COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
The Immunogenicity and Safety of COVID-19 and Influenza Vaccine Co-administration and Interval in Immunocompromised Hosts
McGill University Health Centre/Research Institute of the McGill University Health Centre
660 participants
Nov 20, 2024
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria1
- 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 Criteria8
- 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
Interventions
National Advisory Committee on Immunization (NACI) recommended seasonal inactivated influenza vaccine for moderate to severely immunocompromised patients by age at baseline
Updated NACI recommended COVID-19 booster for moderate to severely immunocompromised patients at a 3-month interval
National Advisory Committee on Immunization (NACI) recommended seasonal inactivated influenza vaccine for moderate to severely immunocompromised patients by age 1-month following initial COVID-19 booster
Updated NACI recommended COVID-19 booster for moderate to severely immunocompromised patients at a 6-month interval
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06599658