The Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases

This study has been completed.
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00607217
First received: January 10, 2008
Last updated: January 20, 2009
Last verified: September 2008
  Purpose

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.

Condition Intervention Phase
Coronary Artery Diseases
Myocardial Infarction
Stable Angina
Biological: influenza vaccine
Biological: placebo for influenza vaccine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Controlled Trial of Serologic and Clinical Efficacy of Influenza Vaccine in Post-Myocardial Infarction Patients and in Those With Stable Angina Pectoris

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

Primary Outcome Measures:
  • Influenza infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Magnitude of change in the antibody titer against each of the three influenza vaccine antigens [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Protective antibody (≥1:40) titer after vaccination [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Influenza-related death [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: January 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 2006-2007 vaccination campaign of Influvac (SolvayPharma)

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).

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00607217

Locations
Iran, Islamic Republic of
Shaheed Modarres Medical Center
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Shahid Beheshti Medical University
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)
  More Information

Publications:

Responsible Party: Maryam Keshtkar-Jahromi, Infectious Diseases and Tropical Medicine Research Center, SBMU, Tehran, Iran
ClinicalTrials.gov Identifier: NCT00607217     History of Changes
Other Study ID Numbers: SBMU- 86-03-105-5433B, SMMC- 13861008B
Study First Received: January 10, 2008
Last Updated: January 20, 2009
Health Authority: Iran: Ministry of Health

Keywords provided by Shahid Beheshti Medical University:
Coronary artery diseases
Myocardial infarction
Stable angina
Influenza
Vaccine

Additional relevant MeSH terms:
Angina Pectoris
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Infarction
Influenza, Human
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Ischemia
Pathologic Processes
Necrosis
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014