智飞生物重组新冠疫苗在乌兹别克斯坦获批使用

2021-03-02 JACKZHAO MedSci原创

乌兹别克斯坦政府已批准由安徽智飞龙科马生物制药有限公司开发的新冠疫苗(CHO细胞)用于乌兹别克斯。

乌兹别克斯坦创新部周一表示,乌兹别克斯坦政府已批准由安徽智飞龙科马生物制药有限公司开发的新冠疫苗(CHO细胞)用于乌兹别克斯坦

乌兹别克斯坦官方最近表示,它将从3月开始实施自愿接种。乌兹别克斯坦副总理贝佐德·穆萨耶夫(Behzod Musayev)在一次会议上说:“在我们国家,疫苗接种将是自愿的。如果一个人拒绝接种疫苗,将不会对他(她)采取任何措施。”

乌兹别克斯坦官员说,大规模疫苗接种运动的第一阶段将覆盖410万人,重点接种人群将为老年人和残疾人,医疗保健和教育系统的雇员以及执法机构的成员接种疫苗。

乌兹别克斯坦去年12月下旬参加了名为ZF2001的疫苗的国际多中心Ⅲ期临床试验。这款重组新冠疫苗于年11月18日启动中国国内Ⅲ期临床试验。这项临床试验将在18周岁及以上人群中开展,采取随机、双盲、安慰剂对照的国际多中心临床试验,全球共计划招募29000人。乌兹别克斯坦是该款疫苗首个海外临床试验点,这也是国内首个在国外启动Ⅲ期临床试验的重组亚单位新冠疫苗,乌国按计划将有5000名志愿者参与试验。

ZF2001由中科院微生物所高福院士团队与安徽智飞龙科马生物制药有限公司联合研发的新冠病毒重组蛋白亚单位疫苗,即将病毒的关键抗原蛋白用体外重组的方式表达后制备成疫苗。主要是针对新冠病毒S蛋白上的受体结合结构域(RBD区)进行疫苗研发。在高福院士团队的带领下,将两个新冠病毒RBD串联表达出二聚体蛋白,制备成重组蛋白亚单位疫苗,作为我国重点布局的五条疫苗路线之一,重组亚单位新冠疫苗拥有自主知识产权,由微生物所高福院士和严景华研究员团队研发,戴连攀研究员是成果主要完成人之一。

去年10月30日,中科院微生物所顺利完成Ⅰ/Ⅱ期临床试验揭盲,揭盲数据显示,临床试验结果符合预期,疫苗显示出了很好的安全性和免疫原性。

 

Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD protein vaccine against COVID-19 in adults: pooled analysis of two randomized, double-blind, placebo-controlled, phase 1 and 2 trials,doi: https://doi.org/10.1101/2020.12.20.20248602

去年12月底,中科院微生物所安徽智飞龙科马生物制药联合在线发表在MedRxiv一二期临床试验数据显示,在2020年6月22日至9月15日期间,共有50名参与者参加了1期研究(平均年龄32.6岁),有900名参与者进入了2期研究(平均年龄43.5岁),以接受两剂疫苗或安慰剂或三剂时间表。对于这两个试验,在大多数参与者中都没有局部或全身性不良反应或症状较轻。

两项试验均未发现与疫苗相关的严重不良事件。在三剂后,在1期研究中,所有接受25μg或50μg剂量疫苗的参与者以及分别为97%(25μg组)和93%(50μg组)的参与者中均检测到中和抗体,在第二阶段的研究中。第1阶段的25μg组的SARS-CoV-2中和几何平均滴度(GMT)在第1阶段为94.5,在50μg组为117.8,在第2阶段,在25μg组中为102.5,在50μg组中为69.1。超过一组COVID-19康复样品的水平(GMT,51)。疫苗诱导了TH1和TH2的平衡反应。与25μg组相比,50μg组未显示出增强的免疫原性。

1期和2期试验中的体液免疫反应,doi: https://doi.org/10.1101/2020.12.20.20248602

总之,ZF2001具有良好的耐受性,没有与疫苗相关的严重不良事件。 在第0、30和60天进行免疫活性检测中,中和抗体的血清转化率为93-100%,GMT超过了恢复期血清样品的大小。同样,这种疫苗引起中等程度的细胞免疫反应,被检测为与TH1 / TH2细胞相关的细胞因子的平衡产生。

Neutralization of SARS-CoV-2 VOC 501Y.V2 by human antisera elicited by both inactivated BBIBP-CorV and recombinant dimeric RBD ZF2001 vaccines,doi: https://doi.org/10.1101/2021.02.01.429069

今年2月初,中国疾病预防控制中心高福团队在bioRxiv发布正在开展3期临床试验的国产重组蛋白亚单位新冠疫苗和批准上市的国产灭活新冠疫苗(北京生物制品研究所等联合开发的BBIBP-CorV灭活新冠疫苗)对南非新变种(501Y.V2)的保护效果。结果显示,虽然这两种疫苗接种者血清对南非新变种的中和效果稍有下降,但是依然保留大部分中和活性,提示这两种疫苗对南非新变种依然有保护效果。

doi: https://doi.org/10.1101/2021.02.01.429069

文章称,研究者为每种疫苗选择了12个来自临床试验参与者的血清样本,无论是ZF2001还是BBIBP-corV受试者的12份血清样本都基本保留了南非变异毒株的中和作用。与它们和新冠病毒毒株WT或D614G的滴度相比,几何平均滴度(GMTs)下降幅度均是1.6倍。令人鼓舞的是,减少量明显少于以前报道的康复患者血清(超过10倍)或来自mRNA疫苗接受者体内的抗体血清(超过6倍)的减少量。

A组(智飞重组蛋白疫苗):相比原株,对南非突变株的几何平均滴度(GMT)从106.1下降到了66.6,降幅1.6倍;相对流行株,GMT从93.2下降到66.6。

但本项研究样本量太小,仅为体外血清测试,不是真实的III期保护率(国外披露的是真实的III期临床保护率),另外智飞重组蛋白和国药灭活对南非株的血清中和滴度均下降1.6倍,这个数字十分准确需要进一步研究。

目前,中科院微生物所和智飞生物正在积极推动该疫苗在乌兹别克斯坦、印度尼西亚、巴基斯坦、厄瓜多尔的III期临床试验。据知情人士称,,一二期详细数据正式发表或在近期发布。三期试验仍在进行中,预计4月份结束。

近日,据中国经济导报报道称,位于合肥高新区的安徽智飞龙科马生物制药有限公司第七生产车间,目前已经开始了重组蛋白新冠疫苗试生产。

 参考文献:

Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD protein vaccine against COVID-19 in adults: pooled analysis of two randomized, double-blind, placebo-controlled, phase 1 and 2 trials,doi: https://doi.org/10.1101/2020.12.20.20248602

Neutralization of SARS-CoV-2 VOC 501Y.V2 by human antisera elicited by both inactivated BBIBP-CorV and recombinant dimeric RBD ZF2001 vaccines,doi: https://doi.org/10.1101/2021.02.01.429069

 

版权声明:
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料,版权均属于梅斯医学所有。非经授权,任何媒体、网站或个人不得转载,授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章,或“梅斯号”自媒体发布的文章,仅系出于传递更多信息之目的,本站仅负责审核内容合规,其内容不代表本站立场,本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。
在此留言
评论区 (5)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=945050, encodeId=8ea1945050e0, content=666 , beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201110/2d55d24dc5fd419d994b7b920c79731b/d3c8bdca983c4af1b90220a8192e353a.jpg, createdBy=e14e5296465, createdName=飞翔的乌龟, createdTime=Wed Mar 03 09:17:55 CST 2021, time=2021-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1029178, encodeId=5b2510291e831, content=新冠肺炎,疫情何时才能消失, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=公卫新人, createdTime=Wed Mar 03 01:16:51 CST 2021, time=2021-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=944960, encodeId=fa1594496098, content=太棒了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211019/df01a4bfb64246379ddfef3370d04115/e1274c8eb5e440918f56f83bcfea9031.jpg, createdBy=3a345397082, createdName=Jessica, createdTime=Tue Mar 02 22:51:11 CST 2021, time=2021-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=944958, encodeId=c569944958e2, content=好评哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210302/94ef5871017543a58804cf654161daa5/260027aaa1ac432ea17903787cf76cea.jpg, createdBy=03fd5464915, createdName=ms1000001662743966, createdTime=Tue Mar 02 22:41:20 CST 2021, time=2021-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=944946, encodeId=12c9944946f6, content=期待三期, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200529/3611e9bb629c4e5b81fbd8ce784b06cc/128487eae357460bb98f67d86230c218.jpg, createdBy=ab235268530, createdName=神盾医疗局局长Jack, createdTime=Tue Mar 02 22:27:51 CST 2021, time=2021-03-02, status=1, ipAttribution=)]
    2021-03-03 飞翔的乌龟

    666

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=945050, encodeId=8ea1945050e0, content=666 , beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201110/2d55d24dc5fd419d994b7b920c79731b/d3c8bdca983c4af1b90220a8192e353a.jpg, createdBy=e14e5296465, createdName=飞翔的乌龟, createdTime=Wed Mar 03 09:17:55 CST 2021, time=2021-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1029178, encodeId=5b2510291e831, content=新冠肺炎,疫情何时才能消失, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=公卫新人, createdTime=Wed Mar 03 01:16:51 CST 2021, time=2021-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=944960, encodeId=fa1594496098, content=太棒了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211019/df01a4bfb64246379ddfef3370d04115/e1274c8eb5e440918f56f83bcfea9031.jpg, createdBy=3a345397082, createdName=Jessica, createdTime=Tue Mar 02 22:51:11 CST 2021, time=2021-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=944958, encodeId=c569944958e2, content=好评哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210302/94ef5871017543a58804cf654161daa5/260027aaa1ac432ea17903787cf76cea.jpg, createdBy=03fd5464915, createdName=ms1000001662743966, createdTime=Tue Mar 02 22:41:20 CST 2021, time=2021-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=944946, encodeId=12c9944946f6, content=期待三期, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200529/3611e9bb629c4e5b81fbd8ce784b06cc/128487eae357460bb98f67d86230c218.jpg, createdBy=ab235268530, createdName=神盾医疗局局长Jack, createdTime=Tue Mar 02 22:27:51 CST 2021, time=2021-03-02, status=1, ipAttribution=)]
    2021-03-03 公卫新人

    新冠肺炎,疫情何时才能消失

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=945050, encodeId=8ea1945050e0, content=666 , beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201110/2d55d24dc5fd419d994b7b920c79731b/d3c8bdca983c4af1b90220a8192e353a.jpg, createdBy=e14e5296465, createdName=飞翔的乌龟, createdTime=Wed Mar 03 09:17:55 CST 2021, time=2021-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1029178, encodeId=5b2510291e831, content=新冠肺炎,疫情何时才能消失, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=公卫新人, createdTime=Wed Mar 03 01:16:51 CST 2021, time=2021-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=944960, encodeId=fa1594496098, content=太棒了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211019/df01a4bfb64246379ddfef3370d04115/e1274c8eb5e440918f56f83bcfea9031.jpg, createdBy=3a345397082, createdName=Jessica, createdTime=Tue Mar 02 22:51:11 CST 2021, time=2021-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=944958, encodeId=c569944958e2, content=好评哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210302/94ef5871017543a58804cf654161daa5/260027aaa1ac432ea17903787cf76cea.jpg, createdBy=03fd5464915, createdName=ms1000001662743966, createdTime=Tue Mar 02 22:41:20 CST 2021, time=2021-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=944946, encodeId=12c9944946f6, content=期待三期, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200529/3611e9bb629c4e5b81fbd8ce784b06cc/128487eae357460bb98f67d86230c218.jpg, createdBy=ab235268530, createdName=神盾医疗局局长Jack, createdTime=Tue Mar 02 22:27:51 CST 2021, time=2021-03-02, status=1, ipAttribution=)]
    2021-03-02 Jessica

    太棒了!

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=945050, encodeId=8ea1945050e0, content=666 , beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201110/2d55d24dc5fd419d994b7b920c79731b/d3c8bdca983c4af1b90220a8192e353a.jpg, createdBy=e14e5296465, createdName=飞翔的乌龟, createdTime=Wed Mar 03 09:17:55 CST 2021, time=2021-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1029178, encodeId=5b2510291e831, content=新冠肺炎,疫情何时才能消失, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=公卫新人, createdTime=Wed Mar 03 01:16:51 CST 2021, time=2021-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=944960, encodeId=fa1594496098, content=太棒了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211019/df01a4bfb64246379ddfef3370d04115/e1274c8eb5e440918f56f83bcfea9031.jpg, createdBy=3a345397082, createdName=Jessica, createdTime=Tue Mar 02 22:51:11 CST 2021, time=2021-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=944958, encodeId=c569944958e2, content=好评哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210302/94ef5871017543a58804cf654161daa5/260027aaa1ac432ea17903787cf76cea.jpg, createdBy=03fd5464915, createdName=ms1000001662743966, createdTime=Tue Mar 02 22:41:20 CST 2021, time=2021-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=944946, encodeId=12c9944946f6, content=期待三期, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200529/3611e9bb629c4e5b81fbd8ce784b06cc/128487eae357460bb98f67d86230c218.jpg, createdBy=ab235268530, createdName=神盾医疗局局长Jack, createdTime=Tue Mar 02 22:27:51 CST 2021, time=2021-03-02, status=1, ipAttribution=)]
    2021-03-02 ms1000001662743966

    好评哦

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=945050, encodeId=8ea1945050e0, content=666 , beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201110/2d55d24dc5fd419d994b7b920c79731b/d3c8bdca983c4af1b90220a8192e353a.jpg, createdBy=e14e5296465, createdName=飞翔的乌龟, createdTime=Wed Mar 03 09:17:55 CST 2021, time=2021-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1029178, encodeId=5b2510291e831, content=新冠肺炎,疫情何时才能消失, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=公卫新人, createdTime=Wed Mar 03 01:16:51 CST 2021, time=2021-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=944960, encodeId=fa1594496098, content=太棒了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211019/df01a4bfb64246379ddfef3370d04115/e1274c8eb5e440918f56f83bcfea9031.jpg, createdBy=3a345397082, createdName=Jessica, createdTime=Tue Mar 02 22:51:11 CST 2021, time=2021-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=944958, encodeId=c569944958e2, content=好评哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210302/94ef5871017543a58804cf654161daa5/260027aaa1ac432ea17903787cf76cea.jpg, createdBy=03fd5464915, createdName=ms1000001662743966, createdTime=Tue Mar 02 22:41:20 CST 2021, time=2021-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=944946, encodeId=12c9944946f6, content=期待三期, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200529/3611e9bb629c4e5b81fbd8ce784b06cc/128487eae357460bb98f67d86230c218.jpg, createdBy=ab235268530, createdName=神盾医疗局局长Jack, createdTime=Tue Mar 02 22:27:51 CST 2021, time=2021-03-02, status=1, ipAttribution=)]
    2021-03-02 神盾医疗局局长Jack

    期待三期

    0

相关资讯

2021年2月27日全球新冠肺炎(COVID-19)疫情简报,确诊超1亿1396万,新冠致全球多国人口出生严重下滑

Worldometers世界实时统计数据显示,截至北京时间2021年2月27日8时21分,全球累计确诊新冠肺炎(COVID-19)病例超过11396万例,新增418,600例,达到113,961,40

2021年3月1日全球新冠肺炎(COVID-19)疫情简报,确诊超1亿1466万,美国接种疫苗超7000万支

Worldometers世界实时统计数据显示,截至北京时间2021年3月1日7时21分,全球累计确诊新冠肺炎(COVID-19)病例超过11466万例,新增298,195例,达到114,663,819

这些人不得接种新冠疫苗

我国从2020年12月15日开始对重点人群开展新冠病毒疫苗接种工作,目前已经过去了两个多月的时间,现在各地的新冠病毒疫苗接种工作进展如何?接种证明能否替代核酸检测报告?老人、孕妇、备孕期、哺乳期妇女…

国内部分地区已启动新冠疫苗大规模接种!在哪里接种?

“你打新冠疫苗了吗?”春节过后,不少人见面的问候语变成了这句话。

国家药监局附条件批准国药中生武汉公司新型冠状病毒灭活疫苗(Vero细胞)注册申请

2月25日,国家药品监督管理局附条件批准国药集团中国生物武汉生物制品研究所有限责任公司的新型冠状病毒灭活疫苗(Vero细胞)注册申请。该疫苗适用于预防由新型冠状病毒感染引起的疾病(COVID-19)。