A P. falciparum MSP1 p42/QS-21 malaria vaccine

描述：(改编自申请者摘要)疟疾是一种 每年影响3亿多人，对150万人来说是致命的。 STTR第一阶段项目的总体目标是产生cGMP疟疾 恶性疟原虫42 kDa C末端多肽疫苗 裂殖子表面蛋白-1(MSP1.42)将与QS21佐剂配制用于 临床前研究和未来的临床I期试验。提出了证据 MSP1.42/QS-21在Aotus猴体内对恶性疟原虫的保护作用 模特。数据也支持了大规模MSP1.42的可行性 杆状病毒系统的生产及标准品纯化 层析法。该项目的目标是(1)生产主细胞 用于病毒储存和多肽生产的昆虫细胞系银行， (2)重组MSP1.42病毒库的制备 杆状病毒；(3)在生物反应器中生产MSP1.42抗原；(4) MSP1.42的纯化；(5)分析方法的建立 产品规格；(6)cGMP免疫原性评价 MSP1.42/QS21制剂在小鼠和兔体内的应用及其对兔的疗效。这些 研究将为临床提供cGMP材料和临床前信息 STTRII期试验MSP1.42/QS21。 建议的商业应用：不可用

DESCRIPTION: (Adapted from Applicant's Abstract) Malaria is a disease which affects more than 300 million people each year and is fatal for 1.5 million. The overall objective of this STTR Phase I project is to produce a cGMP malaria vaccine consisting of the 42 kDa C-terminal polypeptide of P. falciparum merozoite surface protein-1 (MSP1.42) to be formulated with QS21 adjuvant for preclinical studies and a future clinical Phase I trial. Evidence is presented that MSP1.42/QS-21 protects against P. falciparum malaria in the Aotus monkey model. Data is also presented supporting the feasibility of large-scale MSP1.42 production in the baculovirus system and its purification by standard chromatography. The goals of the project are (1) production of master cell banks of insect cell lines for virus stock and polypeptide production, respectively; (2) preparation of a virus stock of recombinant MSP1.42 baculovirus; (3) production of bulk MSP1.42 antigen in a bioreactor; (4) purification of MSP1.42; (5) establishment of analytical methods to define product specifications; and (6) evaluation of the immunogenicity of the cGMP MSP1.42/QS21 formulation in mice and Aotus and of its efficacy in Aotus. These studies will provide cGMP material and preclinical information for a clinical trial of MSP1.42/QS21 during STTR Phase II. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE