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瑞科生物-B(02179.HK):阿聯酋批准開展RECOV序貫加強免疫的II/III期臨牀試驗
格隆匯 04-13 07:41

格隆匯4月13日丨瑞科生物-B(02179.HK)發佈公吿,公司已就其重組蛋白新冠肺炎疫苗 ReCOV(“ReCOV”)獲得阿拉伯聯合酋長國(“阿聯酋”)國家衞生與預防部的臨牀試驗批准,可開展序貫加強免疫的II/III期臨牀研究,以評價 ReCOV在成人受試者中作為異源加強針的免疫原性和安全性。

該臨牀試驗針對先前已完成兩劑滅活COVID-19疫苗基礎免疫,且末次接種時間距ReCOV異源加強接種3至12個月的人羣,是一項多中心、隨機、觀察者盲、陽性對照的II/III期研究,共計劃入組1,950例成人受試者。該研究安全性與免疫原性數據預期將於2022年發佈,支持ReCOV作為異源加強免疫劑提交阿聯酋緊急使用授權(EUA)。

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