Lancet Infect Dis:BBIBP-CorV新冠肺炎灭活疫苗1/2期研究获得成功

2020-10-17 MedSci原创 MedSci原创

BBIBP-CorV新冠肺炎灭活疫苗是安全的,耐受性良好。在接种后第42天在所有疫苗受者均产生了SARS-Cov-2体液反应。基础接种联合1次强化接种的免疫应答效果优于单次双倍剂量接种

为了遏制Covid-19大流行,需要加快疫苗的研发速度。 近日研究人员评估了灭活的严重急性呼吸综合征冠状病毒2(SARS-cov-2) 候选物疫苗BBIBP-CorV在人类中的安全性和免疫原性。

本次研究是在中国河南省商丘市梁园区疾病控制和预防中心进行了随机、双盲、安慰剂对照的1/2阶段试验。18-80岁的健康志愿者参与,参与者基线筛查时血清特异性IGM/IgG SARS-Cov-2抗体为阴性,分为2组年龄组(18-59岁和60岁及以上人群),在第0和28天接种2剂量的疫苗或安慰剂,剂量规格为2 μg, 4 μg和8 μg。在第2阶段研究中,18-89岁的参与随机接受疫苗或安慰剂,其中疫苗组分为:第0天8 μg 单次接种,第0和14天,第0和21天以及第0和28天2次接种,每次剂量为4 μg。研究的主要终点为安全性和耐受性,次要终点为免疫原性。

在第1阶段研究中,192名志愿者参与,平均年龄53.7岁,其中2个年龄段,各剂量组和安慰剂组各有24名志愿者。144名疫苗接种者中,42人(29%)在接种后的头7天内报告了至少一个不良反应。最常见的不良事件为发热(18-59岁剂量组中,2、4以及8μg发热率分别为4%,4%和8%,60及以上组中,8μg组发热率为4%)。总体上,不良事件较为温和,接种后28天未发生严重不良事件。18-59岁参与者中,接种后42天的中和抗体平均几何滴度为:2μg组87.7,4μg组211.2,8μg组228.7;在60岁及以上组中,分别为80.7、131.5和170.87,安慰剂组仅为2.0。在第2阶段研究中,448名志愿者参与,平均年龄41.7岁,各组均有84名参与者。23%的志愿者在7天内报告了至少1次不良事件。1名接受4μg安慰剂接种的患者出现3级发热,为自限性。不良事件均较为温和,最常见的系统性不良事件为发热(1-2%)。接种后第28天,0,14天4μg组的抗体滴度为169.5、0,21天4μg组为282.7、0,28天4μg组为218.0,第0天8μg组为14.7。

研究认为,BBIBP-CorV新冠肺炎灭活疫苗是安全的,耐受性良好。在接种后第42天在所有疫苗受者均产生了SARS-Cov-2体液反应。基础接种联合1次强化接种的免疫应答效果优于单次双倍剂量接种。

原始出处:

Prof Shengli Xia et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial.Lancet Infect Dis. October 15,2020.

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    2021-05-14 zhaojie88
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    2021-02-26 howi
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    2020-10-29 1581f8c42cm

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    2020-10-17 公卫新人

    新冠肺炎,疫情何时才能消失

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    2020-10-17 goodbing

    顶刊就是不一样,质量很高,内容精彩!学到很多

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