How safe and immunogenic is the Moderna vaccine in people with rheumatic diseases?
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Scientific Study Title:
COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune Diseases
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Why did we do this research?

People with autoimmune rheumatic diseases, such as rheumatoid arthritis and systemic lupus erythematosus are at higher risk for severe infections. The immune systems of these patients are often suppressed due to their disease or its treatments, which could also impact how well vaccines work. Since the initial vaccine trials had excluded immunosuppressed patients, we evaluated the safety and immunogenicity (ability to generate anti-Covid antibodies) of the Moderna Spikevax vaccine in these patients. These were key questions for which there were no data at the time the study was designed.

What did we do?

  • We conducted a year-long study involving 220 participants, including adults with:
  • Rheumatoid arthritis (131 patients),
  • Systemic lupus erythematosus (23 patients),
  • other rheumatic diseases using prednisone (8 patients), and
  • healthy controls (58 people)
  • Participants received three doses of the Moderna Spikevax COVID-19 vaccine. We conducted evaluations on safety, generation of antibodies in response to vaccines, and COVID-19 infection rates. We compared these results between the rheumatic disease groups and the healthy controls, looking at:
  • self-reported adverse events,
  • levels of anti-Spike antibodies,
  • cellular immune responses to Spikevax, and
  • reported COVID-19 infections.

What are the next steps?

Following this study, we conducted a trial to evaluate strategies to enhance responses to COVID vaccines in patients on rituximab.

The Research Team

Principal Investigators

  • Ines Colmegna, MD, Research Scientist, Arthritis Research Canada (McGill University)
  • Paul R. Fortin, (https://arthritisresearch.ca/paul-fortin/) MD, MPH, FRCPC, Senior Scientist, Arthritis Research Canada, (Université Laval)

Co Investigators

  • Sasha Bernatsky, MD, MSc, PhD (McGill University)
  • Brian Ward, MD, DTM&H, MDCM, (McGill University)
  • Louis Flamand, PhD, MBA (Université Laval)
  • Marc Dionne, MD, MPH, FRCPC (Université Laval)

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