康希諾生物(06185.HK):關於在18歲及以上成人中開展的雙價吸入用重組新型冠狀病毒疫苗(5型腺病毒載體)臨牀試驗研究成果
格隆匯12月29日丨康希諾生物(06185.HK)發佈公吿,公司的O株╱原始株雙價吸入用新冠疫苗(“O株╱原始株雙價吸入用新冠疫苗”)開展了“在18歲及以上成人中開展的雙價吸入用重組新型冠狀病毒疫苗(5型腺病毒載體)臨牀試驗”,目前已獲得階段性數據。O株╱原始株雙價吸入用新冠疫苗為針對Omicorn變異株開發,尚在臨牀研究階段。
該臨牀研究於2022年9月啟動,在重慶開展,共450人入組,正在開展長期隨訪。研究為在18歲及以上已接種3劑新冠滅活疫苗且距末次接種間隔≥3個月的人羣開展的隨機、盲法、平行對照的試驗,所有受試者均按照1:1:1比例隨機接種一劑次的O株╱原始株雙價吸入用新冠疫苗(“雙價疫苗組”)、O株單價吸入用新冠疫苗(“O株單價疫苗組”)或原始株單價吸入用新冠疫苗(“原始株單價疫苗組”)。每個組計劃招募150名受試者,總計450人,其中≥60歲老年人約佔30%。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、2個月、3個月、4個月、6個月採集樣本開展體液免疫、細胞免疫和黏膜免疫檢測。
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