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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV
• Intervention / Treatment: Other: HIV positive subjects; Other: Non-infected control subjects

Detailed Description

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

• Study Type: Observational
• Enrollment (Anticipated): 270

Contacts and Locations

• Study Contact: Name: Janet K Yamamoto, PhD; Phone Number: 352-294-4145; Email: yamamoto@ufl.edu
• Study Contact Backup: Name: Alek Aranyos; Phone Number: 352-294-4196; Email: aaranyos1@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida
    • Jacksonville, Florida, United States, 32209
      • UF Center for AIDS Research Education and Service

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

HIV positive individuals between 18 and 65 years old

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HIV positive subjects; This group will provide a blood sample.	Other: HIV positive subjects; This group will provide a blood sample.
Non-infected control subjects; This group consist of de-identified blood samples from a commercial source.	Other: Non-infected control subjects; This group will be de-identified blood samples from a commercial source.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
T cell proliferation in response to viral epitopes	120 hours (5 days)

Secondary Outcome Measures

Outcome Measure	Time Frame
Cytokine production in response to viral epitopes	24 hours (1 day)
Cytotoxin production in response to viral epitopes	8 hours

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Janet K Yamamoto, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: March 10, 2015
• First Submitted That Met QC Criteria: March 16, 2015
• First Posted (Estimate): March 17, 2015

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: HIV; vaccine; T cell
• Other Study ID Numbers: IRB201401012-N; 5R01AI030904 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No