Open AccessImmunogenicity and safety of a recombinant fusion protein vaccine (V-01) against coronavirus disease 2019 in healthy adults: a randomized, double-blind, placebo-controlled, phase II trial
Author(s) -
Ya-Jun Shu,
Jianfeng He,
Rongjuan Pei,
Peng He,
Huang Zhu-hang,
Shaomin Chen,
Zhiqiang Ou,
Jinglong Deng,
Peiyu Zeng,
Jian Zhou,
Yuan-Qin Min,
Fei Deng,
Hua Peng,
Zheng Zhang,
Bo Wang,
Zhong-Hui Xu,
Wuxiang Guan,
Zhongliang Hu,
Jikai Zhang
Publication year - 2021
Publication title -
chinese medical journal/chinese medical journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.537
H-Index - 63
eISSN - 2542-5641
pISSN - 0366-6999
DOI - 10.1097/cm9.0000000000001702
Subject(s) - medicine , regimen , placebo , immunogenicity , randomized controlled trial , clinical trial , adverse effect , immunology , antibody , pathology , alternative medicine
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.