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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514543-28-00
Acronym
IVAMI
Enrollment
50
Registered
2024-09-16
Start date
2024-10-21
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with stable coronary artery disease

Brief summary

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).

Detailed description

1) Plasma concentration of inflammatory markers of CVD risk: interleukin (IL)-6, IL-1b, and tumor necrosis factor-α), NT-pro-BNP, fibrinogen., 2) Plasma concentration of arterial vulnerability markers: Apolipoprotein B, lipoprotein(a), LDL., 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., 4) Antibody titer at 1 month measured by the hemagglutination inhibition titer for each strain of the vaccine.

Interventions

Sponsors

Centre Hospitalier Regional Universitaire De Tours
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
1) Plasma concentration of inflammatory markers of CVD risk: interleukin (IL)-6, IL-1b, and tumor necrosis factor-α), NT-pro-BNP, fibrinogen., 2) Plasma concentration of arterial vulnerability markers: Apolipoprotein B, lipoprotein(a), LDL., 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., 4) Antibody titer at 1 month measured by the hemagglutination inhibition titer for each strain of the vaccine.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026