Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Profiling Immunological Parameters in the Cord Blood of Neonates Exposed to Plasmodium Falciparum in Utero
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), October 2008
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00772642
  Purpose

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
Malaria

MedlinePlus related topics: Malaria
U.S. FDA Resources
Study Type: Observational
Official Title: Profiling Immunological Parameters in the Cord Blood of Neonates Exposed to Plasmodium Falciparum in Utero

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 120
Study Start Date: October 2008
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:
  • Age greater than or equal to 18 years
  • Healthy female in 3rd trimester of pregnancy
  • Resident of Bancoumana
  • Willingness to allow cord and placental blood samples to be stored and used for future studies of the immune response to malaria
  • Ability to give informed consent and willingness to comply with study requirements and procedures

EXCLUSION CRITERIA:

  • Currently taking corticosteroids or other immunosuppressants
  • Underlying heart disease, bleeding disorder, or other condition that in the judgment of the Principal Investigator (PI) could increase the risk to the volunteer
  • Fever greater than or equal to 37.5 degree C or evidence of an acute infection
  • Anemia (hemoglobin less than 9 g/dL)
  • Participation in another clinical protocol that requires the administration of an experimental vaccine or experimental treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772642

Contacts
Contact: Peter D. Crompton, M.D. (301) 594-9655 pcrompton@mail.nih.gov

Locations
Mali
Malaria Research and Training Center Recruiting
Bamako, Mali
Sponsors and Collaborators
  More Information

Publications:
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

Keywords provided by National Institutes of Health Clinical Center (CC):
Cross-Sectional
Plasmodium Falciparum Malaria
Cord Blood
Immunology
Mali
Malaria
Cord Blood

Study placed in the following topic categories:
Protozoan Infections
Parasitic Diseases
Malaria
Malaria, Falciparum

Additional relevant MeSH terms:
Coccidiosis

ClinicalTrials.gov processed this record on January 14, 2009