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Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)

ConditionsInfluenza (Pandemic)Avian InfluenzaVaccination
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • H5N1 vaccine (Arepanrix, GSK)

    Biological/Vaccine

    2 doses of H5N1 vaccine, 3 weeks apart, given IM (deltoid)

  • Placebo

    Biological/Vaccine

    2 doses of 0.5mls normal saline, 3 weeks apart, given IM (deltoid)

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: H5N1 vaccineActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Seroprotection and seroconversion 6 weeks after dose 1

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.

Time frame
6 weeks after dose 1 and 3 weeks after dose 2

Secondary outcomes

1

Seroprotection and seroconversion after dose 1 and comparison with after dose 2

Time frame
6 weeks after dose 1
2

T and B cell immunity after dose 1 and dose of vaccine

Time frame
3 and 6 weeks post dose 1
3

Durability of immunity at 6 months post dose 1

Time frame
6 months post dose 1
4

Local and systemic adverse events to vaccination

Time frame
Until 6 months post dose 2

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Laval University

Collaborator

Source ClinicalTrials.gov
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