三葉草生物-B(02197.HK):對首批受試者進行COVID-19候選疫苗SPECTRA的同源加強劑給藥
格隆匯1月5日丨三葉草生物-B(02197.HK)宣佈,於2022年1月5日,首批受試者已完成公司COVID-19候選疫苗SCB-2019(CpG 1018加鋁佐劑)同源加強針的接種。這些受試者在進展中的全球2/3期臨牀試驗(三葉草生物的聯合佐劑使用的三聚體重組蛋白COVID-19疫苗保護效力及安全性研究("SPECTRA"))中已接種SCB-2019(CpG 1018加鋁佐劑)進行基礎免疫。公司於2021年9月發佈了SPECTRA研究試驗中SCB-2019(CpG1018加鋁佐劑)的最終有效數據,該研究將繼續獲取更多免疫原性及安全性數據。
這項雙盲、隨機及對照研究旨在評估兩種SCB-2019劑量配方(全劑量:30微克抗原加CpG 1018加鋁佐劑;半劑量:15微克抗原加CpG 1018加鋁佐劑)作為同源加強針的免疫原性和安全性,約4,000名成年受試者將完成加強針接種,這些受試者均已在約6個月前接種過兩劑SCB-2019(CpG 1018加鋁佐劑)。
此外,針對基礎免疫接種SCB-2019(CpG 1018加鋁佐劑)的青少年(12-18歲)亞組進行的免疫原性和安全性評估範圍已擴大至1,200名受試者。關於同源加強針和青少年亞組的初始數據預計於2022年上半年發佈。
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