Status:
RECRUITING
High vs. Standard Dose Influenza Vaccines in Lung Transplant (Repeater)
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Immunization; Infection|Transplantation Infection|Influenza
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 Ce...
Detailed Description
The study is a phase II, single-center, double-blind, randomized controlled immunogenicity and safety trial comparing two doses of HD-IIV to two doses of SD-IIV over two consecutive years in lung tran...
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
- No children have been enrolled in the DMID protocol number 22-0014; therefore, only adults will be enrolled in this current study
Key Trial Info
Start Date :
September 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07192458
Start Date
September 17 2025
End Date
December 1 2029
Last Update
October 7 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232