An observational study in Malaria, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Recruiting at 1 site in Mali. Open to female participants aged 15 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
Background:
- Malaria is a disease that affects many people in African countries. It is caused by germs that are spread by mosquito bites. It can be fatal if not diagnosed and treated right away. Children younger than 5 and pregnant women are most at risk to get malaria. Researchers want to create a vaccine that will prevent malaria infection during pregnancy.
Objectives:
- To create a vaccine that will prevent malaria infection during pregnancy. To assess possible vaccines using in-vitro tests with parasites taken from pregnant women.
Eligibility:
- Pregnant women ages 15-25
Design:
Malaria caused by Plasmodium falciparum continues to be a global problem with devastating consequences. Pregnancy malaria is associated with low birth weight (LBW), maternal anemia, and gestational hypertension; and both inflammation and the fetal response to infection may contribute to these poor outcomes. Pregnancy malaria (PM) is caused by P. falciparum-infected erythrocytes that bind to the placental receptor chondroitin sulfate A (CSA) and sequester in the placenta, where they cause disease and death for the mother and her offspring. Women become resistant to pregnancy malaria as they acquire antibodies that target surface proteins of placental parasites. Malaria vaccine candidates targeting the parasite s liver stage or blood stage may not protect pregnant women and their unborn children. The primary hypothesis in this study is that antibodies raised in animals against recombinant pregnancy malaria vaccine candidates will have a similar functional activity as naturally acquired antibodies. Up to 2492 malaria-infected pregnant women will be recruited into a cross sectional study that will be conducted in Ouelessebougou and neighboring districts, Mali. Women presenting for antenatal visit at the health centers in Ouelessebougou District will be enrolled. Samples collected from the women will be used in in-vitro assays to assess the functional activity of immunoglobulin G (IgG) raised against pregnancy malaria vaccine candidates as the primary outcome of this study. For our secondary outcomes, we will examine functional activity of naturally acquired antibodies specific to the vaccine candidates. Functional activity by IgG to vaccine candidates will be compared to the activity obtained with control proteins using appropriate statistical methods, including adjustment for possible confounders such as parasite density in the assay, to determine if the candidates elicit the type of immune response observed in naturally exposed population.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's planned enrollment of 7,476 is above the median of 582 across 204 observational studies indexed under Malaria.
Browse Malaria studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pregnant women age 15-25 years presenting for antenatal consultations or delivery at health centers or hospital in Ouelessebougou and neighboring districts@@@@@@
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A study participant must satisfy the following criteria to be enrolled in this study:
EXCLUSION CRITERIA:
Malaria-infected pregnant Women
Measure of functional activity of animal IgG against vaccine candidates to block binding of fresh pregnancy malaria isolates to the placental receptor CSA
Time frame: Approximately 1 year
Plan to share: No
Started Jul 2015 (actual). Primary completion is estimated for Jun 2028, 155 months after the start.
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