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.

抽象的 我们已成功开发出一种高度免疫原性、优化且可冻干的针对表位的二价疫苗 炭疽疫苗，简称 LND-LF-VLP，采用我们新颖的专有平台技术， 将疫苗靶序列整合到高度免疫原性的病毒样颗粒中。这种新疫苗的目标 两个不同的中和决定簇，目前批准的疫苗 Biothrax 不针对这两个决定簇 炭疽病。当与人类使用佐剂配制时，这种新疫苗有可能非常快速地引发 只需一两次注射即可产生保护性免疫力。我们的提案将重点关注两个总体目标：1） 证明了在人用佐剂中使用 LND-LF-VLP 进行两次免疫接种的功效，以保护 用炭疽芽孢杆菌 Ames 菌株进行高剂量气溶胶孢子攻击的兔子和 2) 进行优化和 制定 LND-LF-表达、纯化和质量保证的标准操作程序 VLP 疫苗最终能够由合同制造组织扩大生产规模。这 以新表位为重点的VLP疫苗有望成为一种高度稳定、安全且具有战略意义的炭疽新疫苗。