A 2016 NIH grant to UW-Madison and Brigham and Women’s Hospital for conducting an influenza vaccine trial will take advantage of infrastructure support from two clinical research networks managed by ICTR (WiNHR, MARCH) and will also be the first project nationally to test the SMART IRB model, which includes a master IRB agreement and standard operating procedures to facilitate single IRB review of multi-site research.
Orly Vardeny, PharmD, MS, Associate Professor of Pharmacy and Medicine, began investigating alternative immunization strategies to improve protection from influenza infection in heart failure patients during her time as an ICTR KL2 Scholar (2006-2010). Despite the known association of influenza infection with increased risk of cardiovascular events, influenza vaccine is still widely underutilized in this population.
Recent trials have suggested that higher-dose influenza vaccine may overcome impaired immune responses in those with advanced heart disease and provide a cardio protective benefit. Vardeny and her collaborators at Brigham and Women’s Hospital developed the INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure (INVESTED) trial, which received a $21 million grant from the National Heart, Lung, and Blood Institute (NHLBI). Vardeny notes,
Results from this study have the potential to inform health care policy of optimal vaccination strategies among patients who are at especially high risk for influenza-related complications and could have a direct effect on human health in a relatively short time frame.
INVESTED is a prospective, randomized, double-blind, active-controlled, pragmatic trial, comparing two formulations of influenza vaccine in high risk cardiovascular patients. This fall the INVESTED trial began enrolling the first 500 participants from select sites. Enrollment will jump to 3000 participants for the 2017-2018 influenza season and ultimately reach a planned 9,300 subjects from 200+ sites drawn from four research consortiums in the U.S. and Canada. Clinical coordinating center duties will be shared by both awardee institutions.
Using the SMART IRB model, ICTR will help manage 11 sites, and the UW Health Sciences (HS)-IRB will serve as the reviewing IRB for 16 sites.