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

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 2010年1月15日向TRAC委员会提交了6只成年雌性恒河猴的动物申请。将动物分配至下表中定义的四个组之一。 所有动物将用50 μ g纯化的rRBD（受体结合结构域）免疫原加对照或测试佐剂（也在下表中列出）皮下免疫。 PBS将用作阴性对照（即无佐剂）。 CpG-C ISS-ODN是一种常用佐剂，将用于比较试验佐剂（rOv-ASP-1）的免疫原性和安全性。 基于在小鼠中观察到的初步结果，我们预期测试佐剂rOv-ASP-1将提供等于或上级于CpG的免疫应答。 将在第0、28、56、168和336天进行免疫接种。 将在每次免疫接种前和免疫接种后一周采集血样，以测量抗体和细胞因子应答。 将进行体格检查、CBC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。 含量类别名称 分配至组的动物数量 免疫接种 组1 1 50 ug rRBD + PBS（无佐剂） 组2 2 50 ug rRBD + 50 ug rOv-ASP-1 组3 2 50 ug rRBD + 100 ug rOv-ASP-1 第4组 1 50 ug rRBD + 250 ug CpG-C ISS-ODN

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