Clinical Trial

Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)

Study acronym: PIVOT

Recruiting Phase 3

Record status

This record was last updated December 18, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

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.

Protocol Amendment History 2 amendments

This ClinicalTrials.gov record has been amended 2 times since 2025-11-16; most recent amendment 2025-12-11.

Trial Details

NCT Number	NCT07240558
Lead Sponsor	University Health Network, Toronto Collaborators: Laval University
Conditions	Influenza (Pandemic), Avian Influenza, Vaccination
Enrollment	120 participants
Start Date	2025-11-03
Primary Completion	2026-06-30 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-12-18