The objective of the IVVE study was to assess the feasibility of randomizing heart failure (HF) patients to either inactivated influenza vaccine or to placebo to assess whether influenza vaccine can reduce adverse vascular events in this population.

Demonstration of influenza vaccine leading to a reduction in major adverse vascular events in HF patients would lead to a major change in how these patients are managed.

Primary endpoint:

A composite of major adverse vascular events, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for heart failure.

Mark Loeb

This is the largest randomized trial to test if influenza vaccine compared to control reduces adverse vascular events in high risk individuals.

The Principal Investigator of the IVVE study was Mark Loeb, Division Director, Infectious Diseases, McMaster University.

Vitheya Thanabalan, Research Coordinator at the Mark Loeb Research Group, worked on IVVE.

Vitheya Thanabalan

IVVE at ACC 2022 - Download PDF
Study Type

Interventional - Drug

Study Design

Multi-centre, placebo RCT

NO. of Countries


NO. of Sites


NO. of Participants


Study Period

2015 - 2022




McMaster University

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