Can a stronger flu shot protect lung transplant patients better?
NCT ID NCT07192458
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether giving lung transplant recipients a high-dose flu vaccine for two years in a row provides better protection against the flu than the standard-dose vaccine. About 60 people who already took part in a previous flu vaccine study will be randomly assigned to receive either the high-dose or standard-dose shot each season. The goal is to see if the stronger vaccine leads to a stronger immune response and fewer flu complications, while also checking for side effects and any impact on the transplanted lung.
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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 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2029
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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18 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Lung transplant recipient who enrolled and completed Visits 1, 2, and 3 of the DMID protocol number 22-0014 during the prior 2024-2025 or 2025-2026 influenza season, respectively * Anticipated to be available for the duration of the study * Can be reached by telephone, text message, email, or electronic health record messaging Exclusion Criteria: * Recipient of multi-organ, extra-pulmonary, and/or hematopoietic stem cell transplant * Recipient of a re-do lung transplant * History of Guillain-Barre syndrome * History of receiving the current season's influenza vaccine prior to study enrollment and/or Visit 1 of this follow-up study * Pregnant person * Laboratory-confirmed influenza disease after September 1st in the current influenza season and before enrollment in this follow-up study (patient can still receive the second influenza vaccination despite proven influenza disease after enrollment) * CMVIG/IVIG/SCIG receipt within 28 days of each vaccine * Receipt of rituximab or other B-cell depleting antibody (including proteasome inhibitors) therapy within 3 months of 1st vaccine dose (Day 0) * Receipt of T-cell depleting therapies (anti-thymocyte globulin, alemtuzumab, daratumumab) between the completion of Visit 3 of the initial study and enrollment in this follow-up study * Investigator concern about study participation * Note: Criteria for temporarily delaying vaccine administration: The following conditions are temporary or self-limiting, and a participant may be included in the study once the condition has resolved, provided that the participant is otherwise eligible: * Fever ≥100.4ºF/38.0ºC (oral measurement), or an acute severe illness within 48 hours of enrollment * Receipt of any live vaccines within four weeks or any inactivated vaccines within two weeks prior to potential study vaccination No children have been enrolled in the DMID protocol number 22-0014; therefore, only adults will be enrolled in this current study
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Vanderbilt University Medical Center
RECRUITINGNashville, Tennessee, 37232, United States
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Other studies related to the condition(s) this trial covers.
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