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High vs. Standard Dose Influenza Vaccines in Lung Transplant Patients

This study is for lung transplant recipients to compare two different flu vaccines: Fluzone High Dose Inactivated Influenza Vaccine and Fluzone Standard Dose Inactivated Influenza Vaccine. The goal is to see which vaccine creates a stronger immune response (immunogenicity) and to check for any side effects (safety). You can join if you are an adult lung transplant recipient who previously participated in a specific related study (DMID protocol number 22-0014). The study aims to enroll 60 participants. The status of this study is currently unclear, so it's not actively recruiting new participants at this moment.

Study design
This is a phase II, single-center, double-blind, randomized controlled study comparing two doses of each vaccine over two consecutive years. It plans to include 60 participants.
What's involved
Participants will receive four total doses of either Fluzone High Dose or Fluzone Standard Dose vaccine over two consecutive influenza seasons. Safety will be monitored for 7 days after each vaccination.
Compensation
Not stated in the trial record.
Follow-up
Your immune response will be measured four to eight weeks after your second study vaccination, and safety will be monitored for 7 days after each vaccination.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07192458

High vs. Standard Dose Influenza Vaccines in Lung Transplant (Repeater)

Recruiting
PHASE2Ages 18+InterventionalPrevention
Vanderbilt University Medical Center
~60 participants
Updated 2025-10-07 on ClinicalTrials.gov
What's tested:Fluzone High Dose Inactivated Influenza VaccineFluzone Standard Dose Inactivated Influenza Vaccine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Immunogenicity: Geometric Mean Titers of Influenza Vaccine Antibodies
Measured over Four-eight weeks following the second study vaccination
+2 more outcomes measured

Conditions

Immunization; Infection|Transplantation Infection|Influenza
Influenza

Explore related trials

Lung Transplantation

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Natahsa Halasa, MD, MPH · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

Who to contact

Natahsa Halasa, MD, MPH
[email protected]
615-322-2250
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Immunogenicity: Geometric Mean Titers of Influenza Vaccine AntibodiesFour-eight weeks following the second study vaccination

    HAI GMT to influenza antigens four-eight weeks following the second study vaccination

  • Safety - The number of participants reporting solicited injection site reactionsWithin 7 days post vaccination

    Solicited Injection-site Adverse Events Following each Vaccination Dose (Pain, Tenderness, Swelling/induration, Erythema/redness)

  • Safety - The number of participants reporting systemic adverse eventsWithin 7 days post vaccination

    Systemic adverse events (Fatigue/malaise, headache, nausea, body ache/myalgia (not at the injection site), general activity level, vomiting, and fever)