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.
Trial 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. Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Laval University
- Responsible party
- Principal investigator, Victoria Hall, University Health Network, Toronto
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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial): Safety and Immunogenicity of Pandemic Influenza Vaccine in Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT07240558
- Acronym / sponsor ID
- PIVOT / TID-2024-002
- Conditions
- Influenza (Pandemic), Avian Influenza, Vaccination
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Laval University
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, placebo control trial 1:1
| Arm | Type | Receives |
|---|---|---|
| H5N1 vaccine | Active comparator | Biological: H5N1 vaccine (Arepanrix, GSK)This arm will receive 2 doses of approved H5N1 vaccine, 3 weeks apart |
| Placebo | Placebo comparator | Biological: PlaceboThis arm will receive 2 doses of normal saline (placebo), 3 weeks apart |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 and greater than 3 months post-transplant
- Stable graft function
- eGFR >30mL/min/1.73m2
- Able to provide informed consent
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H5N1 vaccine (Arepanrix, GSK)2 doses of H5N1 vaccine, 3 weeks apart, given IM (deltoid) | Biological | H5N1 vaccine |
| Placebo2 doses of 0.5mls normal saline, 3 weeks apart, given IM (deltoid) | Biological | Placebo |
Primary outcome
Seroprotection and seroconversion 6 weeks after dose 1
Time frame: 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.
6 secondary outcomes
Seroprotection and seroconversion after dose 1 and comparison with after dose 2
Time frame: 6 weeks after dose 1
T and B cell immunity after dose 1 and dose of vaccine
Time frame: 3 and 6 weeks post dose 1
Durability of immunity at 6 months post dose 1
Time frame: 6 months post dose 1
Local and systemic adverse events to vaccination
Time frame: Until 6 months post dose 2
Other safety factors
Time frame: Until 6 months post dose 2
Seroprotection and seroconversion after dose 1 and 2 to H5, H1, H3
Time frame: 6 weeks and 3 weeks post dose 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No. Deidentified aggregated data will only be shared with appropriate request and ethical approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroprotection and seroconversion 6 weeks after dose 1 (time frame: 6 weeks after dose 1 and 3 weeks after dose 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.