Influenza Vaccine To Prevent Adverse Vascular Events (RCT-IVVE)

Study Overview
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Brief Summary
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A multi-centre, randomized, placebo controlled, trial. Participants at high-risk for vascular events from the network of INTER- CHF will be randomized to inactivated influenza vaccine or placebo and followed prospectively over three influenza seasons. 5,000 participants will be enrolled prior to influenza season, randomized to either influenza vaccine or saline placebo, either of which they will receive annually for three years and then followed over each of the influenza seasons.

Detailed Description
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Cardiovascular disease is a major cause of morbidity and mortality. There is recent evidence that infection due to influenza may precipitate vascular events such as myocardial infarctions and strokes. There is some evidence that influenza vaccination may prevent such events but the data are inconclusive. The investigators propose a randomized controlled trial to assess whether influenza vaccination will prevent vascular illness. Adults with clinical heart failure will be randomized to inactivated influenza vaccine or saline placebo each year for three consecutive years. They will be followed over six months for a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalizations for heart failure using standardized criteria. Rigorous demonstration of influenza vaccine leading to a reduction in major adverse vascular events in patients with heart failure would lead to a major change in how these patients are managed. Given the large burden of disease both in Canada and globally, the possibility to reduce cardiovascular and stroke related death is a compelling reason to conduct this trial.

Official Title
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A Randomized Controlled Trial of Influenza Vaccine to Prevent Adverse Vascular Events

Conditions
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Heart Failure, Influenza

Intervention / Treatment
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* Other: Sterile saline
* Drug: inactivated trivalent influenza vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years and NYHA (New York Heart Association) functional class II, III and IV Exclusion Criteria: Anaphylactic reaction to a previous dose of TIV(trivalent influenza vaccine) Known IgE( Immunoglobulin E)-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock Guillain-Barré syndrome within eight weeks of a previous influenza vaccine Anaphylactic reaction to neomycin Patients who have had influenza vaccine in two of the three previous years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Influenza vaccine<br>Participants at high risk for adverse vascular events will be immunized with 0.5 ml dose of inactivated trivalent influenza vaccine prior to the influenza season. | Drug: inactivated trivalent influenza vaccine<br>* 0.5 ml dose injected intramuscularly<br>* Other names: VAXIGRIP vaccine;|
| Placebo Comparator: Placebo vaccine<br>Participants at high risk for adverse vascular events will be vaccinated with a 0.5 ml dose of sterile saline prior to the influenza season. | Other: Sterile saline<br>* 0.5 ml dose injected intramuscularly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse cardiovascular event | The primary outcome will be a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalizations for heart failure using standardized criteria. | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular (CV) death | CV death alone will be a secondary outcome. | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Vaccine, Heart failure, Vascular