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Trial of high-dose influenza vaccine in patients with HF, MI launches
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Brigham and Women’s Hospital announced the launch of a trial to evaluate a high-dose formulation of an influenza vaccine in patients with HF or recent MI.
The INVESTED trial will enroll 9,300 patients with a history of HF or a recent MI and randomly assign them to receive either a high-dose influenza vaccine or a standard-dose vaccine, according to a press release issued by the institution. The researchers will evaluate the high-dose strategy for reduction of CV- or pulmonary-related hospitalization or death.
The NHLBI awarded a grant to Brigham & Women’s and the University of Wisconsin – Madison, in collaboration with investigators from the University of Toronto, the Veterans Administration and the National Patient-Centered Clinical Research Network, to fund the trial, according to the release.
“The high morbidity and health care costs among patients with high-risk CVD, along with the reduced immune responses to standard-dose influenza vaccines in patients with heart failure, provides a compelling rationale to investigate alternative influenza vaccination strategies in this group,” Scott D. Solomon, MD, the Edward D. Frohlich Distinguished Chair at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, said in the release. “INVESTED will be the first large trial to test whether a novel influenza vaccination strategy will lead to reduced hospitalization or death in a vulnerable population.”
A previous study found that in patients over age 65, a high-dose influenza vaccine reduced confirmed influenza risk by 24%. INVESTED will be the first trial to test the high-dose vaccine on patients with heart disease, according to the release.
“We know that influenza vaccine is a great way to protect people from the flu virus and avoid the dangerous [CV] events that are associated with the flu,” Mark A. Creager, MD, immediate past president of the American Heart Association, said in the release. “We look forward to learning whether a higher-dose vaccine can increase that benefit for high-risk patients [with CVD].”