High-dose versus standard-dose flu vaccine for lung transplant recipients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase II, single-center, randomized, double‑blind trial comparing two doses of high‑dose inactivated influenza vaccine (HD‑IIV) to two doses of standard‑dose inactivated influenza vaccine (SD‑IIV) given over two consecutive influenza seasons to lung transplant recipients. Participants previously enrolled in the DMID 22‑0014 protocol will be randomized to receive either HD‑IIV or SD‑IIV and will ultimately receive four doses of the assigned vaccine across two seasons. The primary focus is on immunogenicity and safety, with antibody responses measured after vaccination and safety monitoring throughout. The trial is conducted at Vanderbilt University Medical Center and follows standard randomized, blinded procedures to limit bias.

Why it matters

Who can join: the full rules

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

Where it's running

• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Natahsa Halasa, MD, MPH — Vanderbilt University Medical Center
• Study coordinator: Natahsa Halasa, MD, MPH
• Email: natasha.halasa@vumc.org
• Phone: 615-322-2250

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.