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New vaccine trial aims to protect transplant patients from bird flu pandemic

NCT ID NCT07240558

Vaccine Sponsor: University Health Network, Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a two-dose pandemic H5N1 (bird flu) vaccine in 120 organ transplant recipients to see if it is safe and produces a strong immune response. Transplant patients are especially vulnerable to severe flu, and there is no data yet on how well this vaccine works in them. Participants must be at least 18 years old, more than 3 months post-transplant, and have stable kidney function.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 and greater than 3 months post-transplant * Stable graft function * eGFR \>30mL/min/1.73m2 * Able to provide informed consent Exclusion Criteria: * Allergy to vaccine components; * Previous life-threatening reaction to influenza vaccine (ie Guillain Barré Syndrome); * Ongoing or recent therapy for acute rejection (within the previous 30 days); * Ongoing active cytomegalovirus (CMV) infection with viral load of greater or equal to 1000 international units/ml in the last 7 days; * Febrile illness in the past 2 weeks; * Rituximab in the last 6 months; * Receiving treatment for active or acute infection; * Unable to provide informed consent; * 2025 seasonal influenza vaccination in preceding 6 weeks; * Recent other vaccination in last 14 days; * Receipt of intravenous immunoglobulin in last 30 days or expected to receive in next 30 days; Life expectancy \< 3 months; * Diagnosis of influenza virus infection in the last 90 days. * Pregnancy known at the time of enrolment

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Conditions

The condition(s) this trial relates to.

avian influenza influenza prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Avian influenza Influenza, pandemic Vaccination

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • University Health Network

    RECRUITING

    Toronto, Ontario, M5G2N2, Canada

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