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Deprecated: Implicit conversion from float 300.79999999999995 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Vaccine 2021 ; 39 (20): 2746-2754 Nephropedia Template TP
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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 #MMPMID33875266
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
Vaccine 2021[May]; 39 (20): 2746-2754 PMID33875266show ga
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.