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三葉草生物-B(02197.HK)宣佈其RSV候選疫苗SCB-1019獲美國IND臨牀試驗批准並啟動重複接種的臨牀研究
格隆匯 03-24 07:07

格隆匯3月24日丨三葉草生物-B(02197.HK)發佈公吿,公司RSV候選疫苗SCB-1019(未使用佐劑的二價RSVPreF-三聚體亞單位候選疫苗,基於三葉草生物Trimer-Tag蛋白質三聚體化疫苗研發平台)已獲美國食品藥品監督管理局(FDA)臨牀申報(IND)的批准,並且用於評估該候選疫苗重複接種的Ⅰ期臨牀試驗已完成首批受試者入組。

正在美國進行的重複接種Ⅰ期臨牀試驗招募了多達160名老年受試者(60-85歲),他們在至少2個流行季前接種過首劑來自GSK的RSV疫苗(AREXVY),受試者將隨機分組接受SCB-1019的異源重複接種、AREXVY的同源重複接種或生理鹽水安慰劑。該研究將評估SCB-1019在重複接種方案中的安全性、反應原性和免疫原性。此外,針對SCB-1019在呼吸道聯合疫苗(三聚體PreF疫苗:RSV+hMPV±PIV3)中的評估研究,按計劃將於2025年啟動I期臨牀試驗。

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