Phase I/IIA Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Thymon, LLC
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Anti-Tat Antibody Titer
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Anti-Tat Antibody Titer
时间窗: 5 weeks
ELISA based chemiluminescent assay to determine the anti-Tat antibody response
次要结局
未报告次要终点