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The Russian Ministry of Health has approved the restructuring of the Lijun Group's novel coronavirus fusion protein vaccine to conduct phase III clinical research.
Release time:
2021-11-12
On November 8, the Russian Ministry of Health announced on the National Research License Registration website that it has issued a license approving the "Recombinant Novel Coronavirus Fusion Protein Vaccine" (V-01) developed by Livzon Mabpharm Inc. in Zhuhai, China, to conduct Phase III clinical research. This involves a "randomized, double-blind, placebo-controlled, international multicenter Phase III clinical trial to evaluate the efficacy, safety, and immunogenicity of the recombinant novel coronavirus (SARS-CoV-2) fusion protein vaccine (V-01) in adults aged 18 and older."
On November 8, the website of the National Research License Registration of the Russian Ministry of Health announced that the Ministry has issued a license approving the "recombinant novel coronavirus fusion protein vaccine" (V-01) developed by Livzon Mabpharm Inc. in Zhuhai, China, to conduct phase III clinical research. This involves a "randomized, double-blind, placebo-controlled, international multicenter phase III clinical trial to evaluate the efficacy, safety, and immunogenicity of the recombinant novel coronavirus (SARS-CoV-2) fusion protein vaccine (V-01) in adults aged 18 and older."
Currently, V-01 is undergoing an international multicenter, randomized, double-blind, placebo-controlled phase III clinical trial in healthy adults aged 18 and older who have completed two doses of inactivated vaccine, assessing the protective efficacy, safety, and immunogenicity of the booster sequential immunization in Pakistan and Malaysia. Phase III clinical trials are also ongoing in the Philippines and Indonesia. The approval of this phase III clinical trial in Russia will further accelerate the development process of V-01 and contribute to the fight against the pandemic.
V-01 is an innovative recombinant protein vaccine for COVID-19 developed in collaboration between Livzon Mabpharm and the Institute of Biophysics of the Chinese Academy of Sciences. The project for V-01 was initiated in July 2020, and it received approval for clinical trials from the National Medical Products Administration of China in early 2021, with the indication for the prevention of diseases caused by novel coronavirus infection (COVID-19).
The domestic phase II clinical trial of V-01 is as follows: (1) A total of 880 subjects were enrolled in the phase II clinical trial conducted in the population aged 18 and older, including 440 in the adult group (ages 18 to 59) and 440 in the elderly group (≥60 years, with the maximum age being 83 years); (2) The purpose of the trial is to preliminarily evaluate the safety and immunogenicity of the trial vaccine; (3) The trial results show that in terms of safety, the incidence of adverse events related to the trial vaccine is low, the severity of adverse reactions is mild (mainly grade 1), the duration is short, most recover within 1-3 days, and no serious adverse events related to the vaccine or adverse events requiring special attention were observed. In terms of immunogenicity, after two doses of vaccination following a 0, 21-day schedule, 14 days later, the seroconversion rate of neutralizing antibodies in the target dose vaccine group can reach over 97% in the overall population, and both adult and elderly vaccine recipients can quickly produce 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 demonstrate that V-01 has good safety and immunogenicity in the population that meets the clinical trial protocol and can proceed to the next phase of clinical trials. The data from the domestic phase I and II clinical trials of V-01 were published in July 2021 in "Emerging Microbes & Infections" and "Chinese Medical Journal" (English version), respectively.
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