Randomized Trial Evaluating the Non-specific Effects of Different BCG Strains in Guinea-Bissau: Effects on Early-life Mortality and Morbidity
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16,390
- 试验地点
- 1
- 主要终点
- Rate of all-cause mortality overall and stratified by maternal BCG scar status and sex
研究概览
简要总结
The trial will be a two-year outcome assessor-blinded RCT at the maternity ward of hospital Simão Mendes (HNSM) in urban Bissau, Guinea-Bissau to compare BCG-Japan versus BCG-Russia 1:1 in 15,000 infants with respect to mortality, morbidity and case-fatality rate during hospital admission. The trial will also examine the association between BCG strains and BCG skin reaction characteristics by six weeks (data collected by telephone) and at two and six months (data collected at home-visits to a subgroup of the cohort).
As a secondary aim, this large study will be used to further evaluate the role of maternal BCG immune priming for overall health, since there are indications that maternal BCG scarring enhances the non-specific effects of BCG.
详细描述
This two-year outcome assessor-blinded RCT will be conducted at the maternity ward of hospital Simão Mendes (HNSM) in urban Bissau, Guinea-Bissau to compare BCG-Japan versus BCG-Russia 1:1 in 15,000 infants with respect to mortality, morbidity and case-fatality rate during hospital admission.
The trial will also examine the association between BCG strains and BCG skin reaction characteristics by six weeks (data collected by telephone) and at two and six months (data collected at home-visits to a subgroup of the cohort).
HYPOTHESES
The aim is to investigate the following hypotheses:
- Compared with BCG-Russia, receiving BCG-Japan is associated with
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
Following informed consent, the mother selects, from a stack of envelopes, a closed envelope that contains a sealed randomization lot indicating allocation to either BCG-Japan or BCG-Russia. The mother, inclusion assistant and vaccinator will thus not be blinded to the intervention allocation. All assistants assessing outcomes during the follow-up procedures outlined and providers of care will be blinded to the randomization allocation.
入排标准
- 年龄范围
- 0 Days 至 42 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants present at the HNSM maternity ward on the day of discharge or procuring vaccination at the ward.
排除标准
- •Infants older than 6 weeks (>42 days) of age
- •Infants that have already received either BCG or oral polio vaccine (OPV)
- •Infants that are moribund due to gross malformation or acute illness (about to die or be transferred to the pediatric ward according to the local health physician assessment; the latter children may be recruited when they are discharged from the pediatric ward or the neonatal intensive care unit).
研究组 & 干预措施
BCG-Japan
Infants randomized to receive BCG-Japan at discharge from the Maternity Ward will receive one 0.05 ml dose of Mycobacterium bovis BCG live attenuated vaccine BCG-Japan (Tokyo BCG Laboratory) by intradermal injection in the left deltoid region. Dependent on national supply, infants will receive oral polio vaccine (OPV) at the time of BCG vaccination.
干预措施: BCG-Japan (Biological)
BCG-Russia
Infants randomized to receive BCG-Russia at discharge from the Maternity Ward will receive one 0.05 ml dose Mycobacterium bovis BCG live attenuated vaccine BCG-Russia-I (Serum Institute of India) by intradermal injection in the left deltoid region. Dependent on national supply, infants will receive oral polio vaccine (OPV) at the time of BCG-vaccination.
干预措施: BCG-Russia (Biological)
结局指标
主要结局
Rate of all-cause mortality overall and stratified by maternal BCG scar status and sex
时间窗: Six weeks of age
Data on mortality is collected from all available information sources (admission at HNSM, telephone follow-up, HDSS data)
次要结局
- Rate of hospital admissions overall and stratified by maternal BCG scar status and sex(Six weeks and six months of age)
- Prevalence of different BCG skin reaction types(Two and six months of age)
- Size of BCG skin reactions(Two and six months of age)
- Prevalence of BCG skin reactions(Six weeks and six months of age)
- Rate of adverse events(6 months)
- In-hospital case-fatality risk ratio overall and stratified by maternal BCG scar status and sex(Six weeks and six months of age)