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Analysis of Immune Responses to HIV Vaccines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00068978
Recruitment Status : Completed
First Posted : September 16, 2003
Last Update Posted : September 18, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
This study will evaluate a test designed to measure immune system responses to HIV and HIV vaccines.

Condition or disease
Acquired Immunodeficiency Syndrome HIV Infections

Detailed Description:

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 Design

Study Type : Observational
Estimated 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

Information from the National Library of Medicine

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


Locations
United States, California
Core Immunology Laboratory
San Francisco, California, United States, 94103
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Joseph M. McCune, MD, PhD University of California at San Francisco
More Information

Publications:

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