Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)

NCT07240558 | Recruiting Phase 3

• 2 other identifiers: TID-2024-002196762
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza (Pandemic); Avian Influenza; Vaccination

Outcome Measures

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.

  6 weeks after dose 1 and 3 weeks after dose 2

Secondary Outcomes (6)

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

  6 weeks after dose 1

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

  3 and 6 weeks post dose 1

• Durability of immunity at 6 months post dose 1

  6 months post dose 1

• Local and systemic adverse events to vaccination

  Until 6 months post dose 2

• Other safety factors

  Until 6 months post dose 2

Study Arms (2)

H5N1 vaccine

ACTIVE COMPARATOR

This arm will receive 2 doses of approved H5N1 vaccine, 3 weeks apart

Biological: H5N1 vaccine (Arepanrix, GSK)

Placebo

PLACEBO COMPARATOR

This arm will receive 2 doses of normal saline (placebo), 3 weeks apart

Biological: Placebo

Interventions

H5N1 vaccine (Arepanrix, GSK) BIOLOGICAL

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

H5N1 vaccine

Placebo BIOLOGICAL

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Laval University: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G2N2, Canada

RECRUITING

MeSH Terms

Conditions

Influenza, Human; Influenza in Birds

Interventions

arepanrix; halofantrine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Bird Diseases; Animal Diseases

Central Study Contacts

Victoria G Hall, MBBS MPH

CONTACT

1 416 340 4800; victoria.hall@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Victoria Hall, Principal Investigator, Clinician-Investigator and Infectious Diseases physician

Model Details: Randomized, placebo control trial 1:1

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 21, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)