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

NCT02389595 | Active Not Recruiting

• 1 other identifier: IRB201401012-N
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV

Keywords

HIV; vaccine; T cell

Outcome Measures

Primary Outcomes (1)

• T cell proliferation in response to viral epitopes

  120 hours (5 days)

Secondary Outcomes (2)

• Cytokine production in response to viral epitopes

  24 hours (1 day)

• Cytotoxin production in response to viral epitopes

  8 hours

Study Arms (2)

HIV positive subjects

This group will provide a blood sample.

Other: HIV positive subjects

Non-infected control subjects

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

Other: Non-infected control subjects

Interventions

HIV positive subjects OTHER

This group will provide a blood sample.

HIV positive subjects

Non-infected control subjects OTHER

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

Non-infected control subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV positive individuals between 18 and 65 years old

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Florida: lead

Study Sites (2)

University of Florida

Gainesville, Florida, 32611, United States

Location

UF Center for AIDS Research Education and Service

Jacksonville, Florida, 32209, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum Whole Blood T cells

Study Officials

• Janet K Yamamoto, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: March 17, 2015
• Study Start: May 1, 2015
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

US (2)