- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00772642
Immune Parameters in the Cord Blood of Newborns Exposed to Malaria in the Womb
Profiling Immunological Parameters in the Cord Blood of Neonates Exposed to Plasmodium Falciparum in Utero
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.
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Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Bamako, Mali
- Malaria Research and Training Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 999909004
- 09-I-N004
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