Actively Recruiting
Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)
Led by University Health Network, Toronto · Updated on 2025-12-18
120
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
L
Laval University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and more than 3 months post-transplant
- Stable graft function
- Estimated glomerular filtration rate (eGFR) greater than 30 mL/min/1.73m2
- Able to provide informed consent
You will not qualify if you...
- Allergy to vaccine components
- Previous life-threatening reaction to influenza vaccine such as Guillain Barré Syndrome
- Treatment for acute rejection within the past 30 days
- Active cytomegalovirus (CMV) infection with viral load ≥ 1000 IU/ml in the last 7 days
- Fever or illness in the past 2 weeks
- Rituximab treatment within the last 6 months
- Treatment for active or acute infection
- Unable to provide informed consent
- Seasonal influenza vaccination within the previous 6 weeks
- Other vaccination within the last 14 days
- Intravenous immunoglobulin received in the last 30 days or expected in the next 30 days
- Life expectancy less than 3 months
- Influenza virus infection diagnosed in the last 90 days
- Known pregnancy at time of enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Health Network
Toronto, Ontario, Canada, M5G2N2
Actively Recruiting
Research Team
V
Victoria G Hall, MBBS MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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