Actively Recruiting

Age: 1Day - 45Years
All Genders
Healthy Volunteers
NCT01168271

Host and Parasite Factors That Influence Susceptibility to 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 2026-04-08

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 continues to be a global problem with devastating consequences. A greater understanding of the immunologic and parasitologic factors associated with infection and disease is badly needed, and will accelerate the development of highly protective vaccines for both mothers and children. Pregnancy malaria is associated with low birth weight, maternal anemia, and gestational hypertension, and both inflammation and the fetal response to infection may contribute to these poor outcomes. Childhood malaria is a major cause of mortality, and we have found that risk of childhood malaria is related to in utero exposure to pregnancy malaria, as well as other host factors like iron status and constitutive cytokine levels. Pregnancy malaria is caused by a distinct parasite binding phenotype, and as our primary hypothesis in this study we speculate that severe childhood malaria parasites may also have distinct features. A longitudinal cohort study will be conducted in Ouelessebougou, Mali an area of intense seasonal transmission. Up to 2000 pregnant women and their infants and 2000 children ages 0 - 3 will be enrolled and followed to age 5 years, with clinical evaluation and periodic venous and peripheral blood samples obtained. In addition, 2000 febrile children up to age 10 years will be enrolled at the Ouelessebougou district health centers or the Gabriel Toure Pediatric Hospital in Bamako, Mali, with acute and convalescent samples being obtained and 500 pregnant women enrolled at the health centers and hospital in Ouelessebougou district or the Gabriel Toure Hospital in Bamako for a case-control study on pregnancy malaria and preeclampsia. Clinical, parasitologic and host response (including immunologic) endpoints will be analyzed using appropriate statistical methods, including possible confounders, to determine factors associated with infection and disease in pregnant woman and young children.

CONDITIONS

Official 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 newborns living in Ouelessebougou district for at least one year
  • Children who participated in the first cohort of pregnant women and newborn infants
  • Children aged 3 years or younger living in Ouelessebougou district for at least one year
  • Febrile hospitalized children aged 0-10 years, with or without malaria, in Ouelessebougou or Gabriel Toure Hospital in 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 for parity, age, and pregnancy trimester
  • Participants or their parent/guardian must understand the study and provide informed consent
Not Eligible

You will not qualify if you...

  • Chronic, debilitating illness other than malaria based on medical history and exam
  • Conditions that could increase risk to the participant as judged by the investigator
  • Previous participation in a malaria vaccine trial

AI-Screening

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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.

CONTACT

P

Patrick E Duffy, M.D.

CONTACT

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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