Investigating the Mortality and the Morbidity Impact of Oral Polio Vaccine at Birth
试验速览
- 阶段
- 不适用
- 试验地点
- 1
- 主要终点
- Mortality by sex
研究概览
简要总结
Our group has discovered that routine vaccinations in childhood may have non-specific and sex-differential effects on overall mortality. The effects are so large that they may have marked effects on overall mortality and seriously distort female-to-male mortality rates in high-mortality settings. We recently experienced periods during which oral polio vaccine (OPV) was lacking. Hence, some children did not get the recommended OPV at birth. We were following all infants as a part of a vitamin A supplementation trial. Surprisingly, we discovered that not receiving OPV was associated with significantly lower mortality in boys, but not in girls. We bled a subgroup of the children. Receiving OPV at birth significantly dampened the immunological response to BCG given at birth in both sexes. Based on these observations, receiving OPV at birth may have two negative effects, first, it may increase male mortality, and second, it may interfere with immunity against tuberculosis. OPV at birth is given for logistic reasons, to boost polio immunity. There have been no polio cases in Guinea-Bissau for the last 10 years. Hence, there is every reason to test in a randomised trial whether not receiving OPV at birth is associated with 1) mortality, morbidity and growth and 2) immunological response to BCG.
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
- — 至 1 Month(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Normal birth weight, no overt illness or gross malformations -
排除标准
- 未提供
研究组 & 干预措施
A
Oral polio vaccine
干预措施: Oral polio vaccine (Biological)
B
No oral polio vaccine
结局指标
主要结局
Mortality by sex
次要结局
- Morbidity, growth, immunology
