COVID-19 Vaccine in Immunosuppressed Adults With Autoimmune Diseases

Phase 3

Completed

• Conditions: Covid19; Rheumatic Diseases; SLE; Rheumatoid Arthritis

• Registration Number: NCT04806113
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2021-03-11
• Study First Submitted: 2021-03-12
• Study First Submitted QC: 2021-03-17
• Study First Posted: 2021-03-19
• Primary Completion: 2021-06-13
• Study Completion: 2022-06-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-17
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Frequency and grade of any unsolicited AEs (including 'significant disease flares'*)	during the 28-day follow-up period post-each vaccine dose.	\* 'Significant' disease flares: defined as worsening of clinical disease activity documented by the treating physician and requiring intensification of therapy.
Frequency and grade of each solicited local and systemic adverse events (AEs)	during a 7-day follow-up period post each vaccination

Secondary Outcome Measures

Name	Time	Method
Geometric mean titer (GMT) of antibody	at Day 57
Percentage of patients who seroconverted	baseline and Day 57	defined as a 4-fold increase in antibody titer
Geometric mean fold rise (GMFR) in IgG titer	baseline and Day 57

Trial Locations

Locations (1)

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada