Safety and immunogenicity of CoronaVac in healthy adults: A prospective observational multicenter real-world study in Henan Province, China.

IF 5.5 1区 农林科学 Q1 IMMUNOLOGY
Virulence Pub Date : 2024-12-01 Epub Date: 2024-02-07 DOI:10.1080/21505594.2024.2310450
Benchen Rao, Ling Wang, Mengzhao Yang, Hong Luo, Junyi Sun, Shanshuo Liu, Haiyu Wang, Xuemei Wang, Lei Li, Chengyu Yuan, Zujiang Yu, Zhigang Ren
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引用次数: 0

Abstract

Vaccination has emerged as the primar approach for managing the COVID-19 pandemic. Despite certain clinical trials reporting the safety and immunogenicity of CoronaVac, additional multicenter real-world studies are still necessary. In this study, we recruited 506 healthy volunteers who were not infected with COVID-19 or vaccinated. Each participant provided peripheral blood samples three times: prior to the first dose of vaccine, prior to the second dose, and 8 weeks following the second dose. Ultimately, 388 participants completed the entire follow-up process. No serious adverse events were observed among any of the participants. Within 1 week of vaccination, 13.4% of participants experienced systemic adverse reactions, with fatigue (5.93%) and dizziness (3.35%) being the most frequent. Although some clinical indicators, including creatinine, significantly changed after vaccination (p < 0.05), the mean of all altered indicators remained within the normal range. The positive rates of neutralizing antibodies (NAb), IgG, and IgM were 12.3%, 18.85%, and 5.24% prior to the second dose, respectively; and 57.99%, 86.34%, and 2.32% at 8 weeks following the second dose, respectively. Additionally, seven indicators, such as sex, age, and BMI, were significantly correlated with NAb (p < 0.05). Finally, a prediction model was developed based on age, monocytes, and alanine aminotransferase (ALT) with an AUC value of 87.56% in the train set and 80.71% in the test set. This study demonstrated that safety and immunogenicity of CoronaVac were good. The prediction model based on the baseline clinical characteristics prior to vaccination can help to develop more suitable vaccination strategies.

CoronaVac 在健康成人中的安全性和免疫原性:中国河南省前瞻性多中心真实世界观察研究。
接种疫苗已成为控制 COVID-19 大流行的首要方法。尽管某些临床试验报告了 CoronaVac 的安全性和免疫原性,但仍有必要进行更多的多中心实际研究。在这项研究中,我们招募了 506 名未感染 COVID-19 或未接种疫苗的健康志愿者。每位参与者都提供了三次外周血样本:第一剂疫苗接种前、第二剂疫苗接种前和第二剂疫苗接种后 8 周。最终,388 名参与者完成了整个随访过程。所有参与者均未出现严重不良反应。接种后一周内,13.4%的参与者出现了全身性不良反应,其中最常见的是疲劳(5.93%)和头晕(3.35%)。虽然一些临床指标(包括肌酐)在接种疫苗后发生了显著变化(P
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来源期刊
Virulence
Virulence IMMUNOLOGY-MICROBIOLOGY
CiteScore
9.20
自引率
1.90%
发文量
123
审稿时长
6-12 weeks
期刊介绍: Virulence is a fully open access peer-reviewed journal. All articles will (if accepted) be available for anyone to read anywhere, at any time immediately on publication. Virulence is the first international peer-reviewed journal of its kind to focus exclusively on microbial pathogenicity, the infection process and host-pathogen interactions. To address the new infectious challenges, emerging infectious agents and antimicrobial resistance, there is a clear need for interdisciplinary research.
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