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A T Cell-based HIV Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02389595
Recruitment Status : Recruiting
First Posted : March 17, 2015
Last Update Posted : January 23, 2020
Sponsor:
Collaborators:
Janet K. Yamamoto Donor Fund
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of Florida

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
HIV Other: HIV positive subjects Other: Non-infected control subjects

Detailed Description:
As a participant in this study a blood drawn will performed.

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Study Type : Observational
Estimated 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
Study Start Date : May 2015
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.




Primary Outcome Measures :
  1. T cell proliferation in response to viral epitopes [ Time Frame: 120 hours (5 days) ]

Secondary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Serum Whole Blood T cells


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV positive individuals between 18 and 65 years old
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02389595


Contacts
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Contact: Janet K Yamamoto, PhD 352-294-4145 yamamoto@ufl.edu
Contact: Alek Aranyos 352-294-4196 aaranyos1@ufl.edu

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Janet K Yamamoto, PhD    352-294-4145    yamamoto@ufl.edu   
Contact: Shannon R Roff, DVM    352-294-4152    shannon.roff@ufl.edu   
Principal Investigator: Janet K Yamamoto, PhD         
UF Center for AIDS Research Education and Service Recruiting
Jacksonville, Florida, United States, 32209
Contact: Mobeen H Rathore, MD    904-224-3739    mobeen.rathore@jax.ufl.edu   
Contact: Kathleen A Thoma, CCRA    904-224-3059    kathleen.thoma@jax.ufl.edu   
Principal Investigator: Janet K Yamamoto, PhD         
Sponsors and Collaborators
University of Florida
Janet K. Yamamoto Donor Fund
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Janet K Yamamoto, PhD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02389595    
Other Study ID Numbers: IRB201401012
5R01AI030904 ( U.S. NIH Grant/Contract )
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
HIV
vaccine
T cell
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs