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临床试验/NCT06524336
NCT06524336进行中(未招募)不适用

Host Immune Dynamics Following Seasonal Malaria Chemoprevention in African Children

Malaria Consortium1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
300
试验地点
1
主要终点
Innate and adaptive immune responses

研究概览

简要总结

The study aims to identify immune features linked to protection against malaria, examining variations by age and sex, and measuring changes in immune responses over time following seasonal malaria chemoprevention (SMC). The primary objectives are:

  1. Thorough examination of antibody immune responses in individuals before and after one or more SMC rounds.
  2. Thorough examination of both innate and adaptive cellular immune responses in people residing in areas with regular SMC use.

Participants will include children aged 3 to 59 months who have received at least two or three SMC rounds, as well as children aged 5 to 15 years with no prior SMC exposure.

Upon identifying participants, study details will be provided, and written informed consent obtained. Demographic and clinical information will be collected using standard case record forms, including previous SMC uptake and routine malaria control interventions. Information on SMC use will be obtained from SMC cards/existing medical records, detailing the number of cycles received, adherence, and general health condition, including previous diseases and EPI vaccine uptake.

Data Collection:

  • Face-to-face interviews by trained research assistants.
  • Clinical assessments, including temperature, weight, and mid-upper arm circumference (MUAC).
  • Sickle cell status testing at enrolment via samples analyzed at the Molecular Research Laboratory (MOLAB).
  • Hemoglobin measurement using a HemoCue analyzer.

Malaria Diagnosis:

  • Blood samples collected for malaria diagnosis using rapid diagnostic tests (RDTs) and microscopy.
  • RDTs, such as Paracheck Pf, will be performed according to manufacturer instructions, with results available within 15 minutes.
  • Participants testing positive for malaria will receive a full course of antimalarial treatment and counselling to visit the nearest health facility if symptoms worsen.

Thick Blood Smears:

  • New glass slides labelled with participant ID will be used for thick blood smears.
  • Blood smears will be dried and stored in a cool, dust-free environment before transportation to central laboratories.
  • Slides will be stained with 2% Giemsa for 30 minutes and evaluated for parasitemia and gametocytes, with densities calculated accordingly.

The study will help understand the immune responses to malaria and the efficacy of SMC in different age groups.

详细描述

This will be a prospective cohort study with participant enrolment done in two districts in the Karamoja sub region.

The study population will consist of children aged 3 to 59 months - the target age group for SMC. A representative sample of children in the 5-15 years age group to characterize immune dynamics and responses in this age group as a comparator age group will be enrolled as well.

Inclusion criteria

  • Children aged 3 to 59 months and 5-15 years in the selected districts
  • Provision of Informed consent by parents/caregivers

Exclusion criteria

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
3 Months 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 3 to 59 months and 5-15 years in the selected districts
  • Provision of Informed consent by parents/caregivers

排除标准

  • Children known to be immunosuppressed due to malnutrition, HIV or other chronic diseases

结局指标

主要结局

Innate and adaptive immune responses

时间窗: one year

Number of study participants with cellular phenotypes and functions that are protective from malaria

Antibody immune response

时间窗: one year

Number of study participants with protective antimalarial antibodies

次要结局

  • surrogate markers that predict risk of malaria(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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