Clinical trial NCT04050566: Malaria Birth Cohort (MBC) in Agogo, Ghana
Official title: Analysis of Anti-malarial Immunity Development in Early Life in a Prospective Birth Cohort in Agogo, Ghana
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malaria
Keywords: Malaria
Immunity development
Plasmodium diversity
Lead sponsor: Bernhard Nocht Institute for Tropical Medicine
Sponsor class: OTHER_GOV
Collaborators: name: Kwame Nkrumah University of Science and Technology
name: Kumasi Centre for Collaborative Research (KCCR)
name: Heidelberg University
name: KEMRI-Wellcome Trust Collaborative Research Program
name: Agogo Presbyterian Hospital
First posted: 2019-08-08
Enrollment: 1800
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women visiting Agogo Presbyterian Hospital (APH) for their antenatal care visit and the newborn children born to these mothers

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Malaria episodes
timeFrame: First 36 months of life
Secondary outcomes:
measure: T cell repertoire
timeFrame: First 36 months of life
Other outcomes:
Locations:
city: Agogo
country: Ghana
facility: Agogo Presbyterian Hospital
Study officials:
affiliation: Bernhard Nocht Institute for Tropical Medicine
name: Jürgen May, Prof
role: STUDY_DIRECTOR
affiliation: Kwame Nkrumah University of Science & Technology (KNUST)
name: John H Amuasi, Dr
role: STUDY_DIRECTOR
affiliation: Bernhard Nocht Institute for Tropical Medicine
name: Eva Mertens, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bernhard Nocht Institute for Tropical Medicine
name: Nicole Struck, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kumasi Centre for Collaborative Research
name: Oumou Maiga-Ascofaré, PhD
role: PRINCIPAL_INVESTIGATOR
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