Should you get your COVID and flu shots together? new study aims to find out for immunocompromised patients
NCT ID NCT06599658
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study is testing whether giving the COVID-19 booster and flu vaccine at the same time is as good as giving them a month apart for people with weakened immune systems. It also compares getting a COVID-19 booster every 3 months versus every 6 months. The trial involves 660 adults with conditions like rheumatoid arthritis, lupus, inflammatory bowel disease, HIV, or who have had an organ transplant. Researchers will measure immune responses through blood tests and track side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- COVID-19 booster vaccine and seasonal influenza vaccine
- What this could lead to
- If successful, this could show the best way to time vaccines for immunocompromised people, improving protection against COVID-19 and flu.
- What could go wrong
- This is a Phase 2 trial, so results are still early. The findings may not apply to all immunocompromised groups, and vaccine responses can vary widely.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 660 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: <!-- --> 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centre hospitalier de l'Université de Montréal (CHUM)
RECRUITINGMontreal, Quebec, H2X 0C1, Canada
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Maisonneuve -Rosemont Installation
RECRUITINGMontreal, Quebec, H1T2M4, Canada
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Research Institute of McGill University Health Centre
RECRUITINGMontreal, Quebec, H4A 3J1, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Home antibody tests put to the test: can you read your own COVID-19 result?
- Smartphone app aims to catch rheumatoid arthritis before it takes hold
- DNA test for infections: can it guide antibiotic decisions?
- Can lung ultrasound reveal COVID-19's signature in the lungs?
- Can a pill replace steroids for lupus flares?
- Could your Donor's gut bacteria decide whether a stool transplant works?