Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00170638
Status:
COMPLETED
Last Update Posted:
2008-04-25
First Post:
2005-09-13
Brief Title:
Tuberculosis Immunity in Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Tuberculosis Immunity in Children
Status:
COMPLETED
Status Verified Date:
2008-01
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:
The purpose of this study is to gain a better understanding of how immunity to tuberculosis TB is maintained in children When children get tuberculosis it is more likely to spread to other parts of the body than when adults get it This study will compare the blood cells that fight TB in children to the blood cells that fight TB in adults Children enrolled in this study will have blood drawn on 1 or 2 occasions Adult participants will be leukapheresed a process in which blood passes through a machine collecting specific blood cells and returning the remaining blood to the body An estimated 260 subjects will be enrolled in this study
Detailed Description:
Tuberculosis TB is the number one cause of infectious morbidity and mortality worldwide accounting for 8 million cases and 3 million deaths annually The impact of TB on children is particularly devastating in that children are more likely than adults to develop active TB following exposure to the bacterium M tuberculosis Mtb and once infected children are much more likely than adults to develop disseminated disease including miliary disease bone and joint disease and meningitis These clinical differences likely reflect fundamental differences of the immune system of children and adults The first specific aim of this study is to determine if severity of disease following Mtb infection in young children is associated with TH2-type immunity and conversely if absence of disease following Mtb infection is associated with TH1-type immunity by comparison of the magnitude and phenotype of Mtb-specific T cell responses in children less than or equal to 10 years old with disseminated TB including miliary disease and meningitis localized disease as defined by disease contained in the thoracic cavity pulmonary pleural and cardiac extrapulmonary lymph nodes lymphadenitis gastrointestinal tract or bone osteomyelitis and latent Mtb infection LTBI defined as individuals with a positive Tuberculin Skin Test TST and without radiographic or clinical evidence of active tuberculosis The second specific aim of this study is to determine if immunologic immaturity is associated with the development of TH2-type immunity following Mtb infection and conversely if immunologic maturity is associated with the development of TH1-type immunity following Mtb infection by characterizing the magnitude and phenotype of Mtb-specific T cell responses in individuals with localized disease comparing 0-1 year olds 2-4 year olds 5-10 year olds and adults and LTBI comparing 0-1 year olds 2-4 year olds 5-10 year olds and adults The data obtained from the present study may contribute to an improved understanding of TB immunity in children which in turn may help in the development of a more effective TB vaccine for infants and young children The number of participants is estimated to be 260 subjects to be enrolled over the course of 5 years
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