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现行新型冠状病毒疫苗的临床试验进展 被引量:3

Progress in clinical trials of SARS-CoV-2 vaccine
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摘要 为有效预防新型冠状病毒的感染及控制病毒的传播,疫苗的研制迫在眉睫。截至2020年9月28日,WHO公布现有40项新型冠状病毒疫苗临床试验正在进行,疫苗类型包括灭活疫苗、病毒载体疫苗、DNA疫苗和mRNA疫苗等,每类疫苗都有其优缺点。其中新型冠状病毒灭活疫苗、黑猩猩腺病毒载体疫苗和5型腺病毒载体疫苗等7款候选疫苗在Ⅰ/Ⅱ期临床试验中均显示出较高的安全性及免疫原性。虽然接种候选疫苗后受试者体内均产生了较高滴度的新型冠状病毒特异性抗体及中和抗体,但中和抗体的维持时间、疫苗接种后长期的不良反应以及疫苗的稳定性等还有待Ⅲ期临床试验进一步研究。 In order to effectively prevent the infection and control the spread of the SARS-CoV-2,the development of SARS-CoV-2 vaccines is imminent.WHO announced that there are forty SARS-CoV-2 vaccines under progress currently by Sep 28,2020,including inactivated vaccines,virus vector vaccines,DNA vaccines,mRNA vaccines,and etc.Each type of vaccines has its own advantages and disadvantages.Seven candidate vaccines have shown promising immunogenicity and tolerable safety in phase or phaseⅡclinical trials,including chimpanzee adenovirus-vectored vaccine(ChAdOx1-nCoV-19),purified inactivated SARS-CoV-2 virus vaccine(PiCoVacc)and adenovirus type-5-vectored COVID-19 vaccine(Ad5-nCoV),and etc.Although high titers of SARS-CoV-2 specific antibodies and neutralizing antibodies were induced after vaccination,the persistence of neutralizing antibodies,long-term adverse reactions after vaccination,and the stability of vaccines need further evaluation in phaseⅢclinical trials of various candidate vaccines.
作者 李珊珊 顾静文 张菁 杨海静 魏琼 曹国英 王晶晶 LI Shan-shan;GU Jing-wen;ZHANG Jing;YANG Hai-jing;WEI Qiong;CAO Guo-ying;WANG Jing-jing(Huashan Worldwide Medical Center,Huashan Hospital Afiliated to Fudan University,SHANCHAI 200040,China;Phase I Clinical Research Center,Huashan Hospital Afiliated to Fudan University,SHANCHAI 200040,China)
出处 《中国新药与临床杂志》 CAS CSCD 北大核心 2021年第5期321-329,共9页 Chinese Journal of New Drugs and Clinical Remedies
基金 十三五新药创制重大专项(2017ZX09304005)。
关键词 疫苗 严重急性呼吸综合征冠状病毒2型 新型冠状病毒肺炎 临床试验 免疫原性 疫苗 vaccines severe acute respiratory syndrome coronavirus 2 COVID-19 clinical trial immunogenicity vaccine
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