Enabling the Scalable Aseptic Manufacturing and In-Vivo Testing of Novel, Solid Unit Dose, Viral Vector Vaccines for Administration by Enesi’s Needle Free ImplaVax® Delivery Technology

通过 Enesi 的无针 ImplaVax® 给药技术实现新型固体单位剂量病毒载体疫苗的可扩展无菌生产和体内测试

• 批准号: 105442
• 金额: $ 110.91万
• 依托单位: ENESI PHARMA LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2019
• 资助国家: 英国
• 起止时间: 2019 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=105442
• 关键词: Enabling; Scalable; Aseptic; Manufacturing; Vivo

Vaccines are one of the most cost-effective ways of delivering lasting benefit to human health and healthcare systems worldwide - it is estimated that they save 9 million lives each year.Today, vaccines are not only being used to prevent common childhood infectious diseases such as measles, polio, and whooping cough. Modern developments in biology have led to the creation of a range of highly targeted vaccines based on vector delivery vehicles such as vaccinia and adenovirus that can be tailored for optimum effectiveness. With such efficiency and specificity, vector-based vaccines are being developed for diseases as broad as influenza, small pox, HIV, other lethal and rare infectious diseases, allergy, biodefence, cancers, and even ultra-personalised medicines tailored to the exact needs of a patient.Most vaccines available today are delivered in a liquid/suspension form with a needle and syringe. Whilst established practice there are significant challenges innate to this presentation including needle-stick injury, cross contamination risk, sharps disposal risk, dosing error, subject pain and stress, poor thermal stability, and excessive wastage.Additionally, multiple injections are generally required to generate a lasting effect on a subjects' immune system. Ensuring an individual's compliance to a 'Prime-Boost' dosing schedule is challenging, especially when dosing is often days if not weeks apart.Enesi has developed a game changing technology that has the potential to revolutionise vaccination worldwide. Rather than delivering a vaccine in the traditional liquid form, our ImplaVax(r) technology allows the facile delivery of highly effective unit solid dose vaccine implants to the subject.Comparative pre-clinical studies using a range of classical vaccines have demonstrated that ImplaVax(r) solid dose vaccines outperform liquid equivalents with a superior and faster immune response, regimen sparing, and enhanced thermal stability. Human factor studies also indicate a strong preference (91%) for the needle-free ImplaVax(r) delivery system across all subject groups evaluated with ease and speed of administration scoring very highly.This project seeks to build on these foundations and will include the development of a robust aseptic-capable solid dose implant manufacturing processes, testing the implants on stability and conducting focused non-clinical immunogenicity studies to demonstrate the performance of the solid dose vaccine in-vivo.Success will give a high confidence that such a process can be applied to all vector-based vaccines with all associated ImplaVax(r) benefits and the potential become a mainstay of both prophylactic and therapeutic treatment in human health.

疫苗是为全球人类健康和医疗保健系统带来持久利益的最具成本效益的方式之一 - 据估计，疫苗每年可挽救 900 万人的生命。如今，疫苗不仅用于预防常见的儿童传染病，例如麻疹、脊髓灰质炎和百日咳。现代生物学的发展导致了一系列基于载体传递载体（例如牛痘和腺病毒）的高度针对性的疫苗的产生，这些疫苗可以定制以获得最佳效果。凭借如此高效和特异性，基于载体的疫苗正在开发用于广泛的疾病，如流感、天花、艾滋病毒、其他致命和罕见的传染病、过敏、生物防御、癌症，甚至是根据人们的确切需求量身定制的超个性化药物。当今大多数可用的疫苗都是通过针头和注射器以液体/悬浮液形式输送的。虽然已建立的实践存在固有的重大挑战，包括针刺伤、交叉污染风险、锐器处置风险、剂量错误、受试者疼痛和压力、热稳定性差以及过度浪费。此外，通常需要多次注射才能产生对受试者的免疫系统产生持久影响。确保个人遵守“Prime-Boost”剂量计划具有挑战性，特别是当剂量通常相隔数天甚至数周时。Enesi 开发了一种改变游戏规则的技术，有可能彻底改变全世界的疫苗接种。我们的 ImplaVax(r) 技术不是以传统的液体形式提供疫苗，而是可以轻松地将高效的单位固体剂量疫苗植入物递送给受试者。使用一系列经典疫苗的临床前比较研究表明，ImplaVax(r) ）固体剂量疫苗的性能优于液体疫苗，具有更出色、更快速的免疫反应、节省方案和增强的热稳定性。人为因素研究还表明，所有受试者组都强烈偏爱无针 ImplaVax(r) 给药系统（91%），该系统的给药便捷性和速度评分非常高。该项目力求建立在这些基础上，并将包括开发强大的无菌固体剂量植入物制造工艺，测试植入物的稳定性并进行有针对性的非临床免疫原性研究，以证明固体剂量疫苗在体内的性能。成功将使人们高度相信这样的工艺可以是适用于所有基于载体的疫苗，具有所有相关的 ImplaVax(r) 优点，并有可能成为人类健康预防性和治疗性治疗的支柱。