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 我们成功开发了一种高度免疫原性，优化和冻干的表位，二价 炭疽疫苗，称为LND-LF-VLP，使用我们的新型专有平台技术 将疫苗靶序列纳入高度免疫原性病毒等颗粒中。这个新的疫苗目标 两种不同的中和决定因素，这些决定因素不是由Biothrax靶向的，目前已批准的疫苗 炭疽病。当用人使用佐剂配制时，这种新疫苗有可能非常迅速 只注射一次或两次防护性免疫。我们的建议将重点关注两个总体目的：1） 通过LND-LF-VLP在人使用佐剂中证明两种免疫的功效 来自高剂量气溶胶孢子挑战的兔子炭疽菌艾米斯菌株和2）以优化和 为LND-LF-的表达，纯化和质量保证制定标准操作程序 VLP疫苗以合同制造组织最终扩大生产的方式。这 以新型表位为中心的VLP疫苗有望成为一种高度稳定，安全和战略性的新疫苗。