NCT04050566

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2019

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

6 years

First QC Date

August 5, 2019

Last Update Submit

August 27, 2021

Conditions

Keywords

MalariaImmunity developmentPlasmodium diversity

Outcome Measures

Primary Outcomes (1)

  • Malaria episodes

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

    First 36 months of life

Secondary Outcomes (1)

  • T cell repertoire

    First 36 months of life

Study Arms (2)

Mothers

900 mothers recruited during pregnancy

Children

900 children born to the recruited mothers

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study recruits pregnant women at any point during their pregnancy
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agogo Presbyterian Hospital

Agogo, Ghana

RECRUITING

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Jürgen May, Prof

    Bernhard Nocht Institute for Tropical Medicine

    STUDY DIRECTOR
  • John H Amuasi, Dr

    Kwame Nkrumah University of Science & Technology (KNUST)

    STUDY DIRECTOR
  • Eva Mertens, PhD

    Bernhard Nocht Institute for Tropical Medicine

    PRINCIPAL INVESTIGATOR
  • Nicole Struck, PhD

    Bernhard Nocht Institute for Tropical Medicine

    PRINCIPAL INVESTIGATOR
  • Oumou Maiga-Ascofaré, PhD

    Kumasi Centre for Collaborative Research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Mertens, PhD

CONTACT

Nicole Struck, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department Head

Study Record Dates

First Submitted

August 5, 2019

First Posted

August 8, 2019

Study Start

April 8, 2019

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

September 1, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations