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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02389595
• Other study ID #: IRB201401012-N
• Status: Active, not recruiting
• Start date: May 2015
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 270
• Est. completion date: May 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• HIV positive subjects
This group will provide a blood sample.
• Non-infected control subjects
This group will be de-identified blood samples from a commercial source.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida
United States	UF Center for AIDS Research Education and Service	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T cell proliferation in response to viral epitopes		120 hours (5 days)
Secondary	Cytokine production in response to viral epitopes		24 hours (1 day)
Secondary	Cytotoxin production in response to viral epitopes		8 hours