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

Heart Failure Clinical Trial

— RCT-IVVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02762851
• Other study ID #: RCT-IVVE 2015
• Status: Recruiting
• Phase: Phase 4
• Start date: June 2016
• Est. completion date: December 2020

Study information

• Verified date: October 2018
• Source: McMaster University
• Contact: Mark Loeb, MD, MSc.
• Phone: 905-525-9140
• Email: loebm[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Heart Failure
• Influenza
• Influenza, Human

Intervention

Other:
• Sterile saline
0.5 ml dose injected intramuscularly

Drug:
• inactivated trivalent influenza vaccine
0.5 ml dose injected intramuscularly

Locations

Country	Name	City	State
Cameroon	Douala General Hospital	Douala
China	Fuwai Hospital	Beijing	Xicheng District
India	Centre for Chronic Disease Control	New Delhi
Kenya	Aga Khan University	Nairobi
Lebanon	American University of Beirut Medical Center	Beirut
Mozambique	Maputo Central Hospital (Full Trial)	Maputo
Nigeria	Bayero University and Aminu Kano Teaching Hospital	Kano
Philippines	University of Philippines	Manila	Emita
Saudi Arabia	King Saud Univeristy	Riyadh
Sudan	AlShaab Teaching Hospital	Khartoum
Uganda	Mulago Hospital	Kampala
United Arab Emirates	Sheikh Khalifa Medical City	Abu Dhabi
Zambia	University of Zambia School of Medicine	Lusaka

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Countries where clinical trial is conducted

Cameroon,  China,  India,  Kenya,  Lebanon,  Mozambique,  Nigeria,  Philippines,  Saudi Arabia,  Sudan,  Uganda,  United Arab Emirates,  Zambia, 

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* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cardiovascular (CV) death	CV death alone will be a secondary outcome.	Six months