Immune response after COVID‑19 vaccination during maintenance therapy in immune-mediated inflammatory diseases: an observational cohort study (IMPACT)
The vaccines targeting SARS-CoV-2 (the virus causing COVID-19), are highly efficacious in preventing COVID‑19 in the general population. Immune-mediated inflammatory diseases (IMID) such as rheumatoid arthritis, spondyloarthritis, inflammatory bowel disease, or psoriasis affect up to 5% of Canadians, many of whom are treated with immunosuppressive medications. Currently, the efficacy of COVID‑19 vaccines in patients with IMIDs is not known since they were excluded from the original vaccine studies. Very little is also known about protection offered by the vaccines to immunosuppressed patients against new variants of SARS-CoV-2 that has spread across Canada. Therefore, our aim is to therefore conduct a study to determine whether patients with IMIDs on immunosuppressive medications mount an adequate immune response to COVID‑19 vaccines. We plan to recruit a total of 600 subjects (525 with IMIDs treated with immunosuppressive treatment as well as patients not on such medications, and 75 healthy controls). We will collect blood samples before, and at four-to-five time-points after, COVID‑19 vaccination. We will then test these blood samples for antibody responses as well as cellular immune response using our established laboratory methods to determine whether immune response to vaccination is compromised in IMID patients treated with immunosuppressive therapy. We will also determine the immune response against new variants of the SARS-CoV-2 virus. The results of this study will determine whether IMID patients treated with immunosuppressive medications still generate a protective immune response to the original SARS-CoV-2 and new variants after COVID‑19 vaccination. We will then ensure that all stakeholders – patient groups, public health administrators and policy makers- are informed, and recommendations made for appropriate vaccination schedule for these potentially vulnerable patients.
