NCT00002402已完成1 期
Phase I/II Trial to Evaluate the Safety and Immunogenicity of AIDSVAX B/B and B/E Vaccines in the United States
VaxGen8 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2001年8月31日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 8
研究概览
简要总结
The purpose of this study is to see if it is safe and effective to give AIDSVAX B/B or AIDSVAX B/E, two potential HIV vaccines, to HIV-negative volunteers.
详细描述
Patients are randomized to 1 of the 2 following arms and administered 1 or 2 injections into the deltoid muscle at 0, 1, 6, and 12 months:
Arm A: Patients receive 1 of 3 doses of AIDSVAX B/B vaccine (MN rgp120/HIV-1 plus GNE8 rgp120/HIV-1) in alum adjuvant.
Arm B: Patients receive AIDSVAX B/E (MN rgp120/HIV-1 plus A244 rgp120/HIV-1) vaccine in alum adjuvant.
Patients are evaluated at 1 hr, 3 days, and 14 days after each immunization and at 18 months after the first immunization.
An interim analysis is performed after all patients receive the second dose (at 1 month).
研究设计
- 研究类型
- Interventional
- 主要目的
- Prevention
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must:
- •Be HIV-uninfected men and women at low or intermediate risk for HIV-1 infection.
排除标准
- 未提供
研究者
研究点 (8)
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