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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:
6305892
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:
1999
资助国家:
美国
项目状态:
已结题
起止时间:
1999-12-01 至 2000-11-30

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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期试验旨在扩展关于两种HIV-1疫苗策略的安全性和免疫原性的可用数据:金丝雀痘病毒载体vCP 205(Pasteur Merieux康诺特)或vCP 205 + SF-2 rgp 120(Chiron Vaccines)。这些疫苗策略已在健康免疫活性成人的I期研究中进行了评价,并显示出良好的耐受性和免疫原性。本疫苗试验的目标是将试验扩展到更大的人群基础,以便比I期研究数据更精确地估计安全性特征和免疫原性。志愿者将被招募和筛选。确定合格的受试者将入组24个月研究,每年进行一次随访访视,持续2年。 本多中心试验共将研究420例受试者。我们的网站将特别提供关于注射毒品使用者(IDUs)疫苗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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