Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial

Zhu Feng-Cai; Li Yu-Hua; Guan Xu-Hua; Hou Li-Hua; Wang Wen-Juan; Li Jing-Xin; Wu Shi-Po; Wang Bu-Sen; Wang Zhao; Wang Lei; Jia Si-Yue; Jiang Hu-Dachuan; Wang Ling; Jiang Tao; Hu Yi; Gou Jin-Bo; Xu Sha-Bei; Xu Jun-Jie; Wang Xue-Wen; Wang Wei; Chen Wei

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Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial

机译：重组腺病毒型-5的安全性，耐受性和免疫原性 - 5载体-19疫苗：剂量升级，开放标记，非随机化，首先试验

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Background A vaccine to protect against COVID-19 is urgently needed. We aimed to assess the safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 (Ad5) vectored COVID-19 vaccine expressing the spike glycoprotein of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strain.

机译：背景技术迫切需要避免防止Covid-19的疫苗。我们旨在评估重组腺病毒型-5（AD5）的安全性，耐受性和免疫原性，所述Covid -19疫苗表达严重急性呼吸综合征冠状病毒2（SARS-COV-2）菌株的穗糖蛋白。

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来源
《The Lancet》 |2020年第10240期|共10页
作者
Zhu Feng-Cai; Li Yu-Hua; Guan Xu-Hua; Hou Li-Hua; Wang Wen-Juan; Li Jing-Xin; Wu Shi-Po; Wang Bu-Sen; Wang Zhao; Wang Lei; Jia Si-Yue; Jiang Hu-Dachuan; Wang Ling; Jiang Tao; Hu Yi; Gou Jin-Bo; Xu Sha-Bei; Xu Jun-Jie; Wang Xue-Wen; Wang Wei; Chen Wei;
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作者单位

Jiangsu Prov Ctr Dis Control &

Prevent NHC Key Lab Enter Pathogen Microbiol Nanjing 210009;

China Natl Inst Food &

Drug Control Beijing Peoples R China;

Hubei Prov Ctr Dis Control &

Prevent Wuhan Peoples R China;

Beijing Inst Biotechnol Beijing 100071 Peoples R China;

Jiangsu Prov Ctr Dis Control &

Prevent NHC Key Lab Enter Pathogen Microbiol Nanjing 210009;

Jiangsu Prov Ctr Dis Control &

Prevent NHC Key Lab Enter Pathogen Microbiol Nanjing 210009;

Beijing Inst Biotechnol Beijing 100071 Peoples R China;

Beijing Inst Biotechnol Beijing 100071 Peoples R China;

Hubei Prov Ctr Dis Control &

Prevent Wuhan Peoples R China;

Hubei Prov Ctr Dis Control &

Prevent Wuhan Peoples R China;

Jiangsu Prov Ctr Dis Control &

Prevent NHC Key Lab Enter Pathogen Microbiol Nanjing 210009;

Jiangsu Prov Ctr Dis Control &

Prevent NHC Key Lab Enter Pathogen Microbiol Nanjing 210009;

China Natl Inst Food &

Drug Control Beijing Peoples R China;

Beijing Inst Microbiol &

Epidemiol State Key Lab Pathogen &

Biosecur Beijing Peoples R China;

Beijing Inst Microbiol &

Epidemiol State Key Lab Pathogen &

Biosecur Beijing Peoples R China;

CanSino Biol Tianjin Peoples R China;

Huazhong Univ Sci &

Technol Tongji Med Coll Tongji Hosp Res Ctr Wuhan 430032 Peoples R China;

Beijing Inst Biotechnol Beijing 100071 Peoples R China;

Shanghai Canming Med Technol Shanghai Peoples R China;

Huazhong Univ Sci &

Technol Tongji Med Coll Tongji Hosp Res Ctr Wuhan 430032 Peoples R China;

Beijing Inst Biotechnol Beijing 100071 Peoples R China;

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正文语种 eng
中图分类医药、卫生;
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1. Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial [J] . Zhu Feng-Cai, Li Yu-Hua, Guan Xu-Hua, The Lancet . 2020,第10240期

机译：重组腺病毒型-5的安全性，耐受性和免疫原性 - 5载体-19疫苗：剂量升级，开放标记，非随机化，首先试验
2. Safety and immunogenicity of a candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine: a dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial [J] . The Lancet infectious diseases . 2020,第7期

机译：候选中东呼吸综合征冠状病毒病毒 - 矢量疫苗的安全性和免疫原性：剂量升级，开放标签，非随机性，不受控制，阶段1试验
3. Safety and immunogenicity of a candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine: a dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial (vol 23, pg 861, 2020) [J] . The Lancet infectious diseases . 2020,第7期

机译：候选中东呼吸综合征冠状病毒病毒 - 矢量疫苗的安全性和免疫原性：剂量升级，开放标签，非随机性，不受控制，第1阶段试验（Vol 23，PG 861,2020）
4. RAPID, COST-EFFECTIVE AND SCALABLE GMP-COMPLIANT SIMIAN ADENOVIRUS-VECTORED VACCINE PRODUCTION FOR EARLY-PHASE CLINICAL TRIALS USING ENTIRELY DISPOSABLE PRODUCT-CONTACT COMPONENTS [C] . Alexander Douglas, Thomas Merritt, Sofiya Fedosyuk, Conference on vaccine technology VI . 2018

机译：快速，成本有效且可扩展的符合GMP标准的猿猴腺病毒载体疫苗生产，用于早期临床试验，使用完全可放置的与产品接触的组件
5. Uncovering the Mechanisms Underlying the Immunogenicity of Adenovirus Vaccine Vectors [D] . Nidetz, Natalie Frances. 2018

机译：揭示腺病毒疫苗载体免疫原性的机制
6. Safety tolerability and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation open-label non-randomised first-in-human trial [O] . Feng-Cai Zhu, Yu-Hua Li, Xu-Hua Guan, -1

机译：重组腺病毒5型载体COVID-19疫苗的安全性耐受性和免疫原性：剂量递增开放标签非随机首次人类试验
7. Faculty Opinions recommendation of Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial. [O] . Suresh Mahalingam 2020

机译：教师意见建议的安全性，耐受性和重组腺病毒型-5的免疫原性 - 5型环酰-19疫苗：剂量 - 升级，开放标签，非随机性，首先审判。

Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial

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