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SARS-CoV-2 inactivated vaccine (Vero cells) shows good safety in repeated administration toxicity test of Sprague Dawley rats
The outbreak of COVID-19 has posed a serious threat to global public health. Vaccination may be the most effective way to prevent and control the spread of the virus. The safety of vaccines is the focus of preclinical research, and the repeated dose toxicity test is the key safety test to evaluate t...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier Ltd.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8064818/ https://www.ncbi.nlm.nih.gov/pubmed/33901607 http://dx.doi.org/10.1016/j.fct.2021.112239 |
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author | Huang, Zhangqiong Jiang, Qinfang Wang, Yixuan Yang, Jinling Du, Tingfu Yi, Hongkun Li, Cong Li, Yun wu, Zhengcun Fan, Shengtao Liao, Yun Zhang, Ying Wang, Lichun Jiang, Guorun Tang, Donghong Ye, Yousong Wang, Chenyun Li, Zheli Li, Zhisai Zhang, Caixing Ma, Kaili Li, Qihan |
author_facet | Huang, Zhangqiong Jiang, Qinfang Wang, Yixuan Yang, Jinling Du, Tingfu Yi, Hongkun Li, Cong Li, Yun wu, Zhengcun Fan, Shengtao Liao, Yun Zhang, Ying Wang, Lichun Jiang, Guorun Tang, Donghong Ye, Yousong Wang, Chenyun Li, Zheli Li, Zhisai Zhang, Caixing Ma, Kaili Li, Qihan |
author_sort | Huang, Zhangqiong |
collection | PubMed |
description | The outbreak of COVID-19 has posed a serious threat to global public health. Vaccination may be the most effective way to prevent and control the spread of the virus. The safety of vaccines is the focus of preclinical research, and the repeated dose toxicity test is the key safety test to evaluate the vaccine before clinical trials. The purpose of this study was (i) to observe the toxicity and severity of an inactivated SARS-CoV-2 vaccine (Vero cells) in rodent Sprague Dawley rats after multiple intramuscular injections under the premise of Good Laboratory Practice principles and (ii) to provide a basis for the formulation of a clinical trial scheme. The results showed that all animals in the experimental group were in good condition, no regular changes related to the vaccine were found in the detection of various toxicological indexes, and no noticeable stimulating reaction related to the vaccine was found in the injected local tissues. The neutralizing antibodies in the low- and high-dose vaccine groups began to appear 14 days after the last administration. In the negative control group, no neutralizing antibodies were observed from the administration period to the recovery period. Therefore, the repeated administration toxicity test of the inactivated SARS-CoV-2 vaccine (Vero cells) in Sprague Dawley rats showed no obvious toxic reaction. It was preliminarily confirmed that the vaccine can stimulate production of neutralizing antibodies and is safe in Sprague Dawley rats. |
format | Online Article Text |
id | pubmed-8064818 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Elsevier Ltd. |
record_format | MEDLINE/PubMed |
spelling | pubmed-80648182021-04-26 SARS-CoV-2 inactivated vaccine (Vero cells) shows good safety in repeated administration toxicity test of Sprague Dawley rats Huang, Zhangqiong Jiang, Qinfang Wang, Yixuan Yang, Jinling Du, Tingfu Yi, Hongkun Li, Cong Li, Yun wu, Zhengcun Fan, Shengtao Liao, Yun Zhang, Ying Wang, Lichun Jiang, Guorun Tang, Donghong Ye, Yousong Wang, Chenyun Li, Zheli Li, Zhisai Zhang, Caixing Ma, Kaili Li, Qihan Food Chem Toxicol Article The outbreak of COVID-19 has posed a serious threat to global public health. Vaccination may be the most effective way to prevent and control the spread of the virus. The safety of vaccines is the focus of preclinical research, and the repeated dose toxicity test is the key safety test to evaluate the vaccine before clinical trials. The purpose of this study was (i) to observe the toxicity and severity of an inactivated SARS-CoV-2 vaccine (Vero cells) in rodent Sprague Dawley rats after multiple intramuscular injections under the premise of Good Laboratory Practice principles and (ii) to provide a basis for the formulation of a clinical trial scheme. The results showed that all animals in the experimental group were in good condition, no regular changes related to the vaccine were found in the detection of various toxicological indexes, and no noticeable stimulating reaction related to the vaccine was found in the injected local tissues. The neutralizing antibodies in the low- and high-dose vaccine groups began to appear 14 days after the last administration. In the negative control group, no neutralizing antibodies were observed from the administration period to the recovery period. Therefore, the repeated administration toxicity test of the inactivated SARS-CoV-2 vaccine (Vero cells) in Sprague Dawley rats showed no obvious toxic reaction. It was preliminarily confirmed that the vaccine can stimulate production of neutralizing antibodies and is safe in Sprague Dawley rats. Elsevier Ltd. 2021-06 2021-04-24 /pmc/articles/PMC8064818/ /pubmed/33901607 http://dx.doi.org/10.1016/j.fct.2021.112239 Text en © 2021 Elsevier Ltd. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
spellingShingle | Article Huang, Zhangqiong Jiang, Qinfang Wang, Yixuan Yang, Jinling Du, Tingfu Yi, Hongkun Li, Cong Li, Yun wu, Zhengcun Fan, Shengtao Liao, Yun Zhang, Ying Wang, Lichun Jiang, Guorun Tang, Donghong Ye, Yousong Wang, Chenyun Li, Zheli Li, Zhisai Zhang, Caixing Ma, Kaili Li, Qihan SARS-CoV-2 inactivated vaccine (Vero cells) shows good safety in repeated administration toxicity test of Sprague Dawley rats |
title | SARS-CoV-2 inactivated vaccine (Vero cells) shows good safety in repeated administration toxicity test of Sprague Dawley rats |
title_full | SARS-CoV-2 inactivated vaccine (Vero cells) shows good safety in repeated administration toxicity test of Sprague Dawley rats |
title_fullStr | SARS-CoV-2 inactivated vaccine (Vero cells) shows good safety in repeated administration toxicity test of Sprague Dawley rats |
title_full_unstemmed | SARS-CoV-2 inactivated vaccine (Vero cells) shows good safety in repeated administration toxicity test of Sprague Dawley rats |
title_short | SARS-CoV-2 inactivated vaccine (Vero cells) shows good safety in repeated administration toxicity test of Sprague Dawley rats |
title_sort | sars-cov-2 inactivated vaccine (vero cells) shows good safety in repeated administration toxicity test of sprague dawley rats |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8064818/ https://www.ncbi.nlm.nih.gov/pubmed/33901607 http://dx.doi.org/10.1016/j.fct.2021.112239 |
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