Role of BCG Vaccination as Booster on Salmonella Typhi Vaccine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- anti-salmonella typhi Vi antigen antibody titer 2 weeks post TFV
研究概览
简要总结
The BCG (bacillus Calmette-Guerin) vaccine is used for the protection against tuberculosis.
Apart from it's protective effect against tuberculosis BCG vaccine has been shown to have non-specific effects on the innate immune system and is in epidemiological studies associated with reduced mortality due to infectious diseases.
Several studies have shown that BCG can boost the effect of other vaccines. The present study aims to investigate the boosting effect of BCG on the response to typhoid fever vaccine (TFV) and to assess the non-specific effects of BCG on the innate immune system at early timepoints by vaccinating volunteers with either TFV alone or BCG followed by TFV 14 days later.
The study hypothesis is that when BCG is given 14 days before typhoid fever vaccine a better vaccination result in terms of antibody production will be accomplished against typhoid fever due to the effects of BCG on the innate immune system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Healthy volunteers
排除标准
- •Born in Salmonella typhi endemic country
- •Pregnancy
- •Oral medication except anticonceptive drugs
- •Previous vaccination with BCG and/or TFV
结局指标
主要结局
anti-salmonella typhi Vi antigen antibody titer 2 weeks post TFV
时间窗: 2 weeks
anti-salmonella typhi Vi antigen antibody titers at 2 weeks after TFV will be compared between TFV only and TFV after BCG groups.
anti-salmonella typhi Vi antigen antibody titer 3 months post TFV
时间窗: 3 months
anti-salmonella typhi Vi antigen antibody titers at 3 months after TFV will be compared between TFV only and TFV after BCG groups.
次要结局
- Change in ex vivo cytokine responses(0, 1 and 4 days; 2 weeks, 3 months)