MTBVAC in Newborns: Epidemiological Study In Tuberculosis-Endemic Regions of Sub-Saharan Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Tuberculosis prevalence in children living in urban area in Senegal.
研究概览
简要总结
A cross-sectional childhood M. tuberculosis infection survey of age-specific rates (defined by positivity to the test QuantiFERON-TB Gold Plus) will be conducted in Senegal to collect information on the local TB endemic to inform site selection, sample size, and recruitment strategies for a future efficacy trial of vaccine candidate MTBVAC in young children.
详细描述
MTBVAC is a new TB vaccine candidate based on an attenuated clinical isolate of M. tuberculosis. The clinical development consortium of this EDCTP program is preparing for future years an MTBVAC efficacy trial by setting up a network of three African sites in South Africa, Senegal and Madagascar. Each site has established an operational clinical research infrastructure. As a first step, Senegal site needs to collect crucial epidemiological data on TB in children, to allow a rapid transition to a phase 3 trial in infants.
The primary objective is to estimate the prevalence of TB infection by the QuantiFERON-TB Gold Plus technique in 500 children splined in 1-year, 2-year, 5-year, and 12-year-old age groups living in the study area (Saint Louis, Senegal).
Secondary objectives are:
- To study the socio-demographic characteristics, the vaccination history of each subject and the possible tuberculous contacts he has.
- To map selected populations (from GPS residence data) according to the status (infected or uninfected) of each subject.
- To ensure the orientation of children found positive by the QuantiFERON-TB Gold Plus test for care and follow-up related to the TB diagnosis and treatment at one of the Health Centers (THC) located in the study areas.
- To estimate the number of tuberculosis cases detected in children aged up to 12 years and resident in the study area from THC registries and data from the National Tuberculosis Control Plan (PNB).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 11 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children resident in the study area (St Louis City)
- •Obtaining written consent from one of the parents / guardians.
- •Children meeting one the following age criterion:
- •1-year old child (12 months -1/+4 months);
- •2-year-old child (24 months -1/+4 months);
- •5-year old child (60 months +/-6 months);
- •12-year old child (12 years old +/-6 months);
排除标准
- •Child resident outside the study area.
- •Participation refusal by one of the parents / guardians.
- •Objection of the child belonging to the 12-year old group.
- •Child with a known chronic pathology (severe asthma, epilepsy, type 1 diabetes, severe immunosuppression ...)
- •Child considered by the Principal Investigator as medically unfit to participate in the study.
结局指标
主要结局
Tuberculosis prevalence in children living in urban area in Senegal.
时间窗: 2 days
To estimate the prevalence of TB infection by QuantiFERON-TB Gold Plus test in children aged 1 year, 2 years, 5 years and 12 years in the city of Saint Louis, Senegal. Blood samples are incubated with TB antigens and then Interferon Gamma production is evaluated by Elisa.
次要结局
- health survey of the cohort(2 hours)
研究者
Gilles Riveau, PharmD, PhD
CEO
Biomedical Research Center EPLS