COvid-19 Vaccine Booster in Immunocompromised Rheumatic Diseases (COVBIRD)
Rheumatoid Arthritis, Autoimmune Rheumatologic Disease, Systemic Lupus Erythematosus
About this trial
This is an interventional prevention trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria
- Diagnosis of a SARD (Rheumatoid arthritis, systemic lupus erythematosus (SLE), juvenile inflammatory arthritis, systemic sclerosis (SSc), idiopathic inflammatory myositis (IIM), overlap connective tissue diseases, mixed connective tissue disease, undifferentiated connective tissue diseases, giant-cell arteritis, and the ANCA-Associated Vasculitis: granulomatosis with polyangiitis (GPA; formerly known as Wegener's granulomatosis), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA; previously known as Churg-Strauss syndrome);
- Has received 3 or 4 doses of an mRNA vaccine;
- Age 18 years and older;
- Male or non-pregnant female;
- Rituximab treatment within last 12 months;
- Able to comprehend the study protocol and provide informed consent.
Exclusion Criteria
- Any medical disease or condition that, in the opinion of the site Principal Investigator or sub-investigator, precludes study participation;
- Significant behavioral disturbances;
- Previous diagnosis of hepatitis B, hepatitis C or HIV;
- Acute illness, with or without fever within 72 hours prior to vaccination;
- History of hypersensitivity or severe allergic reaction such as anaphylaxis to a component of the vaccine or to a previous vaccine;
- Any vaccine received in the 30 days prior to the fourth or fifth dose of COVID-19 vaccine;
- Any vaccine scheduled to be received in the 30 days following the administration of the fourth or fifth dose of COVID-19 vaccine and that cannot be postponed;
- People who experienced inflammation of the heart or lining of the heart (myocarditis or pericarditis) after a previous dose of an mRNA vaccine or protein subunit vaccine.
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Sites / Locations
- Research Institute - McGill University Health CentreRecruiting
- Centre de recherche du CHU de Québec - Université LavalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
No Intervention
Active Comparator
Trajectory A
Trajectory B
Trajectory B5
Participants who have received 3 doses of an mRNA vaccine, will be offered a choice between a fourth dose of an mRNA vaccine and a dose of a protein subunit vaccine (PSV) (Novavax NUVAXOVID) For the Moderna SPIKEVAX Bivalent Original/Omicron BA.4/5: participants will receive one (1) intramuscular injection of 0.5 mL (50 mcg). For the Novavax Nuvaxovid vaccine: participants will receive one (1) intramuscular injection of 0.5 mL (5 mcg) of Novavax Nuvaxovid.
Participants who have already received a 4 doses or more of COVID-19 vaccine in the community at inclusion and do not wish to receive a 5th dose of vaccine in the study.
Participants who have received 4 doses of an mRNA vaccine at inclusion and wish to receive a dose of a protein subunit vaccine (PSV) (Novavax NUVAXOVID) as a fifth dose. For the Novavax Nuvaxovid vaccine: participants will receive one (1) intramuscular injection of 0.5 mL (5 mcg) of Novavax Nuvaxovid.