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

Active, not recruiting

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

• Registration Number: NCT04798625
• Lead Sponsor: Diakonhjemmet Hospital

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.

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 Timeline

• Study Start: 2021-02-15
• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-12
• Study First Posted: 2021-03-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23
• Primary Completion: 2026-02-15
• Study Completion: 2027-02-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
BASDAI	Within 4 weeks of the patient receiving the final dose of vaccine	BASDAI questionnaire to assess disease activity in spondyloarthritis
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
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
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
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

Trial Locations

Locations (2)

Akershus University Hospital; 🇳🇴 Lørenskog, Norway

Diakonhjemmet Hospital; 🇳🇴 Oslo, Norway