Vaccine Response to COVID-19 Vaccines in Patients Using Immunosuppressive Medication (Nor-vaC)

Diakonhjemmet Hospital

Status: Active, not recruiting

Conditions: Autoimmune Hepatitis; Liver Transplant; Complications; Spondyloarthritis; Ulcerative Colitis; Psoriatic Arthritis; Crohn Disease; Rheumatoid Arthritis

Study type: Observational

Funder types: Other

Identifiers

NCT04798625

DIA2021-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,300 participants in 7 patient groups

Rheumatoid arthritis

Description:

Patients with a clinical diagnosis of rheumatoid arthritis and treated with immunosuppressive medication

Psoriatic arthritis

Description:

Patients with a clinical diagnosis of psoriatic arthritis and treated with immunosuppressive medication

Spondyloarthritis

Description:

Patients with a clinical diagnosis of spondyloarthritis and treated with immunosuppressive medication

Crohn disease

Description:

Patients with a clinical diagnosis of Crohn disease and treated with immunosuppressive medication

Ulcerative colitis

Description:

Patients with a clinical diagnosis of ulcerative colitis and treated with immunosuppressive medication

Autoimmune hepatitis

Description:

Patients with a diagnosis of autoimmune hepatitis and treated with immunosuppressive medication

Liver transplant

Description:

Patients who have undergone liver transplantation and are treated with immunosuppressive drugs