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

Sponsor

Diakonhjemmet Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04798625

Collaborator

University Hospital, Akershus (Other)

1,600

Enrollment

Locations

Anticipated Duration (Months)

800

Patients Per Site

11.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Psoriatic Arthritis Spondyloarthritis Crohn Disease Ulcerative Colitis Autoimmune Hepatitis Liver Transplant; Complications

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Norwegian Study of Vaccine Response to COVID-19 Vaccines in Patients Using Immunosuppressive Medication Within Rheumatology and Gastroenterology: the Nor-vaC Study

Actual Study Start Date :

Feb 15, 2021

Anticipated Primary Completion Date :

Feb 15, 2026

Anticipated Study Completion Date :

Feb 15, 2027

Arms and Interventions

Arm	Intervention/Treatment
Rheumatoid arthritis Patients with a clinical diagnosis of rheumatoid arthritis and treated with immunosuppressive medication
Psoriatic arthritis Patients with a clinical diagnosis of psoriatic arthritis and treated with immunosuppressive medication
Spondyloarthritis Patients with a clinical diagnosis of spondyloarthritis and treated with immunosuppressive medication
Crohn disease Patients with a clinical diagnosis of Crohn disease and treated with immunosuppressive medication
Ulcerative colitis Patients with a clinical diagnosis of ulcerative colitis and treated with immunosuppressive medication
Autoimmune hepatitis Patients with a diagnosis of autoimmune hepatitis and treated with immunosuppressive medication
Liver transplant Patients who have undergone liver transplantation and are treated with immunosuppressive drugs

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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
Treatment with relevant immunosuppressive and/or immunomodulating medication *
Adult patients (> 18 years)
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