Analysis of Immune Responses to HIV Vaccines
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ClinicalTrials.gov Identifier: NCT00068978 |
Recruitment Status
:
Completed
First Posted
: September 16, 2003
Last Update Posted
: September 18, 2007
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Condition or disease |
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Acquired Immunodeficiency Syndrome HIV Infections |
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.
Study Type : | Observational |
Enrollment : | 200 participants |
Observational Model: | Defined Population |
Observational Model: | Natural History |
Time Perspective: | Cross-Sectional |
Time Perspective: | Retrospective/Prospective |
Official Title: | Flow Cytometry Study of T Cell Responses to HIV Vaccines |
Study Start Date : | April 2003 |


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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00068978
United States, California | |
Core Immunology Laboratory | |
San Francisco, California, United States, 94103 |
Principal Investigator: | Joseph M. McCune, MD, PhD | University of California at San Francisco |
Publications of Results:
ClinicalTrials.gov Identifier: | NCT00068978 History of Changes |
Other Study ID Numbers: |
5R01AI047062-03 ( U.S. NIH Grant/Contract ) |
First Posted: | September 16, 2003 Key Record Dates |
Last Update Posted: | September 18, 2007 |
Last Verified: | August 2007 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Seronegativity HIV Preventive Vaccine HIV Therapeutic Vaccine |
Additional relevant MeSH terms:
HIV Infections Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immune System Diseases Slow Virus Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |