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Lizhu Group: The sequential booster of the reorganized COVID-19 fusion protein vaccine can produce good protection against Omicron
Published Time：
2022-02-17
Lizhu Group (000513.SZ) recently announced that its controlling subsidiary, Zhuhai Lizhu Monoclonal Antibody Biotechnology Co., Ltd. (referred to as "Lizhu Monoclonal Antibody"), in cooperation with the Institute of Biophysics, Chinese Academy of Sciences, has completed the interim primary data analysis of the Phase III clinical trial of its sequential booster "recombinant novel coronavirus fusion protein vaccine" (referred to as "V-01") and obtained key data.
The announcement shows that this sequential booster regimen is designed as a sequential booster based on two doses of inactivated vaccine, using a relatively strong and superior efficacy standard, which is different from the traditional blank placebo control group. The Phase III clinical trial of V-01 sequential booster was conducted in Pakistan and Malaysia, planning to inject V-01 booster or blank placebo in a 1:1 ratio among a total of 10,722 healthy adults aged 18 and above who completed 2 doses of inactivated vaccine 3-6 months ago.
As of the date of this key data analysis, 10,241 subjects were actually enrolled, and a total of 110 cases of primary endpoint events were monitored after vaccination (the protocol requires analysis when at least 103 primary endpoint events are observed).
According to the results of the current stage analysis: Compared with two doses of inactivated vaccine, the incidence rate per person-year in the V-01 sequential booster group and the two-dose inactivated vaccine group were 6.73% and 12.80%, respectively, showing a significant difference (P=0.0012); the absolute protective efficacy of V-01 sequential booster was 61.35%, showing significantly superior efficacy. The absolute protective efficacy of V-01 sequential booster has met the WHO standard.
Genotyping sequencing of 60 of all the effectively submitted samples in this trial showed that all were Omicron (the rest are still undergoing next-generation sequencing), indicating that V-01 sequential booster can produce good protection against COVID-19 caused by Omicron infection. At the same time, no safety concerns of note were found.
Source: Xinhua Net
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