Yang Bei-Fang, Jin Jing, He Xi-Ran, Yang Zhong-Hua, Qian Xiao'ai, Tong Ye-Qing, Ke Chang-Xian, Li Zhao-Hong, Li Zhao-Xia, Zhong Lin-Feng, Gan Ze-Hong, Zhang Xian-Feng, Zeng Ying
Center for Clinical Trial of Vaccines, Hubei Institute for Infectious Disease, Control and Prevention, Hubei Provincial Center for Disease Control and Prevention, Wuhan, China.
Guangzhou Patronus Biotech Co., Ltd., Guangzhou, China.
Expert Rev Vaccines. 2025 Dec;24(1):81-90. doi: 10.1080/14760584.2024.2446288. Epub 2025 Jan 5.
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 (-value <0.0001). LYB001 recipients reported more adverse reactions than ZF2001 recipients (21.4% vs. 15.0%); however, all adverse reactions in the LYB001 group were mild-to-moderate.
LYB001 is highly immunogenic and retains a well-characterized safety profile in adults aged ≥ 18 years.
www.clinicaltrials.gov, identifier is NCT05664932.
LYB001是一种重组蛋白新冠疫苗，在病毒样颗粒（VLP）上以高度免疫原性阵列展示受体结合域（RBD）。本研究评估了LYB001作为加强针的免疫原性和安全性。
在这项随机、活性对照、双盲3期试验中，年龄≥18岁的参与者接受了LYB001或ZF2001（重组新冠疫苗）加强针。主要终点是比较加强针接种后14天针对奥密克戎BA.4/5的中和抗体几何平均滴度（GMT）。
总体而言，纳入了1200名年龄≥18岁的参与者，599人接受了LYB001，601人接受了ZF2001。基于相似的基线水平，针对奥密克戎BA.4/5的14天GMT比值（LYB001/ZF2001）为1.39（95%CI：1.25，1.56），表明LYB001具有优越性（95%CI下限>1）。加强针接种后第14天和第28天，LYB001诱导的刺突蛋白结合IgG浓度显著高于ZF2001诱导的浓度（P值<0.0001）。LYB001接种者报告的不良反应比ZF2001接种者多（21.4%对15.0%）；然而，LYB001组的所有不良反应均为轻至中度。
LYB001具有高度免疫原性，在年龄≥18岁的成年人中保持了特征明确的安全性。
