Nature communications · 2022
Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients in a randomized phase 2 trial.
Клиническое исследование II фазыСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Kaabi Nawal Al, Yang Yun Kai, Du Li Fang, Xu Ke, Shao Shuai, Liang Yu, Kang Yun, Su Ji Guo, Zhang Jing, Yang Tian, Hussein Salah, ElDein Mohamed Saif, Yang Sen Sen, Lei Wenwen, Gao Xue Jun, Jiang Zhiwei, Cong Xiangfeng, Tan Yao, Wang Hui, Li Meng, Mekki Hanadi Mekki, Zaher Walid, Mahmoud Sally, Zhang Xue, Qu Chang, Liu Dan Ying, Zhang Jing, Yang Mengjie, Eltantawy Islam, Hou Jun Wei, Lei Ze Hua, Xiao Peng, Wang Zhao Nian, Yin Jin Liang, Mao Xiao Yan, Zhang Jin, Qu Liang, Zhang Yun Tao, Yang Xiao Ming, Wu Guizhen, Li Qi Ming
Аннотация
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.