Status:
RECRUITING
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Centre hospitalier de l'Université de Montréal (CHUM)
Conditions:
COVID 19
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this pragmatic embedded open-label, 2 x 2 factorial phase II randomized controlled trial is to evaluate strategies to improve COVID-19 booster and influenza vaccine immunogenicity in peopl...
Detailed Description
Background: People living with immunocompromising conditions (PLIC) are more susceptible to complications related to respiratory infections. According to Statistics Canada data, in 2020 approximately...
Eligibility Criteria
Inclusion
- \- All participants must meet ALL the following inclusion criteria: i. Adults (≥18 years) ii. Received the primary mRNA COVID-19 vaccine series (i.e., ≥3 doses) iii. Have at least one of the following immunocompromising conditions:
- a) Received a solid organ transplant (SOT) ≥3-months ago, and treated with a conventional maintenance immunosuppression regimen; b) People living with HIV (PLWH) receiving ART for ≥6 months who meet at least one of the following conditions: i) AIDS-defining illness in the last 6 months, ii) TB diagnosis in the last 6-months, iii) CD4\<200 cells/µL in the last 6 months, iv) CD4%\<15% in the last 6 months, or v) absence of HIV viral suppression in the last 6 months; c) Inflammatory bowel disease (IBD) treated with a conventional or biologic immunosuppressive agent for ≥3 months; d) Rheumatoid arthritis or systemic lupus erythematosus (herein referred to as rheumatological disease (RD)) treated with a conventional or biologic immunosuppressive agent for ≥3 months.
Exclusion
- Potential participants who meet ANY of the following criteria will be excluded:
- i. Received any of the following:
- Annual vaccination against influenza \< 6 months ago
- COVID-19 booster \< 3 months ago ii. History of any of the following:
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- life-threatening reaction any component of the IIV or COVID-19 vaccines
- Guillain-Barre syndrome or myocarditis within 6 weeks of a previous influenza or COVID-19 vaccination
- Contraindication to intramuscular vaccines such as bleeding disorder, severe thrombocytopenia, etc; iii. Receiving intravenous immunoglobulins; iv. Have underlying primary inborn errors of immunity; v. Receiving chemotherapy such as cyclophosphamide \< 6-months ago; vi. Unable to provide informed consent
Key Trial Info
Start Date :
November 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT06599658
Start Date
November 20 2024
End Date
March 31 2027
Last Update
August 28 2025
Active Locations (2)
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1
Research Institute of McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
2
Research Institute of McGill University Health Centre
Montreal, Quebec, Canada, H4A 3S5