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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥ 18 and greater than 3 months post-transplant - Stable graft function - eGFR \>30mL/min/1.73m2 - Able to provide willing to sign a consent form Who Should NOT Join This Trial: - 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 willing to sign a consent form; - 2025 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Age ≥ 18 and greater than 3 months post-transplant * Stable graft function * eGFR \>30mL/min/1.73m2 * Able to provide informed consent Exclusion Criteria: * 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; * 2025 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

Treatments Being Tested

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