Influenza Vaccine To Prevent Adverse Vascular Events:Pilot

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. 600 participants will be enrolled prior to influenza season and randomized to either influenza vaccine or saline placebo.

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. This pilot study will provide needed data to establish the feasibility of a larger study.

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

Conditions
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Heart Failure

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years and NYHA functional class II, III and IV Exclusion Criteria: Anaphylactic reaction to a previous dose of TIV Known IgE-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 | Drug: inactivated trivalent influenza vaccine<br>* 0.5 ml dose injected intramuscularly<br>* Other names: VAXIGRIP vaccine;|
| Placebo Comparator: placebo vaccination<br>Participants at high risk for adverse vascular events will be immunized with a 0.5 ml dose of sterile saline inactivated during 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 |
| --- | --- | --- |
| Feasibility | If no more than 5% of all recruited subjects crossed over from one study group to the other, and if there is at least 98% follow up. | Six months | 

Secondary 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 | 
| Cardiovascular 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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vascular, influenza, vaccine, heart failure