💬In plain words
What the trial is, and whether it could suit you
This will be a follow-up study to the "Comparison of High Dose vs. Standard Dose Influenza Vaccine in Lung Allograft Recipient" study (DMID Protocol Number 22-0014) at Vanderbilt University Medical Center.
Lung transplantation is a life-saving therapy for patients with advanced lung disease, and is also associated with an improvement in quality of life. However, due to the need for life-long immunosuppression to prevent acute cellular rejection and chronic lung allograft dysfunction ("chronic rejection"), lung transplant recipients are at risk for developing major infections. In fact, one-year survival is 85%, with infection being the leading cause of death within the first year post-transplant. We will conduct a follow-up phase II, randomized, double-blind trial to assess the impact of subsequent administration of two doses of HD-IIV compared to two doses of SD-IIV among lung recipient
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
💊
What it tests
- Fluzone High Dose Inactivated Influenza Vaccine
- Fluzone Standard Dose Inactivated Influenza Vaccine
Vanderbilt University Medical Center
Nashville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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