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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(xù)保護(hù)的在研預(yù)防用單克隆抗體。

2022年3月3日督阿，國際權(quán)威醫(yī)學(xué)期刊《新英格蘭醫(yī)學(xué)雜志》今日發(fā)表了預(yù)防用單抗nirsevimab III期臨床試驗的詳細(xì)結(jié)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(xù)保護(hù)的在研長效抗體赠槽。該試驗入組進(jìn)入第一個呼吸道合胞病毒流行季的足月嬰兒或晚期早產(chǎn)兒（胎齡35周或以上）并達(dá)到其主要終點耍休。研究結(jié)果顯示，與安慰劑相比，單劑nirsevimab保護(hù)嬰兒免受需要就診的呼吸道合胞病毒引發(fā)的下呼吸道感染（如毛細(xì)支氣管炎或肺炎）的有效率達(dá)到74.5%，具有統(tǒng)計學(xué)意義（95% CI 49.6至87.1 ; p<0.001)甜紫。

研究者還對III期及IIb期試驗中呼吸道合胞病毒導(dǎo)致住院的情況進(jìn)行了預(yù)先設(shè)定的合并分析降宅，結(jié)果發(fā)現(xiàn)在足月兒和早產(chǎn)兒（胎齡大于28周）中骂远，nirsevimab 在建議劑量下降低RSV相關(guān)住院發(fā)生率的有效率達(dá)到77.3% (95% CI 50.3至89.7, P<0.001)。僅在MELODY試驗中腰根，研究者已觀察到呼吸道合胞病毒感染導(dǎo)致住院的患者人數(shù)出現(xiàn)減少（62.1%, 95% CI: -8.6%至86.8%; P=0.07）激才，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额嘿，而在496名安慰劑組中有8名因此住院瘸恼。

美國西北大學(xué)范伯格醫(yī)學(xué)院兒科學(xué)副教授、美國伊利諾伊州芝加哥市Ann & Robert H. Lurie兒童醫(yī)院臨床與社區(qū)試驗科學(xué)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册养，我們看到呼吸道合胞病毒感染出現(xiàn)了反彈东帅，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(yī)療系統(tǒng)造成的巨大負(fù)擔(dān)。這些令人振奮的研究數(shù)據(jù)顯示修梭，nirsevimab 有望保護(hù)所有嬰兒不受RSV侵害茴茁，這將帶來這種疾病預(yù)防現(xiàn)狀的重大轉(zhuǎn)變。

基于III期和II/III期臨床試驗以及IIb期臨床試驗的結(jié)果纸级，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(xù)保護(hù)泣奏。

賽諾菲疫苗全球研發(fā)負(fù)責(zé)人Jean-Fran?ois Toussaint表示：“在這三項關(guān)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(chuàng)的針對呼吸道合胞病毒的預(yù)防手段描刹。針對健康晚期早產(chǎn)兒和足月嬰兒的III期MELODY臨床結(jié)果是實現(xiàn)上述目標(biāo)的重大里程碑县堰。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(xù)保護(hù)的預(yù)防手段∑糯蓿”

有望提供快速保護(hù)

Nirsevimab是首款用于保護(hù)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茴支，目標(biāo)是通過免疫注射單劑nirsevimab為嬰兒提供快速直接的保護(hù)。Nirsevimab是首個在III期臨床試驗中保護(hù)嬰兒不受RSV侵害的在研預(yù)防用單克隆抗體十卖。呼吸道合胞病毒是導(dǎo)致所有嬰兒發(fā)生下呼吸道感染（包括毛細(xì)支氣管炎和肺炎）最常見的原因卓您，也是導(dǎo)致嬰兒住院的主要原因。

國家呼吸系統(tǒng)疾病臨床醫(yī)學(xué)研究中心顧問壤趴、首都醫(yī)科大學(xué)附屬北京兒童醫(yī)院涎拉、深圳市兒童醫(yī)院申昆玲教授表示，呼吸道合胞病毒的傳染性很強的圆，與新冠病毒相似鼓拧，所有嬰幼兒都有被感染的風(fēng)險。目前國內(nèi)在RSV預(yù)防和治療領(lǐng)域，尚無有效的藥物或預(yù)防手段季俩。期待預(yù)防用單克隆抗體nirsevimab的早日上市钮糖，填補RSV感染預(yù)防領(lǐng)域的一大空白。希望加速國內(nèi)相關(guān)臨床試驗進(jìn)展酌住，早日獲批進(jìn)入預(yù)防接種體系店归，讓所有中國的嬰幼兒受益±椅遥”

據(jù)悉消痛，預(yù)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都哭。全球上市申請已于2022年上半年啟動秩伞。

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(fā)和上市欺矫，保護(hù)千萬中國嬰兒免受呼吸道合胞病毒的侵害烟渴。

參考文獻(xiàn)：

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