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

Active, not recruiting

• Conditions: HIV
• Interventions: Other: HIV positive subjects; Other: Non-infected control subjects

• Registration Number: NCT02389595
• Lead Sponsor: University of Florida

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2015-03-10
• Study First Submitted QC: 2015-03-16
• Study First Posted: 2015-03-17
• Study Start: 2015-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-07
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

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

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV positive subjects	HIV positive subjects	This group will provide a blood sample.
Non-infected control subjects	Non-infected control subjects	This group consist of de-identified blood samples from a commercial source.

Primary Outcome Measures

Name	Time	Method
T cell proliferation in response to viral epitopes	120 hours (5 days)

Secondary Outcome Measures

Name	Time	Method
Cytotoxin production in response to viral epitopes	8 hours
Cytokine production in response to viral epitopes	24 hours (1 day)

Trial Locations

Locations (2)

UF Center for AIDS Research Education and Service; 🇺🇸 Jacksonville, Florida, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States