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Completed

NCT Number: NCT06508437

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Infections Inflammation Inflammatory Response Influenza, Human Myocardial Ischemia Orthomyxoviridae Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vascular Diseases Virus Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chru de Trousseau

Tours, 37000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Influenza vaccination

Biological

Standard Dose QIV (15µg Hemagglutinin) - VaxigripTetra Suspension for injection, 0,5ml prefilled syringe

Primary outcomes

  1. Plasma concentration of high-sensitivity C-reactive protein (hsCRP)

    Time frame: Between baseline and 1-month follow up

    Change from baseline in peripheral blood hsCRP concentrations (mg/L) between study group

Secondary outcomes

  1. Other Plasma inflammatory markers : Tumor necrosis factor alpha (TNF-α), Interleukin 1 beta (IL-1β), Interleukin-6 (IL-6 )

    Time frame: 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

  2. Other Plasma inflammatory markers : N-terminal pro-B-type natriuretic peptide

    Time frame: 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

  3. Other Plasma inflammatory markers : fibrinogen

    Time frame: Between baseline and 1-month follow up

    Change from baseline in peripheral blood markers: fibrinogen concentrations (g/L) between study group

  4. Plasma arterial vulnerability markers

    Time frame: 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

  5. Immunoinflammatory markers in circulating immune cells : T cell response

    Time frame: 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.

  6. Immunoinflammatory markers in circulating immune cells : T cell population

    Time frame: 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.

  7. Circulating immune cells profile : percentage of peripheral immune cells

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

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

Acronym: IVAMI

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2024
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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