The Effect of Bacille Calmette Guerin (BCG) Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants
The Effect of BCG Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants
Background:
Each year, more than half a million babies are infected with HIV by mother-to child transmission in developing countries. Many of these babies get sick and develop HIV disease (AIDS) at a very young age. Exposure to other infectious diseases may influence this early progression to AIDS. BCG is a live tuberculosis vaccine made from cow tuberculosis. It is routinely given at birth to most babies, also to babies born to HIV-positive mothers. BCG can cause disease (BCGosis) in HIV-infected babies. More importantly, BCG may also trigger immune responses in the body that lead to the spread of the HIV virus and early progression to AIDS.
Objective(s) and Hypothesis:
The researchers will investigate whether BCG causes progression of HIV by doing a clinical trial: babies born to HIV-positive mothers will be randomly allocated to get the BCG vaccine at birth or at 14 weeks of age. In these 2 groups of babies, the researchers will compare:
- The percentage of babies who progress to HIV disease
- Blood markers of HIV disease (the amount of virus and protective white blood cells in the body)
- The body's immune response to BCG vaccine and other childhood vaccines
- The percentage of children who develop BCG scarring, BCG vaccine complications and tuberculosis.
Potential Impact:
BCG is the most widely given vaccine worldwide and is routinely given to babies born to HIV-positive mothers in developing countries. Any effect that BCG has on HIV progression in babies will have a significant public health impact in settings with a high burden of HIV disease.
研究概览
研究类型
注册 (预期的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
-
-
Western Cape Province
-
Cape Town、Western Cape Province、南非、7505
- Desmond Tutu TB Centre
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Maternal HIV status verified
- Study consent
- Uncomplicated singleton pregnancy with delivery planned at local health facility
- Resident in study area
Exclusion Criteria:
- Active tuberculosis or tuberculosis contact in mother
- No consent
- Planning to move out of study area
- Not planning on delivering at local maternal obstetric unit
- Not planning on attending local baby clinic
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
BCG-induced cellular immune responses
大体时间:1 year
|
1 year
|
次要结果测量
结果测量 |
大体时间 |
---|---|
BCG scarring
大体时间:18 months
|
18 months
|
Serum antibody responses
大体时间:52 weeks
|
52 weeks
|
Tuberculosis incidence
大体时间:1 year
|
1 year
|
合作者和调查者
调查人员
- 首席研究员:Anneke C Hesseling, MD、Desmond Tutu TB Centre, Dept. Pediatrics and Child Health, Stellenbosch University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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