Ex Vivo Evaluation of Immunity Activation Face to Staphylococcus Aureus Antigens and Adjuvants of a Vaccine Candidate in Cells From Haemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- EX VIVO measure of innate immunity: induction of oxidative burst to S. aureus vaccine antigens
研究概览
简要总结
S. aureus is a leading cause of severe infections notably in haemodialysis patients. These patients have a high risk of S. aureus nasal carriage, with a rate of persistent carriage near 30%. These carriers are particularly at risk of S. aureus infections as we previously shown. High risk of S. aureus infections such as bacteremia occurred notably in patients with dialysis catheters. Decolonization of carriers may prevent such infections however this approach has limits. Development of an effective S. aureus vaccine is crucial. To date, past vaccines tested (phase III) failed to achieve their end points. Target of only one or few antigens, absence of cellular response induction and possibly no impact on carriage are probably the reasons of the failures.
详细描述
In an attempt to minimize failure in a clinical phase, ex vivo analysis of immune response of leucocytes of haemodialysis patients face to S. aureus and the impact of antigens and adjuvants of a candidate vaccine may help.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient starting haemodialysis for chronic hemodialysis.
- •Patient starting haemodialysis on catheter
- •Patient who signed the informed consent form
排除标准
- •Pregnant woman
- •Patient who starts Haemodialysis for over 3 months
- •Patient with anemia (hemoglobin <7 g / dL)
结局指标
主要结局
EX VIVO measure of innate immunity: induction of oxidative burst to S. aureus vaccine antigens
时间窗: Up to 12 months
Measured by blood samples 0, 6 and 12 months
EX VIVO measure of innate immunity : phenotype activation of different cell types from PBMCs (peripheral blood mononuclear cells) to S. aureus vaccine antigens
时间窗: Up to 12 months
Measured by blood samples 0, 6 and 12 months.
EX VIVO measure of acquired immunity: measures of S. aureus antibodies titre in serum to S. aureus vaccine antigens
时间窗: Up to 12 months
Measured by blood samples 0, 6 and 12 months.
EX VIVO measures of innate immunity: chemokines and cytokines secretions to S. aureus vaccine antigens
时间窗: Up to 12 months
Measured by blood samples 0, 6 and 12 months.
EX VIVO measure of innate immunity: functional capacity of neutrophils to S. aureus vaccine antigens
时间窗: Up to 12 months
Measured by blood samples at 0, 6 and 12 months
次要结局
- Incidence of persistant portage of S. aureus in the nose haemodialysis patients.(Months 0 and 6 and 12)
- Number of infection by S. aureus in new haemodialysis patients.(Month 12)
- EX VIVO measure of acquired immunity: measures of S. aureus antibodies titre in serum to S. aureus vaccine adjuvants(Months 0 and 6 and 12)
- EX VIVO measure of innate immunity : phenotype activation of different cell types from PBMCs (peripheral blood mononuclear cells) to S. aureus vaccine adjuvants(Months 0 and 6 and 12)
- EX VIVO measures of innate immunity: chemokines and cytokines secretions to S. aureus vaccine adjuvants(Months 0 and 6 and 12)
- Analysis of the S. aureus clonal complexes of nasal carriage strains from haemodialysis patients.(Months 0 and 6 and 12)
- EX VIVO measure of innate immunity: induction of oxidative burst to S. aureus vaccine adjuvants(Months 0 and 6 and 12)
- Investigation of the presence of antigens of interest selected for the vaccine approach in strains of S. aureus in the nasal carriage(Months 0 and 6 and 12)
- EX VIVO measure of innate immunity: functional capacity of neutrophils to S. aureus vaccine adjuvants(Months 0 and 6 and 12)
- Survival rate to S.aureus in the whole blood(Months 0 and 6 and 12)