The Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases

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ClinicalTrials.gov Identifier: NCT00607217

Recruitment Status : Completed

First Posted : February 5, 2008

Last Update Posted : January 22, 2009

Sponsor:

Information provided by:

Shahid Beheshti University of Medical Sciences

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Diseases Myocardial Infarction Stable Angina	Biological: influenza vaccine Biological: placebo for influenza vaccine	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

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	360 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
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
Study Start Date :	January 2008
Actual Primary Completion Date :	September 2008
Actual Study Completion Date :	September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina Coronary Artery Disease Flu Flu Shot Heart Attack

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

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 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)

Outcome Measures

Primary Outcome Measures :

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 ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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Ages Eligible for Study:	25 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607217

Locations

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Iran, Islamic Republic of
Shaheed Modarres Medical Center
Tehran, Iran, Islamic Republic of

Sponsors and Collaborators

Shahid Beheshti University of Medical Sciences

Investigators

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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:

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.

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.

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.

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.

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.

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.

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Responsible Party:	Maryam Keshtkar-Jahromi, Infectious Diseases and Tropical Medicine Research Center, SBMU, Tehran, Iran
ClinicalTrials.gov Identifier:	NCT00607217
Other Study ID Numbers:	SBMU- 86-03-105-5433B SMMC- 13861008B
First Posted:	February 5, 2008 Key Record Dates
Last Update Posted:	January 22, 2009
Last Verified:	September 2008

Keywords provided by Shahid Beheshti University of Medical Sciences:


Coronary artery diseases Myocardial infarction Stable angina Influenza Vaccine

Additional relevant MeSH terms:

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Influenza, Human Coronary Artery Disease Myocardial Ischemia Coronary Disease Myocardial Infarction Angina Pectoris Angina, Stable Infarction Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Ischemia	Pathologic Processes Necrosis Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Chest Pain Pain Neurologic Manifestations Vaccines Immunologic Factors Physiological Effects of Drugs

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