COvid-19 Vaccines Booster in Immunocompromised Rheumatic Diseases (COVBIRD)

Fortin, Paul R | $995,312

Quebec Université Laval 2021 CIHR Operating Grant

In the midst of a fourth wave and the circulation of the delta variant, Quebec and Ontario offer a third dose of mRNA COVID‑19 vaccine to immunosuppressed patients including people living with systemic autoimmune rheumatic diseases (SARD). However, the safety and the response to a third dose of vaccine in rheumatic disease patients is unknown. Moreover, initial results from an ongoing study demonstrated that SARD patients treated with rituximab, a drug that depletes cells producing antibodies, have a poor response to two doses of an mRNA vaccine. Since this group is also less likely to respond to a third vaccine dose, defining strategies to enhance responses to COVID‑19 vaccines in these vulnerable patients is a priority. Hypothesis: A fourth dose of a non-mRNA vaccine, in SARD patients treated with Rituximab who do not respond to a third dose, is safe and enhances the number of patients who develop post-vaccine antibody responses. Primary Aims: To evaluate the safety of a 4th dose of vaccine in SARD patients treated with rituximab and the vaccine induced antibody responses. Secondary Aims: To compare the response following a 4th dose of a non-mRNA vaccine; to evaluate the effect of immunosuppressive treatment on the response post-4th dose; to compare the rates of disease flares post-4th dose of a non-mRNA vaccine; to assess the persistence of humoral responses induced by a 4th dose of a non-mRNA vaccines. Design: This multicenter clinical trial will enroll SARD patients on rituximab who did not respond to a third dose of a COVID‑19 vaccine. These patients will be offered a 4th dose of non-mRNA COVID‑19 vaccines that will be approved in the coming months by Health Canada. Significance: This study is key to inform public health authorities on the advantage of using specific vaccine types to achieve satisfactory vaccination in the most vulnerable SARD patients.

With funding from the Government of Canada

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