COVID-19 Vaccines Boosters in Immunocompromised Rheumatic Diseases (COVBIRD)
A study on the advantage of using specific vaccine types to achieve satisfactory vaccination in
the most vulnerable patients
As successive waves of COVID-19 continue to occur and new variants emerge, people with systemic autoimmune rheumatic diseases worry about their risk of infection and whether multiple doses of vaccines are safe or might cause flare-ups of their disease. One of the most vulnerable group of patients are people treated with rituximab, a drug that depletes cells producing antibodies. Previous studies showed they have a poor response to mRNA types of vaccines, putting them at high risk of severe COVID-19 despite vaccination.
Ongoing research is needed on the safety and effectiveness of multiple doses of COVID vaccines in people with auto-immune diseases taking drugs that suppress the immune system. Testing new types of vaccines, that are not mRNA vaccines, are essential in order to find the right type of vaccine that works for people taking medications such as Rituximab.
What the Study will do
This study will compare the safety and effectiveness of booster doses of COVID-19 vaccines in people with systemic autoimmune disease treated with rituximab. The study hypothesis is that effectiveness is better when the booster dose is a vaccine from a different group than the one used for primary immunization (mix-and-match approach).
The Research Study
Design: This multicenter clinical trial will enroll 287 patients with different types of systemic autoimmune disease treated with rituximab who received three doses of a mRNA COVID-19 vaccine. These patients will be offered a 4th dose of a non-mRNA COVID-19 vaccine (a protein subunit vaccine, Novavax NUVAXOVID) or a fourth dose of the mRNA vaccine. The two types of boosters will be compared for their ability to induce a good immune response to SARS-CoV2 and the duration of the protection (i.e., effectiveness), and whether the boosters cause flares of the auto-immune disease (i.e., safety)
Significance: This study is key to informing public health authorities on the advantage of using specific vaccine types to achieve satisfactory vaccination in the most vulnerable patients with autoimmune rheumatic diseases.
Paul Fortin, Rheumatology, MD, MPH, FRCPC
Dr. Fortin obtained his medical degree from ‘Université Laval’ in Quebec City and graduated from McGill University in Rheumatology. He then obtained a Master’s in Public Health from Harvard University School of Public Health. He followed three years of special training in clinical epidemiology as a Harvard post-doctoral research fellow under the direction of Dr. Matthew H. Liang at the Robert Breck Brigham Multi-Purpose Arthritis Center of the Brigham and Women’s Hospital. He returned as an Assistant and then Associate Professor of Medicine at McGill University and to the Montreal General Hospital/McGill University Health Centre and Research Institute between 1992 and 2000, where he was funded uninterruptedly by operating grants from The Arthritis Society (TAS) and/or the Canadian Institutes of Health Research (CIHR).
Dr. Fortin has been working on a better understanding of the bio-psycho-social impact of chronic rheumatic diseases such as systemic lupus erythematosus (SLE), the antiphospholipid antibody syndrome (APS), systemic autoimmune rheumatic diseases (SARD) and rheumatoid arthritis. He is particularly interested in clinical applications of translational research and in developing interventions for the treatment of SLE, APS and SARD.
His methodological interests cover the development and validation of health status measures and other clinical tools such as measures of disease activity or damage in SLE. His other methodological interests include the development of risk profiles for arterial or venous thrombosis in APS, the testing of treatments of disease activity or cardiovascular disease in SLE, or the validation of biological markers in SLE and SARD.
Inés Colmegna, Rheumatology, MD
Dr Colmegna received her MD from Universidad del Salvador, Buenos Aires – Argentina. She completed her residency training in internal medicine at CEMIC and rheumatology at the IREP, both of which are institutions affiliated to the University of Buenos Aires. She subsequently pursued a rheumatology post-doctoral fellowship at Louisiana State University (New Orleans, LA-USA) and an immunology post-doctoral fellowship at the Lowance Center for Human Immunology – Emory University (Atlanta, GA-USA). In 2010, Dr Colmegna moved to Canada as a clinician scientist in the Division of Rheumatology at McGill University. Since then, she has been supported by the Fonds de recherche Santé Québec (FRSQ) Chercheur Boursier program (currently she holds a Chercheur Boursier Senior Award).
Dr Colmegna’s team studies mechanisms implicated in the pathogenesis of rheumatoid arthritis (RA), and interventions to reduce the risk of comorbidities in RA (e.g. infections and cardiovascular disease). Dr Colmegna’s work is funded by the Canadian Institutes of Health, The Arthritis Society, and The Canadian Rheumatology Association (CIORA).