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A Study of Immune System Activity in Healthy Adults

Completed
Conditions
HIV Infections
HIV Seronegativity
Registration Number
NCT00014053
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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 (CD45RA+/CD62L+) 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-DR+/CD38+ 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
48
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (9)

Case Western Reserve Univ

🇺🇸

Cleveland, Ohio, United States

Univ of California San Francisco

🇺🇸

San Francisco, California, United States

Univ of Colorado Health Sciences Ctr

🇺🇸

Denver, Colorado, United States

Rush Presbyterian - Saint Luke's Med Ctr

🇺🇸

Chicago, Illinois, United States

Washington Univ School of Medicine

🇺🇸

St Louis, Missouri, United States

Northwestern Univ Med School

🇺🇸

Chicago, Illinois, United States

Univ of Hawaii

🇺🇸

Honolulu, Hawaii, United States

Univ of Texas Galveston

🇺🇸

Galveston, Texas, United States

Univ of Washington

🇺🇸

Seattle, Washington, United States

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