Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Kidney Transplant Recipients -ChronoVAX
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Comparison of antibody titer (seroconversion) 4 weeks after inactivated influenza vaccine injection in each arm.
研究概览
简要总结
Immune response to influenza vaccine in kidney transplant patients
详细描述
Seasonal influenza vaccination is recommended for kidney transplant patients, as influenza is responsible for significant morbidity and mortality in this immunocompromised population. Nevertheless, injection of influenza vaccine induces a protective immune response in only 20% to 40% of patients. Today, there are no recommendations regarding the injection time of influenza vaccine in the general population or in immunocompromised patients. In this context, recent studies conducted in healthy subjects have shown that the time of vaccination can have an impact on vaccine efficacy. This is the case for BCG, influenza, COVID-19. On this basis, we formulate the main hypothesis that the administration of influenza vaccine to kidney transplant patients would be more effective when carried out 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
- •Renal transplant patient;
- •Follow-up at Nice University Hospital;
- •Age > 18 years;
- •Indication for influenza vaccination
- •Free and informed consent;
- •Immunosuppressive treatment including anti-calcineurin and/or Mycophenolate Mofetil (with or without corticoids).
排除标准
- •Known hypersensitivity to influenza vaccine or egg proteins;
- •Influenza vaccination for the 2023-2024 season already performed;
- •Current infection;
- •Current acute medical condition;
- •Treatment of rejection within the previous 3 months;
- •Immunosuppressive therapy including CTLA4 agonist, mTOR inhibitor, complement inhibitor, anti-CD19;
- •Polyvalent immunoglobulin infusion within the preceding 3 months;
- •Vulnerable persons (minors, adults under guardianship or trusteeship, pregnant women, persons deprived of their liberty, persons unable to speak French);
- •Subjects not affiliated to the Social Security system.
结局指标
主要结局
Comparison of antibody titer (seroconversion) 4 weeks after inactivated influenza vaccine injection 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.(8 months)
- Comparison the evolution of antibody titres reacting in each arm.(7 months)
- Evolution of the number of CD4+ T cells in each arm.(7 months)
- Evolution of the number of memory B cells in each arm.(7 months)
- Evolution of the number of CD8+ T cells in each arm.(7 months)