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Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)
Sponsor: University Health Network, Toronto
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.
Official title: Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial): Safety and Immunogenicity of Pandemic Influenza Vaccine in Organ Transplant Recipients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-11-03
Completion Date
2026-12-31
Last Updated
2025-12-18
Healthy Volunteers
No
Interventions
H5N1 vaccine (Arepanrix, GSK)
2 doses of H5N1 vaccine, 3 weeks apart, given IM (deltoid)
Placebo
2 doses of 0.5mls normal saline, 3 weeks apart, given IM (deltoid)
Locations (1)
University Health Network
Toronto, Ontario, Canada