The Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases

NCT00607217 | Completed Phase 2 DMC

• 2 other identifiers: SBMU- 86-03-105-5433BSMMC- 13861008B
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

This study wishes to understand:

1. 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. 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.

Conditions

Coronary Artery Diseases; Myocardial Infarction; Stable Angina

Keywords

Coronary artery diseases; Myocardial infarction; Stable angina; Influenza; Vaccine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (3)

CAD-Exp

EXPERIMENTAL

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

Biological: influenza vaccine

CAD-Control

PLACEBO COMPARATOR

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

Biological: placebo for influenza vaccine

Healthy-Control

EXPERIMENTAL

Enrolled healthy subjects serve as control for CAD-Exp

Biological: influenza vaccine

Interventions

influenza vaccine BIOLOGICAL

Intramuscular injection of one 0.5-mL dose of influenza vaccine

Also known as: 2006-2007 vaccination campaign of Influvac (SolvayPharma)

CAD-Exp

placebo for influenza vaccine BIOLOGICAL

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

CAD-Control

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \. 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Shaheed Modarres Medical Center

Tehran, Tehran Province, Iran

Location

Related Publications (6)

• 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.

  PMID: 15367555 BACKGROUND

• 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.

  PMID: 16702489 BACKGROUND

• 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.

  PMID: 11994246 BACKGROUND

• 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.

  PMID: 14563288 BACKGROUND

• 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.

  PMID: 12244032 BACKGROUND

• 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.

  PMID: 10987628 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction; Angina, Stable; Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

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

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

  STUDY CHAIR

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: February 5, 2008
• Study Start: January 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 22, 2009

Record last verified: 2008-09

Locations

IR (1)