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New treatment option for Influenza (Pandemic)
Official title Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)
ClinicalTrials.gov ID: NCT07240558
What this study is testing
What is H5N1 vaccine (Arepanrix, GSK)?
H5N1 vaccine (Arepanrix, GSK) is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for influenza (pandemic).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Influenza is an important pathogen in transplant recipients. The current widespread outbreak of highly pathogenic H5N1 avian influenza (HPAI) in livestock, and the occurrence of several human cases of infection suggest that the next influenza pandemic may be soon approaching.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 and greater than 3 months post-transplant
- Stable graft function
- eGFR \>30mL/min/1.73m2
- Able to provide informed consent
You likely can't join if
- 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;
See the full eligibility criteria
- Age ≥ 18 and greater than 3 months post-transplant
- Stable graft function
- eGFR \>30mL/min/1.73m2
- Able to provide informed consent
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.