The Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases

Study Overview
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Brief Summary
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This study wishes to understand: whether vaccination against influenza in coronary artery disease (myocardial infarction and stable angina) patients is as effective as it is in healthy subjects; 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
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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).

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

Conditions
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Coronary Artery Diseases, Myocardial Infarction, Stable Angina

Intervention / Treatment
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* Biological: influenza vaccine
* Biological: placebo for influenza vaccine
* Biological: influenza vaccine


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery diseases, Myocardial infarction, Stable angina, Influenza, Vaccine