Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Patients With Chronic Renal Failure - CHRONOVAX 2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 735
- 试验地点
- 1
- 主要终点
- Antibody titers (seroconversion) at 4 weeks after injection of inactivated influenza vaccine in each arm.
研究概览
简要总结
Immune response to influenza vaccine in patients with chronic renal insufficiency.
详细描述
Seasonal influenza vaccination is recommended for patients with chronic renal insufficiency, as influenza is responsible for significant morbidity and mortality in this immunocompromised population. However, the immune response to this vaccination is limited in this population.
There are currently no recommendations concerning the timing of influenza vaccine in the general population or in immunocompromised patients.
In this context, recent studies have shown that the time of vaccination can have an impact on vaccine efficacy. This is the case for BCG, influenza and COVID vaccinations.
On this basis, our main hypothesis is that the administration of influenza vaccine to patients with chronic kidney failure is more effective in the morning than in the evening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic renal failure patient at stage 4 or 5 (i.e. estimated GFR < 30mL/min/1.73m2); or Dialysis patient; or renal transplant patient regardless of GFR;
- •Age ≥ 18 years;
- •Indication for influenza vaccination;
- •Express free and informed consent.
排除标准
- •Known hypersensitivity to influenza vaccine or egg proteins;
- •Previous influenza vaccination for the current season;
- •Current infection;
- •Current acute illness;
- •Treatments with a major impact on vaccine response:
- •Treatment of rejection within the previous 3 months;
- •Renal transplantation with induction performed within the previous 6 months;
- •Immunosuppressive treatment including CTLA4 agonist, complement inhibitor, anti-CD20;
- •Treatments that may distort the serological response: Polyvalent immunoglobulin infusion within the preceding 3 months;
- •Vulnerable persons (minors, adults under guardianship or trusteeship, persons deprived of their liberty, persons unable to speak French);
- •Subjects not affiliated to Social Security.
研究组 & 干预措施
Morning injection
VAXIGRIPTETRA influenza vaccine injection between 07:00 am and 11:00 am.
干预措施: Vaccine injection (Other)
Evening injection
VAXIGRIPTETRA influenza vaccine injection between 05:00 pm and 09:00 pm.
干预措施: Vaccine injection (Other)
结局指标
主要结局
Antibody titers (seroconversion) at 4 weeks after injection of inactivated influenza vaccine in each arm.
时间窗: 7 months
Seroconversion will be defined as an increase in antibody titer of at least 4-fold (≥4) over pre-vaccination titer AND an antibody titer ≥ 1:40 (seroprotection) four weeks post-vaccination, for at least one of the three vaccine antigens.
次要结局
- Number of seasonal influenza virus infections in each arm at 4 weeks(7 months)
- Number of seasonal influenza virus infections in patients with chronic renal insufficiency at 6 months(12 months)
- Antibody titers reacting in each arm(7 months)
- Number of anti-vaccine antibodies inhibiting hemmagglutination(7 months)
- Number of neutralizing anti-vaccine antibodies(7 months)