瑞科生物-B(02179.HK):ReCOV與mRNA疫苗的比對研究已完成全部受試者入組及研究疫苗接種
格隆匯8月19日丨瑞科生物-B(02179.HK)發佈公吿,有關ReCOV與mRNA疫苗的比對研究獲菲律賓國家食品藥品監督管理局(“FDA”)許可。其重組蛋白新冠肺炎疫苗ReCOV(“ReCOV”)與輝瑞mRNA疫苗COMIRNATY®對照的II期臨牀試驗已完成全部受試者入組及給藥。從取得試驗批准到受試者全部入組及給藥僅用2周時間,充分彰顯集團臨牀團隊高效率的執行力。此項II期臨牀試驗共入組600名受試者,加強免疫接種完成後,所有受試者均將接受安全性和免疫原性隨訪。
ReCOV為公司綜合運用新型佐劑、蛋白工程平台等技術平台研發的重組新冠肺炎疫苗,其佐劑採用的是自主研發的新型佐劑BFA03。根據公司進行的相關研究,ReCOV可誘導高滴度廣譜中和抗體和Th1偏向性T細胞免疫反應,對奧密克戎變種病毒、德爾塔變種病毒等變種病毒具有良好的交叉中和作用和免疫持久性,具有總體安全性良好、生產易放大、生產成本低、製劑穩定性好、可在室温儲存運輸等一系列綜合優勢。
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