Analysis of Immune Responses to HIV Vac… | Clinical Trial

Key information

Conditions

Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Core Immunology Laboratory

San Francisco, California, 94103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Official study title

Flow Cytometry Study of T Cell Responses to HIV Vaccines

Important dates

Study start: 2003
First posted: Sep 16, 2003
Registry last updated: Sep 18, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed