IBD (general)Recruiting

COVID-19 Booster and IIV Schedule in Immunocompromised Hosts

Phase 2 · Testing Inactivated influenza vaccine (IIV) at baseline, COVID-19 Vaccines at a 3-month interval… · 3 sites · McGill University Health Centre/Research Institute of the McGill University Health Centre

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing Inactivated influenza vaccine (IIV) at baseline (a biologic), COVID-19 Vaccines at a 3-month interval (a biologic), Inactivated influenza vaccine at Month 1 (a biologic) and COVID-19 Vaccines at a 6-month interval (a biologic) to see if it can prevent disease or complications. Condition(s) listed: COVID 19, Influenza and Rheumatoid Arthritis (RA).

Participants are assigned to groups by chance (randomized).

It is open-label: participants know what they are receiving.

Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.

Who can join

Ages 18 and older
Any sex

Some of the main requirements, copied from the record:

\- 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:
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:…

There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 660 participants are expected to take part.
Start date: 2024-11-20.
Main results expected around 2027-03-31 (estimate from the record).
3 study sites listed (3 marked recruiting) in Canada.

Main thing being measured

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…)

In the researchers’ words

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.

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Recruiting
Phase	Phase 2
Study type	Interventional
Conditions	COVID 19; Influenza; Rheumatoid Arthritis (RA); Systemic Lupus Erthematosus; Inflammatory Bowel Disease; Solid Organ Transplant Recipients; Immunocompromised Host; People Living With HIV
Lead sponsor	McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators	Centre hospitalier de l'Université de Montréal (CHUM)
Enrollment	660 (estimated)
Start date	2024-11-20
Primary completion (est.)	2027-03-31
First posted	2024-09-19
Last updated	2026-03-10
Official title	The Immunogenicity and Safety of COVID-19 and Influenza Vaccine Co-administration and Interval in Immunocompromised Hosts
ClinicalTrials.gov ID	NCT06599658

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

Full eligibility criteria (from the record)

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\&lt;200 cells/µL in the last 6 months, iv) CD4%\&lt;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 \&lt; 6 months ago
  2. COVID-19 booster \&lt; 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 \&lt; 6-months ago; vi. Unable to provide informed consent

Locations (3)

Site	City	Country	Site status
Maisonneuve -Rosemont Installation	Montreal, Quebec	Canada	Recruiting
Centre hospitalier de l'Université de Montréal (CHUM)	Montreal, Quebec	Canada	Recruiting
Research Institute of McGill University Health Centre	Montreal, Quebec	Canada	Recruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.