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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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 kidney transplant patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 and greater than 3 months post-transplant

• Stable graft function; eGFR \>30mL/min/1.73m2

• Able to provide informed consent

Locations
Other Locations
Canada
University Health Network
RECRUITING
Toronto
Contact Information
Primary
Victoria G Hall, MBBS MPH
victoria.hall@uhn.ca
1 416 340 4800
Time Frame
Start Date: 2025-11-03
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 120
Treatments
Active_comparator: H5N1 vaccine
This arm will receive 2 doses of approved H5N1 vaccine, 3 weeks apart
Placebo_comparator: Placebo
This arm will receive 2 doses of normal saline (placebo), 3 weeks apart
Related Therapeutic Areas
Sponsors
Leads: University Health Network, Toronto
Collaborators: Laval University

This content was sourced from clinicaltrials.gov

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