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How safe and immunogenic is the Moderna vaccine in people with rheumatic diseases?

 

Scientific Study Title:

COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune Diseases

 

Principal Investigators:

Paul R. Fortin MD, MPH, FRCPC

Tenured Professor, Division of Rheumatology, Department of Medicine, Université Laval

Canada Research Chair on Systemic Autoimmune Rheumatic Diseases

Clinician-Scientist, Centre de recherche du CHU de Québec-Université Laval

Senior Scientist, Arthritis Research Canada

Ines Colmegna,  MD

Associate Professor, Division of Rheumatology, Department of Medicine, McGill University

Scientist, Research Institute of the McGill University Health Sciences

Infectious Diseases and Immunity in Global Health Program

 

Co Investigators:

Sasha Bernatsky, Brian Ward, Louis Flamand and Marc Dionne

 

Start Date:

2021

 

End Date:

2022

 

Why do this research?

This study was done to evaluate the safety and effectiveness of two doses of a mRNA-based SARS-CoV2 vaccine (Moderna) in people with a rheumatic disease. Vaccines stimulate the production of antibodies which help protect people from infectious diseases like COVID-19. People with rheumatic disease like rheumatoid arthritis (RA) and systemic Lupus Erythematosus (SLE) often have impaired immune responses that may result from their disease itself or from the medications they need to control their disease.  This impairment of their immune system may decrease their bodies’ ability to form antibodies to vaccines or maintain those antibodies long term. If that occurs, they may have a lower level of protection from the vaccine. Also, It is important to determine whether a mRNA vaccine can cause a flare up of symptoms of a rheumatic disease.

 

What will be done?

This research study recruited 220 participants (165 patients with a rheumatic disease and 55 healthy controls) aged 18 years or older. Participants received two doses from a mRNA vaccine, Moderna, which is one of the vaccines approved by Health Canada. The time between the two doses was 28 days. Evaluation will include determining their anti-COVID-19 response and adverse effects post-vaccination.

 

Who is involved

Adults, diagnosed with RA or SLE, on stable treatment and who receive rheumatology care at University of Laval (Quebec City) or at McGill University Health Centre (Montreal) were eligible for the study. Recruitment of specific groups of patients based on age (above and below 65 years of age), and treatment (SLE on mofetil mycophenolate, RA on methotrexate, non-rituximab biologics, rituximab or small molecules) was done. The results of this study will have implications on the decision to make in the near future about whether patients with RA and SLE need special attention at the time of their anti-COVID-19 vaccination.

 

Funding Agency:

Province of Quebec, Ministry of Health

 

How will people get involved?

Recruitment for this study is completed and we are currently analyzing the primary aims of the study.

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