University Health Centre conducts a clinical trial of COVID-19 Vaccine in Immunosuppressed Adults With Autoimmune Diseases
McGill University Health Centre/Research Institute of the McGill University Health Centre is starting a new clinical trial of COVID-19 Vaccine in Immunosuppressed Adults With Autoimmune Diseases.
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.
The clinical trial started on March 11, 2021 and will continue throughout March 15, 2022.
Frequency and grade of any unsolicited AEs (including 'significant disease flares) will be primary outcome measure. Significant' disease flares: defined as worsening of clinical disease activity documented by the treating physician and requiring intensification of therapy.
Among the exclusion criteria are:
- Positive pregnancy test either at screening or just prior to each vaccine administration.
- Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation.
- Acute illness, as determined by the site PI or appropriate sub-investigator, with or without fever [oral temperature >38.0°C (100.40F)] within 72 hours prior to each vaccination.
- Diagnosis of hepatitis B, hepatitis C virus, or human immunodeficiency virus (HIV).
- History of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines.
- Participation in another clinical trial or plan to do so during the study. If a patient was on a drug trial, recruitment could occur following 2 half-lives of the study drug.
- Vaccines within the 2 weeks prior to any dose of COVID-19 vaccine or until 30 days after any dose of COVID-19 vaccine.
The full list can be viewed at the link below.
The contacts and locations are the McGill University Health Centre, Montreal, Quebec, Canada. For more details: https://ichgcp.net/clinical-trials-registry/NCT04806113
