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RECRUITING
NCT07240558
PHASE3

Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

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

BIOLOGICAL

H5N1 vaccine (Arepanrix, GSK)

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

BIOLOGICAL

Placebo

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

Locations (1)

University Health Network

Toronto, Ontario, Canada