COVID-19 Booster and IIV Schedule in Immunocompromised Hosts

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study ID
NCT06599658
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Inactivated influenza vaccine (IIV) at baseline — BIOLOGICAL
    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 — BIOLOGICAL
    Updated NACI recommended COVID-19 booster for moderate to severely immunocompromised patients at a 3-month interval
  • Inactivated influenza vaccine at Month 1 — BIOLOGICAL
    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 — BIOLOGICAL
    Updated NACI recommended COVID-19 booster for moderate to severely immunocompromised patients at a 6-month interval

Study Details

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 Dates

First listed
Sep 19, 2024
Start date
Nov 20, 2024
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
660 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Group 1
    Covid-19 booster every 3 months and Inactivated influenza vaccine (IIV) at baseline
  • Experimental: Group 2
    Covid-19 booster every 3 months and IIV at 1 month
  • Experimental: Group 3
    Covid-19 booster every 6 months and IIV at baseline
  • Experimental: Group 4
    Covid-19 booster every 6 months and IIV at 1 month

Primary Outcome Measure

Median neutralization capacity against prevalent SARS-CoV-2 variant [ Time Frame: 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 ]

Central Contacts

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