Immune Parameters in the Cord Blood of Newborns Exposed to Malaria in the Womb

NCT00772642 | Completed

• 2 other identifiers: 99990900409-I-N004
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study, conducted by the Malaria Research and Training Center at the University of Bamako, Mali, and the NIAID, will examine how exposure to the malaria parasite in the womb affects the developing immune system of newborns. Little is known about how such exposure in the womb may affect the immune system or alter the risk of malaria or responsiveness to vaccination after birth. A better understanding of this process may provide information useful for childhood vaccination strategies in areas where malaria is widespread. Women 18 years of age and older who live in Bancoumana and are in their last trimester of pregnancy and in good health may be eligible for this study. Participants have blood samples drawn from a finger stick and through a needle placed in a vein two times for this study: when they enroll in the study and again when they go to the Bancoumana Health Center to deliver their baby. After the baby and placenta are delivered, blood is collected from the umbilical cord and placenta. ...

Conditions

Malaria

Keywords

Cross-Sectional; Plasmodium Falciparum Malaria; Cord Blood; Immunology; Mali; Malaria

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Malaria Research and Training Center

Bamako, Mali

Location

Related Publications (3)

• Breman JG. The ears of the hippopotamus: manifestations, determinants, and estimates of the malaria burden. Am J Trop Med Hyg. 2001 Jan-Feb;64(1-2 Suppl):1-11. doi: 10.4269/ajtmh.2001.64.1.

  PMID: 11425172 BACKGROUND

• Brustoski K, Kramer M, Moller U, Kremsner PG, Luty AJ. Neonatal and maternal immunological responses to conserved epitopes within the DBL-gamma3 chondroitin sulfate A-binding domain of Plasmodium falciparum erythrocyte membrane protein 1. Infect Immun. 2005 Dec;73(12):7988-95. doi: 10.1128/IAI.73.12.7988-7995.2005.

  PMID: 16299291 BACKGROUND

• Desowitz RS. Prenatal immune priming in malaria: antigen-specific blastogenesis of cord blood lymphocytes from neonates born in a setting of holoendemic malaria. Ann Trop Med Parasitol. 1988 Apr;82(2):121-5. doi: 10.1080/00034983.1988.11812218.

  PMID: 2460040 BACKGROUND

MeSH Terms

Conditions

Malaria; Malaria, Falciparum

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Design

• Study Type: observational
• Time Perspective: OTHER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 11, 2008
• First Posted: October 15, 2008
• Study Start: October 8, 2008
• Study Completion: September 10, 2010
• Last Updated: July 2, 2017

Record last verified: 2010-09-10

Locations

MA (1)