A Phase 1 Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate Safety and Immunogenicity of a Multiantigen HIV (HIV-MAG) pDNA Vaccine With or Without Human IL-12 pDNA GENEVAX® IL-12) and Ad35-GRIN/ENV Vaccine in HIV-Uninfected, Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 3
- 主要终点
- Number of participants with adverse events as a measure of safety and tolerability
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and immunogenicity of multiantigen HIV (HIV-MAG) plasmid DNA (pDNA) vaccine co-administered with recombinant human IL-12 pDNA (GENEVAX® IL-12) followed or preceded by recombinant Ad35-GRIN/ENV HIV vaccine in low-risk for HIV-uninfected healthy adults.
详细描述
The study is a randomized, double-blind placebo-controlled trial assessing the safety and tolerability of HIV-MAG with or without co-administered GENEVAX® IL-12 given intramuscularly by in vivo electroporation (IM/EP) using the Ichor Medical Systems TriGrid Delivery System (TDS-IM) followed by Ad35-GRIN/ENV in each of four different regimens. An additional group will evaluate the safety and tolerability of Ad35-GRIN/ENV followed by HIV-MAG with co-administered GENEVAX® IL-12 given intramuscularly by in vivo electroporation (IM/EP) using the Ichor Medical Systems TriGrid Delivery System (TDS-IM).
Volunteers will be screened up to 42 days before the 1st vaccination and will be followed for 12 months after the first vaccine administration. It is anticipated that it will take approximately 3 months to enrol the study. Approximately 75 volunteers (60 vaccine/15 placebo recipients) will be included in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •healthy male or female adults,
- •18 to 50 years of age (21 to 50 years of age for volunteers in Rwanda),
- •who do not report high-risk behaviour for HIV infection,
- •who are available for the duration of the trial,
- •who are willing to undergo HIV testing,
- •use an effective method of contraception, and
- •who, in the opinion of the principal investigator or designee, understand the study and who provide written informed consent.
- •Principal exclusion criteria:
- •confirmed HIV infection,
- •pregnancy and lactation,
- •significant acute or chronic disease,
- •clinically significant laboratory abnormalities,
- •recent vaccination or receipt of a blood product,
- •previous receipt of an HIV vaccine, and
- •previous severe local or systemic reactions to vaccination or history of severe allergic reactions.
排除标准
- 未提供
结局指标
主要结局
Number of participants with adverse events as a measure of safety and tolerability
时间窗: 13 months approximately
To evaluate the safety and tolerability of HIV-MAG, GENEVAX® IL-12, and Ad35-GRIN/ENV administered in five heterologous prime-boost regimens.
次要结局
- Immunogenicity(12 months)