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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
360
Intramuscular injection of one 0.5-mL dose of influenza vaccine
Intramuscular injection of one 0.5-mL dose of placebo for influenza vaccine
Intramuscular injection of one 0.5-mL dose of influenza vaccine
Shaheed Modarres Medical Center
Tehran, Tehran Province, Iran
Influenza infection
Time frame: 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
Magnitude of change in the antibody titer against each of the three influenza vaccine antigens
Time frame: 1 month
Protective antibody (≥1:40) titer after vaccination
Time frame: 1 month
Influenza-related death
Time frame: 6 months
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