Trials / Active Not Recruiting

Active Not RecruitingNCT04798625

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

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

Status: Active Not Recruiting
Phase: —
Study type: Observational
Enrollment: 2,300 (actual)

Sponsor: Diakonhjemmet Hospital · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Conditions

Timeline

Start date: 2021-02-15
Primary completion: 2026-02-15
Completion: 2027-02-15
First posted: 2021-03-15
Last updated: 2024-02-23

Locations

2 sites across 1 country: Norway

Source: ClinicalTrials.gov record NCT04798625. Inclusion in this directory is not an endorsement.