Effect of Influenza Vaccination on Global Systemic Inflammatory Markers in Patients With Stable Coronary Artery Disease - Randomized Delayed-Start Pilot Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Plasma concentration of high-sensitivity C-reactive protein (hsCRP)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
"Immediate" Vaccination Group
At the inclusion visit (D0), a dose of influenza vaccine will be administered.
干预措施: Influenza Vaccination (Biological)
结局指标
主要结局
Plasma concentration of high-sensitivity C-reactive protein (hsCRP)
时间窗: Between baseline and 1-month follow up
Change from baseline in peripheral blood hsCRP concentrations (mg/L) between study group
次要结局
- Other Plasma inflammatory markers : N-terminal pro-B-type natriuretic peptide(Between baseline and 1-month follow up)
- 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)
- Plasma arterial vulnerability markers(Between baseline and 1-month follow up)
- Other Plasma inflammatory markers : fibrinogen(Between baseline and 1-month follow up)
- Immunoinflammatory markers in circulating immune cells : T cell response(Between baseline and 1-month follow up)
- Circulating immune cells profile : percentage of peripheral immune cells(Between baseline and 1-month follow up)
- Immunoinflammatory markers in circulating immune cells : T cell population(Between baseline and 1-month follow up)