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

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ClinicalTrials.gov Identifier: NCT04798625
Recruitment Status : Active, not recruiting
First Posted : March 15, 2021
Last Update Posted : October 25, 2021
Sponsor:
Collaborator:
University Hospital, Akershus
Information provided by (Responsible Party):
Guro Løvik Goll, Diakonhjemmet Hospital

Study Description
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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
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
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Study Type : Observational
Estimated 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 : February 15, 2021
Estimated Primary Completion Date : February 15, 2026
Estimated Study Completion Date : February 15, 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. BASDAI [ Time Frame: Within 4 weeks of the patient receiving the final dose of vaccine ]
    BASDAI questionnaire to assess disease activity in spondyloarthritis

  4. 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

  5. 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

  6. 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


Biospecimen Retention:   Samples With DNA
Whole blood Serum White blood cells

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04798625


Locations
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Norway
Akershus University Hospital
Lørenskog, Norway
Diakonhjemmet Hospital
Oslo, Norway
Sponsors and Collaborators
Diakonhjemmet Hospital
University Hospital, Akershus
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Guro Løvik Goll, Principal investigator, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier: NCT04798625    
Other Study ID Numbers: DIA2021-1
First Posted: March 15, 2021    Key Record Dates
Last Update Posted: October 25, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Spondylarthritis
Crohn Disease
Hepatitis, Autoimmune
Hepatitis
Liver Diseases
Digestive System Diseases
Joint Diseases
Musculoskeletal Diseases
Autoimmune Diseases
Immune System Diseases
 Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Intestinal Diseases
Spondylarthropathies
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Hepatitis, Chronic