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Study on the Effect of Influenza Vaccine on Inflammation in Patients with Stable Coronary Artery Disease Using B/Phuket/3073/2013-like Virus and Drug Combination

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the flu vaccine, known as VAXIGRIPTETRA, on patients with stable coronary artery disease. Coronary artery disease is a condition where the blood vessels supplying the heart become narrowed or blocked, which can lead to chest pain or heart attacks. The flu vaccine used in this study is designed to protect against four different strains of the influenza virus, including Influenza A and Influenza B types.

The purpose of the study is to evaluate how the flu vaccine affects inflammation in the body, specifically looking at a marker called high-sensitivity C-reactive protein (hsCRP). Inflammation is the body's response to injury or infection, and it can play a role in heart disease. Participants in the study will receive the flu vaccine either immediately or after a one-month delay. The study will measure changes in inflammation levels over this period.

Throughout the study, additional markers related to heart disease risk and immune response will be monitored. These include substances like interleukin-6 and tumor necrosis factor-alpha, as well as the presence of certain immune cells. The study aims to provide insights into how the flu vaccine might influence inflammation and immune function in people with stable coronary artery disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on age (60 years or older) and a diagnosis of stable coronary artery disease.

    Consent is required, and participants must be able to attend follow-up visits and communicate with study staff.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to measure baseline levels of high-sensitivity C-reactive protein (hsCRP) in the blood.

    This assessment helps to establish a starting point for evaluating changes in inflammation.

  3. Step 3

    Vaccination

    Participants receive the VAXIGRIPTETRA vaccine, which is a quadrivalent influenza vaccine.

    The vaccine is administered as a suspension for injection through an intramuscular injection.

  4. Step 4

    Follow-up period

    Participants are divided into two groups: one group receives the vaccine immediately, and the other group receives it after one month.

    During this period, participants continue their usual activities and report any health changes.

  5. Step 5

    Final assessment

    At the end of the study, one month after vaccination, a final assessment is conducted.

    The primary focus is on measuring the change in hsCRP levels to evaluate the vaccine's impact on inflammation.

    Secondary assessments include measuring other inflammatory markers, arterial vulnerability markers, immune cell characterization, and antibody levels.

Who can join the trial?

5 criteria

  • Participants must be **60 years old or older**.
  • Participants must have **stable coronary artery disease**, which means their heart condition is not currently changing or getting worse.
  • Participants must be able to **follow the study's requirements**, such as attending follow-up visits and communicating with the study staff.
  • Participants must **sign a consent form**, which is a document that shows they agree to take part in the study after understanding what it involves.
  • Participants must be **affiliated with the French social security system**, meaning they are part of the national health insurance in France.

Who cannot join the trial?

3 criteria

  • Patients who do not have stable coronary artery disease. This means the study is only for those whose heart condition is not changing or getting worse.
  • Individuals who are not within the specified age range for the study. The study has a specific age group it is focusing on.
  • People who are part of a vulnerable population. This refers to groups who might need special protection or care.
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Investigated drugs

Influenza Vaccine The influenza vaccine is used in this trial to assess its effect on systemic inflammatory markers in patients with stable coronary artery disease. The vaccine is designed to protect against the flu virus and is being studied to see if it can also reduce inflammation in the body, which is important for patients with heart conditions.

What is already known about the treatment

Influenza Vaccine – The influenza vaccine is administered via injection, typically into the muscle of the upper arm. It is widely used and well-documented in medical literature as a preventive measure against the flu. The main therapeutic indication for the influenza vaccine is to prevent influenza infection, particularly in individuals with underlying health conditions such as stable coronary artery disease. At the molecular level, the vaccine works by stimulating the immune system to produce antibodies against the influenza virus, thereby providing immunity. It is classified as a vaccine under pharmacological classifications.

Investigated diseases

Coronary Artery Disease – This condition involves the narrowing or blockage of the coronary arteries, usually due to a buildup of cholesterol and fatty deposits called plaques. Over time, these plaques can harden or rupture, leading to reduced blood flow to the heart muscle. This can cause symptoms such as chest pain or discomfort, known as angina, especially during physical activity or stress. In stable coronary artery disease, these symptoms are predictable and occur with exertion but improve with rest. The disease progresses slowly, and the risk of complications increases if the plaques continue to grow or if a blood clot forms. Regular monitoring and lifestyle changes are often necessary to manage the condition.
Trial detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase IITrial ID2024-514543-28-00Protocol codeIVAMIEstimated enrolment50 patientsSponsorCentre Hospitalier Regional Universitaire De Tours

sourced from the EU Clinical Trials Register and site verification

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