The Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases

NCT ID: NCT00607217

Last Updated: 2009-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-09-30

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).

Conditions

Coronary Artery Diseases; Myocardial Infarction; Stable Angina

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

CAD-Exp

Enrolled coronary artery disease patients who are randomly assigned to receive influenza vaccine

Group Type: EXPERIMENTAL

influenza vaccine

Intervention Type: BIOLOGICAL

Intramuscular injection of one 0.5-mL dose of influenza vaccine

CAD-Control

Enrolled coronary artery disease patients who are randomly assigned to receive placebo of influenza vaccine

Group Type: PLACEBO_COMPARATOR

placebo for influenza vaccine

Intervention Type: BIOLOGICAL

Intramuscular injection of one 0.5-mL dose of placebo for influenza vaccine

Healthy-Control

Enrolled healthy subjects serve as control for CAD-Exp

Group Type: EXPERIMENTAL

influenza vaccine

Intervention Type: BIOLOGICAL

Intramuscular injection of one 0.5-mL dose of influenza vaccine

Interventions

influenza vaccine

Intramuscular injection of one 0.5-mL dose of influenza vaccine

Intervention Type: BIOLOGICAL

placebo for influenza vaccine

Intramuscular injection of one 0.5-mL dose of placebo for influenza vaccine

Intervention Type: BIOLOGICAL

influenza vaccine

Intramuscular injection of one 0.5-mL dose of influenza vaccine

Intervention Type: BIOLOGICAL

Other Intervention Names

2006-2007 vaccination campaign of Influvac (SolvayPharma); 2006-2007 vaccination campaign of Influvac (SolvayPharma)

Eligibility 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).

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Infectious Diseases and Tropical Medicine Research Center, SBMU, Tehran, Iran

Principal Investigators

Maryam Keshtkar-Jahromi, M.D.; M.P.H.

Role: STUDY_CHAIR

Infectious Diseases and Tropical Medicine Research Center, Shaheed Beheshti Medical University, Tehran, Iran

Hossein Vakili, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Research Center, Shaheed Beheshti Medical University, Tehran, Iran

Mohammad Rahnavardi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Infectious Diseases and Tropical Medicine Research Center, Shaheed Beheshti Medical University, Tehran, Iran

Ali Eskandari, MD

Role: PRINCIPAL_INVESTIGATOR

Shaheed Beheshti University (MC)

Sharareh Gholamin, MD

Role: PRINCIPAL_INVESTIGATOR

Shaheed Beheshti University (MC)

Seyed Mostafa Razavi, MD

Role: PRINCIPAL_INVESTIGATOR

Shaheed Beheshti University (MC)

Locations

Shaheed Modarres Medical Center

Tehran, Tehran Province, Iran

Countries

Iran

References

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. doi: 10.1001/jama.292.11.1333.

Reference Type: BACKGROUND

PMID: 15367555 (View on PubMed)

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. doi: 10.1161/CIRCULATIONAHA.106.174516. No abstract available.

Reference Type: BACKGROUND

PMID: 16702489 (View on PubMed)

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. doi: 10.1161/01.cir.0000016182.85461.f4.

Reference Type: BACKGROUND

PMID: 11994246 (View on PubMed)

Leon 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. doi: 10.1016/s0300-8932(03)76991-7. Spanish.

Reference Type: BACKGROUND

PMID: 14563288 (View on PubMed)

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. doi: 10.1093/aje/kwf073.

Reference Type: BACKGROUND

PMID: 12244032 (View on PubMed)

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. doi: 10.1016/s0735-1097(00)00804-4.

Reference Type: BACKGROUND

PMID: 10987628 (View on PubMed)

Other Identifiers

SMMC- 13861008B

Identifier Type: -

Identifier Source: secondary_id

SBMU- 86-03-105-5433B

Identifier Type: -

Identifier Source: org_study_id