COVID-19 Booster and IIV Schedule in Immunocompromised Hosts

Recruiting now · Phase 2

Conditions studied: COVID 19, Influenza, Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus, Inflammatory Bowel Disease, Solid Organ Transplant Recipients, Immunocompromised Host, People Living With HIV

In brief

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.

Key facts

Study ID: NCT06599658
Run by: McGill University Health Centre/Research Institute of the McGill University Health Centre
People needed: 660
Starts: 2024-11-20
Expected to finish: 2027-03-31
Last updated by the study team: 2026-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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:
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

Where it is running

Maisonneuve -Rosemont Installation — Montreal, Quebec, Canada (enrolling)
Centre hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec, Canada (enrolling)
Research Institute of McGill University Health Centre — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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