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

Rheumatoid Arthritis Clinical Trial

— Nor-vaC  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04798625
• Other study ID #: DIA2021-1
• Status: Active, not recruiting
• Start date: February 15, 2021
• Est. completion date: February 15, 2027

Study information

• Verified date: February 2024
• Source: Diakonhjemmet Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2300
• Est. completion date: February 15, 2027
• Est. primary completion date: February 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

-

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Autoimmune Hepatitis
• Crohn Disease
• Hepatitis, Autoimmune
• Liver Transplant; Complications
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylarthritis
• Spondylitis
• Spondyloarthritis
• Ulcerative Colitis

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lørenskog
Norway	Diakonhjemmet Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital	University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

References & Publications (6)

Bjorlykke KH, Orbo HS, Tveter AT, Jyssum I, Sexton J, Tran TT, Christensen IE, Kro GB, Kvien TK, Jahnsen J, Munthe LA, Chopra A, Warren DJ, Mjaaland S, Haavardsholm EA, Grodeland G, Provan SA, Vaage JT, Syversen SW, Goll GL, Jorgensen KK. Four SARS-CoV-2 — View Citation

Christensen IE, Jyssum I, Tveter AT, Sexton J, Tran TT, Mjaaland S, Kro GB, Kvien TK, Warren DJ, Jahnsen J, Munthe LA, Haavardsholm EA, Vaage JT, Grodeland G, Lund-Johansen F, Jorgensen KK, Syversen SW, Goll GL, Provan SA. The persistence of anti-Spike an — View Citation

Jorgensen KK, Hoivik ML, Chopra A, Benth JS, Ricanek P, Moum PB, Jyssum I, Bolstad N, Warren DJ, Vaage PJT, Munthe PLA, Lundin PKEA, Anisdahl K, Syversen SW, Goll GL, Lund-Johansen F, Medhus AW, Jahnsen PJ. Humoral immune response to SARS-CoV-2 vaccinatio — View Citation

Jyssum I, Kared H, Tran TT, Tveter AT, Provan SA, Sexton J, Jorgensen KK, Jahnsen J, Kro GB, Warren DJ, Vaage EB, Kvien TK, Nissen-Meyer LH, Anderson AM, Grodeland G, Haavardsholm EA, Vaage JT, Mjaaland S, Syversen SW, Lund-Johansen F, Munthe LA, Goll GL. — View Citation

Syversen SW, Jyssum I, Tveter AT, Sexton J, Christensen IE, Tran TT, Bjorlykke KH, Mjaaland S, Warren DJ, Kvien TK, Chopra A, Kro GB, Jahnsen J, Munthe LA, Haavardsholm EA, Grodeland G, Vaage JT, Provan SA, Jorgensen KK, Goll GL. Immunogenicity and safety — View Citation

Syversen SW, Jyssum I, Tveter AT, Tran TT, Sexton J, Provan SA, Mjaaland S, Warren DJ, Kvien TK, Grodeland G, Nissen-Meyer LSH, Ricanek P, Chopra A, Andersson AM, Kro GB, Jahnsen J, Munthe LA, Haavardsholm EA, Vaage JT, Lund-Johansen F, Jorgensen KK, Goll — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serological response	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	Cellular response	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
Secondary	Adverse events	Occurence of patient-reported adverse events related to vaccination against COVID-19	Reported by patient for the first 48 hours following each vaccine dose
Secondary	BASDAI	BASDAI questionnaire to assess disease activity in spondyloarthritis	Within 4 weeks of the patient receiving the final dose of vaccine
Secondary	Partial Mayo score	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
Secondary	Harvey-Bradshaw index (HBI)	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
Secondary	DAS28	Disease Activity Score 28 to assess disease activity in RA and PsA	Within 4 weeks of the patient receiving the final dose of vaccine