Lung transplant patients may get better flu protection with high-dose vaccine
NCT ID NCT05215327
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This study compares a high-dose flu vaccine to the standard dose in 270 lung transplant recipients who are 1 to 35 months post-transplant. The goal is to see if the high-dose vaccine triggers a stronger immune response and provides better protection against influenza. Participants will receive two doses of either vaccine within the same flu season.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 270 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2022
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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16 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Lung allograft recipients 2. Age ≥16 years at time of enrollment 3. ≥1 month (30 days) and \<36 months post-lung transplant 4. Anticipated to be available for duration of the study 5. Can be reached by telephone, email, or text message Exclusion Criteria: 1. Recipient of multi-organ, extra-pulmonary, and/or hematopoietic stem cell transplant 2. Recipient of a re-do lung transplant 3. History of severe hypersensitivity to previous influenza vaccination or anaphylaxis to eggs/egg protein 4. History of Guillain-Barre syndrome 5. HIV positive patients, by history or documentation from previous test 6. History of known severe latex hypersensitivity 7. History of receiving the current season's influenza vaccine post-transplant prior to enrollment in the study 8. Pregnant female 9. Proven influenza disease after September 1st and before first study vaccine (patient can still receive the second influenza vaccination despite proven influenza disease once enrolled) 10. CMVIG/IVIG/SCIG receipt within 28 days of each vaccine 11. Receipt of rituximab or other B-cell depleting antibody (including proteasome inhibitors) therapy within 3-months of 1st study vaccine (Day 0). 12. Receipt of augmented T-cell depleting therapy within 3-months of 1st study vaccine (Day 0) 13. Investigator concern about study participation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
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Other studies related to the condition(s) this trial covers.
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