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

作者：Nawal Al Kaabi, Yun Yang, Yu Liang, Ke Xu, Xuefeng Zhang, Yun Kang, Yu Jin, Jun Hou, Jing Zhang, Tian Yang, Salah Eldin Hussein, Mohamed Saif ElDein, Ze Hua Lei, Hao Zhang, Shuai Shao, Zhao Ming Liu, Ning Liu, Xiang Zheng, Ji Guo Su, Sen Yang, Xiangfeng Cong, Yao Tan, Wenwen Lei, Xue 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, 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 · 发表于：Signal Transduction and Targeted Therapy · 年份：2023 · DOI：10.1038/s41392-022-01295-2 · 被引用次数：9 · 研究领域：SARS-CoV-2 and COVID-19 Research、Viral gastroenteritis research and epidemiology、Vaccine Coverage and Hesitancy

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 enrollment. The participants were randomly assigned with 1:1 to receive a booster dose of NVSI-06-09 or BBIBP-CorV. The 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 strains. Between May 25 and 30, 2022, 516 adults received booster vaccination with 260 in NVSI-06-09 group and 256 in BBIBP-CorV group. Interim results showed a similar safety profile between two booster groups, with low incidence of adverse reactions of grade 1 or 2. For 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 ...