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

• 批准号: 8358134
• 负责人: Preston A Marx
• 金额: $ 3.2万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-05-01 至 2012-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8358134
• 关键词: Adjuvant; Animals; Antibodies; Antigens; Biopsy; Blood; Blood specimen; Funding; Grant; Human; Immune response; Immunization; Macaca mulatta; Measures; Monitor; National Center for Research Resources; Pilot Projects; Primates; Principal Investigator; Proteins; Research; Research Infrastructure; Resources; Safety; Source; Testing; Time; United States National Institutes of Health; Vaccine Adjuvant; asparaginase; base; cost; cytokine; immunogenicity; lymph nodes; male; novel; pathogen; receptor binding; response

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. The purpose of this pilot study is to compare the immunogenicity and safety of the experimental adjuvant rOv-ASP-1 against a negative control (PBS, no adjuvant) as well as a commonly used adjuvant (CpG-C ISS-ODN). Six male rhesus macaques were assigned to this project in April 2010 and placed in one of three experimental groups. All animals were immunized subcutaneously three times with 50ug purified rRBD (receptor binding domain) immunogen plus a control or test adjuvant; Group 1 (n=1) received PBS (no adjuvant), Group 2 (n=2) received 50 ug rOv-ASP-1, Group 3 (n=2) received 100 ug rOv-ASP-1 and Group 4 (n=1) received 250 ug CpG-C ISS-ODN. Blood samples were collected prior to, the day of and seven days after each immunization to measure antibody and cytokine responses. After the third immunization, antibody titers were significantly elevated. Based on these results, the final two immunizations were postponed until the antibody titers diminished. Blood was collected monthly to monitor antibody titers and cytokine responses. Recent results indicate that titers are returning to lower levels and we anticipate immunizing the animals a fourth and last time in March 2011. Blood samples will be collected prior to, the day of and days 7, 30 and 60 post-immunization to measure antibody and cytokine responses. Lymph node biopsies will also be collected 7 and 60 days post-immunization to monitor immune responses. All animals will be released to the TNPRC after the Day 60 post-immunization.

该副本是利用资源的众多研究子项目之一 由NIH/NCRR资助的中心赠款提供。对该子弹的主要支持 而且，副投影的主要研究员可能是其他来源提供的 包括其他NIH来源。 列出的总费用可能 代表subproject使用的中心基础架构的估计量， NCRR赠款不直接向子弹或副本人员提供的直接资金。 这项试验研究的目的是比较实验性辅助ROV-ASP-1与阴性对照（PBS，无辅助）以及常用辅助剂（CPG-C ISS-ODN）的免疫原性和安全性。 2010年4月，将六个男性恒河猕猴分配到该项目，并分为三个实验组之一。 用50盎司纯化的RRBD（受体结合结构域）免疫原理，对照或对照或测试辅助对所有动物进行三次免疫三次免疫三次。第1组（n = 1）接收到PBS（无辅助），第2组（n = 2）接收到50 ug rov-asp-1，第3组（n = 2）接收到100 ug rov-asp-1和第4组（n = 1）接收到250 ug cpg-c-c cpg-c iss-odn。 在每次免疫后的第二天和七天之前收集血液样本，以测量抗体和细胞因子反应。 第三次免疫后，抗体滴度显着升高。 基于这些结果，将最后两次免疫进行推迟，直到抗体滴度减少。 每月收集血液以监测抗体滴度和细胞因子反应。 最近的结果表明，滴度正在恢复到较低的水平，我们预计将在2011年3月第四和上次对动物进行免疫。将在免疫后的第7、30和60天之前收集血液样本，以测量抗体和细胞因子反应。 免疫后7天和60天还将收集淋巴结活检，以监测免疫反应。 免疫后60天后，所有动物将被释放到TNPRC。