Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients in a randomized phase 2 trial

Nawal Al Kaabi, Yun Kai Yang, Li Fang Du, Ke Xu, Shuai Shao, Yu Liang, Yun Kang, Ji Guo Su, Jing Zhang, Tian Yang, Salah Hussein, Mohamed Saif ElDein, Sen Sen Yang, Wenwen Lei, Xue Jun Gao, Zhiwei Jiang, Xiangfeng Cong, Yao Tan, Hui Wang, Meng Li, Hanadi Mekki Mekki, Walid Zaher, Sally Mahmoud, Xue Zhang, Chang Qu, Dan Ying Liu, Jing Zhang, Mengjie Yang, Islam Eltantawy, Jun Wei Hou, Ze Hua Lei, Peng Xiao, Zhao Nian Wang, Jin Liang Yin, Xiao Yan Mao, Jin Zhang, Liang Qu, Yun Tao Zhang (), Xiao Ming Yang (), Guizhen Wu () and Qi Ming Li ()
Additional contact information
Nawal Al Kaabi: Sheikh Khalifa Medical City, SEHA
Yun Kai Yang: China National Biotec Group Company Limited
Li Fang Du: National Vaccine and Serum Institute (NVSI)
Ke Xu: Chinese Center for Disease Control and Prevention (China CDC)
Shuai Shao: National Vaccine and Serum Institute (NVSI)
Yu Liang: National Vaccine and Serum Institute (NVSI)
Yun Kang: National Engineering Center for New Vaccine Research
Ji Guo Su: National Vaccine and Serum Institute (NVSI)
Jing Zhang: National Vaccine and Serum Institute (NVSI)
Tian Yang: China National Biotec Group Company Limited
Salah Hussein: Sheikh Khalifa Medical City, SEHA
Mohamed Saif ElDein: Sheikh Khalifa Medical City, SEHA
Sen Sen Yang: National Engineering Center for New Vaccine Research
Wenwen Lei: Chinese Center for Disease Control and Prevention (China CDC)
Xue Jun Gao: Lanzhou Institute of Biological Products Company Limited
Zhiwei Jiang: Beijing Key Tech Statistical Consulting Co., Ltd
Xiangfeng Cong: National Engineering Center for New Vaccine Research
Yao Tan: National Engineering Center for New Vaccine Research
Hui Wang: Beijing Institute of Biological Products Company Limited
Meng Li: China National Biotec Group Company Limited
Hanadi Mekki Mekki: Union 71
Walid Zaher: G42 Healthcare
Sally Mahmoud: G42 Healthcare
Xue Zhang: China National Biotec Group Company Limited
Chang Qu: China National Biotec Group Company Limited
Dan Ying Liu: China National Biotec Group Company Limited
Jing Zhang: Chinese Center for Disease Control and Prevention (China CDC)
Mengjie Yang: Chinese Center for Disease Control and Prevention (China CDC)
Islam Eltantawy: G42 Healthcare
Jun Wei Hou: National Vaccine and Serum Institute (NVSI)
Ze Hua Lei: National Vaccine and Serum Institute (NVSI)
Peng Xiao: G42 Healthcare
Zhao Nian Wang: China National Biotec Group Company Limited
Jin Liang Yin: China National Biotec Group Company Limited
Xiao Yan Mao: Lanzhou Institute of Biological Products Company Limited
Jin Zhang: Beijing Institute of Biological Products Company Limited
Liang Qu: China National Biotec Group Company Limited
Yun Tao Zhang: China National Biotec Group Company Limited
Xiao Ming Yang: China National Biotec Group Company Limited
Guizhen Wu: Chinese Center for Disease Control and Prevention (China CDC)
Qi Ming Li: National Vaccine and Serum Institute (NVSI)

Nature Communications, 2022, vol. 13, issue 1, 1-11

Abstract: Abstract NVSI-06-08 is a potential broad-spectrum recombinant COVID-19 vaccine that integrates the antigens from multiple SARS-CoV-2 strains into a single immunogen. Here, we evaluate the safety and immunogenicity of NVSI-06-08 as a heterologous booster dose in BBIBP-CorV recipients in a randomized, double-blind, controlled, phase 2 trial conducted in the United Arab Emirates (NCT05069129). Three groups of healthy adults over 18 years of age (600 participants per group) who have administered two doses of BBIBP-CorV 4-6-month, 7-9-month and >9-month earlier, respectively, are randomized 1:1 to receive either a homologous booster of BBIBP-CorV or a heterologous booster of NVSI-06-08. The incidence of adverse reactions is low, and the overall safety profile is quite similar between two booster regimens. Both Neutralizing and IgG antibodies elicited by NVSI-06-08 booster are significantly higher than those by BBIBP-CorV booster against not only SARS-CoV-2 prototype strain but also multiple variants of concerns (VOCs). Especially, the neutralizing antibody GMT against Omicron variant induced by heterologous NVSI-06-08 booster reaches 367.67, which is substantially greater than that boosted by BBIBP-CorV (GMT: 45.03). In summary, NVSI-06-08 is safe and immunogenic as a booster dose following two doses of BBIBP-CorV, which is immunogenically superior to the homologous boost with another dose of BBIBP-CorV.

Date: 2022
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DOI: 10.1038/s41467-022-31379-0

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