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、设备和治疗方法（包括新疫苗）来改善医疗保健。事实上，疫苗开发正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Covid-19大流行广泛说明了更快和更好地开发疫苗的重要性。该项目将利用t细胞反应及其相关受体机制和结构的最新知识，开发一种新的、可重复的方法来测试制造的疫苗。降低成本，改善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细胞免疫反应以达到治疗或预防效果。随着疫苗的开发和生产，最成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测定。传统上，动物试验或患者样本用于确定疫苗效力；然而，这些检测费时、昂贵、表现出较高的可变性，并有伦理方面的考虑。标准化的基于细胞的效价测定通常更可靠，故障率更低，并且可以显著降低成本。此外，基于细胞的测定在伦理上也更容易被接受（NC3R倡议），不需要动物，并且监管机构更倾向于QC释放测试。由于疫苗效力测定是非常具体的，取决于目标抗原，该项目还旨在展示一种平台应用，这意味着测定格式可以针对不同的疫苗抗原进行修改，无论是肿瘤相关抗原、微生物抗原还是耐受诱导抗原。一般来说，使用这种检测方法所导致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，但对低收入和中等收入国家很重要。该项目将侧重于检测，以支持申请人针对人类乳头状瘤病毒（HPV）相关疾病（如宫颈癌）的新疫苗（OVM-100）。这种疾病在迫切需要这种治疗的中低收入国家尤其普遍。这种方法迄今尚未开发，因为与现有的动物试验相比，最初的开发成本很高。总体而言，该项目旨在提供更便宜（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。可获得专利的发明将受到保护，目的是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.