Principal Investigator: Dr. Sasha Bernatsky

Affiliation: Research Institute of the McGill University Health Centre

Start Year: 2022

The vaccines targeting SARSCoV2 (the virus responsible for COVID-19), are up to 95% effective based on studies in the general population. Patients with
immune mediated inflammatory diseases such as rheumatoid arthritis, spondyloarthritis, other rheumatic diseases (e.g., vasculitis and systemic lupus
erythematosus), inflammatory bowel disease, or psoriasis were excluded from the original studies, so it is not clear how effective the vaccines will be in
these populations, or whether there might be significant side effects, or flares in autoimmune diseases. We will study these issues, including whether there
is a good immune response to the vaccine in over 2000 patients with various autoimmune and inflammatory diseases who are treated with standard
medications, including medications called “biologics”. Before and at several time-points after the vaccination(s), patients with IMIDs will be invited to
perform finger-prick blood tests at home and mail in each blood spot on cards to the laboratory. These will be analyzed for antibodies against SARSCoV2. If
there is a trend towards reduced immune response in groups of patients, we will perform more in-depth experiments using blood samples from those
patients to clarify the reasons for reduced immune responses. To answer safety questions, patients will be invited to complete questionnaires (some by
phone) before and at several time-points after the vaccine, regarding symptoms of possible side effects from the vaccine or COVID-19 infection. Disease
flares will also be monitored by questionnaires and phone calls. Provincial medical records will be cross-referenced with study data to determine doctor
visits and hospital admissions related to possible side effects from the vaccine, or disease flares, or COVID-19 infection. The study population consists of
adult (>18 years old) patients with IMIDs, recruited from our network across Canada (St. John’s, Quebec City, Sherbrooke, Montreal, Toronto, Hamilton,
Winnipeg, Calgary, Vancouver). A total of 2320 IMID patients (500-600 patients each for IBD, RA, SLE, SpA, and psoriasis) as well as non-IMID controls
(many from the CanPath registry), will provide questionnaire data and bio-samples for immunogenicity studies.