TY - JOUR T1 - Sterilizing immunity against SARS-CoV-2 in hamsters conferred by a novel recombinant subunit vaccine JF - bioRxiv DO - 10.1101/2020.12.18.423552 SP - 2020.12.18.423552 AU - Yangtao Wu AU - Xiaofen Huang AU - Lunzhi Yuan AU - Shaojuan Wang AU - Yali Zhang AU - Hualong Xiong AU - Rirong Chen AU - Jian Ma AU - Ruoyao Qi AU - Meifeng Nie AU - Jingjing Xu AU - Zhigang Zhang AU - Liqiang Chen AU - Min Wei AU - Ming Zhou AU - Minping Cai AU - Yang Shi AU - Liang Zhang AU - Huan Yu AU - Junping Hong AU - Zikang Wang AU - Yunda Hong AU - Mingxi Yue AU - Zonglin Li AU - Dabing Chen AU - Qingbing Zheng AU - Shaowei Li AU - Yixin Chen AU - Tong Cheng AU - Jun Zhang AU - Tianying Zhang AU - Huachen Zhu AU - Qinjian Zhao AU - Quan Yuan AU - Yi Guan AU - Ningshao Xia Y1 - 2020/01/01 UR - http://biorxiv.org/content/early/2020/12/20/2020.12.18.423552.abstract N2 - A safe and effective SARS-CoV-2 vaccine is essential to avert the on-going COVID-19 pandemic. Here, we developed a subunit vaccine, which is comprised of CHO-expressed spike ectodomain protein (StriFK) and nitrogen bisphosphonates-modified zinc-aluminum hybrid adjuvant (FH002C). This vaccine candidate rapidly elicited the robust humoral response, Th1/Th2 balanced helper CD4 T cell and CD8 T cell immune response in animal models. In mice, hamsters, and non-human primates, 2-shot and 3-shot immunization of StriFK-FH002C generated 28- to 38-fold and 47- to 269-fold higher neutralizing antibody titers than the human COVID-19 convalescent plasmas, respectively. More importantly, the StriFK-FH002C immunization conferred sterilizing immunity to prevent SARS-CoV-2 infection and transmission, which also protected animals from virus-induced weight loss, COVID-19-like symptoms, and pneumonia in hamsters. Vaccine-induced neutralizing and cell-based receptor-blocking antibody titers correlated well with protective efficacy in hamsters, suggesting vaccine-elicited protection is immune-associated. The StriFK-FH002C provided a promising SARS-CoV-2 vaccine candidate for further clinical evaluation.Competing Interest StatementThe authors have declared no competing interest. ER -