Immunogenicity and safety of NVSI-06-07 as a heterologous booster after priming with BBIBP-CorV:a phase 2 trial

查看全文 作　　者：Nawal Al [1,2]Kaabi;Yun Kai [3]Yang;Jing [4,5]Zhang;Ke [6]Xu;Yu [4,5]Liang;Yun [4,5]Kang;Ji Guo [4,5]Su;Tian [3]Yang;Salah [1]Hussein;Mohamed Saif [1]ElDein;Shuai [4,5]Shao;Sen Sen [4,5]Yang;Wenwen [6]Lei;Xue Jun [7]Gao;Zhiwei [8]Jiang;Hui [9]Wang;Meng [3]Li;Hanadi Mekki [10]Mekki;Walid [11]Zaher;Sally [11]Mahmoud;Xue [3]Zhang;Chang [3]Qu;Dan Ying [3]Liu;Jing [6]Zhang;Mengjie [6]Yang;Islam [11]Eltantawy;Peng [11]Xiao;Zhao Nian [3]Wang;Jin Liang [3]Yin;Xiao Yan [7]Mao;Jin [9]Zhang;Ning [4,5]Liu;Fu Jie [4,5]Shen;Liang [3]Qu;Yun Tao [3]Zhang;Xiao Ming [3]Yang;Guizhen [6]Wu;Qi Ming [4,5]Li

机构地区：[1]Sheikh Khalifa Medical City,SEHA,Abu Dhabi,United Arab Emirates;[2]College of Medicine and Health Sciences,Khalifa University,Abu Dhabi,United Arab Emirates;[3]China National Biotec Group Company Limited,Beijing,China;[4]The Sixth Laboratory,National Vaccine and Serum Institute(NVSI),Beijing,China;[5]National Engineering Center for New Vaccine Research,Beijing,China;[6]National Institute for Viral Disease Control and Prevention,Chinese Center for Disease Control and Prevention(China CDC),Beijing,China;[7]Lanzhou Institute of Biological Products Company Limited,Lanzhou,China;[8]Beijing Key Tech Statistical Consulting Co.,Ltd,Beijing,China;[9]Beijing Institute of Biological Products Company Limited,Beijing,China;[10]Union 71,Abu Dhabi,United Arab Emirates;[11]G42 Healthcare,Abu Dhabi,United Arab Emirates

出　　处：《Signal Transduction and Targeted Therapy》索引2022年第7卷第7期,共11页

基　　金：funded by Lanzhou Institute of Biological Products Company Limited.We would like to thank Prof.Guoyong Yuan from the University of Hong Kong for providing SARS-CoV-2 Omicron virus applied in live-virus neutralization assay。 摘　　要：The increased coronavirus disease 2019(COVID-19)breakthrough cases pose the need of booster vaccination.We conducted a randomised,double-blinded,controlled,phase 2 trial to assess the immunogenicity and safety of the heterologous prime-boost vaccination with an inactivated COVID-19 vaccine(BBIBP-CorV)followed by a recombinant protein-based vaccine(NVSI-06-07),using homologous boost with BBIBP-CorV as control.Three groups of healthy adults(600 individuals per group)who had completed two-dose BBIBP-CorV vaccinations 1–3 months,4–6 months and≥6 months earlier,respectively,were randomly assigned in a 1:1 ratio to receive either NVSI-06-07 or BBIBP-CorV boost.Immunogenicity assays showed that in NVSI-06-07 groups,neutralizing antibody geometric mean titers(GMTs)against the prototype SARS-CoV-2 increased by 21.01–63.85 folds on day 28 after vaccination,whereas only 4.20–16.78 folds of increases were observed in control groups.For Omicron variant,the neutralizing antibody GMT elicited by homologous boost was 37.91 on day 14,however,a significantly higher neutralizing GMT of 292.53 was induced by heterologous booster.Similar results were obtained for other SARS-CoV-2 variants of concerns(VOCs),including Alpha,Beta and Delta.Both heterologous and homologous boosters have a good safety profile.Local and systemic adverse reactions were absent,mild or moderate in most participants,and the overall safety was quite similar between two booster schemes.Our findings indicated that NVSI-06-07 is safe and immunogenic as a heterologous booster in BBIBP-CorV recipients and was immunogenically superior to the homologous booster against not only SARS-CoV-2 prototype strain but also VOCs,including Omicron. 关键词：PHASE neutral GMT

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Immunogenicity and safety of NVSI-06-07 as a heterologous booster after priming with BBIBP-CorV:a phase 2 trial

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