NHP PILOT STUDY OF A NOVEL PROTEIN ADJUVANT FOR VACCINES AGAINST HUMAN PATHOGENS

NHP 针对人类病原体疫苗的新型蛋白质佐剂的试点研究

基本信息

批准号：
8173048
负责人：
Preston A Marx
金额：
$ 3.94万
依托单位：
TULANE UNIVERSITY OF LOUISIANA
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-05-01 至 2011-04-30
项目状态：
已结题

项目摘要

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. An animal request was submitted to the TRAC committee on 1/15/10 for six adult female Rhesus macaques. The animals will be assigned to one of four groups as defined in the table below. All animals will be immunized subcutaneously with 50 ug purified rRBD (receptor binding domain) immunogen plus a control or test adjuvant (also listed in the table below). PBS will serve as a negative control (i.e. no adjuvant). CpG-C ISS-ODN is a commonly used adjuvant and will be used to compare the immunogenicity and safety of the test adjuvant (rOv-ASP-1). We anticipate, based on preliminary results seen in mice, that the test adjuvant, rOv-ASP-1, will provide immune responses that are equal to or superior to the CpG. Immunizations will be given on Days 0, 28, 56, 168 and 336. Blood samples will be collected prior to and one week after each immunization to measure antibody and cytokine responses. Physical exams, CBC and chemistries (including liver panels) will be performed to monitor the health of the animals and to detect any adverse reactions to the immunizations. Group Designation # of animals assigned to group Immunization given Group 1 1 50 ug rRBD + PBS (no adjuvant) Group 2 2 50 ug rRBD + 50 ug rOv-ASP-1 Group 3 2 50 ug rRBD + 100 ug rOv-ASP-1 Group 4 1 50 ug rRBD + 250 ug CpG-C ISS-ODN

该子项目是利用该技术的众多研究子项目之一资源由 NIH/NCRR 资助的中心拨款提供。子项目及研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金，因此可以在其他 CRISP 条目中表示。列出的机构是对于中心来说，它不一定是研究者的机构。 2010 年 1 月 15 日，我们向 TRAC 委员会提交了一份关于六只成年雌性恒河猴的动物申请。这些动物将被分配到下表中定义的四个组中的一组。所有动物将用 50 ug 纯化的 rRBD（受体结合域）免疫原加上对照或测试佐剂（也在下表中列出）进行皮下免疫。 PBS 将作为阴性对照（即无佐剂）。 CpG-C ISS-ODN 是常用的佐剂，将用于比较测试佐剂（rOv-ASP-1）的免疫原性和安全性。根据在小鼠中观察到的初步结果，我们预计测试佐剂 rOv-ASP-1 将提供等于或优于 CpG 的免疫反应。将在第 0、28、56、168 和 336 天进行免疫接种。将在每次免疫之前和之后一周收集血样，以测量抗体和细胞因子反应。将进行体检、全血细胞计数和化学检查（包括肝脏检查），以监测动物的健康状况并检测免疫接种的任何不良反应。组名称分配到组的动物数量给予免疫接种第 1 组 1 50 ug rRBD + PBS（无佐剂）第 2 组 2 50 ug rRBD + 50 ug rOv-ASP-1 第 3 组 2 50 ug rRBD + 100 ug rOv-ASP-1 第 4 组 1 50 ug rRBD + 250 ug CpG-C 国际空间站ODN