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三葉草生物-B(02197.HK)既往感染者保護效力數據發表在《柳葉刀-傳染病學》
格隆匯 04-20 18:58

格隆匯4月20日丨三葉草生物-B(02197.HK)宣佈了全球關鍵2/3期臨牀試驗SPECTRA(評估公司的三聚體重組蛋白及已添加佐劑的COVID-19候選疫苗的保護效力及安全性研究)的更多數據,數據顯示在既往感染人羣中接種SCB-2019(CpG 1018╱鋁佐劑)對新冠肺炎可提供更加顯著的保護作用,該數據已發表在同行評審期刊《柳葉刀-傳染病學》上。

本研究評估了SCB-2019 (CpG 1018╱鋁佐劑)在接種疫苗前既往感染過新冠病毒的受試者中的保護效力、安全性和反應原性。SPECTRA臨牀試驗總共入組30,174名受試者。在完整的分析集中,評估了14,692名基線時有證據暴露於新冠病毒的受試者,其中,7,353人隨機在疫苗組,7,339人隨機在安慰劑組。

針對既往感染新冠病毒的個體進行加強:與既往未感染新冠病毒的安慰劑組受試者相比,既往感染新冠病毒的個體接種一劑和兩劑SCB-2019(CpG 1018╱ 鋁佐劑)顯示出對預防任何新冠毒株感染引發的任何嚴重程度的新冠肺炎的累積保護效力分別為89.7%(95%置信區間[CI]: 82.5 – 94.4)和93.8%(95% CI: 88.9 –97.0);在既往感染新冠病毒的人羣中接種一劑和兩劑SCB-2019 (CpG 1018╱鋁佐劑)與安慰劑組相比較,進一步明顯降低了感染任何嚴重程度新冠肺炎的風險(一劑降低了49.9%和兩劑降低了64.2%)。SCB-2019(CpG 1018╱鋁佐劑)在疫苗組和安慰劑組之間罕見的重度和嚴重不良事件(AEs)是相似的,顯示了良好的安全性。徵集性局部不良事件大多是發生在注射部位的輕微和短暫的疼痛,並在第二劑時發生頻率下降。2綜上所述,這些數據表明基礎免疫接種單劑或兩劑SCB-2019(CpG 1018╱鋁佐劑)可增強既往暴露於新冠病毒的個體預防新冠肺炎的保護作用。SCB-2019(CpG1018╱ 鋁佐劑)是首個且唯一的新冠候選疫苗在一項隨機臨牀試驗中顯示對既往感染個體再次感染任何嚴重程度新冠肺炎具有顯着保護作用,這使本公司有信心將新冠候選疫苗推進為一款通用新冠疫苗加強針。

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