Actively Recruiting

Age: 1Day - 45Years
All Genders
Healthy Volunteers
ID01168271

Host and Parasite Factors Influencing Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-06-01

15000

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Malaria caused by Plasmodium falciparum remains a major global health issue with serious consequences. This research aims to better understand the immune and parasite factors related to infection and disease during pregnancy and early childhood. The study focuses on how pregnancy malaria affects birth outcomes like low birth weight and maternal anemia, and explores how childhood malaria risk may be influenced by exposure before birth and other factors such as iron levels and immune responses. Researchers also investigate whether parasites causing severe childhood malaria have unique characteristics. The study enrolls up to 2000 pregnant women and their newborns, and 2000 children aged 0 to 3 years, who will be followed until age 5. Additionally, 3000 febrile children up to age 10 are recruited from health centers and hospitals for acute and recovery assessments. A separate case-control study includes 500 pregnant women to explore malaria and preeclampsia. Up to 1000 children from the initial birth cohort may be followed for up to 10 years into adolescence and early adulthood. Participants undergo clinical exams and provide periodic blood samples over these periods. Participants will be monitored through clinical evaluations and blood sample collections to analyze parasite presence, immune responses, and host factors. The main outcome is to identify maternal, placental, parasite, and host factors linked to resistance or susceptibility to malaria infection and disease in children up to 5 years old. The study uses careful statistical analysis to understand these associations. Participation may last from birth up to 10 years, with ongoing assessments to track health and malaria outcomes.

CONDITIONS

Brief Title

Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali

Who Can Participate

Age: 1Day - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women aged 15-45 years and their newborn infants residing in Ouelessebougou district for at least one year
  • Children who previously participated in the first cohort of pregnant women and newborn infants
  • Children aged 3 years or younger residing in Ouelessebougou district for at least one year
  • Febrile hospitalized children aged 0-10 years in Ouelessebougou or Gabriel Toure Hospital, Bamako
  • Febrile non-hospitalized children aged 0-10 years with non-severe malaria and no chronic or serious illness
  • Pregnant women aged 15-25 years for a case-control study on pregnancy malaria and preeclampsia, matched by parity, age, and pregnancy trimester
  • Participants or guardians who understand the study and provide informed consent
Not Eligible

You will not qualify if you...

  • Chronic, debilitating illness other than malaria as determined by medical history and examination
  • Any condition judged by the investigator to increase risk to the volunteer
  • Previous participation in a malaria vaccine trial

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - Up to 5 years for infants and children

Participants are observed with clinical evaluation and periodic blood samples to study malaria infection and disease during pregnancy and early childhood.

Periodic visits for clinical evaluation and blood sample collection

Long-term Monitoring

Duration - Up to 10 years

Children originally enrolled at birth and completing the initial study are re-enrolled and followed through later childhood, adolescence, and early adulthood to monitor malaria-related outcomes.

Periodic visits depending on age and study schedule

Trial Site Locations

Total: 2 locations

1

Gabriel Toure Hospital

Bamako, Mali

Actively Recruiting

2

Ouelessebougou Clinical Research Center

Wolossébougou, Mali

Actively Recruiting

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Research Team

M

Michal Fried, Ph.D.

P

Patrick E Duffy, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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Published Research Related To This Trial

A single full-length VAR2CSA ectodomain variant purifies broadly neutralizing antibodies against placental malaria isolates.

Justin Y A Doritchamou, Jonathan P Renn, Bethany Jenkins...

https://pubmed.ncbi.nlm.nih.gov/35103596

Plasma biomarkers of hemoglobin loss in Plasmodium falciparum-infected children identified by quantitative proteomics.

Almahamoudou Mahamar, Patricia A Gonzales Hurtado, Robert Morrison...

https://pubmed.ncbi.nlm.nih.gov/34871370

Malaria Infection Is Common and Associated With Perinatal Mortality and Preterm Delivery Despite Widespread Use of Chemoprevention in Mali: An Observational Study 2010 to 2014.

Almahamoudou Mahamar, Naissem Andemel, Bruce Swihart...

https://pubmed.ncbi.nlm.nih.gov/33846719

Systemic Inflammatory Response to Malaria During Pregnancy Is Associated With Pregnancy Loss and Preterm Delivery.

Michal Fried, Jonathan D Kurtis, Bruce Swihart...

https://pubmed.ncbi.nlm.nih.gov/29020221