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COVID-19 Vaccine Safety and Effectiveness in Patients with Immune-Mediated Inflammatory Diseases 

 

Scientific Study Title:

 

Safety Immunogenicity of Covid-19 Vaccines in Systemic Immune-mediated Inflammatory Diseases (SUCCEED)

 

Principal Investigators:

 

Sasha Bernatsky, Vinod Chandran, Dawn Bowdish, and Carol Hitchon

 

Co-Investigators:

 

Anne-Claude Gingras, Nigil Haroon, Robert Inman, Richard Cook, Gilaad Kaplan, Allison McGeer, Vincent Piguet, Proton Rahman, Mark Silverberg, Tania Watts, Bindee Kuriya, Stephanie Garner, Maggie Larché, John Marshall, Ishac Nazy, J.

Antonio Aviña-Zubieta, Cheryl Barnabe, Gilles Boire, Ines Colmegna, Paul R. Fortin, Glen Hazlewood, Diane Lacaille, Jessica Widdifield, Karen Colwill, and Heidi Wood

 

Study Start Date:

 

April 2021

 

Study End Date:

 

March 2023

 

Why do this research?

 

Immune-mediated Inflammatory Diseases (IMIDs) such as inflammatory bowel disease (Crohn’s and ulcerative colitis), rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus, and psoriasis, are severe, potentially disabling conditions that affect almost 10 per cent of Canadians. Individuals living with IMIDs were excluded from COVID-19 vaccine trials. As a result, regulators, patients, and physicians do not know if COVID-19 vaccination is effective and/or safe in patients with IMIDs.

 

Our study goals are to:

 

  1. Learn whether adult IMID patients have adequate COVID-19 vaccination antibody responses, compared to individuals without an IMID
  2. Establish whether adult IMID patients have the same number of negative events (such as an allergic reaction or joint pain) following COVID-19 vaccination, compared to individuals without an IMID

 

What will be done?

 

Study participants will be recruited from a number of Canadian provinces. The participants will be adult patients with and without an IMID, who have had or are planning to have a COVID-19 vaccine. In British Columbia, study participants will complete up to eight questionnaires over the course of one year, which will collect information on sociodemographic factors (e.g., age, ethnicity, education, income, etc.), COVID-19 vaccines received, disease flares, and any negative events following vaccination. At the same time, participants will do up to eight finger-prick blood tests (similar to what diabetes patients may do to test their blood sugar levels). Results from across Canada will be analyzed to look at the safety and effectiveness of the COVID-19 vaccines in patients with IMIDs.

 

Who is involved?

 

Research teams from across Canada will be participating in this study and recruiting participants. In British Columbia, the project is being led by:

 

Antonio Aviña-Zubieta, MD, MSc, PhD, FRCPC

Senior Scientist, Arthritis Research Canada

Associate Professor of Medicine, Division of Rheumatology, Department of Medicine, University of British Columbia

 

Diane Lacaille, MD, MHSc, FRCPC

Scientific Director, Arthritis Research Canada

Professor of Medicine, Division of Rheumatology, Department of Medicine, University of British Columbia

 

Research staff at the British Columbia site are:

 

Shelby Marozoff, MSc

 

Ayesha Kirmani, MD

 

Who is funding this research?

 

COVID-19 Immunity Task Force (CITF)/Public Health Agency of Canada (PHAC)

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