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康希諾(688185.SH):重組肺炎球菌蛋白疫苗啟動Ib期臨牀試驗並完成首例受試者入組
格隆匯 03-12 15:47

格隆匯3月12日丨康希諾(688185.SH)公佈,公司的重組肺炎球菌蛋白疫苗(“PBPV”)於近日正式啟動Ib期臨牀試驗,並完成首例受試者入組。

PBPV在健康成人中開展的Ia期臨牀試驗結果顯示:候選疫苗安全性良好,未觀察到特殊安全性風險,全部劑量組均可耐受;免疫原性顯著,不同種類抗原的反應符合預期。

Ib期臨牀試驗基於Ia期獲得的研究數據,初步評價候選疫苗應用於老年目標人羣的安全性、免疫原性及免疫持久性,為後續臨牀開發提供依據。

PBPV是全球創新的在研肺炎疫苗,與已上市的23價肺炎球菌多糖疫苗(“PPV23”)和13價肺炎球菌多糖結合疫苗(“PCV13”)不同,並非血清型特異型疫苗,其採用基於肺炎球菌表面蛋白A(PspA,一種幾乎所有肺炎球菌表達的高度保守蛋白)的抗原,包含了四種蛋白,相較於目前上市的PPV23、PCV13,PBPV具有更高血清覆蓋率(至少98%的肺炎球菌株覆蓋率)。在高覆蓋率保護下,可以有效防止“血清型替代”的產生。同時本產品相較多糖疫苗和結合疫苗,生產工藝更為簡便,易於放大和質量控制。

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