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NEJM:GSK植物性新冠疫苗CoVLP+AS03被批准上市,预防变异毒株的有效性高达70%!

2022-05-13 小文子 MedSci原创

CoVLP+AS03是第一个被批准用于人类的植物源性疫苗,也是少数植物生产的生物制药产品之一。

冠状病毒样颗粒疫苗(CoVLP)是一种植物源性重组疫苗,由SARS-CoV-2棘突蛋白与佐剂(AS03)结合而成。在早期研究中,CoVLP + AS03疫苗(Covifenz,Medicago)诱导了强而持久的中和抗体水平和T细胞平衡应答(干扰素-γ和IL-4),两者均有保护作用。The New England Journal of Medicine杂志的一项研究报告了CoVLP+AS03疫苗关键的3期试验的早期结果,评估其有效性和安全性。

这项随机对照研究在85个中心进行。纳入24141名成人(≥18岁),之前未接种过SARS-CoV-2疫苗,也没有Covid-19病史。参与者按1:1随机分配,两次肌肉注射CoVLP+AS03疫苗或安慰剂,间隔21天。第二次注射后7天之内检测到至少160例实验室确诊新冠肺炎病例后,通过至少2个月的中位安全性随访数据计算疫苗有效性。

疫苗有效性的主要结局是接种第2剂后至少7天检测预防症状性Covid-19的效力。阳性病例定义为至少存在一种Covid-19相关症状且通过RT-PCR检测的咽或鼻拭子SARS-CoV-2阳性结果。

结果显示,参与者中位年龄29岁(18~86岁)。截至2021年8月20日,共检出176例新冠肺炎患者,最终确认165例。

无论基线状态如何,165例意向治疗人群的疫苗总有效性为69.5%(95% CI,56.7~78.8)。在157例方案人群中,疫苗组10554名参与者出现39例,安慰剂组9536名参与者出现118例,疫苗有效性为71.0%(95%CI,58.7-80.0)。

在意向治疗人群中,预防中重度疾病的总体疫苗有效性(事后分析)为78.8%(95%CI,55.8~90.8)。在基线检查时血清阴性的参与者中,预防中重度疾病的疫苗有效性为86.0%(95%CI,66.2~95.1)。

安全人群包括24076名参与者(疫苗组12036人,安慰剂组12040人)。对7819名参与者在每次给药后7天内发生的不良反应进行分析。局部和全身不良反应主要是轻度和暂时性的(持续时间为1~3天)。与安慰剂组相比,疫苗组的局部和全身不良反应更多。总体而言,接种第1剂和第2剂后,疫苗组3819名参与者(92.3%)和安慰剂组1677名参与者(45.5%)报告了局部不良反应。疫苗组3612名参与者(87.3%)和安慰剂组2394名参与者(65.0%)报告了全身不良反应。

CoVLP+AS03是第一个被批准用于人类的植物源性疫苗,也是少数植物生产的生物制药产品之一。当前试验中CoVLP+AS03的安全性分析证实了早期研究的观察结果。

原文出处:

K.J. Hager, G. Pérez Marc, P. Gobeil, R.S. Diaz, G, et al, Efficacy and Safety of a Recombinant Plant-Based Adjuvanted Covid-19 Vaccine, The New England Journal of Medicine, 2022, DOI: 10.1056/NEJMoa2201300

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    2022-10-12 xuyong535
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    2022-05-13 病毒猎手

    效果一般般

    0

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    2022-05-11 小元

    NEJM上果然牛,感谢梅斯更新及时

    0

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