Status:
RECRUITING
High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
Northwestern University Feinberg School of Medicine
University of Alabama at Birmingham
Conditions:
Immunization; Infection
Transplantation Infection
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
Lung allograft recipients have a higher burden of influenza disease and greater associated morbidity and mortality compared with healthy controls. Induction and early maintenance immunosuppression is ...
Detailed Description
Study Design: The proposed study is a phase II, multi-center, double-blind, randomized controlled immunogenicity and safety trial comparing two doses of HD-QIV to two doses of SD-QIV in lung allograft...
Eligibility Criteria
Inclusion
- Lung allograft recipients
- Age ≥16 years at time of enrollment
- ≥1 month (30 days) and \<36 months post-lung transplant
- Anticipated to be available for duration of the study
- Can be reached by telephone, email, or text message
Exclusion
- Recipient of multi-organ, extra-pulmonary, and/or hematopoietic stem cell transplant
- Recipient of a re-do lung transplant
- History of severe hypersensitivity to previous influenza vaccination or anaphylaxis to eggs/egg protein
- History of Guillain-Barre syndrome
- HIV positive patients, by history or documentation from previous test
- History of known severe latex hypersensitivity
- History of receiving the current season's influenza vaccine post-transplant prior to enrollment in the study
- Pregnant female
- Proven influenza disease after September 1st and before first study vaccine (patient can still receive the second influenza vaccination despite proven influenza disease once enrolled)
- 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 study vaccine (Day 0).
- Receipt of augmented T-cell depleting therapy within 3-months of 1st study vaccine (Day 0)
- Investigator concern about study participation
Key Trial Info
Start Date :
November 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT05215327
Start Date
November 8 2022
End Date
December 31 2027
Last Update
December 8 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232