Microneedle patch for the stabilization and dose-sparing delivery of rabies vaccine

用于稳定和节省剂量输送狂犬病疫苗的微针贴片

• 批准号: 10759732
• 负责人: Lindsay Woodard
• 金额: $ 26.73万
• 依托单位: LUNA LABS USA, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10759732
• 关键词: Address; Advanced Development; Affect; Anhydrides; Animal Model; Antibodies; Antibody Response; Antigens; Area; Central Nervous System; Cessation of life; Cold Chains; Complex; Computer Models; Developing Countries; Development; Dose; Drug Delivery Systems; Encapsulated; Evaluation; Excipients; Exposure to; Formulation; Future; Geometry; Goals; Government; Hour; Human; Hydrogels; Immune response; Immunity; Immunization; Immunization Programs; Immunology; Infection; Laboratories; Left; Life; Maintenance; Marketing; Monitor; Mus; Needles; Phase; Polymer Chemistry; Polymers; Povidone; Predisposition; Prevention; Property; Prophylactic treatment; Puncture procedure; Rabies; Rabies Vaccines; Rabies virus; Regimen; Route; Safety; Skin; Technology; Temperature; Therapeutic; Tissues; Training; Universities; Vaccination; Vaccines; Work; cost; crosslink; design; fabrication; immunogenic; improved; in vivo; irritation; novel; polymerization; preclinical efficacy; preclinical safety; prototype; remote communities; response; vaccination outcome; vaccine access; vaccine delivery; vaccine efficacy; vaccine trial

PROJECT ABSTRACT Approximately 60,000 human deaths occur each year from rabies. Although rabies vaccines have been developed for pre- and post-exposure prophylaxis (PEP), access to vaccination has limited prevention and treatment of the life-threating infection. Developing countries and remote communities are disproportionally susceptible, compounded by high costs and complex regimens (multiple boosters) associated with treatment. Further, rabies and many other vaccines require maintenance of cold chain up to the point of administration. Vaccine delivery intradermally using a dissolvable microneedle approach could result in key benefits such a more rapid immune response at a reduced administered dose, and improved antigen stability would be significant. Luna Labs therefore proposes to advance development of a resorbable microneedle patch for intradermal administration of human rabies vaccine. The proposed technology builds upon existing work at Luna Labs, and the novel excipient will support the room-temperature stabilization of the vaccine prior to controlled resorption and antigen release. Antigen loading will be optimized, and the approach will enable consistent, reliable immunization with minimal training. The Phase I effort will demonstrate feasibility for microneedle delivery of the stabilized human rabies vaccine in an in vivo study of antigenicity, and future work will expand study of vaccine stability and preclinical safety and efficacy.

项目摘要 每年约有 60,000 人死于狂犬病。尽管狂犬病疫苗已 疫苗接种是为暴露前和暴露后预防 (PEP) 而开发的，但获得疫苗的机会有限。 治疗危及生命的感染。发展中国家和偏远社区不成比例地 易感性，加上与治疗相关的高成本和复杂的方案（多次加强）。 此外，狂犬病和许多其他疫苗需要维持冷链直至给药。 使用可溶解的微针方法进行皮内注射疫苗可能会带来关键的好处，例如 以减少的给药剂量实现更快速的免疫反应，并提高抗原稳定性 重要的。因此，Luna Labs 提议推进可吸收微针贴片的开发 皮内注射人狂犬病疫苗。拟议的技术建立在 Luna 现有工作的基础上 实验室和新型赋形剂将支持疫苗在受控之前的室温稳定性 吸收和抗原释放。抗原加载将得到优化，该方法将实现一致、 只需最少的培训即可获得可靠的免疫。第一阶段的工作将证明微针输送的可行性 稳定的人狂犬病疫苗在体内抗原性研究中的应用，未来的工作将扩大研究范围 疫苗稳定性和临床前安全性和有效性。