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开发一种具有强大预防 SARS-CoV-2 能力的灭活疫苗候选物,BBIBP-CorV。

Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2.

机构信息

Beijing Institute of Biological Products Company Limited, Beijing, China.

National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC), Beijing, China.

出版信息

Cell. 2020 Aug 6;182(3):713-721.e9. doi: 10.1016/j.cell.2020.06.008. Epub 2020 Jun 6.

Abstract

The coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) threatens global public health. The development of a vaccine is urgently needed for the prevention and control of COVID-19. Here, we report the pilot-scale production of an inactivated SARS-CoV-2 vaccine candidate (BBIBP-CorV) that induces high levels of neutralizing antibodies titers in mice, rats, guinea pigs, rabbits, and nonhuman primates (cynomolgus monkeys and rhesus macaques) to provide protection against SARS-CoV-2. Two-dose immunizations using 2 μg/dose of BBIBP-CorV provided highly efficient protection against SARS-CoV-2 intratracheal challenge in rhesus macaques, without detectable antibody-dependent enhancement of infection. In addition, BBIBP-CorV exhibits efficient productivity and good genetic stability for vaccine manufacture. These results support the further evaluation of BBIBP-CorV in a clinical trial.

摘要

由严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2)引起的 2019 年冠状病毒病 (COVID-19) 大流行威胁着全球公共卫生。迫切需要开发一种疫苗来预防和控制 COVID-19。在这里,我们报告了一种灭活的 SARS-CoV-2 疫苗候选物 (BBIBP-CorV) 的中试规模生产,该候选物在小鼠、大鼠、豚鼠、兔子和非人类灵长类动物(食蟹猴和恒河猴)中诱导高水平的中和抗体滴度,以提供针对 SARS-CoV-2 的保护。使用 2μg/剂的 BBIBP-CorV 进行两剂免疫接种,可在恒河猴中高效预防 SARS-CoV-2 经气管内攻击,而不会检测到抗体依赖性增强感染。此外,BBIBP-CorV 具有高效的生产能力和良好的遗传稳定性,可用于疫苗生产。这些结果支持在临床试验中进一步评估 BBIBP-CorV。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/efbb/7275151/7aa215db860a/fx1_lrg.jpg

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