Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects

Study Overview
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Brief Summary
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This protocol represents the second in human study of TUTI-16, and is being conducted to continue to gather safety and human immunogenicity (anti-HIV-1 Tat titers) data of subcutaneously administered TUTI-16.

Detailed Description
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HIV-1 Tat protein, a virally encoded toxin, is secreted by HIV-1 infected cells and acts on uninfected cells, rendering them permissive for HIV-1 replication. HIV-1 Tat enhances chronic viral replication and induces immune suppression. Antibodies to Tat inhibit this Tat-mediated transcellular activation in vitro and minimize chronic plasma viremia. HIV-1 Tat activities can be blocked in vitro and in vivo by anti-Tat antibodies. The Thymon Universal Tat Immunogen (TUTI-16) is a fully synthetic, self-adjuvanting lipopeptide vaccine that is water soluble and administered by subcutaneous injection. In preclinical studies, a priming dose and a three week boost in rats induced a high titer antibody response to the eight known distinct epitope variants of HIV-1 Tat protein. These antibodies block the function of the HIV-1 Tat protein (toxin), which is essential to the maintenance of chronic HIV-1 viremia. Therefore, TUTI-16 has potential as a therapeutic vaccine for HIV-1 in humans.

Official Title
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Phase I/IIA Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects

Conditions
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HIV Infections

Intervention / Treatment
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* Biological: TUTI-16 (0.2mg)
* Biological: TUTI-16 (1.0 mg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and Females Age ≥18 and ≤50 years at Screening HIV negative healthy subjects or HIV-1 seropositive subjects on effective ART for >2 months (undetectable HIV plasma viremia), viral set point before ART >3,000 CD4+ T-cell count ≥ 500/mm3. Exclusion Criteria: Pregnant/nursing females Positive for HBV or HCV Acute Herpetic event Any clinically significant out-of range laboratory value Routine or PRN consumption of immune suppressive medications that the subject is unable or unwilling to discontinue during the study Participation in another investigational drug/vaccine study within 30 days preceding the first injection of investigational agent in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TUTI-16 (0.2mg)<br>Two subcutaneous injections of 0.2 mg at Day 0, and Week 5. | Biological: TUTI-16 (0.2mg)<br>* Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.<br>|
| Experimental: TUTI-16 (1.0 mg)<br>Two subcutaneous injections of 1.0 mg at Day 0, and Week 5. | Biological: TUTI-16 (1.0 mg)<br>* Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-Tat Antibody Titer | ELISA based chemiluminescent assay to determine the anti-Tat antibody response | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, vaccine, lipopeptide, Tat, TUTI-16, THYMON