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國藥集團中國生物新冠滅活疫苗一二期臨床中期結果刊登 有效誘導產生中和抗體
阿思達克 08-14 17:40
國藥集團中國生物於官網公布,昨日(13日)國際醫學期刊《美國醫學會雜誌》刊登了國藥集團中國生物武漢生物製品研究所和中國科學院武漢病毒研究所聯合研製的新冠滅活疫苗一及二期臨床試驗中期結果,為全球新冠滅活疫苗第一篇正式發表的臨床試驗數據文章,該疫苗也是全球第一個被批准進入臨床試驗的新冠滅活疫苗。

該文章涉及了一及二期18至59歲共320名志願者的臨床試驗中期數據。結果表明疫苗能在該年齡組人群中有效誘導產生中和抗體,中和抗體水平也與其他疫苗研究報導的水平相當,證實疫苗具有良好的免疫原性。

在安全性方面,接種疫苗7天內觀察到的主要不良反應為註射部位疼痛,其次是發熱,但均為輕微和自限式的,不需任何治療。研究中無任何與疫苗有關的嚴重不良事件發生。

公告指,除文章已涉及的組別外,一及二期期其餘組別的臨床試驗正在按計劃進行。此外,包含更多受試志願者的三期臨床試驗在阿拉伯聯合酋長國正在開展,將對該疫苗的安全性和有效性試驗作進一步評價。

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