Dataset Information

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.

ABSTRACT:

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.

SUBMITTER: Pu J

PROVIDER: S-EPMC8040531 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature

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Publications

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.

Pu Jing J Yu Qin Q Yin Zhifang Z Zhang Ying Y Li Xueqi X Yin Qiongzhou Q Chen Hongbo H Long Runxiang R Zhao Zhimei Z Mou Tangwei T Zhao Heng H Feng Shiyin S Xie Zhongping Z Wang Lichun L He Zhanlong Z Liao Yun Y Fan Shengtao S Jiang Ruiju R Wang Jianfeng J Zhang Lingli L Li Jing J Zheng Huiwen H Cui Pingfang P Jiang Guorun G Guo Lei L Xu Mingjue M Yang Huijuan H Lu Shan S Wang Xuanyi X Gao Yang Y Xu Xingli X Cai Linrui L Zhou Jian J Yu Li L Chen Zhuo Z Hong Chao C Du Dan D Zhao Hongling H Li Yan Y Ma Kaili K Ma Yunfei Y Liu Donglan D Yao Shibao S Li Changgui C Che Yanchun Y Liu Longding L Li Qihan Q

Vaccine 20210409 20

<h4>Background</h4>This study examined the safety and immunogenicity of an inactivated SARS-CoV-2 vaccine.<h4>Method</h4>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.<h4>Results</h4>Vaccination was completed i ...[more]

PMID: 33875266

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Dataset Information

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.

Background

Method

Results

Interpretation

Trial registration

Publications

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.

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