Control of polio virus fecal shedding (transmission) following a mucosally-adjuvanted fractional dose inactivated polio vaccine

麻痹性脊髓灰质炎是导致弛缓性麻痹的一个毁灭性原因，根除它是联合国儿童基金会的一项重大举措。 世界卫生组织（卫生组织）。向皮内（ID）IPV中添加粘膜佐剂 制剂可以阻止粪便脱落并阻止疾病的环境储存库的延续。 我们将评估一种新型粘膜佐剂的粘膜和细胞介导的免疫效应： 产肠毒素大肠杆菌（ETEC），双突变型不耐热毒素（dmLT）。此外，我们将 研究胃肠道微生物群在调节OPV诱导的PV感染中的作用， 复制能力。在第1年，从已完成的试点试验中立即获得临床样本 评价dmLT-fIPV（CHRMS# 19-0048）的安全性和免疫原性将用于开发 方法和启动免疫学调查。在此期间，监管和行政工作将 最终确定，以支持在第2年启动第二次临床试验。

Paralytic Polio is a devastating cause of flaccid paralysis and its eradication is a major initiative of the World Health Organization (WHO). The addition of a mucosal adjuvant to intradermal (ID) IPV formulations may arrest fecal shedding and halt perpetuation of an environmental reservoir of the disease. We will evaluate the mucosal and cell mediated immune effects of a novel mucosal adjuvant: Enterotoxigenic Escherichia coli (ETEC), double-mutant heat labile toxin (dmLT). In addition, we will investigate the role of the gastrointestinal microbiota in modulating OPV-induced PV infection and replication capacity. In year 1, clinical samples immediately available from a completed pilot trail evaluating the safety and immunogenicity of dmLT-fIPV (CHRMS# 19-0048) will be utilized to develop methods and initiate immunologic investigations. During this time, regulatory and administrative work will be finalized to support the initiation of a second clinical trail in year 2.