所有臨床試驗資料均由資料安全監測委員會(「DSMB」)審查,並於2024 年9 月下旬進行揭盲。資料顯示,在各劑量下ICVAX均展現出良好的安全性。所有 45 名參與者均完成了預定的訪問。與接種ICVAX相關的不良事件均屬於輕微,並沒有嚴重不良事件。總體而言,接受ICVAX疫苗的受試者皆誘導出預期的 T 細胞免疫應答。在接受最佳 ICVAX 劑量的受試者中,大多數人的 T 細胞反應增加了 2 倍以上。特別值得關注的是,受試者體內的一種獨特的 T 細胞亞群在接種ICVAX後有所增長,而這種T細胞亞群是在精英控制者(「EC」)內能夠抑制愛滋病病毒的功能性T細胞。此次一期臨床試驗的主要及次要臨床終點均已達到。醫克生物計畫在未來的科學會議和同行評審的科學期刊上正式發表此次臨床試驗的積極結果。完整的一期試驗資料將提交給監管機構審查,以推動ICVAX疫苗進入二期臨床試驗。
[1] Forrester Consulting. (2024). Business success scale: Cloud infrastructure and security best practices to gain competitive advantage. HashiCorp. Retrieved from https://www.datocms-assets.com/2885/1719373669-hashicorp-tlp.pdf
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