A Phase I/II, Randomized, Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (RBMRNA-176) in Healthy Adults Aged 18 Years and Older

The phase I/II study is to evaluate the safety and immunogenicity of SARS-COV-2 mRNA Vaccine (RBMRNA-176) at different doses in healthy subjects aged 18 years and older.

开始日期2022-01-08

申办/合作机构

阿格纳生物制药有限公司

100 项与 RBMRNA-176(Guangzhou Medical University/Guangzhou Ribobio/Agna Biopharmaceutical) 相关的临床结果

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100 项与 RBMRNA-176(Guangzhou Medical University/Guangzhou Ribobio/Agna Biopharmaceutical) 相关的转化医学

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100 项与 RBMRNA-176(Guangzhou Medical University/Guangzhou Ribobio/Agna Biopharmaceutical) 相关的专利（医药）

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项与 RBMRNA-176(Guangzhou Medical University/Guangzhou Ribobio/Agna Biopharmaceutical) 相关的文献（医药）

Vaccines

Immunization with a Prefusion SARS-CoV-2 Spike Protein Vaccine (RBMRNA-176) Protects against Viral Challenge in Mice and Nonhuman Primates

Article

作者: Pan, Weiqi ; Li, Man ; Dai, Jinlong ; Shi, Yongxia ; Dai, Cailing ; Huang, Yuankeng ; Zhong, Huiling ; Li, Runfeng ; Ma, Qinhai ; Dai, Jun ; Wu, Linping ; Ma, Lin ; Yang, Wei ; Guo, Jianmin ; Wen, Jian ; Zhang, Biliang ; Zhao, Haoting ; Yang, Zifeng ; Zhang, Hong

There is an urgent need for a broad-spectrum and protective vaccine due to the emergence and rapid spreading of more contagious SARS-CoV-2 strains. We report the development of RBMRNA-176, a pseudouridine (Ψ) nucleoside-modified mRNA-LNP vaccine encoding pre-fusion stabilized trimeric SARS-CoV-2 spike protein ectodomain, and evaluate its immunogenicity and protection against virus challenge in mice and nonhuman primates. A prime-boost immunization with RBMRNA-176 at intervals of 21 days resulted in high IgG titers (over 1:819,000 endpoint dilution) and a CD4+ Th1-biased immune response in mice. RBMRNA-176 vaccination induced pseudovirus-neutralizing antibodies with IC50 ranging from 1:1020 to 1:2894 against SARS-CoV-2 spike pseudotyped wild-type and variant viruses, including Alpha, Beta, Gamma, and Kappa. Moreover, significant control of viral replication and histopathology in lungs was observed in vaccinated mice. In nonhuman primates, a boost given by RBMRNA-176 on day 21 after the prime induced a persistent and sustained IgG response. RBMRNA-176 vaccination also protected macaques against upper and lower respiratory tract infection, as well as lung injury. Altogether, these findings support RBMRNA-176 as a vaccine candidate for prevention of COVID-19.

100 项与 RBMRNA-176(Guangzhou Medical University/Guangzhou Ribobio/Agna Biopharmaceutical) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
新型冠状病毒感染	临床2期	中国	阿格纳生物制药有限公司	2022-01-08
冠状病毒感染	临床前	中国	广州市锐博生物科技有限公司	2022-10-11
冠状病毒感染	临床前	中国	广州医科大学	2022-10-11