Atherosclerosis, Coronary Artery Disease, Inflammatory Response
Conditions
Keywords
influenza vaccination, inflammation, atherosclerosis,, coronary disease
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALInfluenza Vaccination
Standard Dose QIV (15µg Hemagglutinin) - VaxigripTetra Suspension for injection, 0,5ml prefilled syringe
Sponsors
University Hospital, Tours
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects aged ≥ 60 years. * With documented stable coronary artery disease. * Subjects who, in the opinion of the investigator, can comply with the protocol requirements (i.e., show up for the follow-up visit and be able to converse with study staff). * Signature of free, written and informed consent by the patient. * Affiliation to a French social security system.
Exclusion criteria
* History of serious reaction to influenza vaccine or refusal of vaccination or contraindication to vaccination. * Participant has received the influenza vaccine within \<6 months or another vaccine. * Acute infection within \<3 months or acute worsening of chronic diseases. * Severe neurocognitive disorders (inability to give informed consent). * Pre-existing medical conditions or medications involving the immune system (rheumatoid arthritis or other inflammatory conditions or active cancer, recent use (within the past year) of immunosuppressive or modulating agents, including oral steroids, chemotherapy, or radiation therapy) . * Cardiovascular surgery or other interventions within 6 months preceding the study or planned during the follow-up period. * Patient's wish or clinical situation requiring co-administration with other vaccines or any factor hindering monitoring. * Patient under guardianship, curatorship or safeguard of justice.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration of high-sensitivity C-reactive protein (hsCRP) | Between baseline and 1-month follow up | Change from baseline in peripheral blood hsCRP concentrations (mg/L) between study group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other Plasma inflammatory markers : N-terminal pro-B-type natriuretic peptide | Between baseline and 1-month follow up | Change from baseline in peripheral blood markers N-terminal pro-B-type natriuretic peptide concentrations (ng/L) between study group |
| Other Plasma inflammatory markers : fibrinogen | Between baseline and 1-month follow up | Change from baseline in peripheral blood markers: fibrinogen concentrations (g/L) between study group |
| Plasma arterial vulnerability markers | Between baseline and 1-month follow up | Change from baseline in peripheral blood markers (g/l) : Apolipoprotein B, lipoprotein(a) and low density lipoproteins cholesterol (LDLc) between study group |
| Other Plasma inflammatory markers : Tumor necrosis factor alpha (TNF-α), Interleukin 1 beta (IL-1β), Interleukin-6 (IL-6 ) | Between baseline and 1-month follow up | 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 |
| Immunoinflammatory markers in circulating immune cells : T cell population | Between baseline and 1-month follow up | 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. |
| Circulating immune cells profile : percentage of peripheral immune cells | Between baseline and 1-month follow up | 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. |
| Immunoinflammatory markers in circulating immune cells : T cell response | Between baseline and 1-month follow up | 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. |
Countries
France
Outcome results
None listed