A Study of Immune System Activity in Healthy Adults

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00014053
First received: April 10, 2001
Last updated: July 29, 2008
Last verified: June 2003
  Purpose

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.


Condition
HIV Infections
HIV Seronegativity

Study Type: Observational
Official Title: A Study of Immune Function in Healthy Adults Aged 18-30 and 45 and Older

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 48
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00014053

Locations
United States, California
Univ of California San Francisco
San Francisco, California, United States, 94110
United States, Colorado
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
United States, Hawaii
Univ of Hawaii
Honolulu, Hawaii, United States, 96816
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
United States, Missouri
Washington Univ School of Medicine
St Louis, Missouri, United States, 63108
United States, Ohio
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
United States, Texas
Univ of Texas Galveston
Galveston, Texas, United States, 775550435
United States, Washington
Univ of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Investigators
Study Chair: Robert Kalayjian
  More Information

Additional Information:
No publications provided by National Institute of Allergy and Infectious Diseases (NIAID)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00014053     History of Changes
Other Study ID Numbers: ACTG A5113, AACTG A5113
Study First Received: April 10, 2001
Last Updated: July 29, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Reference Values
HIV Seropositivity
Immune System
CD4-Positive T-Lymphocytes
HIV Seronegativity
Antigens, CD

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 28, 2014