COVID 19InfluenzaRheumatoid Arthritis (RA)Systemic Lupus ErthematosusInflammatory Bowel DiseaseSolid Organ Transplant RecipientsImmunocompromised HostPeople Living With HIV
Investigational drug(s) / intervention(s)
Inactivated influenza vaccine (IIV) at baselineCOVID-19 Vaccines at a 3-month intervalInactivated influenza vaccine at Month 1COVID-19 Vaccines at a 6-month interval
Inactivated influenza vaccine (IIV) at baseline: National Advisory Committee on Immunization (NACI) recommended seasonal inactivated influenza vaccine for moderate to severely immunocompromised patients by age at baseline
COVID-19 Vaccines at a 3-month interval: Updated NACI recommended COVID-19 booster for moderate to severely immunocompromised patients at a 3-month interval
Inactivated influenza vaccine at Month 1: 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
COVID-19 Vaccines at a 6-month interval: Updated NACI recommended COVID-19 booster for moderate to severely immunocompromised patients at a 6-month interval
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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\<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 Criteria:
* Potential participants who meet ANY of the following criteria will be excluded:
i. Received any of the following:
1. Annual vaccination against influenza \< 6 months ago
2. COVID-19 booster \< 3 months ago ii. History of any of the following:
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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 \< 6-months ago; vi. Unable to provide informed consent
Primary outcome measure(s)
Median neutralization capacity against prevalent SARS-CoV-2 variant — At 1-month and 2-months following the initial COVID-19 booster dose for primary objective 1 and at 12-months and 6-months following initial COVID-19 booster dose for primary objective 2 Median neutralization capacity of patient sera/plasma from each group, as measured by half maximal inhibitory dilution (ID50) against the prevalent SARS-CoV-2 variant circulating at time of measurement. For objective 1, this outcome will be compared between the co- vs. sequential administration arms at 1-month (T1) after the COVID-19 booster (peak humoral response). This outcome will also be compared at 2-months (T2). For objective 2, this outcome will be compared 12-months (T12) after the first COVID-19 booster between participants who have received COVID-19 boosters at 0, 3, 6 and 9 months (3-month interval arm) vs. those who received COVID-19 booster doses at 0 and 6-months (6-month interval arm). This outcome will also be compared at 6-months (T6).
Trial sites (3)
Facility
City
Region
Status
Maisonneuve -Rosemont Installation
Montreal
Quebec
Recruiting
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal
Quebec
Recruiting
Research Institute of McGill University Health Centre
Montreal
Quebec
Recruiting
More McGill University Health Centre/Research Institute of the McGill University Health Centre trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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