China-based Livzon Pharmaceutical Group (HKG: 1513) released clinical data for its recombinant novel coronavirus fusion protein vaccine V-01 and bivalent vaccine V-01D-351, showing strong safety and immunogenicity as sequential booster shots. The vaccines are co-developed by Livzon subsidiary Zhuhai Livzon Monoclonal Antibodies Biotechnology and the Chinese Academy of Sciences’ Institute of Biophysics.
Study Details
The trial enrolled 77 subjects to evaluate V-01 or V-01D-351 as boosters 5-7 months after inactivated COVID-19 primary immunization. Participants included 20 in the V-01D-351 bivalent group, 38 in the V-01 group, and 19 in the inactivated vaccine group.
Safety and Immunogenicity
- Safety: Both V-01 and V-01D-351 were safe and well-tolerated, with mild-to-moderate adverse reactions and no serious events.
- Immunogenicity: Heterologous boosting with V-01 or V-01D-351 induced stronger humoral responses than inactivated vaccine boosters. The V-01D-351 bivalent booster showed the highest neutralizing antibody titers against SARS-CoV-2 prototype, Delta, and Omicron BA.1 strains at Day 14. Titers remained elevated 90 days post-inoculation.
Vaccine Design and Future Plans
The vaccines’ unique molecular design enhances humoral and cellular immunity, offering robust protection against Omicron variants. V-01, filed for emergency sequential use, awaits regulatory decisions in China and is prepared for international submissions.-Fineline Info & Tech
