NCT04806113

COVID-19 Vaccine in Immunosuppressed Adults With Autoimmune Diseases

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Covid19
• Rheumatic Diseases
• Rheumatoid Arthritis
• SLE

Interventions

Type	Name	Description
BIOLOGICAL	Moderna COVID-19 vaccine	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.

Timeline

• Start date: 2021-03-11
• Primary completion: 2021-06-13
• Completion: 2022-06-15
• First posted: 2021-03-19
• Last updated: 2023-03-20

Locations

1 site across 1 country: Canada