Advances in neglected tropical disease vaccines: developing relative potency and functional assays for the Na-GST-1/Alhydrogel hookworm vaccine

A new generation of vaccines for the neglected tropical diseases (NTDs) have now advanced into clinical development, with the Na-GST-1/Alhydrogel Hookworm Vaccine already being tested in Phase 1 studies in healthy adults. The current manuscript focuses on the often overlooked critical aspects of NTD vaccine product development, more specifically, vaccine stability testing programs. A key measure of vaccine stability testing is \"relative potency\" or the immunogenicity of the vaccine during storage. As with most NTD vaccines, the Na-GST-1/Alhydrogel Hookworm Vaccine was not developed by attenuation or inactivation of the pathogen (Necator americanus), so conventional methods for measuring relative potency are not relevant for this investigational product. Herein, we describe a novel relative potency testing program and report for the first time on the clinical lot of this NTD vaccine during its first 60 months of storage at 2–8°C. We also describe the development of a complementary functi...针对被忽视热带病（Neglected Tropical Diseases, NTDs）的新一代疫苗现已进入临床开发阶段，其中Na-GST-1/氢氧化铝佐剂钩虫疫苗（Na-GST-1/Alhydrogel Hookworm Vaccine）已在健康成人群体中开展I期临床试验。本文聚焦于被忽视热带病疫苗研发中常被忽略的关键环节，具体而言即疫苗稳定性测试方案。疫苗稳定性测试的核心指标之一为“相对效价”，即疫苗在储存过程中的免疫原性。与多数被忽视热带病疫苗类似，Na-GST-1/氢氧化铝佐剂钩虫疫苗并非通过减毒或灭活病原体（美洲钩虫，Necator americanus）研发而成，因此传统相对效价检测方法不适用于这款在研疫苗。本文阐述了一种全新的相对效价检测方案，并首次报告了该被忽视热带病疫苗在2~8℃条件下储存首60个月的临床批次检测结果。此外，本研究还介绍了一项互补功能[原文末尾截断]的开发工作。