A tandem-repeat dimeric RBD protein-based covid-19 vaccine zf2001 protects mice and nonhuman primates. Issue 1 (31st December 2022)

• Record Type: Journal Article
• Authors: An, Yaling; Li, Shihua; Jin, Xiyue; Han, Jian-bao; Xu, Kun; Xu, Senyu; Han, Yuxuan; Liu, Chuanyu; Zheng, Tianyi; Liu, Mei; Yang, Mi; Song, Tian-Zhang; Huang, Baoying; Zhao, Li; Wang, Wen; A, Ruhan; Cheng, Yingjie; Wu, Changwei; Huang, Enqi; Yang, Shilong; Wong, Gary; Bi, Yuhai; Ke, Changwen; Tan, Wenjie; Yan, Jinghua; Zheng, Yong-Tang; Dai, Lianpan; Gao, George F.
• Is Part Of: Emerging microbes & infections. Volume 11:Issue 1(2022)
• Page Start: 1058
• Page End: 1071
• Publication Date: 2022-12-31
• Subjects: Covid-19 -- subunit protein vaccine -- zf2001 -- antibody -- immune response; Medical microbiology -- Periodicals; Communicable diseases -- Periodicals; Infection -- Periodicals; 616.9041
• DOI: 10.1080/22221751.2022.2056524
• Languages: English
• ISSNs: 2222-1751

Abstract

ABSTRACT: Safe, efficacious, and deployable vaccines are urgently needed to control COVID-19 in the large-scale vaccination campaigns. We report here the preclinical studies of an approved protein subunit vaccine against COVID-19, ZF2001, which contains tandem-repeat dimeric receptor-binding domain (RBD) protein with alum-based adjuvant. We assessed vaccine immunogenicity and efficacy in both mice and non-human primates (NHPs). ZF2001 induced high levels of RBD-binding and SARS-CoV-2 neutralizing antibody in both mice and non-human primates, and elicited balanced TH 1/TH 2 cellular responses in NHPs. Two doses of ZF2001 protected Ad-hACE2-transduced mice against SARS-CoV-2 infection, as detected by reduced viral RNA and relieved lung injuries. In NHPs, vaccination of either 25 μg or 50 μg ZF2001 prevented infection with SARS-CoV-2 in lung, trachea, and bronchi, with milder lung lesions. No evidence of disease enhancement was observed in both animal models. ZF2001 has been approved for emergency use in China, Uzbekistan, Indonesia, and Columbia. The high safety, immunogenicity, and protection efficacy in both mice and NHPs found in this preclinical study was consistent with the results in human clinical trials.