H5N1 vaccine (Arepanrix, GSK): 2 doses of H5N1 vaccine, 3 weeks apart, given IM (deltoid)
Placebo: 2 doses of 0.5mls normal saline, 3 weeks apart, given IM (deltoid)
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Seroprotection and seroconversion 6 weeks after dose 1 — 6 weeks after dose 1 and 3 weeks after dose 2 Participants with seroprotection (HAI titers greater than or equal to 1:40) after dose 2 AND seroconversion, defined as greater than or equal to 4-fold increase in HAI antibody titers from baseline to after dose 2 to the vaccine-matched H5 avian influenza strain.
Trial sites (1)
Facility
City
Region
Status
University Health Network
Toronto
Ontario
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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