康希諾生物(06185.HK)：《柳葉刀》發表重組新冠病毒疫苗(腺病毒載體)臨試I期研究結果
格隆匯5月25日丨康希諾生物－Ｂ(06185.HK)發佈公告，題為“重組5型腺病毒載體COVID-19疫苗的安全性，耐受性和免疫原性：劑量遞增，開放標籤，非隨機，首次人類試驗”，關於重組新型冠狀病毒疫苗(腺病毒載體)(“Ad5-nCoV”)臨牀試驗I期研究結果的研究論文已發表於《柳葉刀》。
研究論文中摘錄部分摘要如下：
“我們在中國武漢開展了一個Ad5載體COVID-19疫苗的劑量遞增，單中心，開放標籤，非隨機的1期臨牀試驗。按順序登記年齡在18至60歲之間的健康成人，並將其分為三個劑量組(5×1010，1×1011和1.5×1011病毒顆粒)，肌內注射疫苗。主要終點是免疫後7天內的不良事件；安全性觀察持續到接種後的第28天。 ELISA法測定特異性抗體，以SARS-CoV-2病毒和假病毒中和試驗測定疫苗誘導的中和抗體。以酶聯免疫斑點法和流式細胞儀來評估T細胞反應。該研究已在 ClinicalTrials.gov上註冊，登記號NCT04313127。”
“在2020年3月16日至3月27日期間，我們篩選了195個受試者，最終入組108名(男性51%，女性49%；平均年齡36.3歲)，接種低劑量(n = 36)，中劑量(n = 36)或高劑量(n = 36)疫苗。所有入組的受試者都被納入分析。疫苗接種後的7日內，低劑量組有30名(83%)受試者，中等劑量組有30名(83%)受試者，高劑量組有27名 (75%)受試者，報導有至少一種不良反應。最常見的注射部位不良反應是疼痛，在疫苗接種者中有58名(54%)出現疼痛症狀；最常見的全身不良反應是發燒(50 [46%])，疲勞(47 [44%])，頭痛(42 [39%])和肌肉疼痛(18 [17%]。所有劑量組的大多數不良反應為輕度或中度；且接種後28天內未報導嚴重不良事件；接種後 14天ELISA抗體和中和抗體明顯增加，並在接種後28天達到峯值。特異性T細胞反應在接種後第14天達到峯值。”
公告表示，Ad5載體COVID-19疫苗接種後28天可耐受，並具有免疫原性。健康成人中，對 SARS-CoV-2的體液反應在接種後第28天達到峯值，接種後第14天產生快速的特異性T細胞反應。發現表明，Ad5載體COVID-19疫苗值得進一步研究。
Ad5-nCoV由公司與軍事科學院軍事醫學研究院生物工程研究所聯合開發。 Ad5-nCoV採用基因工程方法構建，以複製缺陷型人5型腺病毒為載體，可表達新型冠狀病毒S抗原，擬用於預防新型冠狀病毒感染引起的疾病。
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