The Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases

Phase 2

Completed

• Conditions: Coronary Artery Diseases; Myocardial Infarction; Stable Angina
• Interventions: Biological: influenza vaccine; Biological: placebo for influenza vaccine

• Registration Number: NCT00607217
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

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.

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 Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-10
• Study First Submitted QC: 2008-02-04
• Study First Posted: 2008-02-05
• Status Verified: 2008-09
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Last Update Submitted: 2009-01-20
• Last Update Posted: 2009-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAD-Exp	influenza vaccine	Enrolled coronary artery disease patients who are randomly assigned to receive influenza vaccine
CAD-Control	placebo for influenza vaccine	Enrolled coronary artery disease patients who are randomly assigned to receive placebo of influenza vaccine
Healthy-Control	influenza vaccine	Enrolled healthy subjects serve as control for CAD-Exp

Primary Outcome Measures

Name	Time	Method
Influenza infection	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]	1 month

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shaheed Modarres Medical Center; 🇮🇷 Tehran, Iran, Islamic Republic of