Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

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.

Eligibility criteria

Qualifiers

Age ≥ 18 and greater than 3 months post-transplant

Stable graft function

eGFR >30mL/min/1.73m2

Able to provide informed consent

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • H5N1 vaccine (Arepanrix, GSK)
  • Placebo

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators