NCT07240558 Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)
| NCT ID | NCT07240558 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Health Network, Toronto |
| Condition | Influenza (Pandemic) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-11-03 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 120 participants in total. It began in 2025-11-03 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07240558 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Influenza (Pandemic). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07240558 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 120 participants.
Is NCT07240558 currently recruiting?
Yes, NCT07240558 is actively recruiting participants. Contact the research team at victoria.hall@uhn.ca for enrollment information.
Where is the NCT07240558 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT07240558 clinical trial?
NCT07240558 is sponsored by University Health Network, Toronto. The trial plans to enroll 120 participants.