Influenza (Pandemic)Phase 3PIVOTNCT07240558

Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)

A Phase 3 study testing H5N1 vaccine (Arepanrix, GSK) in people with Influenza (Pandemic) and Avian Influenza, run by University Health Network, Toronto at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Influenza (Pandemic), Avian Influenza, Vaccination
What is being tested?: H5N1 vaccine (Arepanrix, GSK)
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteCanada
Study dates: 3 Nov 2025to 30 Apr 2027
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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;

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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

Trial locations and contacts

1 site in 1 country.

Canada1 site

University Health Network
Toronto, Ontario, M5G2N2

Other trials in Canada

About this study

Official title: Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial): Safety and Immunogenicity of Pandemic Influenza Vaccine in Organ Transplant Recipients

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.

Read the detailed description

This randomized, placebo-controlled, double-blind, single-centre trial will evaluate the immunogenicity and safety of a two-dose regimen of the AS03-adjuvanted inactivated H5N1 vaccine (AREPANRIX™ H5N1, GSK) in adult organ transplant recipients. A total of 120 stable outpatient organ transplant recipients at the University Health Network (Toronto, Canada) will be enrolled and randomized 1:1 to receive two doses of H5N1 vaccine or placebo (0.9% saline) administered intramuscularly 3 weeks apart.

Blood samples collected at baseline (V0), 3 weeks (V1), and 6 weeks (V2) will be analyzed for serologic responses using hemagglutination inhibition (HAI) assays against vaccine and circulating H5N1 strains. In a subset of 60 participants (30 per arm), peripheral blood mononuclear cells will be obtained at each time point to assess cell-mediated immunity, including H5-specific CD4+ and CD8+ T-cell cytokine responses and B-cell immunity.

Participants will be monitored for local and systemic adverse events for 7 days following each dose and followed for 6 months for any adverse events, including rejection, influenza-like illness, and laboratory-confirmed influenza. Long-term immunogenicity will also be assessed at 6 months in vaccine recipients.

Conditions: Influenza (Pandemic), Avian Influenza, Vaccination
Being tested: H5N1 vaccine (Arepanrix, GSK), Placebo
Medical subject headings: Influenza, Human, Influenza in Birds

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

H5N1 vaccine (Arepanrix, GSK)Biological
2 doses of H5N1 vaccine, 3 weeks apart, given IM (deltoid)
PlaceboBiological
2 doses of 0.5mls normal saline, 3 weeks apart, given IM (deltoid)

Study groups in NCT07240558
Study group	Role	What they receive
H5N1 vaccine	Active comparator	This arm will receive 2 doses of approved H5N1 vaccine, 3 weeks apart Receives: Biological: H5N1 vaccine (Arepanrix, GSK)
Placebo	Placebo comparator	This arm will receive 2 doses of normal saline (placebo), 3 weeks apart Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 6 weeks after dose 1
T and B cell immunity after dose 1 and dose of vaccine
Measured: 3 and 6 weeks post dose 1
Durability of immunity at 6 months post dose 1
Measured: 6 months post dose 1
Local and systemic adverse events to vaccination
Measured: Until 6 months post dose 2
Other safety factors
Transplant rejection, influenza like illness, confirmed influenza episodes
Measured: Until 6 months post dose 2
Seroprotection and seroconversion after dose 1 and 2 to H5, H1, H3
Measured: 6 weeks and 3 weeks post dose 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Nov 202530 Apr 2027

First posted21 Nov 2025
Study start3 Nov 2025
Primary completion30 Apr 2027 (estimated)
Study completion30 Apr 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Influenza (Pandemic)Studies of the same condition, open and under way.
More trials run by University Health Network, TorontoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized, placebo control trial 1:1
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07240558
Sponsor's protocol ID: TID-2024-002
Other IDs: 196762
Acronym: PIVOT
Status last verified: Oct 2026
First submitted: 16 Nov 2025
Last updated: 23 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Deidentified aggregated data will only be shared with appropriate request and ethical approval.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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