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 date||2/18/22 → 1/31/23|
- Vanderbilt University Medical Center (VUMC100494 // 1U01AI167789-01)
- National Institute of Allergy and Infectious Diseases (VUMC100494 // 1U01AI167789-01)
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