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Influenza Virus A/California/122/2022 San-022 (H3N2) Strain (Split, Inactivated)

This article discusses a clinical trial investigating the effects of influenza vaccination on inflammation in patients with stable coronary artery disease. The study aims to assess how the flu vaccine impacts systemic inflammatory markers, particularly high-sensitivity C-reactive protein (hsCRP), in this specific patient population. The trial is designed as a randomized delayed-start pilot study, comparing immediate vaccination to delayed vaccination after one month.

Table of Contents

Introduction

A new clinical trial is underway to investigate the effects of an influenza vaccine on patients with stable coronary artery disease. This article will provide detailed information about the vaccine and the study, using simple language to help patients understand the research being conducted.[1]

Vaccine Composition

The vaccine being studied is called VAXIGRIPTETRA, which is a quadrivalent inactivated influenza vaccine. Quadrivalent means it protects against four different strains of the influenza virus. Inactivated means the vaccine contains killed virus particles, which cannot cause infection but can still stimulate an immune response.[1]

The vaccine includes the following components:

  • B/Phuket/3073/2013-like virus (wild type)
  • Influenza virus B/Michigan/01/2021
  • Influenza A/Victoria/4897/2022 IVR-238 (H1N1), inactivated
  • Influenza virus A/California/122/2022 SAN-022 (H3N2) strain (split, inactivated)

These components represent different strains of influenza viruses that are expected to circulate during the 2024-2025 flu season.[1]

Purpose of the Study

The main objective of this study is to evaluate how the influenza vaccine affects systemic inflammation in patients with stable coronary artery disease. Systemic inflammation refers to inflammation throughout the body, which can be measured by certain blood markers.[1]

Specifically, the researchers aim to:

  1. Measure the impact of influenza vaccination on inflammation markers after one month
  2. Assess the vaccine’s effect on markers of arterial vulnerability
  3. Characterize the immune response in circulating blood cells after vaccination
  4. Evaluate the relationship between vaccine-induced antibody responses and inflammation levels

Eligibility Criteria

To participate in this study, patients must meet certain criteria:[1]

Inclusion criteria:

  • Age 60 years or older
  • Documented stable coronary artery disease
  • Ability to comply with study requirements
  • Willingness to provide informed consent

Exclusion criteria:

  • History of serious reactions to influenza vaccines
  • Recent influenza vaccination (within 6 months)
  • Recent acute infections or worsening of chronic diseases
  • Severe cognitive disorders
  • Certain pre-existing medical conditions or medications affecting the immune system
  • Recent or planned cardiovascular surgeries

Study Design

The study is designed as a randomized, delayed-start pilot trial. This means:[1]

  • Participants will be randomly divided into two groups
  • The experimental group will receive the influenza vaccine immediately after enrollment
  • The control group will receive the vaccine after a one-month delay
  • Blood samples will be taken at the start of the study and after one month
  • The vaccine will be administered as a deep subcutaneous injection in the deltoid muscle (upper arm)

Expected Outcomes

The primary outcome the researchers will measure is the level of high-sensitivity C-reactive protein (hsCRP) in the blood. HsCRP is a marker of inflammation in the body. Other outcomes include:[1]

  • Levels of other inflammatory markers such as interleukin-6, interleukin-1b, and tumor necrosis factor-α
  • Markers of arterial vulnerability, including apolipoprotein B and lipoprotein(a)
  • Characteristics of immune cells in the blood
  • Antibody levels against the vaccine strains

Potential Benefits

While the specific benefits of this study are yet to be determined, the research aims to understand how influenza vaccination might affect inflammation in patients with coronary artery disease. If significant benefits are found, this study could lead to larger trials examining the potential cardiovascular benefits of influenza vaccination in this patient population.[1]

Conclusion

This clinical trial represents an important step in understanding how influenza vaccination might affect patients with stable coronary artery disease. By studying the vaccine’s impact on inflammation and immune responses, researchers hope to gain insights that could potentially improve care for these patients in the future.[1]

Aspect Details
Study Type Randomized delayed-start pilot trial
Main Objective Evaluate impact of influenza vaccination on systemic inflammatory response (hsCRP) in stable coronary artery disease patients
Participants Patients ≥60 years with stable coronary artery disease
Intervention Quadrivalent inactivated influenza vaccine for 2024-2025 season
Primary Outcome Change in hsCRP levels at 1 month post-vaccination
Secondary Outcomes Other inflammatory markers, arterial vulnerability markers, immune cell characterization, antibody titers
Study Duration 1 month follow-up per participant
Potential Impact May lead to larger studies on cardiovascular benefits of flu vaccination in coronary artery disease patients

FAQ

  • What is the main objective of this clinical trial? The main objective is to evaluate the impact of influenza vaccination on systemic inflammatory response, specifically measuring high-sensitivity C-reactive protein (hsCRP) levels, in patients with stable coronary artery disease one month after vaccination.
  • Who can participate in this study? Participants must be 60 years or older, have documented stable coronary artery disease, be able to comply with protocol requirements, and provide informed consent. They should not have had a recent influenza vaccine, acute infections, or certain medical conditions affecting the immune system.
  • What vaccine is being used in this trial? The trial uses a quadrivalent inactivated influenza vaccine recommended for the 2024-2025 season. It contains strains of influenza viruses, including A/California/122/2022 San-022 (H3N2) strain.
  • How is the study designed? This is a randomized delayed-start pilot trial. Participants are divided into two groups: one receiving the vaccine immediately after inclusion, and the other receiving it after a one-month delay. Blood samples are taken at inclusion and after one month to compare inflammatory markers between the groups.
  • What are the potential benefits of this research? This study aims to understand how influenza vaccination might affect inflammation in patients with coronary artery disease. If significant benefits are found, it could lead to larger studies examining potential clinical benefits for cardiovascular disease and mortality in this patient group.

Ongoing Clinical Trials on Influenza Virus A/California/122/2022 San-022 (H3N2) Strain (Split, Inactivated)

  • Study on Antibody Responses in Healthy Individuals After Intranasal and Intramuscular Influenza Vaccination with Fluenz Tetra and Vaxigrip Tetra

    Recruiting

    3 1 1 1
    Investigated drugs:
    The Netherlands

  • 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

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Coronary Artery Disease: A condition where the blood vessels supplying the heart become narrowed or blocked, often due to the buildup of plaque. This can lead to reduced blood flow to the heart muscle.
  • High-sensitivity C-reactive protein (hsCRP): A blood test that measures low levels of C-reactive protein, which is a marker of inflammation in the body. It's often used to assess the risk of heart disease.
  • Quadrivalent Influenza Vaccine: A type of flu vaccine that protects against four different influenza viruses: two influenza A viruses and two influenza B viruses.
  • Systemic Inflammatory Markers: Substances in the blood that indicate the presence of inflammation throughout the body. These can include proteins like C-reactive protein, interleukins, and tumor necrosis factor.
  • Randomized Delayed-Start Trial: A study design where some participants receive the treatment immediately, while others receive it after a delay. This allows researchers to compare the effects of immediate versus delayed treatment.
  • Immunomodulator: A substance that affects the functioning of the immune system. In this context, the flu vaccine is being studied for its potential immunomodulatory effects on inflammation.
  • Hemagglutination Inhibition Titer: A laboratory test used to measure the level of antibodies produced in response to a specific strain of influenza virus in a vaccine.

References

  1. http://clinicaltrials.eu/trial/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/