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數據顯示康希諾生物(06185.HK)新冠mRNA疫苗3+1序貫加強更安全及免疫效果更好
阿思達克 02-21 12:20
國際權威醫學期刊《柳葉刀》雜誌預印版平臺SSRN在線發表了康希諾生物(06185.HK)新型冠狀病毒mRNA疫苗CS-2034(以下簡稱「CS-2034」)的最新安全性、免疫原性及有效性的IIb期臨牀研究數據。公開數據顯示,該疫苗具有良好的安全性和免疫原性,且優效於滅活疫苗,目前正在積極推進III期效力臨牀試驗。 研究顯示,在奧密克戎BA.5.2和BF.7變異株流行期間,康希諾生物mRNA新冠疫苗展現出良好的安全性和免疫原性,7天後針對當下流行的奧密克戎BA.5變異株的抗體水平即可達到峯值,是滅活疫苗同源加強的29倍,保護率顯着優於滅活疫苗。 安全性結果顯示,在既往接種過三劑滅活疫苗的人羣中序貫加強接種一劑CS-2034,安全性良好,不良反應發生率及嚴重程度低於目前已上市mRNA疫苗。值得注意的是,60歲及以上老年人組的安全性優於18至59歲成年人組,爲老年人羣後續序貫加強新型冠狀病毒mRNA疫苗的安全性提供了強有力的數據支持。 免疫原性數據顯示,序貫加強1劑康希諾生物新型冠狀病毒mRNA疫苗能快速誘導針對原始株、BA.1和BA.5真病毒的中和抗體。免後14、28天mRNA異源加強組針對BA.5變異株的抗體幾何平均滴度(GMT)約爲滅活疫苗組的34.7及14.4倍,GMI約爲滅活組的38及15.7倍,陽轉率約爲滅活組的25.5及5.2倍。對GMT及陽轉率進行優效性比較,康希諾生物新型冠狀病毒mRNA疫苗組均優於滅活疫苗組。 此外,康希諾生物新型冠狀病毒mRNA疫苗能誘導較強的細胞免疫,CS-2034序貫組7天後的IFN-γ、IL-2、IL-5及IL-13陽性T細胞的頻次均顯着高於用滅活苗進行的同源加強。 值得注意的是,在該疫苗研究階段,國內流行的變異株以BA.5和BF.7爲主,真實世界數據顯示,康希諾生物新型冠狀病毒mRNA疫苗組和滅活疫苗組發病比例具有顯着性差異(P<0.0002),CS-2034組相較於滅活疫苗組的相對保護效率爲37.9% (95% CI, 22.2%,50.4%)。該結果表明康希諾生物新型冠狀病毒mRNA疫苗CS-2034具有良好的針對奧密克戎變異株BA.5/BF.7的保護力。
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