CORE--PRECLINICAL PRIMATE MODELS

此核心的目标是实现标准化协议，以 测试候选疫苗抗原的免疫原性和在非 人类灵长类动物。具体目标是确定最佳剂量和 获得有效和持久的给药途径 确定配子抗体的血清和生殖道滴度 灵长类动物模型中的抗原。我们将特别注意 测量和比较对已定义配子的免疫反应 猕猴输卵管液、宫颈粘液和血清中的抗原 节育发展协会选择的节育物种 分支机构的研究重点。 这个核心的具体功能是：1)确保健康和 用于免疫和生殖研究的灵长类动物福利；2)至 给猴子接种重组蛋白和多肽免疫原； 3)采集灵长类动物血清、输卵管液和宫颈粘液 受试者；4)测定发展为 随着时间的推移，每种动物中的特定免疫原；5)量化 在每种液体中产生的针对特定配子抗原的抗体类别 使用猴子特有的试剂；6)通过以下方式优化免疫反应 不同剂量、不同配方、不同途径和不同时间的抗原传递； 7)确定特定免疫原的安全性。 从D核心获得的信息对于准备大规模- 计划进行的大规模避孕药效试验 主要在加州地区灵长类研究中心(CRPRC) 戴维斯，一旦免疫原性和安全性评估 在这个核心完成。然而，预计会有一些疗效 测试可能在弗吉尼亚州的D芯进行。这种灵活性是 需要最大限度地减少因可用而可能出现的延迟 每个设施里都有猴子和笼子。两者之间的合作 中心一直在进行信息交流，猴子，和 猴子的组织一直是有益的。核心D生成的数据 CRPRC将帮助确定哪些抗原是合适的 人类临床试验的候选人。有见及此，研究将会 专注于确定最小剂量，这将优化和 维持免疫反应。

The objective of this core is to implement standardized protocols to test candidate vaccine antigens for immunogenicity and safety in non- human primates. Specific goals are to determine the optimal dose and route of administration required to obtain effective and persistent serum and reproductive tract titers of antibody of defined gamete antigens in the primate model. Particular attention will be paid to measuring and comparing the immune response to defined gamete antigens in oviductal fluids, cervical mucus and serum in Macaca fascicular is, the species chosen by the Contraception Development Branch for research focus. Specific functions of this core are: 1) to ensure the health and welfare of primates for immunologic and reproductive studies; 2) to inoculate monkeys with recombinant proteins and peptide immunogens; 3) to collect serum, oviductal fluid and cervical mucus from primate subjects; 4) to determine the quantity of antibody developed to specific immunogens in each animal over time; 5) to quantitiate the classes of antibodies arising to defined gamete antigens in each fluid using monkey-specific reagents; 6) to optimize immune responses by varying doses, formulations, routes and timing of antigen delivery; and 7) to determine the safety of specific immunogens. Information obtained from Core D is essential to prepare for large- scale contraceptive efficacy trials which are planned to be conducted mainly at the California Regional Primate Research Center (CRPRC) in Davis, once immunogenicity and safety evaluations have been completed in this core. However, it is anticipated that some efficacy tests may be performed in Core D at Virginia. This flexibility is required to minimize delays that may arise due to availability of monkeys and cages at each facility. Collaboration between the two Centers has been ongoing and exchange of information, monkeys, and monkey tissue has been beneficial. The data generated by the Core D and the CRPRC will help determine which antigens are suitable candidates for human clinical trials. In view of this, studies will focus on identifying the minimal dose which will optimize and and sustain immune responses.