A Phase I Study of Aventis Pasteur Live Recombinant ALVAC-HIV (vCP205, HIV-1 Env/Gag/Pol) in Seronegative Adults Administered (1) Subcutaneously Via Ex Vivo Transfected, Autologous Dendritic Cells, (2) Intradermally, or (3) Intramuscularly

Walter Reed Army Institute of Research (WRAIR)1 个研究点分布在 1 个国家目标入组 36 人开始时间: 2001年8月31日最近更新: 2005年6月24日

适应症

试验速览

阶段: 1 期
发起方
入组人数: 36
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine the best way to administer the candidate HIV vaccine, ALVAC HIV-1 (vCP205).

详细描述

Healthy adult volunteers are assigned randomly to either a vaccine or placebo group. Injections are received either intramuscularly, intradermally, or by delivery under the skin of the volunteer's own white blood cells which have had dendritic cell reinfusion. Volunteers are vaccinated at 0, 1, 3, and 6 month time points. Volunteers are closely monitored for 1 hour after vaccination and keep a diary of symptoms for 1 week post-immunization. Volunteers undergo leukopheresis at the start of the study and after the last vaccination at Walter Reed Army Medical Center. Volunteers receive compensation benefits.

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 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 legal US residents.
•Are healthy adults from 18 to 55 years of age.

排除标准

•Volunteers will not be eligible for this study if they:
•Are HIV-positive.
•Are at highest risk for HIV infection.
•Are pregnant or breast-feeding.
•Are allergic to eggs or neomycin.
•Use certain prescription medications.

研究者

发起方

Walter Reed Army Institute of Research (WRAIR)

申办方类型

Fed

研究点 (1)

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