Specific and Non-specific Effects of Measles and BCG Vaccines for Mother and Child
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 2,400
- 试验地点
- 2
- 主要终点
- Proportion of children with maternal measles antibody
研究概览
简要总结
In Africa, the mortality from infectious diseases remains high. The investigators have discovered that live vaccines such as the BCG vaccine against tuberculosis and the measles vaccine can strengthen resistance to other infections: they have beneficial "non-specific effects". The investigators have now seen signs that these non-specific effects for children are stronger if their mother has been given the same vaccines.
In Africa, BCG vaccine is recommended at birth and measles vaccine at 9 months of age. They are not used beyond childhood.
The investigators will randomize 2400 women to BCG vaccine, measles vaccine, or placebo. The investigators will further randomize their children to an extra early measles vaccine or placebo. The investigators will assess which of the resulting six vaccination schedules are best for women's and children's protection against measles, for the child's immune system, and for general health.
The project will be the first in the world to investigate the importance of vaccinating women with live vaccines.
详细描述
OBJECTIVES The investigators aim to study the effects of providing measles vaccine (MV) or Bacille Calmette-Guérin vaccine (BCG) to women of fertile age, prior to pregnancy, and to study the added effect of providing MV earlier to their children, for measles-specific and non-specific immunity in the child and for overall health in mother and child.
Specific objectives
To study the interaction of maternal MV and BCG and early infant MV with respect to:
- the magnitude of the measles-specific antibody response in women and children
- the proportion of children with maternal measles antibodies at the time of measles immunization
- the viral load following YF vaccination in children
- overall health in women and children
HYPOTHESES
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
BCG is given intradermally and typically results in a local skin reaction that heals leaving a small scar. Measles vaccine is given subcutaneously and typically does not leave any sign of vaccination. Though we do not believe women will be able to distinguish between intradermal and subcutaneous injections, complete blinding on the recipient side will not be possible; those who get a skin reaction after BCG will most likely be able to guess what they received, whereas MV and placebo recipients will not. We do not believe this will influence the results of the blood testing or their treatment of their offspring.
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female women in the fertile age
- •Non-pregnant
- •HIV-negative
- •Living in the BHP HDSS study area
- •Delivered a child that has reached 12 months of age
- •Currently not using contraceptives.
排除标准
- •Positive pregnancy test
- •Positive HIV test
- •Tuberculosis (previous or current)
- •Immunodeficiency
- •Cancer within the last 2 years
- •Mid-upper-arm-circumference<200
- •Acute ongoing infection
结局指标
主要结局
Proportion of children with maternal measles antibody
时间窗: 9 months of age
Children with maternal measles antibody
Yellow fever viral load after yellow fever vaccine
时间窗: 9 months of age
The level of yellow fever virus in the blood following yellow fever vaccine
次要结局
- Measles antibody levels in the women(4 weeks after MV or BCG vaccine)
- Incidence of morbidity in women after MV or BCG compared with placebo(Up to 12 months following vaccination)
- Measles antibody levels in children(13.5 months of age)
- Incidence of morbidity in children subsequently born to BCG, MV or placebo vaccinated mothers(Up to age 13.5 months)