every 3 months for the first year of study, every 6 months thereafter until study completion | Partial Mayo score to assess disease activity in ulcerative colitis |
Countries
Norway
Outcome results
None listed