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

艾滋病毒临床前疫苗开发主协议计划是 启动以使NIAID能够提供资源以加速 开发有前景的疫苗方法。在这个节目中，一系列 的疫苗研究已经启动，以评估候选和原型 非人灵长类动物的艾滋病疫苗。这些研究旨在获得 有关候选人的效力和最佳表现的更多信息 正在进行人类第一阶段临床试验或建议用于 这些试验以及与这些疫苗相同类型的SIV疫苗原型 艾滋病毒疫苗。其他疫苗研究将评估艾滋病毒原型或SIV 提供新呈现系统的疫苗可能能够 引发广泛的交叉反应免疫反应，或已显示出有希望的 初步结果。NIAID已启动与 同意为以下人群提供艾滋病毒和SIV疫苗的研究人员 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接受挑战，以确定 可以获得免受感染或疾病的保护。这个 主协议计划B类承包商，包括 上面列出的承包商将提供、住宿和护理、接种疫苗和 挑战非人类灵长类动物进行各种疫苗研究。这个 承包商将从以下地点获得血清、细胞和其他适当的样本 研究中的动物，并将酌情将样本运往 评估体液免疫反应的承包商，包括 中和抗体，用于评估细胞免疫反应，以及 用于挑战后的病毒学评估。B类承建商 将为他们正在进行的每项研究维护一个数据库，以便 遵循免疫方案、病毒挑战和所有化验 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.