Development of a Recombinant Subunit Ebola Vaccine

重组亚基埃博拉疫苗的开发

• 批准号: 7272257
• 负责人: AXEL T LEHRER
• 金额: $ 47.42万
• 依托单位: PANTHERA BIOPHARMA, LLC
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-06-15 至 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7272257
• 关键词: Adenoviruses; Adjuvant; American; Angola; Antibodies; Antigens; Antiviral Therapy; Bioshield; Bioterrorism; Cavia; Country; DNA Vaccines; Democratic Republic of the Congo; Development; Diagnostic; Disease; Disease Outbreaks; Drosophila genus; Drug Formulations; Ebola Vaccines; Ebola virus; Ensure; Evaluation; Family member; Filoviridae; Filovirus; Flavivirus; Frankfurt-Marburg Syndrome Virus; Glycoproteins; Goals; Government; Hawaii; Human; Hybridomas; Immune response; Immunity; Individual; Infection; Life; Membrane Glycoproteins; Modeling; Morbidity - disease rate; Mus; National Institute of Allergy and Infectious Disease; Pathogenicity; Personal Satisfaction; Persons; Phase; Primates; Protein Subunits; Proteins; Purpose; Readiness; Recombinants; Research; Safety; Sudan; Sudan Ebola virus; System; Testing; USSR; Vaccine Research; Vaccines; Vesicular stomatitis Indiana virus; Viral; Viral Hemorrhagic Fevers; Viral Proteins; Virus; Virus Diseases; Zaire Ebola virus; base; biodefense; cell mediated immune response; concept; cross reactivity; immunogenic; immunogenicity; mortality; nonhuman primate; pre-clinical; prevent; protein folding; protein purification; response; vaccine development; vaccine efficacy

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.

描述(申请人提供)：埃博拉病毒和马尔堡病毒是丝状病毒科仅有的两种病毒，它们引起出血热，在高达90%的人类病例中是致命的。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，这些病毒在生物防护计划和NIAID生物防御研究议程中都被确定为关键的生物防御目标。夏威夷生物技术公司成功生产了几种重组埃博拉病毒蛋白，这些蛋白在小鼠身上显示出很强的免疫原性和保护效果。该项目的具体目标是扩大候选疫苗的抗原库，以诱导对埃博拉和马尔堡病毒的广泛保护，证实疫苗配方在豚鼠和非人类灵长类动物模型中的保护效果，并为第二阶段的临床前开发做好准备。挑战性研究将代表该方法的临床前概念证明，而加入更多的糖蛋白将确保候选疫苗诱导对最具致病性的丝状病毒株的广泛保护性免疫。该候选疫苗有可能单独使用，或与NIAID疫苗研究中心目前正在开发的其他候选疫苗相结合，作为优质增强方法的合作伙伴。一种利用重组亚单位蛋白的安全有效的疫苗将填补该国生物防御准备战略的重要需求。