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Safety and immunogenicity of a mosaic vaccine booster against Omicron and other SARS-CoV-2 variants:a randomized phase 2 trial

引用

Signal Transduction and Targeted Therapy 2023年第2期8卷 672-682页

作者： Nawal Al Kaabi Yun Kai Yang Yu Liang Ke Xu Xue Feng Zhang Yun Kang Yu Qin Jin Jun Wei Hou Jing Zhang Tian Yang salah Hussein mohamed Saif ElDein Ze Hua Lei Hao Zhang Shuai Shao Zhao Ming Liu Ning Liu Xiang Zheng Ji Guo Su Sen Sen Yang Xiangfeng Cong Yao Tan 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 Fu Jie Shen Jin Juan Wu Zi Bo Han Li Fang Du Fang Tang Shi Chen Zhi Jing Ma Fan Zheng Ya Nan Hou Xin Yu Li Xin Li Zhao Nian Wang Jin Liang Yin Xiao Yan Mao Jin Zhang Liang Qu Yun Tao Zhang Xiao Ming Yang Guizhen Wu Qi Ming Li Sheikh Khalifa Medical City SEHAAbu DhabiUAE College of Medicine and Health Sciences Khalifa UniversityAbu DhabiUAE China National Biotec Group Company Limited BeijingChina The Sixth Laboratory National Vaccine and Serum Institute(NVSI)BeijingChina National Engineering Center for New Vaccine Research BeijingChina National Institute for Viral Disease Control and Prevention Chinese Center for Disease Control and Prevention(China CDC)BeijingChina Clinical Medicine Office National Vaccine and Serum Institute(NVSI)BeijingChina Lanzhou Institute of Biological Products Company Limited LanzhouChina Beijing Key Tech Statistical Consulting Co. LtdBeijingChina Beijing Institute of Biological Products Company Limited BeijingChina Union 71 Abu DhabiUAE G42 Healthcare Abu DhabiUAE

An ongoing randomized,double-blind,controlled phase 2 trial was conducted to evaluate the safety and immunogenicity of a mosaic-type recombinant vaccine candidate,named NVSI-06-09,as a booster dose in subjects aged 18 years and older from the United Arab Emirates(UAE),who had administered two or three doses of inactivated vaccine BBIBP-CorV at least 6 months prior to *** participants were randomly assigned with 1:1 to receive a booster dose of NVSI-06-09 or *** primary outcomes were immunogenicity and safety against severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)Omicron variant,and the exploratory outcome was cross-immunogenicity against other circulating *** May 25 and 30,2022,516 adults received booster vaccination with 260 in NVSI-06-09 group and 256 in BBIBP-CorV *** results showed a similar safety profile between two booster groups,with low incidence of adverse reactions of grade 1 or *** immunogenicity,by day 14 post-booster,the fold rises in neutralizing antibody geometric mean titers(GMTs)from baseline elicited by NVSI-06-09 were remarkably higher than those by BBIBP-CorV against the prototype strain(19.67 vs 4.47-fold),Omicron BA.1.1(42.35 vs 3.78-fold),BA.2(25.09 vs 2.91-fold),BA.4(22.42 vs 2.69-fold),and BA.5 variants(27.06 vs 4.73-fold).Similarly,the neutralizing GMTs boosted by NVSI-06-09 against Beta and Delta variants were also 6.60-fold and 7.17-fold higher than those by *** findings indicated that a booster dose of NVSI-06-09 was well-tolerated and elicited broad-spectrum neutralizing responses against divergent SARS-CoV-2 variants,including Omicron and its sub-lineages.

关键词： phase neutral spectrum

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