Effect of Influenza Vaccination on Global Systemic Inflammatory Markers in Patients With Stable Coronary Artery Disease (IVAMI)

Effect of Influenza Vaccination on Global Systemic Inflammatory Markers in Patients With Stable Coronary Artery Disease - Randomized Delayed-Start Pilot Trial

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Atherosclerosis; Inflammatory Response
• Intervention / Treatment: Biological: Influenza Vaccination

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Tours, France, 37000
    • Chru de Trousseau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: "Immediate" Vaccination Group; At the inclusion visit (D0), a dose of influenza vaccine will be administered.	Biological: Influenza Vaccination; Standard Dose QIV (15µg Hemagglutinin) - VaxigripTetra Suspension for injection, 0,5ml prefilled syringe
No Intervention: "Follow-up" vaccination group; At the inclusion visit (D0), no immediate influenza vaccination (which will be administered one month later at the follow-up visit).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2024
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): November 25, 2024

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: coronary disease; inflammation; atherosclerosis,; influenza vaccination
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Ischemia; Pathological Conditions, Signs and Symptoms; Influenza, Human; Inflammation; Coronary Artery Disease; Coronary Disease; Atherosclerosis; Biological Products; Complex Mixtures; Vaccines; Viral Vaccines; Influenza Vaccines
• Other Study ID Numbers: DR240124

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No