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
  Purpose

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


Condition
Acquired Immunodeficiency Syndrome
HIV Infections

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Official Title: Flow Cytometry Study of T Cell Responses to HIV Vaccines

Resource links provided by NLM:


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

Estimated Enrollment: 200
Study Start Date: April 2003
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.

  Eligibility

Genders Eligible for Study:   Both
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
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: NCT00068978

Locations
United States, California
Core Immunology Laboratory
San Francisco, California, United States, 94103
Sponsors and Collaborators
Investigators
Principal Investigator: Joseph M. McCune, MD, PhD University of California at San Francisco
  More Information

Additional Information:
Publications:

ClinicalTrials.gov Identifier: NCT00068978     History of Changes
Other Study ID Numbers: 5R01AI47062-03, 5 R01 AI47062-03
Study First Received: September 12, 2003
Last Updated: September 17, 2007
Health Authority: United States: Federal Government

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
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 22, 2014