Correlating Protection Against Malaria With Serum Profiles Against Plasmodium Falciparum Antigen Repertoires
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Immune correlates of protection against clinical malaria episodes with plasmodium falciparum
研究概览
简要总结
A longitudinal study on immune responses in relation to protection against clinical malaria episodes will be conducted in Apac District, Uganda. Three cohorts will be recruited: children 1 to 5 years of age (n=250), children 6 to 10 years of age (n=125) and adults 25 and above (n=125). After finger prick sampling (~300µL) and examination at enrolment, participants will be followed up for one year. Follow-up will include fortnightly active case detection and three-monthly cross-sectional surveys. Clinical malaria attacks and the associated clinical and parasitological parameters will be related to immunological profiles determined utilizing a protein microarray as a capture substratum to profile the humoral immune response against a vast number of parasite antigens.
For individuals who experience a clinical malaria attack or who are diagnosed with high density parasitaemia (≥15,000 parasites/µL) during cross-sectional surveys, a 5mL blood sample is obtained to determine the diversity of parasite antigens in the population in relation to antigen recognition in the cohort.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 1-5 years, 6-10 years or 25 yearsand above
- •written informed consent must be given
- •the individual must have been resident of the area since birth or for a minimum period of two years
- •the individual must be willing to submit required information and to participate in repeated sampling (total blood volume ~2.5 mL over a period of 12 months)
- •Absence of danger signs (as defined by WHO) or clinical features of AIDS. An HIV-test will be offered to all participants at enrolment and completion of the study.
排除标准
- •unwillingness to sign consent form
- •unwillingness to reside in the study area during the follow-up period
结局指标
主要结局
Immune correlates of protection against clinical malaria episodes with plasmodium falciparum
IMMUNE RESPONSES: protein array. CLINICAL MALARIA EPISODES: (reported) fever with i) P. falciparum parasites; ii) ... at a density \>=5,000 parasites/ul; iii) ... at a density \>=10,000 parasites/ul IMMUNOLOGICALLY PROTECTED INDIVIDUALS: parasitaemic during follow-up without reporting to the health facility with indicators of a clinical malaria episode
次要结局
- Asymptomatic parasite carriage and immune responses in different age-groups exposed to intense malaria transmission
- Geographical patterns in malaria morbidity