Comparison of High Dose vs. Standard Dose Influenza Vaccines in Lung Allograft Recipients

Project: Research project

Project Details


Northwestern University will be assisting in enrolling in the protocol entitled “Comparison of High Dose vs. Standard Dose Influenza Vaccines in Lung Allograft Recipients.” The co-PIs of the site are Michael Ison and Anat Roitberg-Tambur. They will participate as itemized below. • Participation in every 1-2 weekly study calls and protocol development • IRB/regulatory submissions for study • PI will provide oversight for all aspects of study and clinical trial • Consent eligible transplant candidates to study o Enrollment expected to begin in Year 1 o Enrollment expected to continue into Year 3 • Site budgets are reflective of anticipated enrollment at each center based on transplant volume o Approximately 13-20 subjects enrolled and randomized each year of enrollment (for 3 total years) • Randomize transplanted subjects meeting inclusion criteria to standard dose vs. high-dose influenza vaccination per study protocol • Conduct study visits according to protocol, including conducting active influenza surveillance • Collect, process, store, and ship patient biospecimens per study protocol • Collect clinical and study data from subjects per study protocol • Subject follow-up anticipated for the study period • Identify an Independent Safety Monitors within the institution • Review study related safety events and provide necessary information to study PI, IRB, and DSMB when required. • Provide sample storage and conduct Flow Screening PRA for approximately 270 subjects
Effective start/end date2/18/221/31/23


  • Vanderbilt University Medical Center (VUMC100494 // 1U01AI167789-01)
  • National Institute of Allergy and Infectious Diseases (VUMC100494 // 1U01AI167789-01)


Explore the research topics touched on by this project. These labels are generated based on the underlying awards/grants. Together they form a unique fingerprint.