The Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases
Study Details
Study Description
Brief Summary
This study wishes to understand:
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whether vaccination against influenza in coronary artery disease (myocardial infarction and stable angina) patients is as effective as it is in healthy subjects;
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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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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 Design
Arms and Interventions
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Coronary artery disease (CAD) group (CAD-Exp and CAD-Control):
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Patients with the diagnosis of acute, evolving or recent MI (after recovered the acute phase) as defined by:
- 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:
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Ischemic symptoms
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Development of pathologic Qwaves on the ECG
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ECG changes indicative of ischemia (ST segment elevation or depression); OR
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Coronary artery intervention (e.g., coronary angioplasty). 2. Pathologic findings of an acute MI [1]:
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Patients with stable angina pectoris (SA) and documented coronary artery stenosis (angiography).
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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:
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Any acute disease
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Chronic liver or kidney diseases
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Conditions accompanied by immunosuppression (like organ transplantation, HIV)
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Diagnosed malignancy
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Incubation with influenza vaccine within the past 5 years
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Any psychological disease that interferes with regular follow-up
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Congestive heart failure (Killip class IV)
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Unstable angina; AND
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Contradictions of vaccine incubation (like egg allergy).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shaheed Modarres Medical Center | Tehran | Iran, Islamic Republic of |
Sponsors and Collaborators
- 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)
Study Documents (Full-Text)
None provided.More Information
Publications
- Alpert JS, Thygesen K, Antman E, Bassand JP. Myocardial infarction redefined--a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. J Am Coll Cardiol. 2000 Sep;36(3):959-69. Erratum in: J Am Coll Cardiol 2001 Mar 1;37(3):973.
- Gurfinkel EP, de la Fuente RL, Mendiz O, Mautner B. Influenza vaccine pilot study in acute coronary syndromes and planned percutaneous coronary interventions: the FLU Vaccination Acute Coronary Syndromes (FLUVACS) Study. Circulation. 2002 May 7;105(18):2143-7.
- Jackson LA, Yu O, Heckbert SR, Psaty BM, Malais D, Barlow WE, Thompson WW; Vaccine Safety Datalink Study Group. Influenza vaccination is not associated with a reduction in the risk of recurrent coronary events. Am J Epidemiol. 2002 Oct 1;156(7):634-40.
- León de la Fuente R, Gurfinkel EP, Toledo D, Mautner B; Grupo de Estudio FLUVACS. [Flu vaccination in patients with acute coronary syndromes: treatment benefit in prespecified subgroups]. Rev Esp Cardiol. 2003 Oct;56(10):949-54. Spanish.
- Smith SC Jr, Allen J, Blair SN, Bonow RO, Brass LM, Fonarow GC, Grundy SM, Hiratzka L, Jones D, Krumholz HM, Mosca L, Pasternak RC, Pearson T, Pfeffer MA, Taubert KA; AHA/ACC; National Heart, Lung, and Blood Institute. AHA/ACC guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular disease: 2006 update: endorsed by the National Heart, Lung, and Blood Institute. Circulation. 2006 May 16;113(19):2363-72. Erratum in: Circulation. 2006 Jun 6;113(22):e847.
- Thompson WW, Shay DK, Weintraub E, Brammer L, Bridges CB, Cox NJ, Fukuda K. Influenza-associated hospitalizations in the United States. JAMA. 2004 Sep 15;292(11):1333-40.
- SBMU- 86-03-105-5433B
- SMMC- 13861008B