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:
6115807
负责人:
MICHAEL MARMOR
金额:
$2.1万
依托单位国家:
美国
项目类别:
财政年份:
1998
资助国家:
美国
项目状态:
已结题
起止时间:
1998-12-01 至 1999-11-30

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期试验旨在扩大两种HIV-1疫苗策略的安全性和免疫原性的可用数据:金丝猴痘载体vCP205 (Pasteur Merieux Connaught)或含有SF-2 rgp120的vCP205 (Chiron Vaccines)。这些疫苗策略已在健康免疫能力成年人的i期研究中进行了评估,并显示出良好的耐受性和免疫原性。该疫苗试验的目标是将试验扩展到更大的人群基础,以便比第一阶段研究数据更精确地估计安全性和免疫原性。志愿者将被招募和筛选。确定符合条件的患者将参加为期24个月的研究,每年随访2年。这项多中心试验共纳入420名受试者。我们的网站将特别提供关于注射吸毒者(IDUs)疫苗的安全性和免疫原性的信息。
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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