NCT00004579已完成1 期
A Phase I, Dose-Ranging Trial of the Pasteur Merieux Connaught (PMC) Oligomeric HIV-1 gp160MN/LAI-2 Vaccine Alone or Primed With Live Recombinant ALVAC-HIV (vCP205) in HIV Seronegative Adults
Walter Reed Army Institute of Research (WRAIR)1 个研究点 分布在 1 个国家开始时间: 1998年4月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to see whether an HIV vaccine, ALVAC vCP205, is safe and can prevent HIV infection. The vCP205 vaccine will be tested with another vaccine, gp160MN/LAI-2.
详细描述
This study consists of 2 parts:
Part A: Dose-escalation protocol using oligomeric gp160MN/LAI-2. Part B: Placebo-controlled, randomized, double-blind (within arm) study of vCP205 priming with gp160MN/LAI-2 boosting.
Volunteers are followed for at least 1 year.
研究设计
- 研究类型
- Interventional
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers may be eligible for this study if they:
- •Are HIV-negative.
- •Are in good health.
- •Are between ages 18 and
- •Are available for at least 1 year.
- •Are a resident of the United States of America.
- •Agree to practice sexual abstinence or use birth control.
排除标准
- •Volunteers will not be eligible for this study if they:
- •Have ever been given an HIV vaccine or certain other vaccines. (However, rabies vaccines are allowed.)
- •Participate in activities that place them at high-risk for HIV infection, such as injection drug use or unprotected sex with someone who has HIV infection.
- •Have certain psychiatric, medical, or substance abuse problems.
- •Are allergic to eggs or other vaccines.
- •Are an employee at a participating site and have access to study information.
- •Are taking certain medications.
- •Have received blood transfusions within 3 months before entering this study.
- •Are pregnant or breast-feeding.
研究者
研究点 (1)
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