Safety and immunogenicity of a heterologous booster with an RBD virus-like particle vaccine following two- or three-dose inactivated COVID-19 vaccine

作者全名："Yong, Xiaolan; Liu, Jun; Zeng, Ying; Nie, Jing; Cui, Xuelian; Wang, Tao; Wang, Yilin; Chen, Yiyong; Kang, Wei; Yang, Zhonghua; Liu, Yan"

作者地址："[Yong, Xiaolan] North Sichuan Med Coll, Chengdu Xinhua Hosp, Phase Clin Trial Ctr 1, Chengdu, Sichuan, Peoples R China; [Liu, Jun; Nie, Jing] Peoples Hosp Jiangbei Dist, Chongqing Red Cross Hosp, Pulm & Crit Care Med, Chongqing, Peoples R China; [Zeng, Ying; Kang, Wei; Yang, Zhonghua] Guangzhou Patronus Biotech Co Ltd, Dept Med & Registrat, Guangzhou, Guangdong, Peoples R China; [Zeng, Ying; Kang, Wei; Yang, Zhonghua] Yantai Patronus Biotech Co Ltd, Dept Med & Registrat, Yantai, Shandong, Peoples R China; [Cui, Xuelian; Wang, Tao; Wang, Yilin; Chen, Yiyong; Liu, Yan] Chongqing Medleader Biopharm Co Ltd, Dept Med, Chongqing, Peoples R China; [Liu, Yan] Chongqing Med Univ, Coll Pharm, Chongqing, Peoples R China; [Liu, Yan] Chongqing Med Univ, Coll Pharm, 1 Yixueyuan Rd, Chongqing 400016, Peoples R China"

通信作者："Liu, Y (通讯作者)，Chongqing Med Univ, Coll Pharm, 1 Yixueyuan Rd, Chongqing 400016, Peoples R China."

来源：HUMAN VACCINES & IMMUNOTHERAPEUTICS

ESI学科分类：IMMUNOLOGY

WOS号：WOS:001085683500001

JCR分区：Q2

影响因子：4.1

年份：2023

卷号：19

期号：3

开始页：　

结束页：　

文献类型：Article

关键词：SARS-CoV-2; safety; immunogenicity; virus-like particle (VLP); booster

摘要："LYB001 is an innovative recombinant SARS-CoV-2 vaccine that displays a repetitive array of the spike glycoprotein's receptor-binding domain (RBD) on a virus-like particle (VLP) vector to boost the immune system, produced using Covalink plug-and-display protein binding technology. LYB001's safety and immunogenicity were assessed in 119 participants receiving a booster with (1) 30 mu g LYB001 (I-I-30 L) or CoronaVac (I-I-C), (2) 60 mu g LYB001 (I-I-60 L) or CoronaVac in a ratio of 2:1 after two-dose primary series of inactivated COVID-19 vaccine, and (3) 30 mu g LYB001 (I-I-I-30 L) after three-dose inactivated COVID-19 vaccine. A well-tolerated reactogenicity profile was observed for LYB001 as a heterologous booster, with adverse reactions being predominantly mild in severity and transient. LYB001 elicited a substantial increase in terms of the neutralizing antibody response against prototype SARS-CoV-2 28 days after booster, with GMT (95%CI) of 1237.8 (747.2, 2050.6), 554.3 (374.6, 820.2), 181.9 (107.6, 307.6), and 1200.2 (831.5, 1732.3) in the I-I-30 L, I-I-60 L, I-I-C, and I-I-I-30 L groups, respectively. LYB001 also elicited a cross-neutralizing antibody response against the BA.4/5 strain, dominant during the study period, with GMT of 201.1 (102.7, 393.7), 63.0 (35.1, 113.1), 29.2 (16.9, 50.3), and 115.3 (63.9, 208.1) in the I-I-30 L, I-I-60 L, I-I-C, and I-I-I-30 L groups, respectively, at 28 days after booster. Additionally, RBD-specific IFN-gamma, IL-2, IL-4 secreting T cells dramatically increased at 14 days after a single LYB001 booster. Our data confirmed the favorable safety and immunogenicity profile of LYB001 and supported the continued clinical development of this promising candidate that utilizes the VLP platform to provide protection against COVID-19."

基金机构：The authors thank all the participants who volunteered to participate in this first-in-human study of LYB001. [LYB001]

基金资助正文：The authors thank all the participants who volunteered to participate in this first-in-human study of LYB001.