High-dose versus standard-dose flu vaccine for lung transplant recipients
Immunogenicity and Safety of Consecutive High-Dose vs. Standard-Dose Influenza Vaccines Administered Over Successive Seasons in Lung Transplant Recipients
PHASE2 · Vanderbilt University Medical Center · NCT07192458
This study will test whether two yearly doses of the high‑dose flu vaccine produce stronger immune responses than two yearly standard‑dose flu vaccines in people who have received a lung transplant.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center (other) |
| Drugs / interventions | rituximab, alemtuzumab, daratumumab |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT07192458 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are lung transplant recipients who completed Visits 1–3 of the DMID 22‑0014 protocol in the prior 2024–2025 or 2025–2026 influenza season, can attend Vanderbilt for follow‑up, and can be reached by phone, text, email, or EHR messaging.
Not a fit: Patients unlikely to benefit include those who had multi‑organ or redo lung transplants, recent IVIG/CMVIG/SCIG within 28 days of vaccination, a history of Guillain‑Barré syndrome, current pregnancy, or who received the current season's flu vaccine before enrollment.
Why it matters
Potential benefit: If successful, this approach could produce stronger vaccine‑induced immunity and potentially reduce influenza infection or complications in lung transplant recipients.
How similar studies have performed: Prior trials in older adults and some transplant populations have shown higher antibody responses with high‑dose influenza vaccine, but robust data specifically in lung transplant recipients remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nashville, Tennessee
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Immunization, Infection|Transplantation Infection|Influenza, Influenza, Vaccination, Lung Transplantation, High Dose, Fluzone, Standard Dose