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

Project: Research project

Project Details

Description

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
StatusActive
Effective start/end date2/18/221/31/23

Funding

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

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