Immunogenicity and Safety of COVID-19 Vaccine as a Booster Vaccination in Population Aged 18 Years and Above

Summary

A total of 1200 people aged 18 years and older who have completed two or three-dose inactivated COVID-19 vaccine for 6-18 months will be recruited in this study. Subjects will be received 1 dose at day 0 as a booster vaccination.Immunogenicity and safety of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 will be evaluated.

Timeline

Start

2022-12-28

Primary completion

2023-01-18

Completion

2023-12-31

Outcome

Met primary endpoint

paper The 14-day GMT ratio (LYB001/ZF2001) against Omicron BA.4/5 was 1.39 (95% CI: 1.25, 1.56), demonstrating superiority (95% CI lower limit > 1) of LYB001. PMID 39720838 ↗

Publications

• Yang BF, Jin J, He XR, Yang ZH, Qian X, Tong YQ, Ke CX, Li ZH, Li ZX, Zhong LF, Gan ZH, Zhang XF, Zeng Y. Immunogenicity and safety of SARS-CoV-2 recombinant protein vaccine (CHO cell) LYB001 as a heterologous booster following two- or three-dose inactivated COVID-19 vaccine in adults aged >/=18 years: interim results of a randomized, active-controlled, double-blinded, phase 3 trial. Expert Rev Vaccines. 2025 Dec;24(1):81-90. doi: 10.1080/14760584.2024.2446288. Epub 2025 Jan 5.

Drugs

Indications