神州細胞(688520.SH)披露新冠疫苗SCTV01C臨牀試驗免疫持久性分析結果
格隆匯10月19日丨神州細胞(688520.SH)公佈，近日，由公司控股子公司神州細胞工程有限公司(“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)已開展3項臨牀I/II期研究，包括1項未接種人羣的2針接種初次免疫臨牀研究，1項已接種滅活苗人羣的1針序貫加強免疫臨牀研究，以及1項已接種mRNA苗人羣的1針序貫加強免疫臨牀研究。目前已獲得未接種人羣初次免疫後140天的免疫原性檢測結果和2項序貫加強免疫後90天的免疫原性檢測結果。
目前已完成的3項臨牀研究樣品檢測結果顯示，SCTV01C免疫後展示出了突出的免疫持久性：
1. 未接種人羣免疫持久性：接種第2劑SCTV01C後28天(接種第1劑後第56天，即D56)，平均中和抗體滴度開始緩慢下降，至D140時，84天內各變異株真病毒中和抗體滴度下降幅度分別為：35.6%(Alpha)，33.8%(Beta)，38.2%(Delta)，16.6%(Omicron)。四個變異株84天的平均降幅為31%，即平均每月下降約11%。模型估算中和抗體衰減速率，半衰期ᵉ5ᵼf/ᵽ0為120天(有文獻報道其他新冠疫苗在未接種人羣中接種2劑疫苗後的半衰期ᵉ5ᵼf/ᵽ0約60多天)。
2. 序貫加強免疫持久性：已接種滅活苗人羣的序貫加強免疫臨牀I/II期研究結果顯示，1針SCTV01C加強免疫後28天(D28)，針對Delta和Omicron變異株的真病毒中和抗體均達到超高的平均滴度值，至D90時，62天內分別累計下降33.9%(Delta)和37.8%(Omicron)。已接種mRNA苗人羣的序貫加強免疫臨牀I/II期研究結果顯示，1針SCTV01C 加強免疫後 28 天（D28），針對 Delta 和 Omicron 變異株的真病毒中和抗體均達到超高的平均滴度值，至D90時，62天內分別累計下降25.3%(Delta)和26.0%(Omicron)。合併2項序貫加強免疫臨牀I/II期研究分析，62天累計下降幅度平均值為30.8%，即平均每月下降14.9%(有文獻報道其他新冠疫苗第3針加強免疫後平均每月下降約30% )。按SCTV01C序貫加強後第28天的中和抗體滴度1000至4000範圍和平均每月14.9%的衰減速率推算，SCTV01C 加強免疫後12個月時中和抗體仍可維持在170-678的較高滴度值，遠高於文獻報道50%防感染所需中和抗體滴度下限值25.6。
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