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

February 22, 2024 updated by: Guro Løvik Goll, Diakonhjemmet Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

2300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Lørenskog, Norway
        • Akershus University Hospital
      • Oslo, Norway
        • Diakonhjemmet Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Candidate patients will be recruited from the population treated at the two study centres and, if eligible, asked to participate in the observational cohort

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serological response
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
Change from baseline in serum levels of anti-SARS-CoV-2 antibodies
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cellular response
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
Change from baseline in T cell reactivity to SARS-CoV-2
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
Time Frame: Reported by patient for the first 48 hours following each vaccine dose
Occurence of patient-reported adverse events related to vaccination against COVID-19
Reported by patient for the first 48 hours following each vaccine dose
BASDAI
Time Frame: Within 4 weeks of the patient receiving the final dose of vaccine
BASDAI questionnaire to assess disease activity in spondyloarthritis
Within 4 weeks of the patient receiving the final dose of vaccine
Partial Mayo score
Time Frame: 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
Every 3 months for the first year of study, every 6 months thereafter until study completion
Harvey-Bradshaw index (HBI)
Time Frame: 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
Every 3 months for the first year of study, every 6 months thereafter until study completion
DAS28
Time Frame: Within 4 weeks of the patient receiving the final dose of vaccine
Disease Activity Score 28 to assess disease activity in RA and PsA
Within 4 weeks of the patient receiving the final dose of vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diakonhjemmet Hospital

Collaborators

University Hospital, Akershus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2021

Primary Completion (Estimated)

February 15, 2026

Study Completion (Estimated)

February 15, 2027

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

March 12, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Estimated)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIA2021-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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