2012-11-012024-05-14https://scholars.lib.ntu.edu.tw/handle/123456789/657101摘要：DCB07010 (LTh(αK))為財團法人生物技術開發中心研發之新蛋白質佐劑，經由動物藥理試驗證明可較單獨投與抗原更能有效產生抗體。本計 畫將評估 DCB07010 (LTh(αK))佐劑依 7.5µg、15 µg、30 µg 及 45 µg 之 劑量遞增下與三價流感病毒抗原(每株病毒抗原含量分別為 7.5 µg，共22.5 µg)併用的安全性、耐受性與免疫生成性。試驗藥物將在第 0 天及第 7 天各接種一次，每次投予 200 µl (每邊鼻孔投予 100 µl)。試驗之主 要目的為依據體檢、生命徵象、心電圖及實驗室生化檢測值的結果而評 估健康受試者經鼻腔合併使用 DCB07010 與三價流感抗原的安全性。次 要目的則依據受試者的不良反應徵候而評估健康受試者合併 使 用 DCB07010 與三價流感抗原的耐受性，以及以接種前後 HI (Hemagglutination inhibition)效價評估健康受試者合併使用 DCB07010 與三價流感抗原的免疫生成性。<br> Abstract: DCB07010 (LTh(αK)) is a new protein adjuvant developed by Development Centerfor Biotechnology (DCB), and immunogenicity could be enhanced when antigen was administered combined with DCB07010 in animal studies compared with antigen alone. This is an phase 1 study to evaluate safety, tolerability and immunogenicity when DCB07010 given intranasally at escalating dose levels of 7.5µg, 15µg, 30µg and 45µg, in combination with 22.5µg of influenza HA antigen (7.5µg HA of each of three strains, total 22.5µg). The primary endpoint is to assess safety which is based on physical examination, vital signs, ECG, and clinical laboratory test results. Tolerability, which is secondary endpoint in this study, will be assessed based on signs and subjective symptoms of adverse events. Immunogenicity is also being characterized and will be based on HI titers comparing pre- and post-dosing.