Actively Recruiting
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2026-03-10
660
Participants Needed
3
Research Sites
123 weeks
Total Duration
On this page
Sponsors
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
C
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Received the primary mRNA COVID-19 vaccine series (at least 3 doses)
- Have one or more of the following immunocompromising conditions: a) Solid organ transplant recipient at least 3 months ago, on maintenance immunosuppression b) People living with HIV on antiretroviral therapy for at least 6 months with recent AIDS-defining illness, tuberculosis, low CD4 counts, or unsuppressed viral load c) Inflammatory bowel disease treated with immunosuppressive agents for at least 3 months d) Rheumatoid arthritis or systemic lupus erythematosus treated with immunosuppressive agents for at least 3 months
You will not qualify if you...
- Received influenza vaccine less than 6 months ago
- Received COVID-19 booster less than 3 months ago
- History of life-threatening reaction to any component of the influenza or COVID-19 vaccines
- History of Guillain-Barre syndrome or myocarditis within 6 weeks of previous influenza or COVID-19 vaccination
- Contraindications to intramuscular vaccines such as bleeding disorders or severe thrombocytopenia
- Receiving intravenous immunoglobulins
- Have primary inborn errors of immunity
- Received chemotherapy such as cyclophosphamide within the past 6 months
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Maisonneuve -Rosemont Installation
Montreal, Quebec, Canada, H1T2M4
Actively Recruiting
2
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X 0C1
Actively Recruiting
3
Research Institute of McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
Research Team
R
Ruth Sapir-Pichhadze, B.Med.Sc, MD, MSc, PhD, FRCPC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
PREVENTION
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here