Clinical trial NCT02762851: Influenza Vaccine To Prevent Adverse Vascular Events (RCT-IVVE)
Official title: A Randomized Controlled Trial of Influenza Vaccine to Prevent Adverse Vascular Events
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heart Failure
Influenza
Keywords: Influenza
Vaccine
Heart failure
Vascular
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse cardiovascular event
timeFrame: Six months
Secondary outcomes:
measure: Cardiovascular (CV) death
timeFrame: Six months
Other outcomes:
Locations:
city: Douala
country: Cameroon
facility: Douala General Hospital
city: Beijing
country: China
facility: Fuwai Hospital
state: Xicheng District
city: New Delhi
country: India
facility: Centre for Chronic Disease Control
city: Nairobi
country: Kenya
facility: Aga Khan University
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
city: Maputo
country: Mozambique
facility: Maputo Central Hospital (Full Trial)
city: Kano
country: Nigeria
facility: Bayero University and Aminu Kano Teaching Hospital
city: Manila
country: Philippines
facility: University of Philippines
state: Emita
city: Riyadh
country: Saudi Arabia
facility: King Saud Univeristy
city: Khartoum
country: Sudan
facility: AlShaab Teaching Hospital
city: Kampala
country: Uganda
facility: Mulago Hospital
city: Abu Dhabi
country: United Arab Emirates
facility: Sheikh Khalifa Medical City
city: Lusaka
country: Zambia
facility: University of Zambia School of Medicine
Study officials:
affiliation: McMaster University
name: Mark Loeb, MD, MSc.
role: PRINCIPAL_INVESTIGATOR
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