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Observational and randomized studies suggest that influenza vaccine may reduce future cardiovascular events in patients with cardiovascular disease. Beyond classical view of indirect effect, linked to the neutralisation of the virus, it is currently considered whether the vaccination may have a direct effect on inflammatory process.Atherosclerosis is known to be driven both by lipid stress and inflammation both at local and systemic level. The investigators suggest that influenza vaccination could have a positive effect on atherosclerosis by regulating plasma inflammation. The aim of this pilot study is therefore to assess the impact of influenza vaccination in patients with stable coronary artery disease on the circulating inflammatory response, in order to validate its potential immunomodulatory effect. If it is found to be beneficial, it could also constitute a future adjuvant therapeutic tool to traditional pharmacotherapy in the prevention of cardiovascular events.
A multi-center, open-label, randomized delayed-start pilot study in 2 parallel groups will be conducted: participants will be randomized as to when the influenza vaccine will be administered, according to a 1:1 ratio between influenza vaccination immediately after inclusion or at 1-month follow-up. Blood tests for plasmatic inflammation analyses will be collected at baseline and at 1 month after study inclusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Immediate" Vaccination Group | Active Comparator | At the inclusion visit (D0), a dose of influenza vaccine will be administered. |
|
| "Follow-up" vaccination group | No Intervention | At the inclusion visit (D0), no immediate influenza vaccination (which will be administered one month later at the follow-up visit). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Vaccination | Biological | Standard Dose QIV (15µg Hemagglutinin) - VaxigripTetra Suspension for injection, 0,5ml prefilled syringe |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of high-sensitivity C-reactive protein (hsCRP) | Change from baseline in peripheral blood hsCRP concentrations (mg/L) between study group | Between baseline and 1-month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Other Plasma inflammatory markers : Tumor necrosis factor alpha (TNF-α), Interleukin 1 beta (IL-1β), Interleukin-6 (IL-6 ) | Change from baseline in peripheral blood markers: Tumor necrosis factor alpha (TNF-α), Interleukin 1 beta (IL-1β), Interleukin-6 (IL-6 ) concentrations (pg/mL) parbetween study group | Between baseline and 1-month follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chru de Trousseau | Tours | 37000 | France |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D050197 | Atherosclerosis |
| D007251 | Influenza, Human |
| D007249 | Inflammation |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Parallel Assignment
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| Other Plasma inflammatory markers : N-terminal pro-B-type natriuretic peptide | Change from baseline in peripheral blood markers N-terminal pro-B-type natriuretic peptide concentrations (ng/L) between study group | Between baseline and 1-month follow up |
| Other Plasma inflammatory markers : fibrinogen | Change from baseline in peripheral blood markers: fibrinogen concentrations (g/L) between study group | Between baseline and 1-month follow up |
| Plasma arterial vulnerability markers | Change from baseline in peripheral blood markers (g/l) : Apolipoprotein B, lipoprotein(a) and low density lipoproteins cholesterol (LDLc) between study group | Between baseline and 1-month follow up |
| Immunoinflammatory markers in circulating immune cells : T cell response | Differences in the expression level of peripheral blood immune cells by reverse transcription and real-time PCR (RT-qPCR) of genes involved in the T-cell response (CD3, CD4, CD8) between study group. | Between baseline and 1-month follow up |
| Immunoinflammatory markers in circulating immune cells : T cell population | Differences in the expression level of peripheral blood immune cells by reverse transcription and real-time PCR (RT-qPCR) of genes involved in the T-cell orientation : Th1 (Tbet), Th2 (GATA3), Th17 (RORγ), Treg (FOXP3) between study group. | Between baseline and 1-month follow up |
| Circulating immune cells profile : percentage of peripheral immune cells | Differences in peripheral blood immune cells determined by flow cytometry from blood mononuclear cells (PBMC): Percentage of B lymphocytes (CD45+CD19+), T lymphocytes (CD45+CD3+) and monocytes (CD45+CD14+CD11c+) between study group. | Between baseline and 1-month follow up |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |