跳至主要内容
临床试验/NCT04050566
NCT04050566招募中不适用

Analysis of Anti-malarial Immunity Development in Early Life in a Prospective Birth Cohort in Agogo, Ghana

Bernhard Nocht Institute for Tropical Medicine1 个研究点 分布在 1 个国家目标入组 1,800 人开始时间: 2019年4月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,800
试验地点
1
主要终点
Malaria episodes

研究概览

简要总结

Malaria is a major health threat worldwide with an estimated 229 million cases and 409,000 deaths in 2019 (WHO, World Malaria Report 2019). Vulnerable are young children and pregnant women. The study aims to investigate immunity development against malaria with regard to parasite, human, and socioeconomic factors and possible correlations with pathology or protection in a prospective birth cohort.

详细描述

Malaria during pregnancy poses substantial risks for the mother and her foetus. Due to the risk of malaria during early childhood, the study addresses the high malaria morbidity and mortality in young children. Though recognised as a public health issue, it has still not been well understood how clinical immunity against malaria parasites develops, which parasite and host factors play a role in infection susceptibility, and why some infections proceed to develop severe complications while others resolve after a mild disease.

In order to identify interactions between parasite and host, a longitudinal study is performed starting with the recruitment of pregnant women. The study is conducted in Agogo in Ghana, an area with high malaria endemicity. The study design allows to analyse the neonatal immune status at birth, after potential in-utero exposure, and follows the development of immunity over the first 36 months of life. The current paradigm is that time points and frequency of infection as well as the type of variant surface antigen expressed have an impact on the cellular and humoral immune response to malaria, the development of clinical immunity, as well as the risk for future complications.

Starting point of the study is the antenatal care visit of mothers at Agogo Presbyterian Hospital (APH) during pregnancy. During recruitment, the mother will be asked to read and sign an informed consent form approved by the local ethical committee. After consent has been obtained from the mother, biological samples are taken, and a case report form is filled. An identification card with a unique code number is handed out. The first follow-up visit occurs at the birth of the child. At this time point, samples are taken from the mothers and the child. Mothers/primary caregivers are invited to observe the EPI visits offered at their nearest health post for further follow-ups. In the first year after birth, the EPI schedule includes visits at six weeks, ten weeks, 14 weeks, six months, and nine months. During these visits, questionnaires are completed and stool samples are taken. In the first six weeks after birth, the household is visited to complete a household questionnaire including housing characteristics and household assets. Additionally, a women's questionnaire is administered, which collects demographic and socioeconomic background characteristics as well as health and related behavioural data. At 12, 18, 24, and 36 months after birth, mothers/primary caregivers are encouraged to bring their children to the study hospital (APH) for a medical check-up. For the period of 36 months after birth, mothers/primary caregivers are strongly encouraged to visit the study hospital (APH) every time the child experiences a febrile illness or a history of fever in the last week during the observation period.

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 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Catchment area of the EPI (Expanded Program of Immunization) centres with good accessibility to Agogo Prespyterian Hospital (APH)
  • Willingness and able to give informed consent for herself and her child

排除标准

  • Maternal age below 18 years
  • Positive HIV status of mother
  • Refusal or withdrawal of informed consent

结局指标

主要结局

Malaria episodes

时间窗: First 36 months of life

Frequency and severity of malaria episodes as identified by microscopy, PCR, and clinical criteria.

次要结局

  • T cell repertoire(First 36 months of life)

研究者

发起方
Bernhard Nocht Institute for Tropical Medicine
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Jürgen May

Professor, Department Head

Bernhard Nocht Institute for Tropical Medicine

研究点 (1)

Loading locations...

相似试验