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神州細胞(688520.SH):SCTV01E和SCTV01C已進行阿聯酋III期安全性和免疫原性對比臨牀試驗的期中分析並取得積極結果
格隆匯 10-17 18:29

格隆匯10月17日丨神州細胞(688520.SH)公佈,近日,由北京神州細胞生物技術集團股份公司控股子公司神州細胞工程有限公司(簡稱“神州細胞工程”)自主研發的重組新冠病毒2價(Alpha+Beta變異株)S三聚體蛋白疫苗(項目代號:SCTV01C)和4價(Alpha+Beta+Delta+Omicron變異株)S三聚體蛋白疫苗(項目代號:SCTV01E)已進行阿聯酋III期安全性和免疫原性對比臨牀試驗的期中分析並取得積極結果。

SCTV01E和SCTV01C已在阿聯酋開展隨機、雙盲、陽性苗對照的III期序貫加強免疫安全性和免疫原性對比臨牀研究,旨在評價其在≥18週歲未接種過新冠疫苗的健康人羣中的安全性、耐受性和免疫原性。臨牀III期共入組1800名健康志願者,其中已接種2-3劑滅活苗健康志願者1350名(陽性對照苗為國藥滅活苗),已接種2-3劑mRNA苗健康志願者450名(陽性對照苗為輝瑞mRNA苗),SCTV01E、SCTV01C和陽性苗(滅活苗或mRNA苗)按1:1:1比例隨機分配入組。

SCTV01C和SCTV01E是神州細胞工程針對新冠病毒變異快、以原始株為基礎的國內外第一代疫苗對變異株中和抗體滴度和保護率下降等問題自主研發的新一代2價和4價變異株重組蛋白疫苗,臨牀上擬用於預防新型冠狀病毒感染所致疾病(COVID-19)。SCTV01C的活性成分分別包含兩種WHO認定的主要變異株阿爾法(Alpha)和貝塔(Beta)的重組S三聚體蛋白抗原,並採用比傳統鋁佐劑更能顯著增強Th1細胞的水包油新型佐劑。SCTV01E是在SCTV01C的基礎上新增了後續新出現的德爾塔和奧密克戎兩個變異株S三聚體蛋白抗原構成的4價改良型疫苗升級版。

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