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Latest Research Results | Livzon Group's COVID-19 Vaccine V-01 Provides a Better Option for Sequential Boosting
Release time:
2022-07-21
On July 18, the research data on the recombinant novel coronavirus fusion protein vaccine V-01 and V-01D-351 bivalent sequential booster vaccination, developed by the subsidiary of Livzon Pharmaceutical Group, Livzon Monoclonal Antibody, in collaboration with the Institute of Biophysics, Chinese Academy of Sciences, was published in the Journal of Clinical Medicine.
This study aims to verify the safety and immunogenicity of administering the V-01 or V-01D-351 bivalent vaccine (targeting the Delta and Beta strains) as a booster shot 5-7 months after the basic immunization with inactivated COVID-19 vaccine (ICV). A total of 77 subjects were enrolled in the study, including 20 participants in the V-01D-351 bivalent vaccine booster study, 38 in the V-01 booster study, and 19 in the inactivated vaccine booster study.
The study results indicate:
In terms of safety, the V-01 or V-01D-351 bivalent vaccine as a heterologous booster is safe and well-tolerated, with adverse reactions being mostly mild to moderate, the vast majority being mild, and no serious adverse reactions.
In terms of immunogenicity, the heterologous booster immunization induced by the V-01 or V-01D-351 bivalent vaccine demonstrated a superior humoral immune response compared to the homologous booster of the inactivated vaccine. Notably, on the 14th day after administration of the V-01D-351 bivalent vaccine booster, the neutralizing antibody titers against the SARS-CoV-2 prototype strain, Delta, and Omicron BA.1 strains were the highest, with geometric mean titers (GMT) being 22.7, 18.3, and 14.3 times greater than those of the inactivated vaccine booster, 6.2, 6.1, and 3.8 times greater than those of the 10 μg V-01 booster, and 5.2, 3.8, and 3.5 times greater than those of the 25 μg V-01 booster. The heterologous V-01 booster also demonstrated good safety and immunogenicity profiles in elderly subjects.
In addition, the immunogenicity duration of the V-01D-351 bivalent vaccine booster is considerable, with neutralizing antibody responses remaining at a high level up to 90 days post-vaccination. The V-01 and V-01D-351 bivalent vaccines can provide a better option for sequential boosting.
Currently, V-01 has applied for sequential emergency use and has submitted a conditional marketing application to the National Medical Products Administration, both of which are under review. In terms of overseas registration, the application for marketing has been initiated in multiple countries and regions.
The unique molecular design of V-01 and V-01D-351 bivalent vaccines can induce strong humoral and cellular immunity against the coronavirus, and sequential boosting can significantly enhance neutralizing antibody levels, showing good neutralizing ability against Omicron variants, which can more effectively prevent viral escape, and is expected to provide a better solution for booster immunization, contributing to epidemic prevention and control with Livzon's strength.
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