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

Primary Purpose

Heart Failure, Influenza

Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Sterile saline
inactivated trivalent influenza vaccine
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Influenza, Vaccine, Heart failure, Vascular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Douala General Hospital
  • Fuwai HospitalRecruiting
  • Centre for Chronic Disease ControlRecruiting
  • Aga Khan UniversityRecruiting
  • American University of Beirut Medical Center
  • Maputo Central Hospital (Full Trial)Recruiting
  • Bayero University and Aminu Kano Teaching HospitalRecruiting
  • University of PhilippinesRecruiting
  • King Saud UniveristyRecruiting
  • AlShaab Teaching Hospital
  • Mulago HospitalRecruiting
  • Sheikh Khalifa Medical CityRecruiting
  • University of Zambia School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Influenza vaccine

Placebo vaccine

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Cardiovascular (CV) death
CV death alone will be a secondary outcome.

Full Information

First Posted
May 3, 2016
Last Updated
October 25, 2018
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT02762851
Brief Title
Influenza Vaccine To Prevent Adverse Vascular Events (RCT-IVVE)
Acronym
RCT-IVVE
Official Title
A Randomized Controlled Trial of Influenza Vaccine to Prevent Adverse Vascular Events
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Influenza
Keywords
Influenza, Vaccine, Heart failure, Vascular

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Influenza vaccine
Arm Type
Experimental
Arm 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.
Arm Title
Placebo vaccine
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Sterile saline
Intervention Description
0.5 ml dose injected intramuscularly
Intervention Type
Drug
Intervention Name(s)
inactivated trivalent influenza vaccine
Other Intervention Name(s)
VAXIGRIP vaccine
Intervention Description
0.5 ml dose injected intramuscularly
Primary Outcome Measure Information:
Title
Adverse cardiovascular event
Description
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.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Cardiovascular (CV) death
Description
CV death alone will be a secondary outcome.
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Loeb, MD, MSc.
Phone
905-525-9140
Ext
26066
Email
loebm@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Loeb, MD, MSc.
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Douala General Hospital
City
Douala
Country
Cameroon
Individual Site Status
Terminated
Facility Name
Fuwai Hospital
City
Beijing
State/Province
Xicheng District
ZIP/Postal Code
100037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Liang, MD
Email
yan.liang@phri.ca
First Name & Middle Initial & Last Name & Degree
Jun Zhu, MD
Email
junzhuld@hotmail.com
Facility Name
Centre for Chronic Disease Control
City
New Delhi
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorairaj Prabhakaran, MD
Email
dprabhakaran@ccdcindia.org
First Name & Middle Initial & Last Name & Degree
Ambuj Roy, MD
Facility Name
Aga Khan University
City
Nairobi
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerald Yonga, MD
Email
gerald.yonga@aku.edu
Facility Name
American University of Beirut Medical Center
City
Beirut
Country
Lebanon
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marwan Refaat, MD
Phone
+961-1-350000
Ext
5825
Email
mr48@aub.edu.lb
Facility Name
Maputo Central Hospital (Full Trial)
City
Maputo
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albertino Damasceno, MD
Phone
258 2131 0828
Email
tino_7117@yahoo.com.br
Facility Name
Bayero University and Aminu Kano Teaching Hospital
City
Kano
Country
Nigeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamilu Karaye, MD
Phone
234 803 704 2171
Email
kkaraye@yahoo.co.uk
Facility Name
University of Philippines
City
Manila
State/Province
Emita
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lia Palileo, MD
Email
liapalileo@gmail.com
First Name & Middle Initial & Last Name & Degree
Antonio Dans, MD
Facility Name
King Saud Univeristy
City
Riyadh
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khalid Al-Habib, MD
Phone
966 1 288 9999
Email
khalidalhabib13@hotmail.com
Facility Name
AlShaab Teaching Hospital
City
Khartoum
Country
Sudan
Individual Site Status
Terminated
Facility Name
Mulago Hospital
City
Kampala
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Mondo, MD
Phone
256 772 462370
Email
charles_mondo@yahoo.com.au
Facility Name
Sheikh Khalifa Medical City
City
Abu Dhabi
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wael Almahmeed, MD
Email
wmahmeed@emirates.net.ae
Facility Name
University of Zambia School of Medicine
City
Lusaka
Country
Zambia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fastone Goma, MD
Email
gomafm@yahoo.co.uk

12. IPD Sharing Statement

Plan to Share IPD
No
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Loeb M, Roy A, Dokainish H, Dans A, Palileo-Villanueva LM, Karaye K, Zhu J, Liang Y, Goma F, Damasceno A, Alhabib KF, Yonga G, Mondo C, Almahmeed W, Al Mulla A, Thanabalan V, Rao-Melacini P, Grinvalds A, McCready T, Bangdiwala SI, Yusuf S; Influenza Vaccine to Prevent Adverse Vascular Events investigators. Influenza vaccine to reduce adverse vascular events in patients with heart failure: a multinational randomised, double-blind, placebo-controlled trial. Lancet Glob Health. 2022 Dec;10(12):e1835-e1844. doi: 10.1016/S2214-109X(22)00432-6. Erratum In: Lancet Glob Health. 2022 Nov 30;:
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PubMed Identifier
30933856
Citation
Loeb M, Dokainish H, Dans A, Palileo-Villanueva LM, Roy A, Karaye K, Zhu J, Liang Y, Goma F, Damasceno A, AlHabib KF, Yonga G, Mondo C, Almahmeed W, Al Mulla A, Yusuf S; IVVE investigators. Randomized controlled trial of influenza vaccine in patients with heart failure to reduce adverse vascular events (IVVE): Rationale and design. Am Heart J. 2019 Jun;212:36-44. doi: 10.1016/j.ahj.2019.02.009. Epub 2019 Mar 11. Erratum In: Am Heart J. 2019 Dec 12;:
Results Reference
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Influenza Vaccine To Prevent Adverse Vascular Events (RCT-IVVE)

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