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COVID-19 Booster and IIV Schedule in Immunocompromised Hosts

RecruitingPhase 2Ages 18 Years - anyAllMcGill University Health Centre/Research Institut…
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In plain words

What the trial is, and whether it could suit you

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 people living with immunocompromising conditions (PLIC). The main questions it aims to answer are: 1. Is co-administration of seasonal inactivated influenza vaccine (IIV) with the most up-to-date recommended COVID-19 booster dose non-inferior in inducing a 1-month peak protective humoral response against COVID-19, compared to a strategy of sequential administration of COVID-19 booster dose followed by seasonal IIV given one month later? 2. Is the administration of the most up-to-date recommended COVID-19 booster doses at 3-month intervals superior at maintaining a longer term protective humoral immune response, compared to booster doses administered at 6-month intervals? Researchers will compa

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📋 Eligibility rules (as published)
Inclusion Criteria: \- 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\&lt;200 cells/µL in the last 6 months, iv) CD4%\&lt;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 Criteria: * Potential participants who meet ANY of the following criteria will be excluded: i. Received any of the following: 1. Annual vaccination against influenza \&lt; 6 months ago 2. COVID-19 booster \&lt; 3 months ago ii. History of any of the following: <!-- --> 1. life-threatening reaction any component of the IIV or COVID-19 vaccines 2. Guillain-Barre syndrome or myocarditis within 6 weeks of a previous influenza or COVID-19 vaccination 3. 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 \&lt; 6-months ago; vi. Unable to provide informed consent
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What it tests

  • Inactivated influenza vaccine (IIV) at baseline
  • COVID-19 Vaccines at a 3-month interval
  • Inactivated influenza vaccine at Month 1
  • COVID-19 Vaccines at a 6-month interval
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Where

3 sites
Maisonneuve -Rosemont Installation
Montreal, Canada
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Canada
Research Institute of McGill University Health Centre
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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