Viewing Study NCT00014053



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Study NCT ID: NCT00014053
Status: COMPLETED
Last Update Posted: 2008-07-30
First Post: 2001-04-10

Brief Title: A Study of Immune System Activity in Healthy Adults
Sponsor: National Institute of Allergy and Infectious Diseases NIAID
Organization: National Institute of Allergy and Infectious Diseases NIAID

Study Overview

Official Title: A Study of Immune Function in Healthy Adults Aged 18-30 and 45 and Older
Status: COMPLETED
Status Verified Date: 2003-06
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 compare immune system activity in young people and older people who do not have HIV This information will be compared to that of HIV patients in another study

Aging affects immune system activity This study will look at some of the factors involved HIV also affects immune system activity The results from this study using healthy volunteers will be compared to those in another study of HIV-infected patients This may provide information on immune system activity in aging and HIV
Detailed Description: Aging is associated with declines in both cellular and humoral immunity A consistent observation of the aging immune system is a change in T cells Another possible mechanism of diminished cellular immunity associated with age includes accelerated lymphocyte apoptosis Enhanced lymphocyte apoptosis may play an important role in the pathogenesis of HIV disease This study will use healthy volunteers to confirm and expand upon such observations Samples from these volunteers will serve as controls to those from the HIV-infected participants of A5015 a comparison study of 2 age-differentiated cohorts to determine potential mechanisms that might contribute to accelerated HIV-disease progression that is associated with aging

This is a non-treatment study however volunteers receive hepatitis A and tetanus vaccinations Numbers of phenotypically naive CD4 cells CD45RACD62L are compared between healthy HIV-seronegative volunteers and HIV-seropositive patients of A5015 An array of assays to assess baseline differences in immune function between these study populations are performed Expression of markers of activation are compared by measuring the coexpression of HLA-DRCD38 and CD28 on CD4 and CD8 lymphocytes between these populations To investigate possible age-associated differences in apoptosis Fas CD95 expression is measured on CD4 and CD8 T cells by flow cytometry and spontaneous apoptosis is assessed using the propidium iodide method DTH hypersensitivity to skin test antigens lymphocyte proliferation to mitogens soluble antigens recall antigens and neoantigens are compared between the 2 populations Antibody responses to vaccination with tetanus and hepatitis A are assessed Finally thymic size as measured by CT scan and the frequency of T cells that contain TRECs is compared between these 2 populations

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
Secondary ID Type Domain Link
AACTG A5113 None None None