Development of a MSP1-p42 Subunit Vaccine for Malaria

描述(申请人提供)：疟疾是一种热带寄生虫 对世界大部分地区构成重大健康威胁的疾病。每年， 大约有5亿人被感染，200多万人死亡。 非常需要控制这种疾病的传播。其中一个主要的 疟疾疫苗开发的重点是重组疫苗的使用 来自寄生虫不同发育阶段的蛋白质。这个 这项研究的目标是生产高免疫原性的重组 可以与临床相关的佐剂一起努力配制的亚基 将候选疫苗抗原从临床前状态推向临床 状态。第一阶段研究表明msp-1p42抗原被表达 在果蝇细胞表达系统中处于高水平。表达的抗原 已被证明具有相关的抗原性和免疫原性 与本地结构相关联的。第二阶段的研究将进一步表征 大量表达的p42蛋白的免疫原性。美国人的能力 P42抗原在猴子体内产生保护性反应 临床上相关的抗原将被检测。建议的成功 研究将产生一种产品，然后可以在人体上进行测试。 建议的商业应用： 疟疾对世界范围内的健康构成重大威胁。目前，还没有疟疾疫苗。这项拟议的研究将测试疟疾疫苗候选蛋白亚基与临床相关佐剂一起配制时，在Aotus猴子身上引发保护性反应的有效性。这种抗原在与一种或多种临床相关佐剂配制时提供保护性反应的能力，将有助于开发安全、有效和具有成本效益的疟疾疫苗。

DESCRIPTION (provided by the applicant): Malaria is a tropical parasitic disease that poses a significant health threat to much of the world. Each year, approximately 500 million people become infected and more than 2 million die. There is a great need to control the spread of this disease. One of the main focuses of malaria vaccine development has been the on use of recombinant proteins derived from the various developmental stages of the parasite. The goal of the proposed research is to produce highly immunogenic recombinant subunits that can be formulated with clinically relevant adjuvants in an effort to advance candidate vaccine antigens from preclinical status to clinical status. Phase I research demonstrated that the MSP-1 p42 antigen is expressed at high levels in the Drosophila cell expression system. The expressed antigen has been demonstrated to have relevant antigenic and immunogenic properties associated with native structure. Phase II research will further characterize the immunogenic properties of the abundantly expressed p42. The ability of the p42 antigen to provide a protective response in monkeys when formulated with clinically relevant antigens will be tested. The success of the proposed research would result in a product that could then be tested in humans. PROPOSED COMMERCIAL APPLICATIONS: Malaria poses a significant world-wide health threat. Currently, there is no vaccine for malaria. The proposed research will test the efficacy of a malaria vaccine candidate protein subunits to elicit protective responses in Aotus monkeys when formulated with clinically relevant adjuvants. The ability of this antigen to provide a protective response when formulated with one or more clinically relevant adjuvant would contribute to the development of a safe, efficacious and cost effective malaria vaccine.