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CompletedNCT00014053Updated Jul 30, 2008

A Study of Immune System Activity in Healthy Adults

An observational study in HIV Infections and HIV Seronegativity, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 9 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-07-30.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational

Study type
Observational
Enrollment
48
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • HIV Infections
  • HIV Seronegativity

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Keywords

  • Reference Values
  • HIV Seropositivity
  • Immune System
  • CD4-Positive T-Lymphocytes
  • HIV Seronegativity
  • Antigens, CD
03

In context

HIV Infections

4,257 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 48 is below the median of 200 across 713 observational studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Volunteers may be eligible for this study if they:

  • Are willing to undergo HIV testing.
  • Have a negative urine or serum pregnancy test within 30 days prior to study entry (for women volunteers).
  • Are between the ages of 18 and 30 or are 45 or older.

Exclusion criteria

Exclusion Criteria

Volunteers will not be eligible for this study if they:

  • Have HIV infection.
  • Have a serious infection or other serious medical illness that requires treatment and/or hospitalization within 90 days before study entry.
  • Have had cancer.
  • Have received any of the following within 6 months of study entry: systemic corticosteroids; chemotherapy or radiation; erythropoietin, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), or growth hormone; drugs that affect the immune system including thalidomide, interleukins, interferons, or other cytokines; anabolic steroids at high levels; or any experimental agent, unless allowed otherwise by the researchers.
  • Are immune to hepatitis A.
  • Have received tetanus toxoid within 5 years prior to study entry or have a history of severe reaction to tetanus vaccine at any time in the past.
  • Are pregnant or breast-feeding.
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Study design

Enrollment
48 participants
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Study locations

9 sites
  • Univ of California San Francisco
    San Francisco, California 94110, United States
  • Univ of Colorado Health Sciences Ctr
    Denver, Colorado 80262, United States
  • Univ of Hawaii
    Honolulu, Hawaii 96816, United States
  • Northwestern Univ Med School
    Chicago, Illinois 60611, United States
  • Rush Presbyterian - Saint Luke's Med Ctr
    Chicago, Illinois 60612, United States
  • Washington Univ School of Medicine
    St Louis, Missouri 63108, United States
  • Case Western Reserve Univ
    Cleveland, Ohio 44106, United States
  • Univ of Texas Galveston
    Galveston, Texas 775550435, United States
  • Univ of Washington
    Seattle, Washington 98104, United States
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References and documents

Publications

  • Tenorio AR, Spritzler J, Martinson J, Gichinga CN, Pollard RB, Lederman MM, Kalayjian RC, Landay AL. The effect of aging on T-regulatory cell frequency in HIV infection. Clin Immunol. 2009 Mar;130(3):298-303. doi: 10.1016/j.clim.2008.10.001. Epub 2008 Nov 12. PubMed 19008157 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00014053
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
First posted
Aug 31, 2001
Last update
Jul 30, 2008

Study contacts

Robert Kalayjian
study chair
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2003. You cannot join it, but the record below documents what was studied.

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