NCT06508437

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Coronary Artery Disease
• Inflammatory Response
• Atherosclerosis

Interventions

Type	Name	Description
BIOLOGICAL	Influenza Vaccination	Standard Dose QIV (15µg Hemagglutinin) - VaxigripTetra Suspension for injection, 0,5ml prefilled syringe

Timeline

• Start date: 2024-10-21
• Primary completion: 2024-10-31
• Completion: 2024-11-25
• First posted: 2024-07-18
• Last updated: 2025-11-21

Locations

1 site across 1 country: France