格隆汇3月24日丨三叶草生物-B(02197.HK)发布公告，公司RSV候选疫苗SCB-1019(未使用佐剂的二价RSVPreF－三聚体亚单位候选疫苗，基于三叶草生物Trimer-Tag蛋白质三聚体化疫苗研发平台)已获美国食品药品监督管理局(FDA)临床申报(IND)的批准，并且用于评估该候选疫苗重复接种的Ⅰ期临床试验已完成首批受试者入组。
正在美国进行的重复接种Ⅰ期临床试验招募了多达160名老年受试者(60-85岁)，他们在至少2个流行季前接种过首剂来自GSK的RSV疫苗(AREXVY)，受试者将随机分组接受SCB-1019的异源重复接种、AREXVY的同源重复接种或生理盐水安慰剂。该研究将评估SCB-1019在重复接种方案中的安全性、反应原性和免疫原性。此外，针对SCB-1019在呼吸道联合疫苗(三聚体PreF疫苗：RSV+hMPV±PIV3)中的评估研究，按计划将于2025年启动I期临床试验。
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