萬泰生物(603392.SH):凍幹水痘減毒活疫苗IIa臨牀試驗獲得倫理審查批件和CDE藥物臨牀試驗登記與信息公示平台公示文件
格隆匯 8 月 14日丨萬泰生物(603392.SH)公佈,近日,公司研發的凍幹水痘減毒活疫苗(VZV-7D)IIa臨牀試驗獲得了江蘇省疾病預防控制中心倫理審查委員會的倫理審查批件和CDE藥物臨牀試驗登記與信息公示平台公示文件。8月14日公司與臨牀試驗單位、現場單位召開了臨牀啟動會,將於8月17或18日開始IIa期臨牀試驗研究(IIa是考察不同劑量的有效性和安全性,以篩選出合適的IIb臨牀試驗劑量,IIb是考察合適劑量的有效性和安全性),旨在評價該疫苗在3-12週歲健康志願者中的免疫原性和安全性。
水痘是由水痘-帶狀皰疹病毒初次感染引起的急性傳染病,主要發生在嬰幼兒和學齡前兒童。冬春兩季多發,其傳染力強,幼托機構等兒童聚集場所常集中性爆發。水痘疫苗是將水痘病毒減毒株感染人二倍體細胞培養製成的,接種12月齡-12週歲的兒童,是預防水痘的唯一有效手段,但存在引發水痘和帶狀皰疹的風險。
公司研發的凍幹水痘減毒活疫苗(VZV-7D)為新型水痘疫苗。疫苗的主要創新點在於該疫苗採用反向遺傳學技術改造水痘病毒野生株(pOka)獲得的ORF7 表達缺陷的單一毒株。在人-鼠嵌合動物模型中的研究顯示,VZV-7D 不感染人皮膚組織和背根神經節,但仍然保留了在人胸腺T 細胞中的複製能力。與現有疫苗相比,試驗疫苗預期可有效預防水痘,並能消除疫苗接種引發的水痘樣疹及帶狀皰疹的發生風險,具有更好的安全性。
公司研發的凍幹水痘減毒活疫苗(VZV-7D)尚需完成臨牀II期、III期,臨牀試驗結果存在一定的不確定性。
公司研發的凍幹水痘減毒活疫苗(VZV-7D)預計3年之內不會形成產品銷售,對於公司業績不會產生重大影響。
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