Randomized Trial Evaluating the Non-specific Effects of BCG-Bulgaria and BCG-Denmark in Guinea-Bissau: Effects on Mortality, Morbidity, and BCG Skin Reactions
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- All-cause mortality risk
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 vaccination with Bacillus Calmette-Guérin (BCG) Danish strain (AJ Vaccines, Copenhagen 1331 strain) versus BCG-Bulgaria (BB-NCIPD, BCG-SL 222 Sofia strain) 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 kinetics and characteristics.
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 the maternal BCG scar status influences offspring health outcomes.
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-Denmark versus BCG-Bulgaria 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 kinetics and characteristics.
HYPOTHESES
The investigators aim to investigate the following hypotheses:
- Compared with BCG-Bulgaria, receiving BCG-Denmark 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 child's mother/guardian selects, from a stack of envelopes, a closed envelope that contains a sealed randomization lot indicating allocation to either BCG-Denmark or BCG-Bulgaria. The mother, inclusion assistant and vaccinator will thus not be blinded to the intervention allocation. All assistants assessing outcomes during follow-up procedures and providers of care will be blinded to the randomization allocation.
入排标准
- 年龄范围
- 0 Days 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants under one year of age who are vaccinated at the HNSM maternity ward.
排除标准
- •Infants who have already received either BCG or oral polio vaccine (OPV)
- •Infants who 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 can be recruited when they are discharged from the pediatric ward or the neonatal intensive care unit.
研究组 & 干预措施
BCG-Denmark
Infants randomized to receive BCG-Denmark at discharge from the Maternity Ward will receive one 0.05 ml infant dose of Mycobacterium bovis BCG live-attenuated BCG-AJ vaccine by intradermal injection in the left deltoid region. Dependent on national supply, oral polio vaccine will be co-administered.
干预措施: BCG-Denmark (Biological)
BCG-Bulgaria
Infants randomized to receive BCG-Bulgaria at discharge from the Maternity Ward will receive one 0.05 ml infant dose of Mycobacterium bovis BCG live-attenuated BCG-Bulgaria vaccine by intradermal injection in the left deltoid region. Dependent on national supply, oral polio vaccine will be co-administered.
干预措施: BCG-Bulgaria (Biological)
结局指标
主要结局
All-cause mortality risk
时间窗: Six weeks of age
Deaths from all-causes
次要结局
- In-hospital case-fatality rate(Six months of age)
- All-cause mortality risk(Six months of age)
- Hospital admission from all causes(Six months of age)
- BCG skin reaction prevalence and type(Assessed at six months of age)
- BCG skin reaction prevalence, type and size(Assessed at one home visit per child conducted during the first eight weeks of life)
- All-cause mortality risk(One week of age)
- In-hospital case-fatality rate(Six weeks of age)
- Hospital admission from all causes(Six weeks of age)
- BCG skin reaction prevalence and type(Assessed at one week of age)
- BCG skin reaction prevalence and type(Assessed at six weeks of age)