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

作　　者：Nawal Al Kaabi Yun Kai Yang Jing Zhang Ke Xu Yu Liang Yun Kang Ji Guo Su Tian Yang Salah Hussein Mohamed Saif ElDein Shuai Shao Sen Sen Yang Wenwen Lei Xue Jun Gao Zhiwei Jiang Hui Wang Meng Li Hanadi Mekki Mekki Walid Zaher Sally Mahmoud Xue Zhang Chang Qu Dan Ying Liu Jing Zhang Mengjie Yang Islam Eltantawy Peng Xiao Zhao Nian Wang Jin Liang Yin Xiao Yan Mao Jin Zhang Ning Liu Fu Jie Shen Liang Qu Yun Tao Zhang Xiao Ming Yang Guizhen Wu Qi Ming 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》2022年第7期2522-2532,共11页信号转导与靶向治疗（英文）

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 

分 类 号：R563.1[医药卫生—呼吸系统] R392[医药卫生—内科学]