Analysis of Immune Responses to HIV Vaccines

Flow Cytometry Study of T Cell Responses to HIV Vaccines

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00068978

Enrollment

200

Registered

2003-09-16

Start date

2003-04-30

Completion date

Unknown

Last updated

2007-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Immunodeficiency Syndrome, HIV Infections

Keywords

HIV Seronegativity, HIV Preventive Vaccine, HIV Therapeutic Vaccine

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

DEFINED_POPULATION

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion 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

Countries

United States

Outcome results