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Jointly Fighting the Epidemic: The interim main data of the phase III clinical trial of Lizhu Group's V-01 vaccine sequential booster shows good protection against Omicron infection.
Release time:
2022-02-18
The recombinant novel coronavirus fusion protein vaccine (referred to as "V-01") developed by Lijuzhijituan's subsidiary Lijuzhankang in collaboration with the Institute of Biophysics, Chinese Academy of Sciences has completed the mid-term primary data analysis of the sequential booster phase III clinical trial and obtained key data. The trial data indicates thatV-01Sequential boosting againstOmicronhas an absolute protective efficacy of61.35%.The safety is good, andmeets WHO standards.
V-01It is the world's first vaccine designed for strong protective efficacy againstOmicronsequential boosting.IIIPhase clinical research, this clinical protocol is designed as a sequential booster based on two doses of inactivated vaccine, with a relatively strong protective efficacy standard, which is innovative internationally.In all valid samples sent for testing in this trial, 60 samples of novel coronavirus gene typing by first-generation sequencing were all Omicron (the rest are still undergoing second-generation sequencing), indicating that V-01 sequential boosting can provide good protection against COVID-19 caused by Omicron infection. At the same time, no safety issues of concern were found.
V-01 was first initiated and developed in July 2020 by Lijuzhankang in collaboration with the Institute of Biophysics, Chinese Academy of Sciences as an innovativerecombinant novel coronavirus fusion protein vaccine,which has independent intellectual property rights. Thanks to Lijuzhijituan's mature biopharmaceutical R&D platform, V-01 achieved rapid incubation,completing the construction of stable high-expression monoclonal cell lines, development and establishment of cell culture and purification processes, formulation prescription and process development and establishment, establishment of analytical testing methods and quality research, immunogenicity studies, and preclinical safety evaluations within 6 months, and obtained approval for clinical trials from theNational Medical Products Administration of China in January 2021.
In July 2021, the phase II clinical trial data of V-01 with two doses was published in the "Chinese Medical Journal", showing that the vaccine has excellent immunogenicity and safety, especially in the elderly group, where the overall incidence of vaccine-related adverse events is lower than that of the corresponding adult group.
In October 2021, V-01 first obtained the approval from the Pakistan Drug Regulatory Authority for the "evaluation of the protective efficacy, safety, and immunogenicity of the recombinant novel coronavirus fusion protein vaccine (V-01) in healthy adults aged 18 and above who have completed two doses of inactivated vaccine in an international multicenter, randomized, double-blind, placebo-controlled phase III clinical trial" (sequential boosting scheme), and subsequently obtained clinical trial approval from Malaysia for the sequential boosting scheme, fully accelerating the related trial research work.
The results of this trial data will help accelerate themarket process of the V-01 vaccine,in the context of global vaccine distribution imbalance and supply shortages, the early development and market launch of the V-01 vaccine will provide more flexible and scientific vaccination options for domestic and global epidemic prevention, contributing to global epidemic prevention and fulfilling corporate social responsibility.在全球疫苗分配不均衡及供应不足的背景下，V-01疫苗的早日研发上市将为国内及全球抗疫提供更多灵活科学的接种选择，为全球抗疫作贡献，践行企业社会责任。
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