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

Vaccination Influenza (Pandemic)Avian Influenza

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

Inclusion Criteria4

Age ≥ 18 and greater than 3 months post-transplant
Stable graft function
eGFR \>30mL/min/1.73m2
Able to provide informed consent

Exclusion Criteria13

Allergy to vaccine components;
Previous life-threatening reaction to influenza vaccine (ie Guillain Barré Syndrome);
Ongoing or recent therapy for acute rejection (within the previous 30 days);
Ongoing active cytomegalovirus (CMV) infection with viral load of greater or equal to 1000 international units/ml in the last 7 days;
Febrile illness in the past 2 weeks;
Rituximab in the last 6 months;
Receiving treatment for active or acute infection;
Unable to provide informed consent;
seasonal influenza vaccination in preceding 6 weeks;
Recent other vaccination in last 14 days;
Receipt of intravenous immunoglobulin in last 30 days or expected to receive in next 30 days; Life expectancy \< 3 months;
Diagnosis of influenza virus infection in the last 90 days.
Pregnancy known at the time of enrolment