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瑞科生物-B(02179.HK)新佐劑重組帶狀皰疹疫苗REC610完成III期臨牀研究入組
格隆匯 01-02 12:28

格隆匯1月2日丨瑞科生物-B(02179.HK)宣佈,公司自主研發的新佐劑重組帶狀皰疹疫苗REC610 III期臨牀研究已順利完成全部受試者的入組。

該項臨牀研究採用隨機、雙盲、安慰劑對照設計,旨在評估REC610疫苗對40歲及以上健康受試者的保護效力、安全性及免疫原性,已在雲南省、河南省和山西省共計18個研究中心招募24,640名受試者。

帶狀皰疹是一種常見的由潛伏感染的病毒引起的疾病,患者可能併發帶狀皰疹後神經痛,這種劇烈的神經疼痛嚴重損害患者健康,影響患者生活質量。據統計,中國每年約有600萬人罹患帶狀皰疹,且近年來其發病有逐步年輕化的趨勢。根據全球已上市的帶狀皰疹疫苗研究數據,相比減毒活疫苗,新佐劑重組帶狀皰疹疫苗能提供更強的細胞免疫和更高的保護效力。REC610搭載由本公司自主研發的BFA01新型佐劑,可促進機體產生高水平的VZV糖蛋白E(gE)特異性CD4+T細胞和抗體,擬用於在40歲及以上成人中預防帶狀皰疹。目前,中國地區新佐劑重組帶狀皰疹疫苗僅有葛蘭素史克Shingrix®上市銷售,國產替代需求強烈。

此前,REC610分別在菲律賓和中國開展了以Shingrix®為陽性對照的探索性臨牀研究,均取得預期的結果。數據顯示,在40歲及以上健康受試者中,接種兩劑REC610總體安全性良好,未觀察到與研究用疫苗接種相關SAE、AESI或導致提前退出研究的TEAE。REC610可誘導很強的gE特異性免疫應答,其水平與Shingrix®組相當。

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