A tandem-repeat dimeric RBD protein-based covid-19 vaccine zf2001 protects mice and nonhuman primates.

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 TH1/TH2 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.
Authors	Yaling An, Shihua Li, Xiyue Jin, Jian-Bao Han, Kun Xu, Senyu Xu, Yuxuan Han, Chuanyu Liu, Tianyi Zheng, Mei Liu, Mi Yang, Tian-Zhang Song, Baoying Huang, Li Zhao, Wen Wang, Ruhan A, Yingjie Cheng, Changwei Wu, Enqi Huang, Shilong Yang, Gary Wong, Yuhai Bi, Changwen Ke, Wenjie Tan, Jinghua Yan, Yong-Tang Zheng, Lianpan Dai, George F Gao
Journal	Emerging microbes & infections (Emerg Microbes Infect) Vol. 11 Issue 1 Pg. 1058-1071 (Dec 2022) ISSN: 2222-1751 [Electronic] United States
PMID	35311493 (Publication Type: Journal Article)
Chemical References	Antibodies, Neutralizing Antibodies, Viral COVID-19 Vaccines Carrier Proteins Spike Glycoprotein, Coronavirus Vaccines, Subunit spike protein, SARS-CoV-2
Topics	Animals Antibodies, Neutralizing Antibodies, Viral COVID-19 (prevention & control) COVID-19 Vaccines Carrier Proteins Humans Immunogenicity, Vaccine Mice Mice, Inbred BALB C Primates SARS-CoV-2 Spike Glycoprotein, Coronavirus (genetics) Vaccines, Subunit

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