Article
Author: Shen, Fu Jie ; Liang, Yu ; Hussein, Salah ; Lei, Wenwen ; Li, Xin Yu ; Yang, Yun Kai ; Yang, Xiao Ming ; Mekki, Hanadi Mekki ; Li, Xin ; Shao, Shuai ; Mao, Xiao Yan ; Wang, Zhao Nian ; Xu, Ke ; Du, Li Fang ; Kaabi, Nawal Al ; Liu, Dan Ying ; Yin, Jin Liang ; Jin, Yu Qin ; Zhang, Xue ; Yang, Sen Sen ; Han, Zi Bo ; Gao, Xue Jun ; Wu, Guizhen ; Kang, Yun ; Liu, Zhao Ming ; Xiao, Peng ; Ma, Zhi Jing ; Yang, Tian ; Jiang, Zhiwei ; Zaher, Walid ; Zhang, Hao ; Qu, Liang ; Liu, Ning ; Li, Meng ; Wu, Jin Juan ; Zhang, Yun Tao ; Su, Ji Guo ; Lei, Ze Hua ; Eltantawy, Islam ; Zhang, Xue Feng ; Wang, Hui ; Mahmoud, Sally ; Cong, Xiangfeng ; Qu, Chang ; Hou, Jun Wei ; Zhang, Jing ; Hou, Ya Nan ; Zheng, Fan ; Chen, Shi ; Tang, Fang ; Li, Qi Ming ; ElDein, Mohamed Saif ; Tan, Yao ; Yang, Mengjie ; Zhang, Jin ; Zheng, Xiang
AbstractAn 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 BBIBP-CorV. Our 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.