A Randomised, Controlled Trial to Determine If BCG Immunisation At Birth Reduces Allergy and Infection in Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,272
- 试验地点
- 2
- 主要终点
- Lower respiratory tract infection (LRTI)
研究概览
简要总结
- To determine if BCG immunisation at birth, compared to no BCG immunisation, leads to a reduction in measures of allergy and infection in the first 12 months of life.
- To evaluate the immunological mechanisms underlying the non-specific effects of BCG by comparing markers of immunity between the BCG and non-BCG groups.
详细描述
There has been a dramatic rise in allergic diseases worldwide since the 1980s. Asthma rates increased first, followed by eczema, allergic rhinitis and, more recently, food allergy - especially in infants and young children. In Australia, the prevalence of allergic disease is particularly high: up to 30% of children are affected, and eczema and asthma are among the most common chronic diseases of childhood.
Preventing allergic disease by an immunomodulatory intervention early in life would be a major advance with significant implications for individual health and public health resources. Bacillus Calmette-Guérin (BCG) immunisation is a potential intervention with an established safety profile. This vaccine has powerful non-specific effects on the cellular immune response that potentially prime host immunity away from an allergic pathway. Observational data and one small randomised controlled trial (RCT) suggest that BCG immunisation at birth leads to a substantial reduction in allergic disease - however, there is an absence of level 1 evidence.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 10 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BCG
Mycobacterium bovis BCG (Bacille Calmette Guérin) vaccine, Danish Strain 1331
干预措施: BCG (Biological)
结局指标
主要结局
Lower respiratory tract infection (LRTI)
时间窗: 0-12 months
Measured by parent report
Current asthma
时间窗: 5 years of age
Using ISAAC definitions
Atopic sensitisation measured by skin prick test (SPT)
时间窗: 5 years of age
Proportion of participants with a positive SPT defined as wheal diameter ≥2 mm greater than negative control at 15 min to one or more of a panel of food and aeroallergens
Lower respiratory tract infection (LRTI) hospital admissions
时间窗: 0-5 years of age
Proportion of participants with ≥1 hospital admission for LRTI reported by parent
Eczema ever
时间窗: 0-5 years of age
Proportion of participants with eczema measured by Williams' UK diagnostic criteria using parental report of symptoms
Asthma ever
时间窗: 5 years of age
Using ISAAC definitions
次要结局
- Parent report of food allergy(0-5 years of age)
- Egg sensitisation(5 years of age)
- Diarrhoea(Prior to first DTP vaccination)
- Eczema ever(0-5 years of age)
- Atopic sensitisation to multiple allergens measured by SPT(5 years of age)
- Egg allergy(5 years of age)
- Clinical food allergy(5 years of age)
- Atopic sensitisation measured by SPT using a more stringent cut-off(5 years of age)
- Rate of lower respiratory tract infection (LRTI)(0-5 years of age)
- Asthma severity(2-5 years of age)
- Rate of upper respiratory tract infection (URTI)(Prior to first DTP vaccination)
- Rash with fever(Prior to first DTP vaccination)
- Eczema(0-5 years of age)
- Eczema onset(0-5 years of age)
- Eczema severity(0-5 years of age)
- Atopic wheeze(5 years of age)
- Infections(0-5 years of age)
- Rate of fever(Prior to first DTP vaccination)
- Laboratory measures of the immune response(Time Frame: 0-5 years of age)
- Lower respiratory tract infection (LRTI)(0-5 years of age)
- Hospitalisation for respiratory tract infection (RTI)(0-5 years of age)
- Rate of any infection(Prior to first DTP vaccination)