Back to resultsThe Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases
Primary Purpose
Coronary Artery Diseases, Myocardial Infarction, Stable Angina
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
influenza vaccine
placebo for influenza vaccine
influenza vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Diseases focused on measuring Coronary artery diseases, Myocardial infarction, Stable angina, Influenza, Vaccine
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).
Sites / Locations
- Shaheed Modarres Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
CAD-Exp
CAD-Control
Healthy-Control
Arm Description
Enrolled coronary artery disease patients who are randomly assigned to receive influenza vaccine
Enrolled coronary artery disease patients who are randomly assigned to receive placebo of influenza vaccine
Enrolled healthy subjects serve as control for CAD-Exp
Outcomes
Primary Outcome Measures
Influenza infection
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]
Secondary Outcome Measures
Magnitude of change in the antibody titer against each of the three influenza vaccine antigens
Protective antibody (≥1:40) titer after vaccination
Influenza-related death
Full Information
NCT ID
NCT00607217
First Posted
January 10, 2008
Last Updated
January 20, 2009
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00607217
Brief Title
The Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases
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 Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Diseases, Myocardial Infarction, Stable Angina
Keywords
Coronary artery diseases, Myocardial infarction, Stable angina, Influenza, Vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CAD-Exp
Arm Type
Experimental
Arm Description
Enrolled coronary artery disease patients who are randomly assigned to receive influenza vaccine
Arm Title
CAD-Control
Arm Type
Placebo Comparator
Arm Description
Enrolled coronary artery disease patients who are randomly assigned to receive placebo of influenza vaccine
Arm Title
Healthy-Control
Arm Type
Experimental
Arm Description
Enrolled healthy subjects serve as control for CAD-Exp
Intervention Type
Biological
Intervention Name(s)
influenza vaccine
Other Intervention Name(s)
2006-2007 vaccination campaign of Influvac (SolvayPharma)
Intervention Description
Intramuscular injection of one 0.5-mL dose of influenza vaccine
Intervention Type
Biological
Intervention Name(s)
placebo for influenza vaccine
Intervention Description
Intramuscular injection of one 0.5-mL dose of placebo for influenza vaccine
Intervention Type
Biological
Intervention Name(s)
influenza vaccine
Other Intervention Name(s)
2006-2007 vaccination campaign of Influvac (SolvayPharma)
Intervention Description
Intramuscular injection of one 0.5-mL dose of influenza vaccine
Primary Outcome Measure Information:
Title
Influenza infection
Time Frame
6 months
Title
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 Measure Information:
Title
Magnitude of change in the antibody titer against each of the three influenza vaccine antigens
Time Frame
1 month
Title
Protective antibody (≥1:40) titer after vaccination
Time Frame
1 month
Title
Influenza-related death
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryam Keshtkar-Jahromi, M.D.; M.P.H.
Organizational Affiliation
Infectious Diseases and Tropical Medicine Research Center, Shaheed Beheshti Medical University, Tehran, Iran
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hossein Vakili, M.D.
Organizational Affiliation
Cardiovascular Research Center, Shaheed Beheshti Medical University, Tehran, Iran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Rahnavardi, M.D.
Organizational Affiliation
Infectious Diseases and Tropical Medicine Research Center, Shaheed Beheshti Medical University, Tehran, Iran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ali Eskandari, MD
Organizational Affiliation
Shaheed Beheshti University (MC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sharareh Gholamin, MD
Organizational Affiliation
Shaheed Beheshti University (MC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seyed Mostafa Razavi, MD
Organizational Affiliation
Shaheed Beheshti University (MC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaheed Modarres Medical Center
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
15367555
Citation
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.
Results Reference
background
PubMed Identifier
16702489
Citation
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. Erratum In: Circulation. 2006 Jun 6;113(22):e847.
Results Reference
background
PubMed Identifier
11994246
Citation
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.
Results Reference
background
PubMed Identifier
14563288
Citation
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.
Results Reference
background
PubMed Identifier
12244032
Citation
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.
Results Reference
background
PubMed Identifier
10987628
Citation
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. Erratum In: J Am Coll Cardiol 2001 Mar 1;37(3):973.
Results Reference
background
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The Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases
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