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

NCT06508437 | Completed Phase 4 DMC

• 1 other identifier: DR240124
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Inflammatory Response; Atherosclerosis

Keywords

influenza vaccination; inflammation; atherosclerosis,; coronary disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

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

  Between baseline and 1-month follow up

• Other Plasma inflammatory markers : fibrinogen

  Between baseline and 1-month follow up

• Plasma arterial vulnerability markers

  Between baseline and 1-month follow up

• Immunoinflammatory markers in circulating immune cells : T cell response

  Between baseline and 1-month follow up

Study Arms (2)

"Immediate" Vaccination Group

ACTIVE COMPARATOR

At the inclusion visit (D0), a dose of influenza vaccine will be administered.

Biological: Influenza Vaccination

"Follow-up" vaccination group

NO INTERVENTION

At the inclusion visit (D0), no immediate influenza vaccination (which will be administered one month later at the follow-up visit).

Interventions

Influenza Vaccination BIOLOGICAL

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

"Immediate" Vaccination Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

Chru de Trousseau

Tours, 37000, France

Location

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis; Influenza, Human; Inflammation; Coronary Disease

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: October 21, 2024
• Primary Completion: October 31, 2024
• Study Completion: November 25, 2024
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

FR (1)