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.

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.

Publication date: Dec 25, 2024

LYB001 is a recombinant protein COVID-19 vaccine displaying a receptor-binding domain (RBD) in a highly immunogenic array on virus-like particles (VLPs). This study assessed the immunogenicity and safety of LYB001 as a booster. In this randomized, active-controlled, double-blinded, phase 3 trial, participants aged ≥18 years received a booster with LYB001 or ZF2001 (Recombinant COVID-19 Vaccine). The primary endpoint was to compare the geometric mean titer (GMT) of neutralizing antibodies against Omicron BA. 4/5 at 14 days after the booster. Overall, 1,200 participants aged ≥18 years were enrolled, 599 received LYB001, and 601 received ZF2001. Based on similar baseline level, 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. The spike protein-binding IgG concentrations induced by LYB001 were significantly higher than those induced by ZF2001 on day 14 and day 28 after the booster (p-value

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Concepts Keywords
18years CHO cell
Expert COVID-19 vaccine
Inactivated heterologous booster
Vaccine immunogenicity
safety
virus-like particle

Semantics

Type Source Name
disease IDO protein
disease IDO cell
drug DRUGBANK Coenzyme M
drug DRUGBANK Ranitidine
disease MESH Infectious Disease
pathway REACTOME Infectious disease
disease MESH COVID 19 pandemic
disease MESH emergency
drug DRUGBANK Amino acids
disease IDO production
disease IDO history
disease MESH allergy
disease MESH anaphylaxis
disease MESH coronavirus infection
disease MESH psychiatric illness
drug DRUGBANK Etoperidone
drug DRUGBANK Aluminum hydroxide
disease IDO site
disease MESH causality
disease IDO blood
disease MESH Seroconversion
drug DRUGBANK Methionine

Original Article

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