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Active, Not Recruiting

NCT Number: NCT02389595

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HIV

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida, Gainesville, Florida, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

HIV positive subjects

Other

This group will provide a blood sample.

Non-infected control subjects

Other

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

Primary outcomes

  1. T cell proliferation in response to viral epitopes

    Time frame: 120 hours (5 days)

Secondary outcomes

  1. Cytokine production in response to viral epitopes

    Time frame: 24 hours (1 day)

  2. Cytotoxin production in response to viral epitopes

    Time frame: 8 hours

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Selection of a Protective T Cell-based HIV-1/FIV Vaccine Devoid of Viral Enhancing Epitopes

Important dates

Study start
2015
Primary completion
2028
Study completion
2028
First posted
Mar 17, 2015
Registry last updated
Aug 24, 2025

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.

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