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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00772642 |
In malaria endemic areas the fetus is at risk for in utero exposure to Plasmodium falciparum or its soluble products. Little is known about how this exposure modulates the developing fetal immune system, or how this may alter the risk of malaria or responsiveness to vaccination after birth. A clearer understanding of this process may inform childhood vaccination strategies in malaria endemic areas. The objective of this cross-sectional exploratory study is to define the immune profile associated with in utero exposure to P. falciparum by analyzing cord blood samples collected at a site of high malaria transmission in Mali, and to compare this profile to that of U.S. cord blood samples. Pregnant women will be invited to participate in this study during the 3rd trimester of pregnancy. A finger stick blood draw will be collected from the mother at enrollment and peri-partum to determine if she is infected with P. falciparum. Cord blood and placental blood samples will be collected post-partum and processed to obtain mononuclear cells and serum. Cord blood can be obtained from the placenta after delivery without risk to mother or infant and will be used for research purposes only. Mononuclear cells will be analyzed by flow cytometry to characterize subsets of B, T and innate immune cells. Functional assays such as the B and T cell ELISPOT assay and measurements of cytokines in response to in vitro stimulation will also be performed.
Condition |
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Malaria |
Study Type: | Observational |
Official Title: | Profiling Immunological Parameters in the Cord Blood of Neonates Exposed to Plasmodium Falciparum in Utero |
Estimated Enrollment: | 120 |
Study Start Date: | October 2008 |
In malaria endemic areas the fetus is at risk for in utero exposure to Plasmodium falciparum or its soluble products. Little is known about how this exposure modulates the developing fetal immune system, or how this may alter the risk of malaria or responsiveness to vaccination after birth. A clearer understanding of this process may inform childhood vaccination strategies in malaria endemic areas. The objective of this cross-sectional exploratory study is to define the immune profile associated with in utero exposure to P. falciparum by analyzing cord blood samples collected at a site of high malaria transmission in Mali, and to compare this profile to that of U.S. cord blood samples. Pregnant women will be invited to participate in this study during the 3rd trimester of pregnancy. A finger stick blood draw will be collected from the mother at enrollment and peri-partum to determine if she is infected with P. falciparum. Cord blood and placental blood samples will be collected post-partum and processed to obtain mononuclear cells and serum. Cord blood can be obtained from the placenta after delivery without risk to mother or infant and will be used for research purposes only. Mononuclear cells will be analyzed by flow cytometry to characterize subsets of B, T and innate immune cells. Functional assays such as the B and T cell ELISPOT assay and measurements of cytokines in response to in vitro stimulation will also be performed.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
EXCLUSION CRITERIA:
Contact: Peter D. Crompton, M.D. | (301) 594-9655 | pcrompton@mail.nih.gov |
Mali | |
Malaria Research and Training Center | Recruiting |
Bamako, Mali |
Study ID Numbers: | 999909004, 09-I-N004 |
Study First Received: | October 11, 2008 |
Last Updated: | December 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00772642 |
Health Authority: | United States: Federal Government |
Cross-Sectional Plasmodium Falciparum Malaria Cord Blood Immunology |
Mali Malaria Cord Blood |
Protozoan Infections Parasitic Diseases Malaria Malaria, Falciparum |
Coccidiosis |