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COVID-19 Booster and IIV Schedule in Immunocompromised Hosts

Study acronym: CO2I2
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Study sites: 2 to 3v4
  2. Primary completion date: Dec 31, 2025 to Mar 31, 2027
    • Study completion date: Dec 31, 2026 to Mar 31, 2027
    • Collaborators expanded, about 7 words
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of Oct 1, 2024 to Nov 20, 2024
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 compare (1) COVID-19 and Influenza vaccines administered at Day 0 + COVID-19 Booster at a 3-month interval, (2) COVID-19 vaccine administered at Day 0 and Influenza vaccine administered at Day 28 + COVID-19 Booster at a 3-month interval, (3) COVID-19 and Influenza vaccines administered at Day 0 + COVID-19 Booster at a 6-month interval, and (4) COVID-19 vaccine administered at Day 0 and Influenza vaccine administered at Day 28 + COVID-19 Booster at a 6-month interval to see if median neutralization capacity of patient sera is non-inferior in the co- vs. sequential administration arms at 1-month after the initial COVID-19 booster and superior in the 3-month interval arms vs. the 6-month interval arms at 12 months after the initial COVID-19 booster. These outcomes will also be compared at 2-months for question 1 and 6-months for question 2. People living with immunocompromising conditions who take part in the trial will have blood samples drawn to verify immune response, be monitored for changes in clinical events and therapies, and complete questionnaires to verify adverse effects, quality of life and economic impact.
Trial Details
NCT Number NCT06599658
Lead Sponsor McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators: Centre hospitalier de l'Université de Montréal (CHUM)
Conditions
(from sponsor)		 COVID 19, Influenza, Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus, Inflammatory Bowel Disease, Solid Organ Transplant Recipients, Immunocompromised Host, People Living With HIV
Related terms Arthritis, Rheumatoid, COVID-19, Inflammatory Bowel Diseases, Influenza, Human
Enrollment 660 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov