B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, 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) for Stable coronary artery disease

Inclusion criteria

• {"criterion_text":"- Subjects aged ≥ 60 years.\n- With documented stable coronary artery disease.\n- Subjects who, in the opinion of the investigator, can comply with protocol requirements (i.e., show up for the follow-up visit and be able to converse with study staff).\n- Signature of free, written and informed consent by the patient.\n- Subjects aged ≥ 60 years. - With documented stable coronary artery disease. - Subjects who, in the opinion of the investigator, can comply with 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."}

Exclusion criteria

• {"criterion_text":"- History of serious reaction to influenza vaccine or refusal of vaccination or contraindication to vaccination.\n- Participant has received the influenza vaccine within <6 months or another vaccine.\n- Acute infection within <3 months or acute worsening of chronic diseases.\n- Severe neurocognitive disorders (inability to give informed consent).\n- 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) .\n- Cardiovascular surgery or other interventions within 6 months preceding the study or planned during the follow-up period.\n- Patient's wish or clinical situation requiring co-administration with other vaccines or any factor hindering monitoring.\n- Patient under guardianship, curatorship or safeguard of justice."}

Primary endpoints

• {"endpoint_text":"- The primary outcome will be plasma high-sensitivity C-reactive protein (hsCRP) concentration. HsCRP will be measured at inclusion (basal value before vaccination) and at the end of the study (1 month). The variation in the HsCRP value will be compared between the group of subjects vaccinated just after inclusion (intervention group, “immediate” vaccination) and the group of subjects vaccinated at 1 month (control group, “follow-up” vaccination).","definition_or_measurement_approach":"HsCRP will be measured at inclusion (basal value before vaccination) and at the end of the study (1 month). The variation in the HsCRP value will be compared between the group of subjects vaccinated just after inclusion (intervention group, “immediate” vaccination) and the group of subjects vaccinated at 1 month (control group, “follow-up” vaccination)."}

Secondary endpoints

• {"endpoint_text":"- 1) Plasma concentration of inflammatory markers of CVD risk: interleukin (IL)-6, IL-1b, and tumor necrosis factor-α), NT-pro-BNP, fibrinogen.","definition_or_measurement_approach":""}
• {"endpoint_text":"- 2) Plasma concentration of arterial vulnerability markers: Apolipoprotein B, lipoprotein(a), LDL.","definition_or_measurement_approach":""}
• {"endpoint_text":"- 3) Characterization of circulating immune cells: - Expression level of genes involved in the T cell response (CD3, CD4, CD8) and in its Th1 (Tbet), Th2 (GATA3), Th17 (RORγ), Treg (FOXP3) orientation analyzed by an RT- technique qPCR. - Percentage of B lymphocytes (CD45+CD19+), T lymphocytes (CD45+CD3+), and monocytes (CD45+CD14+CD11c+) among PBMCs determined by flow cytometry.","definition_or_measurement_approach":"Gene expression analyzed by RT-qPCR; immune cell subsets determined by flow cytometry as described (percentages among PBMCs)."}
• {"endpoint_text":"- 4) Antibody titer at 1 month measured by the hemagglutination inhibition titer for each strain of the vaccine.","definition_or_measurement_approach":"Hemagglutination inhibition assay to measure strain-specific antibody titers at 1 month."}

Methods

• Screening of patients by clinical study technicians in two recruitment locations at CHRU de Tours by reviewing medical records of patients with regular follow-up in cardiology and geriatrics; patients with scheduled outpatient follow-up visits during the inclusion period are preselected and contacted.
• Eligible patients contacted by telephone or email to inform them about the study, answer questions and to respect a minimum reflection period of at least one day; inclusion visit planned preferably after the routine follow-up consultation or during a dedicated research consultation at CHRU de Tours.

France

Earliest CTIS Part Ii Submission Date

20-08-2024

Latest Decision Or Authorization Date

16-09-2024

Processing Time Days

27

Number Of Sites

2

Number Of Participants

50

Primary sponsor

Full Name

Centre Hospitalier Regional Universitaire De Tours

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France