Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE

NCT06336317 | Recruiting Phase 4

• 1 other identifier: ELIMINATE-2024
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 2

Brief Summary

The goal of this randomized, double-blind, placebo-controlled clinical trial is to investigate the immunological effects of influenza vaccination outside of the influenza season on arterial inflammation in patients with a recent acute myocardial infarction (AMI). The primary objective is to compare the effects of influenza vaccination to those of a placebo in reducing post-myocardial infarction coronary inflammation as measured by coronary computed tomography angiography (CCTA). The main questions it aims to answer are: Does influenza vaccination reduce arterial inflammation as measured by CCTA at week 8 after percutaneous coronary intervention (PCI) in comparison to baseline? Does influenza vaccination modulate systemic inflammation as measured by blood biomarkers and in-vitro challenge tests at week 8 after PCI in comparison to baseline? Researchers will compare the effects of influenza vaccination with those of a placebo.

Conditions

Acute Myocardial Infarction; Cardiovascular Diseases; Inflammatory Response

Keywords

Coronary computed tomography angiography; Percutaneous coronary intervention; Influenza vaccine; Non ST-segment elevation myocardial infarction

Outcome Measures

Primary Outcomes (1)

• The right coronary artery

  Primary endpoint definition is a difference in pericoronary adipose tissue density (perivascular fat attenuation index) around the right coronary artery (RCA) measured by repeated CCTA imaging

  Between baseline and 8 weeks follow up.

Secondary Outcomes (9)

• The whole coronary tree

  Between baseline and 8 weeks follow up.

• Ascending aorta

  Between baseline and 8 weeks follow up.

• Interleukin 1 beta (IL-1β)

  Between baseline and 8 weeks follow up.

• Tumor necrosis factor alpha (TNF-α)

  Between baseline and 8 weeks follow up.

• Interleukin-2 receptor (IL-2r)

  Between baseline and 8 weeks follow up.

Other Outcomes (2)

• Explorative endpoints

  8 weeks follow up

• Explorative endpoints

  Baseline

Study Arms (2)

Vaccination arm

ACTIVE COMPARATOR

Influenza vaccine (Vaxigrip Tetra Sanofi Pasteur Europe).

Biological: Influenza vaccine

Placebo arm

PLACEBO COMPARATOR

Sodium Chloride (Placebo) Solution for infusion, 9mg/ml ATC code: B05BB01

Biological: Placebo

Interventions

Influenza vaccine BIOLOGICAL

VaxigripTetra Suspension for injection, 0,5ml prefilled syringe ATC code: J07BB02

Vaccination arm

Placebo BIOLOGICAL

Sodium Chloride Solution for infusion, 9mg/ml ATC code: B05BB01

Placebo arm

Eligibility Criteria

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

You may qualify if:

• Patients with a diagnosis of non-ST-segment elevation myocardial infarction
• A finalized coronary PCI
• Male or non-fertile female subjects ≥18 years. (Females without childbearing potential, postmenopausal women and women with a history of hysterectomy or other medical conditions that preclude pregnancy)
• Written informed consent
• A CCTA can be scheduled within 7 days after PCI

You may not qualify if:

• Has received influenza vaccination within 6 months
• Other vaccination planned within 8 weeks (including covid-19 booster doses)
• Severe allergy to eggs or previous allergic reaction to influenza vaccine
• Cardiac surgery or staged PCI planned within 8 weeks
• Coronary stent involving the proximal RCA
• Suspicion of febrile illness or acute, ongoing infection
• Hypersensitivity to the active substances or ingredients of Vaxigrip or against any residues, such as eggs (ovalbumin or chicken proteins), neomycin, formaldehyde and octoxinol
• Subjects with endogenic or iatrogenic immunosuppression that may result in reduced immunization response
• Inability to provide informed consent
• Previous randomization in the ELIMINATE trial
• Any non-cardiovascular condition, e.g. malignancy, with a life expectancy of less than 1 year based on the investigator´s clinical judgement.
• Contraindication to coronary CT angiography (e.g., inability to lie flat, contraindication to glyceryl trinitrate, previous contrast allergy or contrast-induced nephropathy, severe renal impairment \[eGFR \<30 mL/min/1.73 m2\])
• Atrial fibrillation
• Uncontrolled chronic inflammatory disease
• Unable to comply with protocol requirements

Sponsors & Collaborators

• Region Örebro County: lead
• The Swedish Heart and Lung Association: collaborator
• Örebro University, Sweden: collaborator
• University of Cambridge: collaborator
• Aarhus University Hospital: collaborator

Study Sites (2)

Aarhus University Hospital, Department of Cardiology

Aarhus, DK-8200, Denmark

NOT YET RECRUITING

Örebro University Hospital

Örebro, 70185, Sweden

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Sara Cajander, MD

  Region Örebro län

  PRINCIPAL INVESTIGATOR

• Ole Frøbert, professor

  Region Örebro län

  STUDY CHAIR

Central Study Contacts

Sara Cajander, MD

CONTACT

+46196021042; sara.cajander@oru.se

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 28, 2024
• Study Start: April 24, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); SE (1)