Baseline Cohort Study to Assess the Malaria Morbidity in Children Living in Future Malaria Vaccine Candidate Trial Sites
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 459
- 试验地点
- 1
- 主要终点
- Number of clinical malaria episodes per child-year at risk meeting the primary case definition
研究概览
简要总结
The BLOOMy study is a longitudinal prospective cohort study of healthy children to assess the incidence of clinical malaria over the main transmission season. Participants will undergo baseline clinical and biological assessments then will receive a curative dose of either artesunate or dihydroartemisinin-piperaquine to clear any existing parasitemia. Clearance of parasites will be confirmed 3 weeks later by Polymerase chain reaction (PCR) and only participants with negative PCR will be definitively enrolled for the longitudinal follow up. Both active and passive case detection will be used to ensure that capture of a high proportion of infections in the cohort is achieved.
Blood samples for immunological assessments will be obtained at Day 0 of each positive blood smear episode before treatment and at Weeks 4 post treatment.
Participants will be followed for a minimum of six months throughout the malaria peak transmission season.
详细描述
The BLOOMy study has two co-Primary objectives:
- To assess the incidence of clinical malaria meeting the primary case definition in children aged 1.5 to 12 years living in the study area over the main transmission season
- To assess the occurrence of reinfection following the radical cure of existing parasitemia.
The secondary objectives are:
- To assess the incidence of clinical malaria meeting various secondary cases definition in children aged 1.5 to 12 years living in the study area over the main transmission season
- To measure the immune responses (humoral and cell-mediated) to a panel of malaria vaccine candidate antigens
- To assess the molecular force of infection
- To pilot and standardize malaria morbidity assessment in three phase 2 malaria vaccine testing sites.
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
- 18 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy children aged 1.5 to 12 years
- •Residence in the study area or surroundings for the period of the study
- •Written informed consent from parents/legally acceptable representatives and an assent for children
排除标准
- •Complicated symptomatic malaria (defined according to standard World Health Organization criteria)
- •Anaemia (Hb<8g/dL),
- •Any (chronic) illness that requires immediate clinical care.
- •Family history of sudden death or of congenital or clinical conditions known to prolong QTcB or QTcF interval or e.g. family history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or severe cardiac disease
- •Any treatment which can induce a lengthening of QT interval
- •Known history of hypersensitivity or allergic reactions to piperaquine or other aminoquinolones
- •Receipt of any blood transfusion or immunoglobulins within 3 months
- •Known history of hypersensitivity or allergic reactions to artesunate
- •Severe malnutrition (weight-for-height being below -3 standard deviation or less than 70% of median of the World Health Organization (WHO) normalized reference values).
- •Weight below 5 kg
- •Current or previous participation in malaria vaccine trials
- •Current active participation in any trial involving administration of investigational drug.
结局指标
主要结局
Number of clinical malaria episodes per child-year at risk meeting the primary case definition
时间窗: 6 months
The primary case definition: Positive P. falciparum parasitemia at a density \> 0 detected by microscopy associated with measured fever (Axillary temperature ≥37.5°C/Tympanic ≥38°C or Forehead temperature ≥37.5°C using non-contact infrared thermometer))
Time to P. falciparum infection detected by positive thick blood smear within 6 months after the enrolment in African children under natural exposure to P. falciparum by treatment group
时间窗: 6 months
次要结局
- Number of clinical malaria episodes per child-year at risk meeting the following secondary cases definition(6 months)
- Number of new P. falciparum clones acquired over time(6 months)
- Immune responses to malaria candidate vaccines in the consortium portfolio(6 months)
研究者
Sodiomon B.Sirima
MD, BA, PhD
Groupe de Recherche Action en Sante