Analysis of Immune Responses to HIV Vaccines

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00068978
First received: September 12, 2003
Last updated: September 17, 2007
Last verified: August 2007

September 12, 2003
September 17, 2007
April 2003
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Complete list of historical versions of study NCT00068978 on ClinicalTrials.gov Archive Site
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Analysis of Immune Responses to HIV Vaccines
Flow Cytometry Study of T Cell Responses to HIV Vaccines

This study will evaluate a test designed to measure immune system responses to HIV and HIV vaccines.

Assays for HIV-specific human CD4 and CD8 T cell immunity are needed in order to evaluate the immune response to HIV vaccines. Such assays should be robust, reproducible, and amenable to high throughput analysis of clinical specimens. Cytokine flow cytometry (CFC) assays can reliably and specifically detect human CD4 and CD8 T cell responses to AIDS-related opportunistic infections, including those caused by cytomegalovirus, Mycobacterium tuberculosis, the Mycobacterium avium complex, cryptococcus, and human papillomavirus. The purpose of this study is to devise and evaluate a similar CFC assay for the detection and quantitation of CD4 and CD8 T cell responses against HIV.

This study will evaluate a "Gag-IFNg CFC" assay by comparing the results of this assay with results from other assays of immune phenotype and function in long-term nonprogressors, untreated patients with progressive HIV disease, and recipients of candidate HIV vaccines. The study will also examine HIV-specific immune responses in HIV infected individuals who appear to exhibit significant immune protection from HIV disease.

Participants in this study will be drawn from other studies currently underway. As a part of those studies, participants will have regular blood tests. Blood samples from those studies will be used in this study. No participants will be directly enrolled in this study.

Observational
Observational Model: Defined Population
Time Perspective: Cross-Sectional
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  • Acquired Immunodeficiency Syndrome
  • HIV Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
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Blood samples from 5 cohorts of HIV infected individuals and 2 cohorts of HIV uninfected individuals will be evaluated.

Varying stages of HIV disease are represented in these cohorts, including:

  • Individuals who have been exposed but who have not seroconverted
  • Individuals who have recently seroconverted
  • HAART-treated patients who receive immune modulators such as IL-2 and therapeutic immunization
  • HAART-treated patients who undergo structured treatment interruptions
  • HAART-treated patients who have durable suppression of viremia
  • HAART-treated patients who experience incomplete suppression of viremia
  • HAART-treated patients followed with careful drug adherence monitoring
  • Long-term nonprogressors
  • Untreated progressors
Both
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Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00068978
5R01AI47062-03, 5 R01 AI47062-03
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National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Joseph M. McCune, MD, PhD University of California at San Francisco
National Institute of Allergy and Infectious Diseases (NIAID)
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP