Actively Recruiting
Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial): Safety and Immunogenicity of Pandemic Influenza Vaccine in Organ Transplant Recipients
Led by University Health Network, Toronto · Updated on 2025-12-18
120
Participants Needed
1
Research Sites
26 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
Researchers are evaluating the safety and immune response of a two-dose regimen of the AS03-adjuvanted inactivated H5N1 influenza vaccine in adult organ transplant recipients. This study is important because transplant patients are at higher risk for serious infection from influenza, especially during outbreaks of highly pathogenic strains like H5N1. The study aims to generate data on vaccine effectiveness in this vulnerable group, which currently lacks immunogenicity information for H5Nx vaccines. Participants will be randomly assigned to receive either two doses of the H5N1 vaccine or placebo (normal saline) given intramuscularly in the deltoid muscle, three weeks apart. The study is double-blind and placebo-controlled, enrolling 120 stable organ transplant recipients. Blood samples will be collected at baseline, 3 weeks, and 6 weeks to measure immune responses, including antibody and cellular immunity. A subset of 60 participants will have additional immune cell analyses. Participants will be monitored for side effects for 7 days after each dose and followed for 6 months for safety and long-term immune response. Throughout the study, participants will undergo blood tests to assess immune responses and will be closely observed for adverse events, including any signs of transplant rejection or influenza-like illness. The main outcome is the level of protection and immune response 6 weeks after the first dose. Safety and durability of immunity will be evaluated up to 6 months post-vaccination. The total study duration includes vaccination, monitoring, and follow-up visits over this time frame to assess both short- and long-term effects of the vaccine in transplant recipients.
CONDITIONS
Brief 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)
- Ongoing or recent treatment for acute rejection within the last 30 days
- Active cytomegalovirus (CMV) infection with viral load ≥ 1000 IU/ml in the last 7 days
- Febrile illness in the past 2 weeks
- Rituximab treatment in the last 6 months
- Receiving treatment for active or acute infection
- Unable to provide informed consent
- 2025 seasonal influenza vaccination in the previous 6 weeks
- Recent vaccination in the last 14 days
- Intravenous immunoglobulin received in the last 30 days or expected within the next 30 days
- Life expectancy less than 3 months
- Influenza virus infection diagnosed in the last 90 days
- Known pregnancy at the time of enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive two doses of vaccine or placebo given intramuscularly 3 weeks apart and are monitored for local and systemic adverse events following each dose.
3 visits (baseline, 3 weeks, and 6 weeks; in-person)
Duration - 6 months
Participants are followed for 6 months after the last dose to monitor for adverse events including rejection, influenza-like illness, and laboratory-confirmed influenza, and to assess long-term immunogenicity.
Visits at 6 months post-dose (in-person or remote assessments)
Trial Site Locations
Total: 1 location
1
University Health Network
Toronto, Ontario, Canada, M5G2N2
Actively Recruiting
Research Team
V
Victoria G Hall, MBBS MPH
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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