Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial) (NCT07240558) | Clinical Trial Compass
RecruitingPhase 3
Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)
Canada120 participantsStarted 2025-11-03
Plain-language summary
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. Transplant patients will likely be uniquely predisposed to serious infection with high morbidity and mortality. There are a number of important reasons that evaluation of prevention strategies are critical in this highly vulnerable population. Currently, there is no data on the immunogenicity of H5Nx vaccines in this highly vulnerable population. The investigators plan to study the safety and immunogenicity of a two-dose regimen of the pandemic influenza H5N1 vaccine in organ transplant patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Seroprotection and seroconversion 6 weeks after dose 1
Timeframe: 6 weeks after dose 1 and 3 weeks after dose 2