The safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in Chinese adults aged 18-59 years: A phase I randomized, double-blinded, controlled trial
Department of Medicine
Immunopathology | Immunoprophylaxis and Therapy | Immunotherapy | Infectious Disease | International Public Health | Patient Safety | Virus Diseases
BACKGROUND: This study examined the safety and immunogenicity of an inactivated SARS-CoV-2 vaccine.
METHOD: In a phase I randomized, double-blinded, placebo-controlled trial involving 192 healthy adults 18-59 years old, two injections of three doses (50 EU, 100 EU, 150 EU) of an inactivated SARS-CoV-2 vaccine or placebo were administered intramuscularly at a 2- or 4-week interval. The safety and immunogenicity of the vaccine were evaluated.
RESULTS: Vaccination was completed in 191 subjects. Forty-four adverse reactions occurred within 28 days, most commonly mild pain and redness at the injection site or slight fatigue. At days 14 and 28, the seroconversion rates were 87.5% and 79.2% (50 EU), 100% and 95.8% (100 EU), and 95.8% and 87.5% (150 EU), respectively, with geometric mean titers (GMTs) of 18.1 and 10.6, 54.5 and 15.4, and 37.1 and 18.5, respectively, for the schedules with 2-week and 4-week intervals. Seroconversion was associated with synchronous upregulation of antibodies against the S protein, N protein and virion and a cytotoxic T lymphocyte (CTL) response. No cytokines and immune cells related to immunopathology were observed. Transcriptome analysis revealed the genetic diversity of immune responses induced by the vaccine.
INTERPRETATION: In a population aged 18-59 years in this trial, this inactivated SARS-CoV-2 vaccine was safe and immunogenic.
TRIAL REGISTRATION: CTR20200943 and NCT04412538.
Inactivated vaccine, Phase I, SARS-CoV-2
DOI of Published Version
Pu J, Yu Q, Yin Z, Zhang Y, Li X, Yin Q, Chen H, Long R, Zhao Z, Mou T, Zhao H, Feng S, Xie Z, Wang L, He Z, Liao Y, Fan S, Jiang R, Wang J, Zhang L, Li J, Zheng H, Cui P, Jiang G, Guo L, Xu M, Yang H, Lu S, Wang X, Gao Y, Xu X, Cai L, Zhou J, Yu L, Chen Z, Hong C, Du D, Zhao H, Li Y, Ma K, Ma Y, Liu D, Yao S, Li C, Che Y, Liu L, Li Q. The safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in Chinese adults aged 18-59 years: A phase I randomized, double-blinded, controlled trial. Vaccine. 2021 May 12;39(20):2746-2754. doi: 10.1016/j.vaccine.2021.04.006. Epub 2021 Apr 9. PMID: 33875266; PMCID: PMC8040531. Link to article on publisher's site
Pu J, Lu S, Li C, Che Y, Liu L, Li Q. (2021). The safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in Chinese adults aged 18-59 years: A phase I randomized, double-blinded, controlled trial. COVID-19 Publications by UMMS Authors. https://doi.org/10.1016/j.vaccine.2021.04.006. Retrieved from https://escholarship.umassmed.edu/covid19/240