MAO/EVALUATION OF AIDS VACCINES IN NON-HUMAN PRIMATE MOD

HIV临床前疫苗开发主协议计划 启动以使NIAID能够提供资源，以加速 开发有前景的疫苗方法。 在这个项目下，一系列 已经启动了疫苗研究，以评估候选疫苗和原型疫苗 非人类灵长类动物的艾滋病疫苗。 这些研究旨在获得 更多关于候选人的功效和最佳表现的信息 正在进行人体I期临床试验或拟用于 这些试验以及与这些相同类型的SIV疫苗原型 艾滋病毒疫苗。 其他疫苗研究将评估原型艾滋病毒或SIV 提供新的呈递系统的疫苗， 引发广泛的交叉反应性免疫反应，或已显示出有希望 初步结果。 NIAID已启动与以下机构的合作安排： 研究人员已经同意提供艾滋病毒和SIV疫苗， 非人灵长类动物的免疫。 在所有的疫苗研究中， 非人灵长类动物将在免疫后被攻击以确定是否 可以获得免受感染或疾病的保护。 的 主协议计划B类承包商，包括 承包商上面列出的，将提供，住房和照顾，免疫， 在各种疫苗研究中挑战非人类灵长类动物。 的 承包商将从以下人员中获得血清、细胞和其他适当的样本： 研究中的动物，并将酌情将样品运送至 体液免疫反应评价承包商，包括 中和抗体，用于评价细胞免疫应答，以及 用于攻毒后的病毒学评估。 B类承包商 将为他们正在进行的每项研究维护一个数据库， 遵循免疫方案、病毒攻毒和所有试验 研究中每只猴子的结果。

The HIV preclinical Vaccine Development Master Agreement Program was initiated to enable the NIAID to provide resources to accelerate the development of promising vaccine approaches. Under this program, a series of vaccine studies have been initiated to evaluate candidate and prototype AIDS vaccines in nonhuman primates. These studies are designed to obtain more information about the efficacy and optimum presentation of candidate HIV vaccines that are in human Phase I clinical trials or proposed for such trials as well as prototype SIV vaccines of the same type as these HIV vaccines. Other vaccine studies will evaluate prototype HIV or SIV vaccines that offer novel presentation systems, may be capable of eliciting broadly cross-reactive immune responses, or have shown promising preliminary results. NIAID has initiated collaborative arrangements with researchers who have agreed to provide HIV and SIV vaccines for immunization of nonhuman primates. In all of the vaccine studies, the nonhuman primates will be challenged after immunization to determine if protection from infection or from disease can be obtained. The contractors in Category B of the Master Agreement Program, including the contractor listed above, will provide, house and care for, immunize, and challenge the nonhuman primates for the various vaccine studies. The contractors will obtain sera, cells, and other appropriate samples from the animals in the studies, and will ship the samples, as appropriate, to contractors for evaluation of humoral immune responses, including neutralizing antibodies, for evaluation of cellular immune responses, and for virological assessment after challenge. The category B contractor will maintain a data base for each study they are conducting in order to follow the immunization protocol, virus challenge, and all the assay results for each monkey in the study.