Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00314899
Status:
COMPLETED
Last Update Posted:
2019-02-01
First Post:
2006-04-13
Brief Title:
Fetal Immunity to Falciparum Malaria
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Fetal Immunity to Plasmodium Falciparum Malaria
Status:
COMPLETED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to find out what effect malaria in the mother has on the development of her childs immune system response to malaria and whether being exposed to malaria in the womb makes a child more likely to get malaria The study will also assess the effect that exposure to malaria in the womb has on the childs growth and development over the first three years of life Study participants will include 480 healthy pregnant women greater than or equal to 15 years of age their healthy offspring 20 healthy people from the United States with no malaria exposure or disease and 40 adult Kenyans who have previously been exposed to malaria or have malaria with no signs of infection Study procedures will include an ultrasound procedure to assess the babys growth and development in the womb blood urine and stool collections Newborns will be examined at birth and at 6 12 18 24 30 and 36 months of age
Detailed Description:
The primary aim of this study is to determine how prenatal exposure to malaria influences development of humoral and cellular immune responses to malaria blood stage antigens from birth to 3 years of age In addition the study will determine the risk factors and mechanisms associated with congenital malaria or exposure of the fetus to malaria blood stage antigens assess how prenatal exposure to malaria affects susceptibility to malaria infection during infancy and evaluate how perinatal exposure to malaria affects growth and development during infancy A primary goal of this research will be to examine a cohort of infants from birth to 36 months of age the predictive value of allele-specific invasion inhibitory antibodies to Merozoite Surface Protein 1 MSP1 and antibody titers to MSP1 will be evaluated with respect to type and magnitude of neonatal cellular and humoral immune response to MSP1 An understanding of natural immunity to MSP1 and the influence of prenatal exposure may be critical to informed interpretation of immunologic parasitologic and clinical endpoints of vaccine trials using blood stage antigens that will be ultimately directed to infants and children Healthy adult pregnant women greater than or equal to 15 years of age and their healthy offspring beginning at birth will be followed until they are 36 months old Newborns will be examined at birth and at 6 12 18 24 30 and 36 months of age Enrollment will occur at time of first visit to the antenatal clinic during the second trimester when peripheral blood stool and urine samples will be obtained from each pregnant woman A finger stick blood sample will be obtained from the mothers at each subsequent antenatal visit to assess the presence of malaria during pregnancy An ultrasound examination will be done on the mothers at the initial antenatal visit to assess gestational age and at 26-30 weeks to assure proper growth and development of fetus and to screen for any potential problems At delivery venous and finger stick blood stool and urine will be obtained from the mother Umbilical cord and placental blood and a placental biopsy will be obtained and thereafter infants will be followed every 6 months plus or minus 2 months A physical examination of infants will be done and peripheral blood stool and urine will be obtained from infants The study population will also include about 20 healthy adult North American control subjects with no malaria exposure or infection and about 40 adult Kenyans who either have been exposed to malaria or have asymptomatic malaria infection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None