A T Cell-based HIV Vaccine

Sponsor
University of Florida (Other)
Overall Status
Recruiting
CT.gov ID
NCT02389595
Collaborator
Janet K. Yamamoto Donor Fund (Other), National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
270
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135
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: HIV positive subjects
  • Other: Non-infected control subjects

Detailed Description

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
270 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Selection of a Protective T Cell-based HIV-1/FIV Vaccine Devoid of Viral Enhancing Epitopes
Actual Study Start Date :
May 1, 2015
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. T cell proliferation in response to viral epitopes [120 hours (5 days)]

Secondary Outcome Measures

  1. Cytokine production in response to viral epitopes [24 hours (1 day)]

  2. Cytotoxin production in response to viral epitopes [8 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Florida Gainesville Florida United States 32611
2 UF Center for AIDS Research Education and Service Jacksonville Florida United States 32209

Sponsors and Collaborators

  • University of Florida
  • Janet K. Yamamoto Donor Fund
  • National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Janet K Yamamoto, PhD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT02389595
Other Study ID Numbers:
  • IRB201401012-N
  • 5R01AI030904
First Posted:
Mar 17, 2015
Last Update Posted:
Feb 12, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Florida

Study Results

No Results Posted as of Feb 12, 2021