AzTrials
AzTrials

MalariaMBCNCT04050566

Malaria Birth Cohort (MBC) in Agogo, Ghana

An observational study of Malaria, run by Bernhard Nocht Institute for Tropical Medicine at 1 site in Ghana.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Malaria
How many people
1,800 participants
Where
1 siteGhana
Study dates
8 Apr 2019to Apr 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Pregnant women visiting Agogo Presbyterian Hospital (APH) for their antenatal care visit and the newborn children born to these mothers

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Nicole Struck, PhD contact

+49 40 42818 ext. 639

struck@bnitm.de

Ghana1 site, 1 recruiting
  • Agogo Presbyterian Hospital

    Agogo

    Nimako Sarpong, Dr, sarpong@kccr.de

    Recruiting

Other trials in Ghana

About this study

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

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.

Read the 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.

Conditions
Malaria
Keywords
Malaria, Immunity development, Plasmodium diversity
Medical subject headings
Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04050566
Study groupRoleWhat they receive
Mothers900 mothers recruited during pregnancy
Children900 children born to the recruited mothers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Malaria episodes

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

    Measured: First 36 months of life

Secondary outcomes (1)
  1. T cell repertoire

    T cell repertoire as measured by FACS analysis

    Measured: First 36 months of life

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2019
  2. Study start8 Apr 2019
  3. Primary completionApr 2025 (estimated)
  4. Study completionApr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04050566
Sponsor's protocol ID
PV5940
Acronym
MBC
Status last verified
Aug 2021
First submitted
5 Aug 2019
Last updated
1 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Malaria, run by Bernhard Nocht Institute for Tropical Medicine at 1 site in Ghana.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Eva Mertens, PhD (+49 40 42818 ext. 243, mertens@bnitm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Malaria episodes (time frame: First 36 months of life). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in