COVID-19 Vaccine in Immunosuppressed Adults With Autoimmune Diseases
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- COVID-19
- Rheumatic Diseases
- Rheumatoid Arthritis
- SLE
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Non-randomized, open label, comparative clinical trial with pragmatic features.Masking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 rheuma...
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.
Tracking Information
- NCT #
- NCT04806113
- Collaborators
- CHU de Quebec-Universite Laval
- Ministere de la Sante et des Services Sociaux
- Investigators
- Principal Investigator: Ines Colmegna, DR RI-MUHC