课题基金 / 基金详情

CANARYPOX ALVAC-HIV VCP205 VACCINE IN HIV-INFECTED ADULTS

CANARYPOX ALVAC-HIV VCP205 VACCINE IN HIV-INFECTED ADULTS
用于 HIV 感染成人的金丝雀痘 ALVAC-HIV VCP205 疫苗
批准号:
6277041
负责人:
MICHAEL MARMOR
金额:
$2.03万
依托单位国家:
美国
项目类别:
财政年份:
1997
资助国家:
美国
项目状态:
已结题
起止时间:
1997-12-01 至 1998-11-30

项目摘要

项目成果

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中文摘要
翻译
这项多中心、随机、安慰剂对照、双盲、 II试验旨在扩大关于 两种HIV-1疫苗策略的安全性和免疫原性:金丝雀痘 载体vCP 205(Pasteur Merieux康诺特)或含SF-2 rgp 120的vCP 205 (喀戎疫苗)。这些疫苗策略已在 在健康免疫功能正常的成人中进行的I期研究, 耐受性和免疫原性良好。这项疫苗试验的目的是 将测试扩展到更大的人群基础,以估计 安全性特征和免疫原性,比可能的更精确 I期研究数据。志愿者将被招募和筛选。 确定合格的受试者将入组24个月的研究, 每年随访2年。 共有420名受试者将 在这项多中心试验中进行研究。我们的网站将特别 提供有关疫苗安全性和免疫原性的信息 在注射毒品使用者中。
英文摘要
This multicenter, randomized, placebo-controlled, double-blinded phase- II trial is directed at expanding the available data regarding the safety and immunogenicity of two HIV-1 vaccine strategies: canarypox vector vCP205 (Pasteur Merieux Connaught) or vCP205 with SF-2 rgp120 (Chiron Vaccines). These vaccine strategies have been evaluated in phase-I studies in healthy immunocompetent adults and have been shown to be well tolerated and immunogenic. The goal of this vaccine trial is to expand testing into a larger population base, in order to estimate the safety profile and immunogenicity with more precision than possible from phase-I study data. Volunteers will be recruited and screened. Those determined to be eligible will be enrolled in the 24-month study, with annual follow-up visits for 2 years. A total of 420 subjects will be studied in this multicenter trial. Our site in particular will provide information on the safety and immunogenicity of the vaccines among injecting drug users (IDUs).
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