Chin Med J (Engl) 2021 Jul 22. Epub 2021 Jul 22.
Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, Guangdong 510440, China Guangdong Provincial Center for Disease Control and Prevention, Guangzhou, Guangdong 511430, China Wuhan Institute of Virology, Chinese Academy of Sciences, Wuhan, Hubei 430071, China National Institutes for Food and Drug Control, Beijing 100050, China Gaozhou Center for Disease Control and Prevention, Maoming, Guangdong 525000, China Livzon Bio Inc., Zhuhai, Guangdong 519045, China Key Laboratory of Infection and Immunity, Institute of Biophysics, Chinese Academy of Sciences, Beijing 100101, China Institute for Hepatology, National Clinical Research Center for Infectious Disease, Shenzhen Third People's Hospital, Shenzhen, Guangdong 518112, China.
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. Read More