Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138372
Status:
COMPLETED
Last Update Posted:
2022-01-20
First Post:
2005-08-26
Brief Title:
Human Immunity to MSP-1 in Western Kenya
Sponsor:
Case Western Reserve University
Organization:
Case Western Reserve University
Study Overview
Official Title:
Human Immunity to MSP-1 in Western Kenya
Status:
COMPLETED
Status Verified Date:
2022-01
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:
This is a study of 125 healthy male and female Kenyan adults aged 18 years and above and 300 healthy male and female Kenyan infants enrolled at 1 month of age and followed to 3 years of age Twenty healthy adults US residents who have no self-reported history of Malaria exposure infection or travel to malaria endemic areas of the world will serve as Malaria Naive Negative Controls The proposed study represents a continuation of molecular and immunologic studies done in human populations describing mechanisms of protection against malaria infection and disease Human investigation of those experiencing natural exposure to malaria infections are justified since they will eventually be the target population for testing malaria vaccine safety and efficacy
Detailed Description:
This study will include two major populations 1 the Adult Repeat Cross Sectional study ARCS will involve 125 healthy Kenya-residents male and female aged 18 years and above and 2 the Pediatric Infant Cohort PIC will include 300 healthy male and female infants who are residents of Kenya In addition 20 healthy adult US residents who have no self-reported history of malaria exposure infection or travel to malaria endemic areas of the world will serve as Malaria Naive Negative Controls MNNC The adult ARCS study will consist of 6 venous blood donations to be completed in one year The primary outcome of the ACRS is to determine the stability of Immune responses to MSP-1 who are clinically protected against P falciparum infections and the secondary outcome is to measure the level and stability of MSP-1 specific IIA activity MSP-1 specific T-cell memory phenotypes and immune functions and lastly to determine the MSP-1 genotypes The PIC study is both home and clinic-based The overall duration of this study will be three years The subjects will be recruited during their routine immunizations visit The data and sample collections consist of monthly home-visits interspersed by clinic-visits every 6 months until the child reaches 3 years old The primary outcome of the PIC study is to evaluate the development of humoral and cellular immunity to MSP-1 in healthy children in relation to their history of P falciparum infections number of episodes of uncomplicated acute malarial infections in the first 3 years of life and secondary outcome is to measure the acquisition of MSP-1 specific IIA activity shifts in T-cell memory phenotypes and amalaira-specific immunity and their association with the history of exposure to P falciparum MSP-1 alleleic variants For the MNNS study the primary objective is to optimize molecular and immunologic assays to be used in Kenya and to determine background level responses in healthy adult and the secondary outcomes aims to measure the level of MSP-1 specific IIA-activity T-cell memory phenotypes and any non-specific immunity to malaria antigens and to provide negative control DNA for P falciparum detection and genotyping studies The result of these studies will provide insight into how the frequency and intensity of prior malaria infection and antigenic polymorphism influence the generation and maintenance of T-cell memory and AB responses to merozoite surface proteins in humans
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