瑞科生物新佐劑重組帶狀皰疹疫苗中國I期臨牀研究完成首批受試者入組
瑞科生物(2179.HK)宣佈其自主研發的新佐劑重組帶狀皰疹疫苗REC610中國I期臨牀試驗已完成首批受試者入組。該研究採用隨機、雙盲、平行對照設計,在雲南省普洱市共招募180例40歲及以上健康受試者,以評價REC610的安全性、耐受性和免疫原性。根據公司此前消息,該產品已完成在菲律賓開展的與GSK Shingrix頭對頭比對臨牀研究,結果顯示REC610在細胞免疫和體液免疫方面均與Shingrix相當。2023年10月,中國CDE同意豁免REC610的中國II期臨牀,批准公司直接在中國開展I期和III期研究。
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