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

疫苗是为世界各地的人类健康和医疗保健系统带来持久好处的最具成本效益的方法之一-据估计，它们每年拯救900万人的生命。今天，疫苗不仅被用于预防常见的儿童传染病，如麻疹、脊髓灰质炎和百日咳。生物学的现代发展导致了一系列高靶向性疫苗的创建，这些疫苗基于载体传递工具，如牛痘和腺病毒，可以定制以实现最佳效果。以这种效率和特异性，基于载体的疫苗正在被开发出来，用于治疗流感、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，甚至是根据患者的确切需求量身定做的超个性化药物。目前可用的大多数疫苗都是通过针头和注射器以液体/悬浮液的形式提供的。虽然已有的实践表明，这一陈述本身存在重大挑战，包括针头刺伤、交叉污染风险、锐器处置风险、剂量错误、受试者疼痛和压力、热稳定性差和过度浪费。此外，通常需要多次注射才能对受试者的免疫系统产生持久的影响。确保个人遵守“Prime-Boost”的剂量计划是具有挑战性的，特别是在剂量通常是几天而不是几周的情况下。Enesi开发了一种改变游戏规则的技术，有可能在全球范围内彻底改变疫苗接种。我们的ImplaVax(R)技术不是以传统的液体形式提供疫苗，而是允许轻松地向受试者提供高效的单位固体剂量疫苗植入。使用一系列经典疫苗进行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，具有更好和更快的免疫反应、节省方案和增强的热稳定性。人类因素研究还表明，在所有受试者中，无针ImplaVax(R)递送系统的强烈偏好(91%)被评估为给药的简便性和速度非常高。该项目寻求在这些基础上建立，并将包括开发一种强大的无菌能力的固体剂量植入物制造工艺，测试植入物的稳定性，并进行有重点的非临床免疫原性研究，以证明固体剂量疫苗的体内性能。成功将使人们高度相信，这样的过程可以应用于所有载体疫苗，具有所有相关的ImplaVax(R)益处，并有可能成为人类健康预防和治疗治疗的中流砥柱。

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.