To Evaluate Bacteriophage OX174 Antigen as a Useful Immunogen in Patients With Immune Deficiency
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Evidence of capacity of switch from IgM to IgG.
研究概览
简要总结
This protocol is designed to ascertain whether the bacteriophage 0X174 neoantigen is safe and effective as an antigen used in the evaluation of primary and secondary immune responses. Bacteriophage 0X174 is given intravenously 2 billion PFU/Kg of body weight; small blood specimens of 3-5 ml (about 1 teaspoon) are collected after 15 minutes, 7 days, 14 days, and 28 days. Blood is collected at intervals following the administration of the bacteriophage and the number of phage/ml is determined by the agar overlay method using suspension of E. coli C and serially diluted patient's serum. Phage-specific IgG and IgM are measured by neutralization assay. Capacity of switch from IgM to IgG is determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subject/parent or guardian willing to sign consent and adhere to study schedule
- •known or suspected primary immune deficiency
排除标准
- •breastfeeding
- •unwilling to sign consent or adhere to study schedule
- •< 2 yrs of age or > 85 yrs of age
- •previous reaction to vaccine
结局指标
主要结局
Evidence of capacity of switch from IgM to IgG.
时间窗: 12 weeks
Blood samples are obtained after each immunizition of Bacteriophage.
次要结局
未报告次要终点