The Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases

January 20, 2009 updated by: Shahid Beheshti University of Medical Sciences

Controlled Trial of Serologic and Clinical Efficacy of Influenza Vaccine in Post-Myocardial Infarction Patients and in Those With Stable Angina Pectoris

This study wishes to understand:

  1. whether vaccination against influenza in coronary artery disease (myocardial infarction and stable angina) patients is as effective as it is in healthy subjects;
  2. whether vaccination really decreases the episodes of influenza infection in those coronary artery disease patients who receive the vaccine than those who do not.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Influenza infection may become complicated in patients with chronic conditions, including coronary artery disease (CAD) [1]. Influenza vaccination is now recommended as part of comprehensive secondary prevention in individuals with coronary and other atherosclerotic vascular disease (evidence level: Class I, Level B) [2]. Although there is controversial evidence pro [3,4] and against [5] the efficacy of influenza vaccination in protecting CAD population against cardiovascular events, the efficacy of vaccine in actual reduction in episodes of influenza infection and its fatal complications in CAD patients has not been, to our knowledge, well studied before. Furthermore, we found no report comparing serologic response to the influenza vaccine antigens between CAD patients and healthy controls.

This study aims to identify the efficacy of influenza vaccination in CAD individuals in terms of both serologic response (as compared with healthy individuals) and clinical outcomes (as compared with CAD patients not vaccinated).

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Coronary artery disease (CAD) group (CAD-Exp and CAD-Control):

  • Patients with the diagnosis of acute, evolving or recent MI (after recovered the acute phase) as defined by:

    1. Typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis with at least one of the following:

  • Ischemic symptoms
  • Development of pathologic Qwaves on the ECG
  • ECG changes indicative of ischemia (ST segment elevation or depression); OR
  • Coronary artery intervention (e.g., coronary angioplasty). 2. Pathologic findings of an acute MI [1]:
  • Patients with stable angina pectoris (SA) and documented coronary artery stenosis (angiography).
  • Healthy Control group: healthy controls, proportionally matched by gender and age with the patient group (separate control groups for MI and SA patients).

Exclusion Criteria:

  • Any acute disease
  • Chronic liver or kidney diseases
  • Conditions accompanied by immunosuppression (like organ transplantation, HIV)
  • Diagnosed malignancy
  • Incubation with influenza vaccine within the past 5 years
  • Any psychological disease that interferes with regular follow-up
  • Congestive heart failure (Killip class IV)
  • Unstable angina; AND
  • Contradictions of vaccine incubation (like egg allergy).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAD-Exp
Enrolled coronary artery disease patients who are randomly assigned to receive influenza vaccine
Biological: influenza vaccine
Intramuscular injection of one 0.5-mL dose of influenza vaccine
Other Names:
  • 2006-2007 vaccination campaign of Influvac (SolvayPharma)
Placebo Comparator: CAD-Control
Enrolled coronary artery disease patients who are randomly assigned to receive placebo of influenza vaccine
Biological: placebo for influenza vaccine
Intramuscular injection of one 0.5-mL dose of placebo for influenza vaccine
Experimental: Healthy-Control
Enrolled healthy subjects serve as control for CAD-Exp
Biological: influenza vaccine
Intramuscular injection of one 0.5-mL dose of influenza vaccine
Other Names:
  • 2006-2007 vaccination campaign of Influvac (SolvayPharma)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Influenza infection
Time Frame: 6 months
6 months
Serologic response (≥4-fold HI titer rise) to each of the 3 antigens of the trivalent vaccine of the 2006-07 campaign [Solomon Islands/3/2006(H1N1), Wisconsin/67/2005 (H3N2), and Malaysia/2506/2004 - like strains]
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Magnitude of change in the antibody titer against each of the three influenza vaccine antigens
Time Frame: 1 month
1 month
Protective antibody (≥1:40) titer after vaccination
Time Frame: 1 month
1 month
Influenza-related death
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Investigators

  • Study Chair: Maryam Keshtkar-Jahromi, M.D.; M.P.H., Infectious Diseases and Tropical Medicine Research Center, Shaheed Beheshti Medical University, Tehran, Iran
  • Principal Investigator: Hossein Vakili, M.D., Cardiovascular Research Center, Shaheed Beheshti Medical University, Tehran, Iran
  • Principal Investigator: Mohammad Rahnavardi, M.D., Infectious Diseases and Tropical Medicine Research Center, Shaheed Beheshti Medical University, Tehran, Iran
  • Principal Investigator: Ali Eskandari, MD, Shaheed Beheshti University (MC)
  • Principal Investigator: Sharareh Gholamin, MD, Shaheed Beheshti University (MC)
  • Principal Investigator: Seyed Mostafa Razavi, MD, Shaheed Beheshti University (MC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

January 10, 2008

First Submitted That Met QC Criteria

February 4, 2008

First Posted (Estimate)

February 5, 2008

Study Record Updates

Last Update Posted (Estimate)

January 22, 2009

Last Update Submitted That Met QC Criteria

January 20, 2009

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBMU- 86-03-105-5433B
  • SMMC- 13861008B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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