An observational study in Malaria, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 2 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-02.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
This study will examine whether resistance to severe malaria is associated with weakening of a specific immune response (TLR-mediated pro-inflammatory cytokine response). Some children with mild malaria go on to develop severe disease, while others do not. The study will analyze certain substances in the blood to try to determine what factors may protect against severe malaria.
Healthy children and children 3 - 10 years of age with severe malaria who are being treated at l'H pital Gabriel Toure in Mamako, Mali, West Africa, may be eligible for this study. Participants have a mall sample of blood drawn from a vein and from two finger pricks.
Malaria remains an important public health threat, responsible for over two million deaths annually, the majority among African children. The mechanisms underlying resistance to the most severe manifestations of malaria remain elusive. Severe malaria has been associated with high levels of pro-inflammatory cytokines that may contribute to the pathogenesis of cerebral malaria, severe anemia and acidosis. This response is thought to be driven primarily by glycosylphosphatidylinositol (GPI) anchors derived from erythrocyte-stage Plasmodium falciparum. It has been suggested that antibodies against GPI are responsible for resistance to severe malaria, which has led to efforts to develop a GPI-based vaccine. An alternative explanation for the development of resistance to severe malaria is down regulation of the innate pro-inflammatory response by repeated ligation of toll-like receptors (TLR) by GPI, or other putative P. falciparum-derived TLR ligands, such as hemozoin. This cross-sectional study at l'Hopital Gabriel Toure in Bamako, Mali, proposes to test the hypothesis that resistance to severe malaria is associated with an attenuation of the TLR-mediated pro-inflammatory cytokine response. After informed consent is obtained from the participant's parent or guardian, 2-3 mL of venous blood will be drawn from each of 60 children: 40 children presenting with acute P. falciparum infection (20 severe and 20 uncomplicated) and 20 healthy, P. falciparum uninfected controls. The blood will be tested for antibody titers against GPI and Merozoite Surface Protein-1 (MSP-1). Peripheral blood mononuclear cells (PBMCs) will be isolated and cultured with GPI, hemozoin, lipoteichoic acid (LTA), lipopolysaccharide (LPS), and cytosine-guanine dinucleotide (CpG). At 24 hours, supernatant will be collected and the following cytokines measured: IL-1, IL-6, IL-8, IL-10, IL-12, and TNF-alpha. A clearer understanding of the responsiveness to TLR ligands in children from malaria endemic areas may provide information on potential intervention strategies such as GPI-based vaccines or the use of TLR agonists as vaccine adjuvants.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 120 is below the median of 600 across 218 observational studies indexed under Malaria.
Browse Malaria studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
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INCLUSION CRITERIA -MALARIA PATIENTS:
INCLUSION CRITERIA -HEALTHY VOLUNTEERS:
EXCLUSION CRITERIA-MALARIA PATIENTS:
EXCLUSION CRITERIA-HEALTHY VOLUNTEERS:
This study is completed, as verified in Nov 2006. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID)