An epitope-focused nanoparticle vaccine for anthrax

针对炭疽的针对表位的纳米颗粒疫苗

• 批准号: 10171761
• 负责人: David C Whitacre
• 金额: $ 98.37万
• 依托单位: VLP BIOTECH, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10171761
• 关键词: Address; Adjuvant; Aerosols; Animal Model; Anthrax Vaccines; Anthrax disease; Antibodies; Antigens; Bacillus anthracis; Biothrax; Category A pathogen; Cold Chains; Contracts; Data; Dose; Engineering; Epitopes; Freeze Drying; Human; Immunity; Immunization; Incidence; Inhalation; Injections; Institute of Medicine (U.S.); Lethal Dose 50; Macaca fascicularis; Mediating; Oryctolagus cuniculus; Performance; Phase; Procedures; Production; Protocols documentation; Qualifying; Reproduction spores; Specificity; Study models; Technology; Toxin; United States National Institutes of Health; Vaccines; Virus-like particle; Work; aerosolized; clinical candidate; design; immunogenic; immunogenicity; nanoparticle; neutralizing antibody; next generation; nonhuman primate; novel; novel vaccines; pre-exposure prophylaxis; programs; quality assurance; scale up; vaccine candidate; vaccine development; weapons

Abstract We have successfully developed a highly immunogenic, optimized and lyophilizable epitope-focused, bivalent anthrax vaccine, referred to as LND-LF-VLP, using our novel proprietary platform technology which incorporates the vaccine target sequence into highly immunogenic virus like particles. This new vaccine targets two distinct neutralizing determinants, which are not targeted by Biothrax, the currently approved vaccine for anthrax. When formulated with human use adjuvants, this new vaccine has potential to elicit very rapid protective immunity with only one or two injections. Our proposal will focus on two overarching aims: 1) to demonstrate the efficacy of two immunizations with the LND-LF-VLP in human use adjuvants for protection of rabbits from high dose aerosol spore challenge with Bacillus anthracis Ames strain and 2) to optimize and develop standard operating procedures for the expression, purification and quality assurance of the LND-LF- VLP vaccine in a manner enabling eventual scale-up production by a contract manufacturing organization. This new epitope-focused, VLP vaccine promises to be a highly stable, safe and strategic new vaccine for anthrax.

摘要 我们已经成功地开发出一种高度免疫原性的、优化的、可冷冻干燥的、聚焦于表位的二价 炭疽疫苗，简称LND-LF-VLP，使用我们新的专有平台技术， 将疫苗靶标序列整合到高度免疫原性的病毒样颗粒中。这种新疫苗针对的是 两个不同的中和决定因素，它们不是BioThrax的靶点，目前批准的疫苗 炭疽热。当用人类使用的佐剂配制时，这种新疫苗可能会非常迅速地引发 只需注射一到两次即可获得保护性免疫。我们的建议将集中于两个首要目标：1) 展示LND-LF-VLP在人类使用佐剂保护猪瘟的两种免疫效果 用炭疽芽孢杆菌Ames菌株攻击兔高剂量气雾剂孢子，2)优化和 为LND-LF的表达、纯化和质量保证制定标准操作规程 VLP疫苗以一种能够由合同制造组织最终扩大生产的方式。这 以表位为中心的新型VLP疫苗有望成为高度稳定、安全和具有战略意义的炭疽新疫苗。