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

Phase 4

Interventions: Other: Sterile saline
Drug: inactivated trivalent influenza vaccine

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo vaccine	Sterile saline	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.
Influenza vaccine	inactivated trivalent influenza vaccine	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.

Primary Outcome Measures

Name	Time	Method
Adverse cardiovascular event	Six months	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.

Secondary Outcome Measures

Name	Time	Method
Cardiovascular (CV) death	Six months	CV death alone will be a secondary outcome.

Locations (13): Centre for Chronic Disease Control
🇮🇳
New Delhi, India
Maputo Central Hospital (Full Trial)
🇲🇿
Maputo, Mozambique
King Saud Univeristy
🇸🇦
Riyadh, Saudi Arabia
Fuwai Hospital
🇨🇳
Beijing, Xicheng District, China
Bayero University and Aminu Kano Teaching Hospital
🇳🇬
Kano, Nigeria
Mulago Hospital
🇺🇬
Kampala, Uganda
Aga Khan University
🇰🇪
Nairobi, Kenya
University of Zambia School of Medicine
🇿🇲
Lusaka, Zambia
Douala General Hospital
🇨🇲
Douala, Cameroon
American University of Beirut Medical Center
🇱🇧
Beirut, Lebanon
University of Philippines
🇵🇭
Manila, Emita, Philippines
AlShaab Teaching Hospital
🇸🇩
Khartoum, Sudan
Sheikh Khalifa Medical City
🇦🇪
Abu Dhabi, United Arab Emirates