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Good news! Lizhu Group's restructured novel coronavirus fusion protein vaccine has entered Phase III clinical trials
Published Time：
2021-08-27
The recombinant novel coronavirus fusion protein vaccine (hereinafter referred to as "V-01") developed by Lizhu Single Antibody Biotechnology Co., Ltd. (hereinafter referred to as "Lizhu Single Antibody"), a subsidiary of Lizhu Group, has commenced global Phase III clinical trials (hereinafter referred to as "Phase III clinical trials"). Lizhu Single Antibody's application for Phase III clinical trials submitted to the Philippine FDA has been approved, and the first subject was successfully enrolled in the Philippines on August 25, 2021. Currently, Lizhu Single Antibody has submitted applications for Phase III clinical trials to more than 10 countries worldwide.
V-01, a novel recombinant COVID-19 protein vaccine jointly developed by Lizhu Single Antibody and the Institute of Biophysics, Chinese Academy of Sciences, began development in July 2020. In early 2021, V-01 received approval from the National Medical Products Administration of China for clinical trials, indicated for the prevention of disease caused by novel coronavirus infection (COVID-19).
The results of the domestic Phase II clinical trial of V-01 are as follows: (1) The Phase II clinical trial of V-01 in individuals aged 18 and above enrolled a total of 880 subjects, including 440 in the adult group (18 to 59 years old) and 440 in the elderly group (≥60 years old) (the oldest being 83 years old); (2) The purpose of the trial was to preliminarily evaluate the safety and immunogenicity of the trial vaccine; (3) The trial results showed: In terms of safety, the incidence of adverse events related to the trial vaccine was low, the severity of adverse reactions was mild (mostly Grade 1), the duration was short, and most recovered spontaneously within 1-3 days. No vaccine-related serious adverse events or adverse events requiring special attention were observed. In terms of immunogenicity, 14 days after two doses of vaccination administered according to a 0, 21-day schedule, the seroconversion rate of neutralizing antibodies in the entire population in the target dose vaccine group reached over 97%. Both adult and elderly vaccine recipients rapidly produced high titers of neutralizing antibodies, with no significant difference in neutralizing antibody titers between the elderly and adult groups; (4) The results of the domestic Phase II clinical trial of V-01 demonstrated that V-01 has good safety and immunogenicity in the population that meets the criteria of this clinical trial protocol and can proceed to the next phase of clinical trials.
Data from the domestic Phase I and Phase II clinical trials of V-01 were published in *Emerging Microbes & Infections* and the *Chinese Medical Journal* (English edition) in July 2021, respectively.
The subject of this Phase III clinical trial approved by the Philippine FDA is: a global, multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the efficacy, safety, and immunogenicity of the recombinant novel coronavirus fusion protein vaccine (V-01) in adults aged 18 and above.
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