Selection of a Protective T Cell-based HIV-1/FIV Vaccine

NCT ID: NCT02389595

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2028-05-31

Brief Summary

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The purpose of this research study is to develop a vaccine against Human immunodeficiency virus (HIV), a disease that causes AIDS in people,. The investigator will be looking at viruses similar to HIV in animals. Since these viruses are very similar to HIV, the blood from humans who have been exposed to HIV will be tested to see if the immune system will recognize the HIV and prevent infection.

HIV targets the immune system by attacking certain T cells called CD4+ T cells. There are parts on the AIDS viruses that help the virus infect these cells and other parts that help the immune system prevent viral infection by activating protective T-cells that fight HIV. Different T-cell populations are very important in most vaccines as they act as "effectors" that work as part of the immune system to recognize and fight off HIV infection. When effector T cells are activated by appropriate "protective" part(s) of the virus they either block HIV from reproducing or kill HIV infected cells. By finding these common protective parts of each of these human and animal AIDS viruses, the investigator hopes to make a vaccine that helps the immune system prevent HIV infection by avoiding parts that attack CD4+ T cells and may worsen HIV infection and selecting for parts that stimulate effector T cells that fight HIV infection.

Detailed Description

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As a participant in this study a blood drawn will performed.

Conditions

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HIV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HIV positive subjects

This group will provide a blood sample.

HIV positive subjects

Intervention Type OTHER

This group will provide a blood sample.

Non-infected control subjects

This group consist of de-identified blood samples from a commercial source.

Non-infected control subjects

Intervention Type OTHER

This group will be de-identified blood samples from a commercial source.

Interventions

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HIV positive subjects

This group will provide a blood sample.

Intervention Type OTHER

Non-infected control subjects

This group will be de-identified blood samples from a commercial source.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male and female subjects between 18 and 65 years old who are HIV positive

Exclusion Criteria

* Persons with other immune diseases that would result in autoimmunity or aberrant immune responses (such as subjects who have undergone chemotherapy within the past year).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janet K Yamamoto, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

UF Center for AIDS Research Education and Service

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB201401012-N

Identifier Type: -

Identifier Source: org_study_id

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