Q1 · CROSS-FIELD
ArticleOA
Author: Xiao, Peng ; Li, Qi Ming ; Li, Meng ; Zhang, Jing ; Yang, Yun Kai ; Liu, Dan Ying ; Zhang, Xue ; Shao, Shuai ; Du, Li Fang ; Kaabi, Nawal Al ; Yin, Jin Liang ; Xu, Ke ; Mahmoud, Sally ; Tan, Yao ; Eltantawy, Islam ; Gao, Xue Jun ; Liang, Yu ; Mekki, Hanadi Mekki ; Qu, Chang ; Su, Ji Guo ; Yang, Sen Sen ; ElDein, Mohamed Saif ; Yang, Xiao Ming ; Lei, Wenwen ; Hussein, Salah ; Mao, Xiao Yan ; Wang, Hui ; Qu, Liang ; Hou, Jun Wei ; Zhang, Jin ; Zaher, Walid ; Wang, Zhao Nian ; Wu, Guizhen ; Zhang, Yun Tao ; Yang, Mengjie ; Lei, Ze Hua ; Cong, Xiangfeng ; Yang, Tian ; Kang, Yun ; Jiang, Zhiwei
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.