Background::Innovative coronavirus disease 2019 (COVID-19) vaccines, with elevated global manufacturing capacity, enhanced safety and efficacy, simplified dosing regimens, and distribution that is less cold chain-dependent, are still global imperatives for tackling the ongoing pandemic. A previous phase I trial indicated that the recombinant COVID-19 vaccine (V-01), which contains a fusion protein (IFN-PADRE-RBD-Fc dimer) as its antigen, is safe and well tolerated, capable of inducing rapid and robust immune responses, and warranted further testing in additional clinical trials. Herein, we aimed to assess the immunogenicity and safety of V-01, providing rationales of appropriate dose regimen for further efficacy study.Methods::A randomized, double-blind, placebo-controlled phase II clinical trial was initiated at the Gaozhou Municipal Centre for Disease Control and Prevention (Guangdong, China) in March 2021. Both younger ( n = 440; 18-59 years of age) and older ( n = 440; ≥60 years of age) adult

作者：Shu Ya-Jun；He Jian-Feng；Pei Rong-Juan；He Peng；Huang Zhu-Hang；Chen Shao-Min；Ou Zhi-Qiang；Deng Jing-Long；Zeng Pei-Yu；Zhou Jian；Min Yuan-Qin；Deng Fei；Peng Hua；Zhang Zheng；Wang Bo；Xu Zhong-Hui；Guan Wu-Xiang；Hu Zhong-Yu；Zhang Ji-Kai

来源：中华医学杂志英文版 2021 年 134卷 16期