Vaccine Response to COVID-19 Vaccines in Patients Using Immunosuppressive Medication
Vaccine Response to COVID-19 Vaccines in Patients Using Immunosuppressive Medication
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.
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. 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.
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

 -