医科院生物所自主研发的新冠病毒灭活疫苗进入Ⅱ期临床试验

2020-06-22 网络 网络

2020年6月20日,由中国医学科学院医学生物学研究所(以下简称医科院生物所)自主研发的

2020年6月20日,由中国医学科学院医学生物学研究所(以下简称医科院生物所)自主研发的新型冠状病毒灭活疫苗,在云南省红河州进入Ⅱ期临床试验,在目前全球疫情依然严峻复杂的形势下,为全球抗疫再次注入“强心剂”。

新冠肺炎疫情发生以来,曾成功研制我国首个Sabin株脊髓灰质炎灭活疫苗、肠道病毒EV71型灭活疫苗的医科院生物所,根据党中央、国务院的总体部署,在中国医学科学院的领导下,义不容辞地承担疫情防控科研攻关任务,成立应急疫苗研发攻关组,在应急疫苗研发、动物模型建立、病毒溯源及传播机理研究等方面开展科研攻关。通过综合多学科力量加快科研攻关,在坚持科学性、确保安全性的基础上加快了疫苗研发进度。

今年2月初,医科院生物所即已启动病毒分离选育工作,并在细胞上进行适应传代培养,完成了疫苗生产毒种的筛选和鉴定,建立了三级种子库并通过了中国食品药品检定研究院的检定。利用“国家昆明高等级生物安全灵长类动物研究中心”的资源优势,初步建立了用于疫苗安全性和保护效果评价的恒河猴动物模型。

3月,旋即开展了SARS-CoV-2感染致病机制及免疫学研究,为疫苗研发奠定了扎实基础,确定了疫苗关键生产工艺体系以及质量控制的标准体系;完成了疫苗在非人灵长类动物体内的安全性、免疫原性及保护效果的评价。

2020年5月13日,医科院生物所收到了国家药品监督管理局下发的《药物临床试验批件》,批准开展Ⅰ/Ⅱ期临床试验。5月15日,正式在四川大学华西第二医院启动Ⅰ期首批人群临床研究,Ⅰ期临床试验主要评价高、中、低不同剂量的新型冠状病毒灭活疫苗(Vero细胞)在健康人群中接种的安全性、耐受性及初步免疫原性。Ⅰ期临床试验采用随机、双盲、安慰剂对照的设计,根据试验方案,从低剂量向高剂量爬坡,临床研究人群从中间年龄段向高年龄段和低年龄段逐步推进,截止目前已完成近200例18~59岁健康成年人的入组,相关研究工作顺利推进中

6月20日正式启动的Ⅱ期首批人群临床研究,将对疫苗在健康人群中接种的免疫原性和安全性开展进一步评价,并确定免疫程序和免疫剂量。Ⅱ期临床研究由云南省疾病预防控制中心疫苗临床研究中心负责组织实施,在云南省弥勒市疾病预防控制中心和云南省个旧市疾病预防控制中心两个研究现场同步启动筛选入组工作。

首批人群的临床研究,将对疫苗在健康人群中接种的免疫原性和安全性开展进一步评价,并确定免疫程序和免疫剂量。Ⅱ期临床研究由云南省疾病预防控制中心疫苗临床研究中心负责组织实施,将在云南省弥勒市疾病预防控制中心和云南省个旧市疾病预防控制中心两个研究现场同步启动筛选入组工作。仪式结束后,两地分别开始首针接种,临床入组工作预计将持续一周左右。

在新冠肺炎疫情全球大流行的背景下,疫苗成为最能有效解决危机的希望。“作为国家公益性事业单位,医科院生物所践行‘国家队’的使命担当,秉承严谨科学的态度,依托国家生物安全重大科技基础设施支撑,充分利用针对人类重大传染病重要技术储备力量,稳健推进新型冠状病毒灭活疫苗的临床研究。”这位负责人表示,他们将尽全力,争取早日为人民群众提供安全、有效和质量可控的疫苗,为保障人民生命健康、维护国家公共卫生安全和全球共同应对新冠肺炎疫情作出新的贡献。

此前,医科院生物所新型冠状病毒灭活疫苗的研究已取得阶段性成果,在积极开展临床试验的同时,产业化实施的工作也在稳步推进,该所在昆明疫苗产业基地规划并设计具有生物安全防护的GMP生产车间,用于新冠灭活疫苗的产业化实施,预计在2020年下半年投入使用,确保国家应急疫苗的供应任务。

医科院生物所长期以来从事病毒疫苗的研发、生产工作。1957年,老一辈科学家顾方舟临危受命,带领研究团队开始进行脊髓灰质炎研究工作。医科院生物所先后研制、生产了脊髓灰质炎减毒活疫苗和Sabin株脊髓灰质炎灭活疫苗,供应全国使用,让数十万儿童免于致残。

武汉生物制品有限公司首席科学家申硕教授表示:中国有四家灭活疫苗厂家临床研究进入II期。合起来产量也不会低。目前为止,临床一期、二期安全性、体液免疫原性数据令人鼓舞。我们在期待进行海外临床三期的保护效力评估。如果三期实战证明安全有效,产能如果真不够,可以扩建生产车间(加生产线),因为车间要符合高等级安全性及cGMP两个条件,成本会高些,管理要求及其严格。相信接下来我国其它技术路线的候选疫苗会陆续进入临床研究,会有多种选择,互补长短,解决可及性问题。

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    2020-06-24 lqvr
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    2020-06-22 公卫新人

    新冠肺炎,疫情何时才能消失

    0

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北京新增6例新冠病毒感染,均与新发地市场有关,45人咽拭子阳性

6月13日,在北京市新型冠状病毒肺炎疫情防控工作第114场新闻发布会上,北京市疾控中心副主任庞星火说,近日,北京市已连续发现多例本地新冠肺炎确诊病例,除昨日通报的1例病例刘某某有出京史外,其余6例病例

日本加速研制国产新冠疫苗

日本一些制药企业正加速研制国产新冠疫苗,疫苗研发获得日本政府力推。厚生劳动省官员说,这是为了确保国内疫苗供应。

NEJM:揭密新冠病毒感染风险可能与血型有关

一项针对意大利和西班牙人群的新研究显示,新冠病毒感染风险可能与血型有关,A型血人群更易感染新冠病毒,而O型血人群更不易感。

Nat Med:新冠病毒感染康复后产生的抗体或只能维持2到3个月,或将演变成季节性流感

新冠病毒感染后,患者免疫强度和持续时间是非常重要的问题,也是决定如何以及何时放松社交疏离政策的关键。先前的研究表明,SARS-CoV、MERS-CoV的抗体至少持续1年。在SARS-CoV感染后,持续