康希諾生物(06185.HK)：3劑滅活疫苗人羣加強接種吸入用新冠疫苗 安全性良好
格隆匯12月28日丨康希諾生物(06185.HK)宣佈，公司開展了"在18歲及以上完成3針新冠滅活疫苗接種的成年人中開展重組新型冠狀病毒疫苗(5型腺病毒載體)序貫加強的免疫原性和安全性的隨機、開放、平行對照臨牀研究"，重組新型冠狀病毒疫苗(5型腺病毒載體)包括肌注式重組新型冠狀病毒疫苗(5型腺病毒載體)(商品名：克威莎®)及吸入用重組新型冠狀病毒疫苗(5型腺病毒載體)(商品名：克威莎®霧優®)，目前已獲得階段性數據。
該臨牀研究於2022年4月啟動，在江蘇開展，共360人入組，正在開展長期隨訪。研究設置招募既往接種過3針滅活疫苗且間隔滿6個月的受試者進行加強免疫，受試者按1:1:1隨機分配至克威莎®霧優®組("吸入組")、克威莎®組("肌注組")或滅活疫苗組("滅活組")，每組約120人。所有受試者在接種後28天內進行系統性安全性觀察並在接種當天、接種後14天、28天、3個月、6個月採集樣本進行免疫原性評價。
1.安全性方面
吸入組免後28天內不良反應總體發生率為9.40%，低於對照組。吸入組不良反應主要為1級，發生率為5.98%，2級為3.42%，未發生3級不良反應。加強接種後6個月內未接到SAE報吿。總體安全性結果顯示，在既往接種過3劑滅活疫苗的人羣中加強接種一劑克威莎®霧優®，安全性良好，尤其是在老年人羣。
2.免疫原性方面
原始株真病毒中和抗體檢測結果顯示，在免前抗體水平均接近陰性的基礎上，加強接種後28天，吸入組抗體的GMT達到672，高於肌注組的583，遠高於滅活組的59。吸入組是滅活組的約11倍。使用臨牀試驗血清對OmicronBA.5假病毒進行交叉中和試驗，吸入組免疫後28天中和抗體結GMT為108，遠高於滅活組同源加強後的19，抗體滴度≥16的比例達81%，滅活組為20%。
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