NCT00002231已完成1 期
GENEVAX-HIV (APL 400-003), a Candidate DNA Vaccine: A Pilot Dose Escalation Study of GENEVAX-HIV Delivered Intramuscularly Using the Biojector 2000 in HIV Seronegative Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to see if it is safe to give GENEVAX-HIV, a new HIV vaccine, to HIV-negative volunteers. This study will also look at how this vaccine affects the immune system of these volunteers.
详细描述
In this open-label study, volunteers are given an intramuscular injection of GENEVAX-HIV vaccine using the Biojector 2000. Safety measures and immune response are assessed accordingly.
研究设计
- 研究类型
- Interventional
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •You may be eligible for this study if you:
- •Are 18 - 60 years old.
- •Are HIV-negative and in good health.
- •Are able to understand how infections such as HIV are spread.
- •Agree to use effective methods of birth control during the study.
排除标准
- •You will not be eligible for this study if you:
- •Have hepatitis B or C.
- •Have any condition that may prevent you from completing the study.
- •Are allergic to bupivacaine, vaccines, or certain local anesthetics.
- •Have taken certain medications or have received certain therapies that may affect your immune system.
- •Have an immune system disorder or have received therapy for an immune system disorder.
- •Have been exposed to HIV within 6 months prior to study entry.
- •Have received an experimental HIV vaccine or any other experimental treatment within 30 days prior to study entry.
- •Have received blood transfusions within 6 months prior to study entry.
- •Abuse alcohol or drugs or have an uncontrolled psychiatric disorder.
- •Are pregnant or breast-feeding.
研究者
研究点 (1)
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