IMCAS Holds Unblinding Meeting of Phase I/II Clinical Trial of Recombinant Subunit Vaccines for COVID-19

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Updatetime:2020-11-06
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The unblinding meeting of recombinant subunit vaccines for COVID-19, which are developed by Institute of Microbiology, Chinese Academy of Science (IMCAS) and Chongqing Zhifei Biological Products Co., Ltd. (Zhifei Bio) was held at IMCAS.

The unblinding results were as expected that this recombinant subunit vaccines for COVID-19 were much safety and immunogenicity in the subjects who satisfied the requirements of the clinical trial project, therefore the next-round clinical trial can be carried out continuously.

As one of the five vaccine routes emphatically arranged by China government is developed by George Fu Gao, CAS academician and YAN Jinghua’ research groups and DAI Lianpan is principal accomplisher for this achievement. This vaccine has an independent intellectual property rights.

The phase I/II clinical trial of the recombinant protein subunit vaccines for COVID-19 is random, double-blind and placebo control to evaluate the security and immunogenicity of the vaccine. The results show that no serious adverse events directly related to the vaccine were found in Phase I/II clinical trial. Furthermore, the unblinding data certifies the tolerance, security and immunogenicity of this vaccine so that we can carry out next-round clinical trial, subsequently.

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