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重磅!抗体阳转率100%!全球新冠灭活疫苗所有受试者全部产生抗体

2020-06-16 MedSci MedSci原创

据微信公众号“中国生物”消息,6月16日,国药中国生物武汉生物制品研究所研制的新冠病毒灭活疫苗Ⅰ/Ⅱ期临床试验盲态审核暨阶段性揭盲会在北京、河南两地同步举行。国务院联防联控机制

据微信公众号“中国生物”消息,6月16日,国药中国生物武汉生物制品研究所研制的新冠病毒灭活疫苗Ⅰ/Ⅱ期临床试验盲态审核暨阶段性揭盲会在北京、河南两地同步举行。国务院联防联控机制疫苗专班、国家科技部生物技术发展中心有关专家出席。

揭盲结果显示:疫苗接种后安全性好、无一例严重不良反应;不同程序、不同剂量接种后,疫苗组接种者均产生高滴度抗体,0,28天程序接种两剂后,中和抗体阳转率达100%

此次武汉生物制品研究所的新冠灭活疫苗临床试验为随机、双盲、安慰剂对照的Ⅰ/Ⅱ期临床研究。4月12日,该新冠灭活疫苗全球首家获得临床试验批件,Ⅰ/Ⅱ期临床试验在河南省武陟县同步启动。

在河南省疾病预防控制中心的主导下,临床试验现场克服了疫情带来的重重困难,连续奋战66天,全球首个获得了新冠灭活疫苗2针接种后的安全性和有效性数据,对不同年龄、不同程序、不同剂量、不同针次的研究结果,均有较为完整的呈现。这也是迄今为止时间最长、数据最全面、效果最理想的新冠疫苗临床研究结果,为我国疫情防控和紧急使用提供了科学、可评价的数据。

中国生物称,此次研究旨在评价新冠灭活疫苗在18-59岁健康受试者中,按照低、中、高剂量和0,14、0,21和0,28不同程序接种后的安全性和免疫原性,重点关注疫苗接种后的细胞免疫变化情况,探索了疫苗接种的免疫程序、免疫剂量、安全性、免疫原性及体内抗体水平的变化趋势。截至目前,Ⅰ/Ⅱ期临床研究受试者共1120人,已全部完成2针次接种。

此次临床试验方案经过了周密设计,揭盲过程严格遵循科学性和严谨性,结果振奋人心,疫苗接种后安全、有效,接种疫苗组受试者均产生高滴度抗体,18-59岁组中剂量按照0,14天和0,21天程序接种两剂后中和抗体阳转率达97.6%,按照0,28天程序接种两剂中和抗体阳转率达100%。

河南省疾控中心副主任赵东阳、研究者夏胜利,郑州大学公共卫生学院施学忠教授、杨永利教授,中国生物党委书记朱京津、总裁吴永林、财务总监胡立刚、副总裁张云涛、临床医学中心副主任杨云凯,武汉生物制品研究所副总经理李新国、首席科学家申硕、病毒一室主任王泽鋆等出席揭盲仪式。武陟县疾控中心、河南恒益等合作机构共同见证。

与此同时,中国生物积极推进Ⅲ期临床的海外合作,与多个国家的企业及机构确定了合作意向。中国生物已率先建成了高生物安全等级生产车间,这也是目前全球唯一符合生物安全和GMP标准、从数量上能够满足紧急接种需求的新冠疫苗生产车间。

疫情防控形势仍然复杂严峻,通过疫苗预防和控制新冠疫情迫在眉睫。此次揭盲的安全性、有效性数据,极大增强了我们赢得疫情防控阻击战最终胜利的信心,同时也为实现新冠疫苗作为全球公共产品的可及性和可负担性,提供有力支撑,做出中国贡献。

相关报道:科兴生物新冠病毒疫苗初步显示安全有效!三期临床试验将在中国和巴西进行

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    2020-06-18 xxxx1054
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    2020-06-17 公卫新人

    新冠肺炎,疫情何时才能消失

    0

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