Novel T cell-based vaccine potency assay to accelerate and improve development and manufacturing

研究人员不断创新，通过新的和改进的医疗诊断、设备和疗法，包括新的疫苗，来改善医疗保健。事实上，疫苗开发越来越多地试图解决癌症、过敏和微生物感染等难以治疗的疾病。最近的新冠肺炎大流行广泛地说明了更快速和更好的疫苗开发的重要性。这个项目将利用T细胞反应及其相关的受体机制和结构的最新知识来开发一种新的、可重复的测试制造疫苗的方法。降低成本，提高生产过程的质量控制和生产速度，将有利于疫苗的开发。更具体地说，疫苗需要诱导T细胞免疫反应才能达到治疗或预防效果。随着疫苗的开发和生产，最有问题的问题之一是疫苗QC(质量控制)释放和稳定性测试的效力分析。传统上，使用动物试验或患者样本来确定疫苗效力；然而，这些分析耗时、成本高、表现出较高的变异性并有伦理考虑。标准化的基于细胞的效力分析通常更可靠，失败率较低，并可以显著降低成本。此外，基于细胞的分析在伦理上也更容易被接受(NC3R倡议)，不需要动物，并且被监管机构首选用于QC释放测试。由于疫苗效力分析非常特异，取决于目标抗原，该项目还旨在展示一个平台应用程序，这意味着可以针对不同的疫苗抗原修改分析格式，无论是与肿瘤相关的、微生物的还是诱导耐受的。一般来说，使用这种检测方法所产生的成本降低和开发时间缩短将导致开发更多针对罕见疾病的疫苗，否则这些疫苗可能被认为是不经济的，而且对低收入和中等收入国家(LMIC)来说很重要。该项目将侧重于支持申请者针对宫颈癌等人乳头瘤病毒(HPV)相关疾病的一种新疫苗(OVM-100)的检测。这种疾病在LMICs中特别流行，那里迫切需要这种治疗。这种方法到目前为止还没有开发出来，因为与现有的动物测试相比，最初的开发成本很高。总体而言，该项目的目标是提供更便宜(30%)、更可靠(故障率降低15%)、快速(2-3天比3-4周)、灵活和强大的技术。可申请专利的发明将受到保护，旨在使该技术在全球范围内可用。

Researchers are continuously innovating to improve healthcare through new and improved medical diagnostics, devices and therapeutics, including new vaccines. Indeed, vaccine development is increasingly attempting to address difficult-to-treat diseases such as cancer, allergy and microbial infections. The recent Covid-19 pandemic has served to widely illustrate the importance of more rapid and improved vaccine development.This project will use the latest knowledge of T-cell responses, and their associated receptor mechanisms and structures to develop a novel, reproducible way of testing manufactured vaccines. Lowering costs and improving the quality control of the manufacturing processes and throughput speed, will benefit vaccine development. More specifically, vaccines need to induce a T-cell immune response for therapeutic effect or prophylaxis. With vaccine development and manufacture, one of the most problematic issues is that of potency assays for vaccine QC (Quality Control) release and stability testing. Traditionally, animal assays or patient samples are used to determine vaccine potency; however, these assays are time-consuming, costly, show higher variability and have ethical considerations.Standardised cell-based potency assays are typically more reliable with a lower failure rate and can significantly reduce costs. Moreover, cell-based assays are also ethically more acceptable (NC3R initiative), not requiring animals, and preferred by the regulatory authorities for QC release testing.Since vaccine potency assays are very specific, depending on the target antigens, the project also aims to demonstrate a platform application, which means that the assay format can be modified for different vaccine antigens, whether tumour-associated, microbial , or tolerance-inducing. Generally, the cost reductions and shortened development times resulting from using such assays will lead to the development of more vaccines for rarer diseases, which might otherwise be considered uneconomic and which are important for Low-and-Middle-Income Countries (LMICs). This project will focus on the assay to support a new vaccine (OVM-100) from the applicant targeting Human Papilloma Virus (HPV) associated diseases such as cervical cancer. This disease is especially prevalent in LMICs where this treatment is desperately needed.This approach has not been developed to date as the initial development is costly compared to existing animal assays. Overall, the project aims to deliver a cheaper (30%), more reliable (15% decrease failure rate), rapid (2-3 days vs 3-4 weeks), flexible and robust technology. Patentable inventions will be protected with the intention to make the technology available globally.