Development of a Recombinant Subunit Ebola Vaccine

描述（由申请方提供）：埃博拉病毒和马尔堡病毒是丝状病毒科的唯一成员，可引起出血热，在高达90%的人类病例中致死。目前还没有疫苗或抗病毒疗法来预防或治疗丝状病毒感染。由于其特殊的杀伤力和武器化的潜力，这些病毒已被确定为生物盾牌项目和NIAID生物防御研究议程的关键生物防御目标。夏威夷生物技术公司已经成功地生产了几种重组埃博拉病毒蛋白，这些蛋白在小鼠中显示出很强的免疫原性和保护效力。该项目的具体目标是扩大候选疫苗的抗原库，以诱导针对埃博拉病毒和马尔堡病毒的广泛保护，确认疫苗制剂在豚鼠和非人灵长类动物模型中的保护效力，并为II期临床前开发产品做好准备。攻毒研究将代表该方法的临床前概念验证，而纳入额外的糖蛋白将确保候选疫苗诱导针对最致病性丝状病毒株的广泛保护性免疫。该候选疫苗有潜力作为一个独立的或作为一个合作伙伴，在一个初免-加强方法与其他候选疫苗目前正在开发的NIAID疫苗研究中心。利用重组亚单位蛋白的安全有效的疫苗将满足该国生物防御准备战略的重要需求。

DESCRIPTION (provided by applicant): Ebola and Marburg viruses, the only members of the family Filoviridae, cause hemorrhagic fevers which are lethal in up to 90% of human cases. No vaccine or antiviral therapy currently exists to prevent or treat Filovirus infection. Due to their exceptional lethality and potential for weaponization, these viruses have been identified as key biodefense targets in both Project Bioshield and the NIAID Biodefense Research agenda. Hawaii Biotech, Inc. has successfully produced several recombinant Ebola virus proteins which show strong immunogenicity and protective efficacy in mice. The specific goals of this project are to expand the antigenic repertoire of the vaccine candidate to induce broad protection against both Ebola and Marburg viruses, to confirm the protective efficacy of the vaccine formulations in guinea pig and non-human primate models, and to ready the product for preclinical development in Phase II. The challenge studies will represent the preclinical proof of concept for the approach, while the inclusion of additional glycoproteins will ensure that the vaccine candidate induces broad protective immunity against the most pathogenic Filovirus strains. The vaccine candidate has potential as a stand alone or as a partner in a prime-boost approach in combination with other vaccine candidates currently being developed by the NIAID Vaccine Research Center. A safe and efficacious vaccine utilizing recombinant subunit proteins would fill an important need in the country's biodefense preparedness strategy.