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全球三期臨床試驗結果顯示:Nirsevimab可顯著保護嬰兒預防呼吸道合胞病毒感染
研發追蹤 生物谷 2022.03.07 82

Nirsevimab 是首款只需注射一劑就能為所有嬰兒在整個呼吸道合胞病毒流行季中提供持續保護的在研預防用單克隆抗體。

2022年3月3日,國際權威醫學期刊《新英格蘭醫學雜志》今日發表了預防用單抗nirsevimab III期臨床試驗的詳細結果,nirsevimab是首款只需注射一劑就能為所有嬰兒在整個呼吸道合胞病毒(RSV)流行季中提供持續保護的在研長效抗體。該試驗入組進入第一個呼吸道合胞病毒流行季的足月嬰兒或晚期早產兒(胎齡35周或以上)并達到其主要終點。研究結果顯示,與安慰劑相比,單劑nirsevimab保護嬰兒免受需要就診的呼吸道合胞病毒引發的下呼吸道感染(如毛細支氣管炎或肺炎)的有效率達到74.5%,具有統計學意義(95% CI 49.6至87.1 ; p<0.001)。

研究者還對III期及IIb期試驗中呼吸道合胞病毒導致住院的情況進行了預先設定的合并分析,結果發現在足月兒和早產兒(胎齡大于28周)中,nirsevimab 在建議劑量下降低RSV相關住院發生率的有效率達到77.3% (95% CI 50.3至89.7, P<0.001)。僅在MELODY試驗中,研究者已觀察到呼吸道合胞病毒感染導致住院的患者人數出現減少(62.1%, 95% CI: -8.6%至86.8%; P=0.07),在nirsevimab組中,994名嬰兒中有6名因呼吸道合胞病毒引起的下呼吸道感染而住院,而在496名安慰劑組中有8名因此住院。

美國西北大學范伯格醫學院兒科學副教授、美國伊利諾伊州芝加哥市Ann & Robert H. Lurie兒童醫院臨床與社區試驗科學主任William Muller博士表示:隨著新冠各項公共防疫政策的逐步放寬,我們看到呼吸道合胞病毒感染出現了反彈,這表明我們需要一種廣泛的免疫方法來幫助減輕呼吸道合胞病毒感染對嬰兒及其家庭和醫療系統造成的巨大負擔。這些令人振奮的研究數據顯示,nirsevimab 有望保護所有嬰兒不受RSV侵害,這將帶來這種疾病預防現狀的重大轉變。

基于III期和II/III期臨床試驗以及IIb期臨床試驗的結果,證實了nirsevimab只需注射一劑就能為所有嬰兒在整個RSV流行季中提供持續保護。

賽諾菲疫苗全球研發負責人Jean-Fran?ois Toussaint表示:“在這三項關鍵性的后期臨床試驗中,我們著重研究為所有嬰兒提供同類首創的針對呼吸道合胞病毒的預防手段。針對健康晚期早產兒和足月嬰兒的III期MELODY臨床結果是實現上述目標的重大里程碑。我們很高興nirsevimab有望成為首個僅需注射一劑就能在RSV流行季為所有嬰兒提供持續保護的預防手段?!?

有望提供快速保護

Nirsevimab是首款用于保護所有嬰兒在第一個呼吸道合胞病毒流行季免受感染的在研長效抗體,目標是通過免疫注射單劑nirsevimab為嬰兒提供快速直接的保護。Nirsevimab是首個在III期臨床試驗中保護嬰兒不受RSV侵害的在研預防用單克隆抗體。呼吸道合胞病毒是導致所有嬰兒發生下呼吸道感染(包括毛細支氣管炎和肺炎)最常見的原因,也是導致嬰兒住院的主要原因。

國家呼吸系統疾病臨床醫學研究中心顧問、首都醫科大學附屬北京兒童醫院、深圳市兒童醫院申昆玲教授表示,呼吸道合胞病毒的傳染性很強,與新冠病毒相似,所有嬰幼兒都有被感染的風險。目前國內在RSV預防和治療領域,尚無有效的藥物或預防手段。期待預防用單克隆抗體nirsevimab的早日上市,填補RSV感染預防領域的一大空白。希望加速國內相關臨床試驗進展,早日獲批進入預防接種體系,讓所有中國的嬰幼兒受益?!?

據悉,預防用單抗nirsevimab已在全球30多個國家開展了臨床研究。針對中國健康嬰兒的三期臨床研究也已啟動。全球上市申請已于2022年上半年啟動。

賽諾菲疫苗與其合作伙伴阿斯利康正在攜手各方,共同推動nirsevimab在中國的研發和上市,保護千萬中國嬰兒免受呼吸道合胞病毒的侵害。

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Clinicaltrials.gov. A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants. (MEDI8897 Ph2b). https://clinicaltrials.gov/ct2/show/results/NCT02878330. Accessed February 2022.

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