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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Jul 22, 2010

Keywords

ClinConnect Summary

This clinical trial is looking at how different factors in both mothers and their babies affect the risk of getting malaria, especially during pregnancy and early childhood. Malaria is a serious disease that can lead to complications like low birth weight and anemia in mothers, as well as increased risk of severe illness in children. By studying up to 2,000 pregnant women and their infants, as well as children aged 0 to 3 years, researchers hope to learn more about the immune responses and characteristics of malaria parasites that lead to these health issues.

To be eligible for the study, pregnant women aged 15-45 who have lived in the Ouelessebougou area for at least a year, along with their newborns, can participate. Additionally, children aged 3 and under from the same area, and hospitalized or outpatient febrile children aged 0-10, may also qualify. Participants can expect to undergo clinical evaluations and have blood samples taken over time to help researchers better understand how malaria affects mothers and children. It's important to note that individuals with certain chronic illnesses or those who have previously participated in malaria vaccine trials will not be eligible to join this study.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• A study participant must satisfy the following criteria to be enrolled in this study:
• • 1. Pregnant women aged 15-45 years and their newborn infants who are residents of the district of Ouelessebougou for at least one year at the time of enrollment; OR
• • 2. Children who previously participated in the 1st cohort of "pregnant women and their newborn infants", OR
• • 3. Children aged 3 years or less, who are residents of the district of Ouelessebougou for at least one year at the time of enrollment, OR
• • 4. Febrile hospitalized children (aged 0-10 years), including those with positive and negative blood smears for P. falciparum in Ouelessebougou or the pediatric service of Gabriel Toure Hospital in Bamako. Febrile non-hospitalized children (aged 0-10 years) with non-severe malaria will be recruited at outpatient clinics in Ouelessebougou district health hospital and nearby facilities, with no chronic or serious illness.
• • 5. Pregnant women aged 15-25 in Ouelessebougou district health centers or maternity unit of Gabriel Toure Hospital in Bamako and for a case-control study of pregnancy malaria and preeclampsia. Cases include women with signs/symptoms of preeclampsia. Control pregnant women without signs/symptoms of preeclampsia will be recruited sequentially after identification of individual cases, matched for parity, age (+/-2 years) and pregnancy trimester.
• • 6. The study participant or parent/guardian understands the study and gives informed consent for participation of themselves and/or their child, and agrees to have samples stored.
• EXCLUSION CRITERIA:
• A participant will be excluded from the study if any one or more of the following criteria are met:
• • 1. Chronic, debilitating illness, other than malaria, determined by history and physical examination of mother or study participant.
• • 2. Conditions that in the judgment of the investigator could increase the risk to the volunteer.
• • 3. History of previous participation in a malaria vaccine trial.