Vaxcyte推進VAX-31嬰兒疫苗第二階段研究

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Vaxcyte推進VAX-31嬰兒疫苗第二階段研究以預防侵襲性肺炎球菌疾病

2025年2月5日,Vaxcyte, Inc.(納斯達克代碼:PCVX)宣布,健康嬰兒的VAX-31第二階段研究的首批參與者已經接種疫苗。該研究的推進是基於對第一階段安全性和耐受性數據的盲評估,這項研究旨在評估VAX-31這款31價肺炎球菌結合疫苗(PCV)在健康嬰兒中的安全性、耐受性和免疫原性。Vaxcyte預計將於2026年中期公布主要三劑免疫接種系列的安全性、耐受性和免疫原性數據,隨後約九個月後公布加強劑的數據。

VAX-31的設計目標

VAX-31旨在覆蓋約94%的侵襲性肺炎球菌疾病和約93%的急性中耳炎,特別針對美國五歲以下的兒童。Vaxcyte的首席執行官兼聯合創始人Grant Pickering表示:“推進到VAX-31嬰兒第二階段研究代表著在評估這一脆弱人群的最廣泛疫苗候選者方面邁出了一大步。”他強調,肺炎球菌結合疫苗(PCVs)在疫苗接種計劃中已經成為基石,為社區提供了關鍵的保護。

研究的具體安排

VAX-31嬰兒第二階段研究是一項隨機、雙盲、主動對照的劑量尋找臨床試驗,將VAX-31與Prevnar 20(PCV20)進行比較。第一階段的研究評估了在三個劑量(低、中、高)下,VAX-31的安全性和耐受性。第二階段將在約750名嬰兒中評估相同劑量的安全性、耐受性和免疫原性。

根據免疫接種實踐諮詢委員會(ACIP)的建議,該研究設計包括在兩個月、四個月和六個月大時接種三劑初次免疫,隨後在12至15個月大時接種加強劑。主要的免疫原性研究終點包括評估VAX-31各劑量的免疫反應,並與PCV20進行比較。

肺炎球菌疾病的背景

肺炎球菌疾病(PD)是由肺炎球菌引起的感染,可能導致侵襲性肺炎球菌疾病(IPD),如腦膜炎和菌血症。根據估計,美國每年約有150,000人因肺炎球菌肺炎住院。肺炎球菌是世界衛生組織認定的急需解決的抗生素耐藥病原體之一,對五歲以下兒童來說,肺炎球菌是全球疫苗可預防死亡的主要原因。

Vaxcyte的未來展望

Vaxcyte正在重新設計疫苗的製造方式,通過現代合成技術來開發高保真疫苗,旨在為人類提供保護。VAX-31和VAX-24這兩款疫苗候選者的潛力不僅在於其廣泛的覆蓋範圍,還在於它們能夠提供對目前流行和歷史上流行的肺炎球菌株的更大保護。

這項研究的進展不僅對於嬰兒的健康至關重要,也對於整個社會的公共衛生具有深遠的影響。隨著抗生素耐藥性問題的加劇,開發更有效的疫苗以預防肺炎球菌疾病的必要性愈發凸顯。Vaxcyte的努力不僅是科學上的突破,更是對抗這些致命疾病的重要一步。

在未來,隨著數據的逐步公布,Vaxcyte的研究成果將可能改變疫苗接種的標準,為更多的嬰兒和成人提供保護,並有助於減少肺炎球菌相關的疾病負擔。

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