RecruitingPhase 3NCT07240558

Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)

Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial): Safety and Immunogenicity of Pandemic Influenza Vaccine in Organ Transplant Recipients


Sponsor

University Health Network, Toronto

Enrollment

120 participants

Start Date

Nov 3, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called H5N1 vaccine (Arepanrix, GSK) and a biological treatment called Placebo for people with avian influenza, influenza (pandemic), and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALH5N1 vaccine (Arepanrix, GSK)

2 doses of H5N1 vaccine, 3 weeks apart, given IM (deltoid)

BIOLOGICALPlacebo

2 doses of 0.5mls normal saline, 3 weeks apart, given IM (deltoid)


Locations(1)

University Health Network

Toronto, Ontario, Canada

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NCT07240558


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