A Phase I Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Trial to Evaluate the Safety and Immunogenicity of a Sendai HIV Vaccine SeV-G(NP) Given Intranasally and Ad35-GRIN Administered Intramuscularly in Prime-Boost Regimens in HIV-Uninfected, Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 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 Sendai HIV vaccine SeV-G(NP) given intranasally and Ad35-GRIN administered intramuscularly in prime-boost regimens in HIV-uninfected, healthy adult volunteers.
详细描述
The study is a randomized, double-blind, placebo-controlled, dose-escalation trial assessing the safety, tolerability, and immunogenicity of SeV-G(NP) given intranasally by drops and Ad35-GRIN administered intramuscularly in each of four prime-boost regimens.
Volunteers will be screened up to 42 days before the 1st vaccination and will be followed for 12 months after the last vaccine administration (16 months after the first vaccination). It is anticipated that it will take approximately 6 months to enroll the study. Approximately 64 volunteers (48 vaccine and 16 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.
排除标准
- •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.
结局指标
主要结局
Number of participants with adverse events as a measure of safety and tolerability
时间窗: 16 months approximately
To evaluate the safety and tolerability of SeV-G(NP) and Ad35-GRIN administered in four prime-boost regimens.
次要结局
- Immunogenicity(16 months)
- Shedding(16 months)