CANARYPOX ALVAC-HIV VCP205 VACCINE IN HIV-INFECTED ADULTS

这项多中心、随机、安慰剂对照、双盲的II期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的现有数据：金丝雀痘载体vCP205(巴斯德·梅里埃康诺)或vCP205与SF-2 rgp120(ChIron疫苗)。这些疫苗策略已经在健康的具有免疫能力的成年人的I期研究中进行了评估，并被证明具有良好的耐受性和免疫原性。这项疫苗试验的目标是将测试扩大到更大的人群基础，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。那些被确定为合格的人将被登记参加这项为期24个月的研究，并每年进行为期两年的随访。在这项多中心试验中，共有420名受试者进行研究。我们的网站尤其将在注射吸毒者(IDU)中提供有关疫苗安全性和免疫原性的信息。

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).