Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Recruiting now
Conditions studied: Malaria
In brief
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 its risk 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 aged 0-3 years will be enrolled and followed to age 5 years, with clinical evaluation and periodic venous and peripheral blood samples being obtained. In addition, up to 3000 febrile hospitalized and non-hospitalized children up to 10 years ofd age 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. Up to 1000 children originally enrolled at birth and completed the "pregnant women and their newborns study" will be re-enrolled and followed for up to 10 years as they age from later childhood through adolescence to early adulthood. 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 women and young children.
Key facts
- Study ID
- NCT01168271
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 15000
- Starts
- 2010-08-30
- Last updated by the study team
- 2026-06-23
Who can join
Age: 0 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- A participant will be excluded from the study if any one or more of the following criteria are met:
- Chronic, debilitating illness, other than malaria, determined by history and physical examination of mother or study participant.
- Conditions that in the judgment of the investigator could increase the risk to the volunteer.
- History of previous participation in a malaria vaccine trial.
Where it is running
- Gabriel Toure Hospital — Bamako, Mali (enrolling)
- Ouelessebougou Clinical Research Center — Wolossébougou, Mali (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.