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利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 2010年1月15日，一份动物申请被提交给TRAC委员会，要求六只成年雌性猕猴。这些动物将被分配到下表所定义的四个组中的一个。所有动物将用50微克纯化的rRBD(受体结合域)免疫原加上对照或试验佐剂(也列在下表中)进行皮下免疫。PBS将作为阴性对照(即无佐剂)。CpG-C ISS-ODN是一种常用的佐剂，将用于比较试验佐剂(ROV-ASP-1)的免疫原性和安全性。根据在小鼠身上看到的初步结果，我们预计试验佐剂ROV-ASP-1将提供与CpG相同或更好的免疫反应。免疫接种时间分别为0、28、56、168和336天。每次免疫前和接种后一周将采集血样，以测定抗体和细胞因子反应。将进行体检、血细胞计数和化验(包括肝脏面板)，以监测动物的健康状况，并检测疫苗接种后的任何不良反应。 被分配到群免疫的动物的群编号# 第1组：50ug rRBD+PBS(无佐剂) 第2组：50ug rRBD+50ug ROV-ASP-1 第3组2 50ug rRBD+100ug ROV-ASP-1 第4组1 50ug 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