Lancet Infect Dis：陈薇团队研发的雾化吸入用新冠疫苗I期临床试验结果发布

2021-07-29 网络网络

由中国工程院院士、军事科学院军事医学研究院研究员陈薇领衔团队研发的雾化吸入用重组新冠疫苗（腺病毒载体）I期临床试验数据，在国际权威医学期刊《柳叶刀·传染病》在线发表。这是全球首个发表的新

由中国工程院院士、军事科学院军事医学研究院研究员陈薇领衔团队研发的雾化吸入用重组新冠疫苗（腺病毒载体）I期临床试验数据，在国际权威医学期刊《柳叶刀·传染病》在线发表。这是全球首个发表的新冠疫苗黏膜免疫临床试验结果。

研究结果显示, 雾化吸入用重组新冠疫苗具有良好的安全性、耐受性和免疫原性。一剂雾化吸入用疫苗仅需肌肉注射疫苗剂量的五分之一，产生的细胞免疫反应水平与肌肉注射相当。肌肉注射重组新冠疫苗后第28天进行雾化吸入加强免疫，可诱导产生高水平中和抗体。该临床试验于2020年9月29日在武汉启动，由陈薇团队联合武汉大学中南医院共同完成，Ⅱ期临床试验正在有序推进。

据悉，雾化吸入用疫苗与已获附条件批准上市的重组新冠疫苗在制剂配方、生产工艺等方面均相同。相较于注射式新冠疫苗形成的细胞免疫和体液免疫，雾化吸入用疫苗可以诱导人体产生黏膜免疫，在病毒入侵的第一道关口预防感染和阻断传播。接种者不需要“打针”，只需通过雾化吸入设备将疫苗吸入呼吸道及肺部，从而获得黏膜免疫、细胞免疫、体液免疫“三重保护”。

参与这项研究的军事科学院军事医学研究院研究员侯利华介绍说，雾化吸入用疫苗只需“吸一吸”即可完成接种，更加安全便捷，适用于大规模人群推广使用。

Sera IgG, IgA, and neutralising antibody response following Ad5-nCoV vaccination

Spike RBD-binding IgG (A) and IgA concentrations (B) by ELISA and SARS-CoV-2 neutralising antibody (C) following Ad5-nCoV vaccination. All groups received the first vaccine on day 0; the LDmu, HDmu, and MIX group received a booster vaccine on day 28. Each data point represents a serum sample. The error bars are geometric mean with 95% CI. Geometric mean concentration and geometric mean titre are reported. Dashed lines shows the lower limit of quantification. 1Dim=low-dose intramuscular injection. 2Dim=high-dose intramuscular injection. Ad5-nCoV=recombinant adenovirus type 5 carrying full-length SARS-CoV-2 spike gene. HDmu=high-dose aerosol vaccine. LDmu=low-dose aerosol vaccine. MIX=intramuscular and aerosol vaccine. RBD=receptor binding domain.

从上述结果来看：单纯雾化吸入的作用与肌肉注射效果相当，而肌肉注射联合雾化吸入，产生的抗体效果最佳。

据了解，由陈薇领衔团队研发的重组新冠疫苗（腺病毒载体）已于2月25日获国家药品监督管理局附条件批准上市，是我国首个获批的国产腺病毒载体新冠病毒疫苗，单针接种且可以在2-8℃条件下运输保存。目前，该型疫苗已获得墨西哥、巴基斯坦、匈牙利、智利、阿根廷等多国紧急使用许可。

原始出处：

Safety, tolerability, and immunogenicity of an aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in adults: preliminary report of an open-label and randomised phase 1 clinical trial.DOI: https://doi.org/10.1016/S1473-3099(21)00396-0

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2022-04-27 医生2402

#I期临床#

117 0
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2021-12-17 839640778

#I期临床试验#

0 0
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2021-11-12 howi

#Lancet#

75 0
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2021-11-27 cmj8wellington

#Dis#

68 0
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2021-07-30 lqvr

#研发#

82 0
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2021-07-30 jiangjun073

#雾化#

104 0
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2021-07-29 公卫新人

新冠肺炎，疫情何时才能消失

88 0
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2021-07-29 goodbing

顶刊就是不一样，质量很高，内容精彩！学到很多

89 0

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