This study will evaluate the Moderna RNA-based COVID-19 vaccine currently approved by Health Canada in people with rheumatic diseases. This study will help understand what the side effects of the vaccine in these patients are, and what is their capacity to develop antibodies that may confer protection from the COVID-19 disease.
The purpose of this study is to evaluate the safety, local reactions (reactogenicity), capacity to form antibodies against the coronavirus (immunogenicity) and long-term persistence of those antibodies following two doses of a Health Canada approved RNA-based COVID-19 vaccine in patients with rheumatic diseases. Two doses from the Moderna vaccine will be administered intramuscularly. The time between dose 1 and dose 2 of the vaccine will be 28 days. This research study will recruit 220 participants (165 patients and 55 healthy controls), men and women, aged 18 years or older.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
220
Two doses from the Moderna vaccine will be administered intramuscularly. The time between dose 1 and dose 2 of the vaccine will be 28 days.
McGill University Health Centre
Montreal, Quebec, Canada
Frequency and grade of each solicited local and systemic adverse events (AEs)
Time frame: during a 7-day follow-up period post each vaccination
Frequency and grade of any unsolicited AEs (including 'significant disease flares'*)
\* 'Significant' disease flares: defined as worsening of clinical disease activity documented by the treating physician and requiring intensification of therapy.
Time frame: during the 28-day follow-up period post-each vaccine dose.
Geometric mean titer (GMT) of antibody
Time frame: at Day 57
Percentage of patients who seroconverted
defined as a 4-fold increase in antibody titer
Time frame: baseline and Day 57
Geometric mean fold rise (GMFR) in IgG titer
Time frame: baseline and Day 57
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