"Safety, immunogenicity and protective effectiveness of heterologous boost with a recombinant COVID-19 vaccine (Sf9 cells) in adult recipients of inactivated vaccines"

作者全名："Luo, Wenxin; Gan, Jiadi; Luo, Zhu; Li, Shuangqing; Wang, Zhoufeng; Wu, Jiaxuan; Zhang, Huohuo; Xian, Jinghong; Cheng, Ruixin; Tang, Xiumei; Liu, Yi; Yang, Ling; Mou, Qianqian; Zhang, Xue; Chen, Yi; Wang, Weiwen; Wang, Yantong; Bai, Lin; Wei, Xuan; Zhang, Rui; Yang, Lan; Chen, Yaxin; Yang, Li; Li, Yalun; Liu, Dan; Li, Weimin; Chen, Lei"

作者地址："[Luo, Wenxin; Gan, Jiadi; Luo, Zhu; Wu, Jiaxuan; Zhang, Huohuo; Xian, Jinghong; Cheng, Ruixin; Tang, Xiumei; Liu, Yi; Yang, Lan; Li, Yalun; Liu, Dan; Li, Weimin] Sichuan Univ, West China Hosp, Dept Pulm & Crit Care Med, Chengdu, Peoples R China; [Luo, Wenxin; Wang, Zhoufeng; Xian, Jinghong; Yang, Lan; Chen, Yaxin; Li, Yalun; Liu, Dan; Li, Weimin] Sichuan Univ, West China Hosp, Inst Resp Hlth, Frontiers Sci Ctr Dis Related Mol Network, Chengdu, Peoples R China; [Luo, Wenxin; Wang, Zhoufeng; Xian, Jinghong; Yang, Lan; Li, Yalun; Liu, Dan; Li, Weimin] Sichuan Univ, West China Hosp, Precis Med Ctr, Precis Med Key Lab Sichuan Prov, Chengdu, Peoples R China; [Luo, Wenxin; Wang, Zhoufeng; Xian, Jinghong; Yang, Lan; Li, Yalun; Liu, Dan; Li, Weimin] West China Hosp, State Key Lab Resp Hlth & Multimorbid, Chengdu, Peoples R China; [Luo, Wenxin; Liu, Dan; Li, Weimin] Sichuan Univ, West China Hosp, Inst Resp Hlth & Multimorbid, Chengdu, Peoples R China; [Luo, Zhu; Yang, Ling; Mou, Qianqian; Zhang, Xue] Sichuan Univ, West China Hosp, Clin Trial Ctr, Chengdu, Peoples R China; [Li, Shuangqing; Zhang, Rui] Sichuan Univ, West China Hosp, Gen Practice Med Ctr, Chengdu, Peoples R China; [Li, Shuangqing; Bai, Lin; Wei, Xuan] Fangcao Community Hlth Serv Ctr Chengdu High tech, Chengdu, Peoples R China; [Xian, Jinghong; Li, Weimin] Chinese Acad Med Sci, West China Hosp, Res Units West China, Chengdu, Peoples R China; [Tang, Xiumei; Mou, Qianqian; Zhang, Xue] Sichuan Univ, West China Sch Nursing, Chengdu, Peoples R China; [Chen, Yi; Wang, Yantong] Sichuan Univ, West China Hosp, Dept Infect Control, Chengdu, Peoples R China; [Wang, Weiwen] Sichuan Univ, West China Hosp, Dept Pathol, Chengdu, Peoples R China; [Yang, Li] Chongqing Med Univ, Affiliated Hosp 1, Dept Resp & Crit Care Med, Chongqing, Peoples R China; [Chen, Lei] Sichuan Univ, West China Hosp, Dept Neurol, Chengdu, Peoples R China"

通信作者："Liu, D; Li, WM (通讯作者)，Sichuan Univ, West China Hosp, Dept Pulm & Crit Care Med, Chengdu, Peoples R China.; Liu, D; Li, WM (通讯作者)，Sichuan Univ, West China Hosp, Inst Resp Hlth, Frontiers Sci Ctr Dis Related Mol Network, Chengdu, Peoples R China.; Liu, D; Li, WM (通讯作者)，Sichuan Univ, West China Hosp, Precis Med Ctr, Precis Med Key Lab Sichuan Prov, Chengdu, Peoples R China.; Liu, D; Li, WM (通讯作者)，West China Hosp, State Key Lab Resp Hlth & Multimorbid, Chengdu, Peoples R China.; Liu, D; Li, WM (通讯作者)，Sichuan Univ, West China Hosp, Inst Resp Hlth & Multimorbid, Chengdu, Peoples R China.; Li, WM (通讯作者)，Chinese Acad Med Sci, West China Hosp, Res Units West China, Chengdu, Peoples R China.; Chen, L (通讯作者)，Sichuan Univ, West China Hosp, Dept Neurol, Chengdu, Peoples R China."

来源：SIGNAL TRANSDUCTION AND TARGETED THERAPY

ESI学科分类：MOLECULAR BIOLOGY & GENETICS

WOS号：WOS:001162671200004

JCR分区：Q1

影响因子：40.8

年份：2024

卷号：9

期号：1

开始页：　

结束页：　

文献类型：Article

关键词：　

摘要："Vaccines have proven effective in protecting populations against COVID-19, including the recombinant COVID-19 vaccine (Sf9 cells), the first approved recombinant protein vaccine in China. In this positive-controlled trial with 85 adult participants (Sf9 cells group: n = 44; CoronaVac group: n = 41), we evaluated the safety, immunogenicity, and protective effectiveness of a heterologous boost with the Sf9 cells vaccine in adults who had been vaccinated with the inactivated vaccine, and found a post-booster adverse events rate of 20.45% in the Sf9 cells group and 31.71% in the CoronaVac group (p = 0.279), within 28 days after booster injection. Neither group reported any severe adverse events. Following the Sf9 cells vaccine booster, the geometric mean titer (GMT) of binding antibodies to the receptor-binding domain of prototype SARS-CoV-2 on day 28 post-booster was significantly higher than that induced by the CoronaVac vaccine booster (100,683.37 vs. 9,451.69, p < 0.001). In the Sf9 cells group, GMTs of neutralizing antibodies against pseudo SARS-CoV-2 viruses (prototype and diverse variants of concern [VOCs]) increased by 22.23-75.93 folds from baseline to day 28 post-booster, while the CoronaVac group showed increases of only 3.29-10.70 folds. Similarly, neutralizing antibodies against live SARS-CoV-2 viruses (prototype and diverse VOCs) increased by 68.18-192.67 folds on day 14 post-booster compared with the baseline level, significantly greater than the CoronaVac group (19.67-37.67 folds). A more robust Th1 cellular response was observed with the Sf9 cells booster on day 14 post-booster (mean IFN-gamma+ spot-forming cells per 2 x 10(5) peripheral blood mononuclear cells: 26.66 vs. 13.59). Protective effectiveness against symptomatic COVID-19 was approximately twice as high in the Sf9 cells group compared to the CoronaVac group (68.18% vs. 36.59%, p = 0.004). Our study findings support the high protective effectiveness of heterologous boosting with the recombinant COVID-19 vaccine (Sf9 cells) against symptomatic COVID-19 of diverse SARS-CoV-2 variants of concern, while causing no apparent safety concerns."

基金机构："National Natural Science Foundation of China [92159302]; Science and Technology Foundation of Sichuan Province, China [2020YFS0572, 2022NSFSC0842]; Key Research and Development Program of Sichuan-Chongqing of the Chongqing Science and Technology Commission [CSTB2022TIAD-CUX0001]; Fundamental Research Funds for the Central Universities [SCU2022D025]; The 1.3.5 Project for Disciplines of Excellence at West China Hospital, Sichuan University [ZYGD22009]"

基金资助正文："This study was supported by National Natural Science Foundation of China (grants 92159302); the Science and Technology Foundation of Sichuan Province, China (2020YFS0572, 2022NSFSC0842); the Key Research and Development Program of Sichuan-Chongqing of the Chongqing Science and Technology Commission (CSTB2022TIAD-CUX0001); the Fundamental Research Funds for the Central Universities (SCU2022D025); the 1.3.5 Project for Disciplines of Excellence at West China Hospital, Sichuan University (ZYGD22009). We are grateful to WestVac BioPharma Co., Ltd. (Chengdu, China) for supplying the recombinant COVID-19 vaccine (Sf9 cells) in this study. We are also grateful to Fangcao Community Health Service Center of Chengdu High-tech Zone of Sichuan Province for assisting the onsite implementation."