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

N/AActive Not RecruitingNCT04798625

Diakonhjemmet Hospital2,300 enrolled

Overview

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. 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.

Study Type

OBSERVATIONAL

Enrollment

2,300

Conditions

Rheumatoid Arthritis Psoriatic Arthritis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 \-

Outcomes

Primary Outcomes

Serological response

Change from baseline in serum levels of anti-SARS-CoV-2 antibodies

Time frame: 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

Secondary Outcomes

Cellular response

Change from baseline in T cell reactivity to SARS-CoV-2

Time frame: 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

Adverse events

Occurence of patient-reported adverse events related to vaccination against COVID-19

Time frame: Reported by patient for the first 48 hours following each vaccine dose

BASDAI

BASDAI questionnaire to assess disease activity in spondyloarthritis

Time frame: Within 4 weeks of the patient receiving the final dose of vaccine

Partial Mayo score

Partial Mayo score to assess disease activity in ulcerative colitis

Time frame: Every 3 months for the first year of study, every 6 months thereafter until study completion

Harvey-Bradshaw index (HBI)

Harvey-Bradshaw index to assess disease activity in Crohn disease