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

McMaster University

Status and phase: Unknown; Phase 4

Conditions: Influenza; Heart Failure

Treatments: Other: Sterile saline; Drug: inactivated trivalent influenza vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT02762851

RCT-IVVE 2015

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5,000 participants in 2 patient groups, including a placebo group

Influenza vaccine

Experimental group

Description:

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.

Treatment:

Drug: inactivated trivalent influenza vaccine

Placebo vaccine

Placebo Comparator group

Description:

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.

Treatment:

Other: Sterile saline