SARS-CoV-2 inactivated vaccine (Vero cells) shows good safety in repeated administration toxicity test of Sprague Dawley rats

Huang, Zhangqiong; Jiang, Qin; Wang, Yixuan; Yang, Jing; Du, Tingfu; Yi, Hongkun; Liu, Cong; Li, Yun; Wu, Zhengcun; Fan, Shengtao; Liao, Yun; Zhang, Ying; Wang, Lichun; Jiang, Guorun; Tang, Donghong; Ye, You-Song; Wang, Chenyun; Li, Zheli; Li, Zhisai; Zhang, Caixing; Ma, Kaili; Li, Qihan

doi:10.1016/j.fct.2021.112239

Cited by 14 publications

(13 citation statements)

References 26 publications

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“…After 14 days since the last administration, the neutralizing antibodies in the low‐ and high‐dose vaccine groups began to appear. There were no regular alterations or notable stimulating reactions related to the vaccine injection in rats 59 …”

Section: Vero Cells Vaccinementioning

confidence: 85%

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An overview on inactivated and live‐attenuated SARS‐CoV‐2 vaccines

Khoshnood

Arshadi

Akrami

et al. 2022

Clinical Laboratory Analysis

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After about 2 years since severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), first infections were detected in Wuhan city of China in December 2019, which was followed by a worldwide pandemic with a record of 5.41 million deaths. Due to urgent need for the development of a safe and effective vaccine for coronavirus disease 2019 (COVID‐19), attempts for producing efficient vaccines are inexhaustibly continuing. According to a report by the World Health Organization (WHO) on COVID‐19 vaccine tracker and landscape, there are 149 vaccine candidates all over the world. Inactivated SARS‐CoV‐2 vaccines as a conventional vaccine platform consist of whole virus particles grown in cell culture and inactivated by chemicals. Because of benefits such as antigenic similarity to real virion inducing humoral and cellular immune responses and ease for transport and storage, these vaccines, including the vaccines produced by Bharat Biotech, Sinopharm, and Sinovac, are in use at large scales. In this study, we have a review on inactivated SARS‐CoV‐2 vaccines that are passing their phase 3 and 4 clinical trials, population which was included in the trials, vaccine producers, the efficiency, adverse effects, and components of vaccines, and other vaccine features.

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Section: Vero Cells Vaccinementioning

confidence: 85%

“…There were no regular alterations or notable stimulating reactions related to the vaccine injection in rats. 59 …”

Section: Vero Cells Vaccinementioning

confidence: 99%

An overview on inactivated and live‐attenuated SARS‐CoV‐2 vaccines

Khoshnood

Arshadi

Akrami

et al. 2022

Clinical Laboratory Analysis

View full text Add to dashboard Cite

show abstract

“…This vaccine, also called as Vero vaccine, is manufactured in collaboration with Institute of Medical Biology and Chinese Academy of Medical Sciences [ 156 ]. This vaccine utilizes the inactivated viral technology [ 157 ].…”

Section: Vaccine Candidates Approved Against Sars-cov-2 Infectionmentioning

confidence: 99%

Variants of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Vaccine Effectiveness

et al. 2022

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The incidence and death toll due to SARS-CoV-2 infection varied time-to-time; and depended on several factors, including severity (viral load), immune status, age, gender, vaccination status, and presence of comorbidities. The RNA genome of SARS-CoV-2 has mutated and produced several variants, which were classified by the SARS-CoV-2 Interagency Group (SIG) into four major categories. The first category; “Variant Being Monitored (VBM)”, consists of Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), Delta (B.1.617.2), Epsilon (B.1.427, B.1.429), Eta (B.1.525), Iota (B.1.526), Kappa (B.1.617.1), Mu (B.1.621), and Zeta (P.2); the second category; “Variants of Concern” consists of Omicron (B.1.1.529). The third and fourth categories include “Variants of Interest (VOI)”, and “Variants of High Consequence (VOHC)”, respectively, and contain no variants classified currently under these categories. The surge in VBM and VOC poses a significant threat to public health globally as they exhibit altered virulence, transmissibility, diagnostic or therapeutic escape, and the ability to evade the host immune response. Studies have shown that certain mutations increase the infectivity and pathogenicity of the virus as demonstrated in the case of SARS-CoV-2, the Omicron variant. It is reported that the Omicron variant has >60 mutations with at least 30 mutations in the Spike protein (“S” protein) and 15 mutations in the receptor-binding domain (RBD), resulting in rapid attachment to target cells and immune evasion. The spread of VBM and VOCs has affected the actual protective efficacy of the first-generation vaccines (ChAdOx1, Ad26.COV2.S, NVX-CoV2373, BNT162b2). Currently, the data on the effectiveness of existing vaccines against newer variants of SARS-CoV-2 are very scanty; hence additional studies are immediately warranted. To this end, recent studies have initiated investigations to elucidate the structural features of crucial proteins of SARS-CoV-2 variants and their involvement in pathogenesis. In addition, intense research is in progress to develop better preventive and therapeutic strategies to halt the spread of COVID-19 caused by variants. This review summarizes the structure and life cycle of SARS-CoV-2, provides background information on several variants of SARS-CoV-2 and mutations associated with these variants, and reviews recent studies on the safety and efficacy of major vaccines/vaccine candidates approved against SARS-CoV-2, and its variants.

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“…1 , 2 Vaccination is considered the most effective way to control and prevent the pandemic, and there is an increasing demand for the development of safe, effective, protective, and affordable vaccines against this condition. 3 - 6 Furthermore, to combat a global pandemic, it is necessary to utilize all available vaccine production platforms to ensure continuous and quick availability of vaccines to all the countries in the world, including middle-income and low-income countries.…”

Section: Introductionmentioning

confidence: 99%

“…This aims to predict the safety of the vaccine’s clinical use in humans, to decrease the chance for adverse effects in clinical trial participants, and to provide information for vaccination protocols. 3 , 16 - 18 Therefore, the aim of this study was to evaluate the systemic toxicity and local tolerance of the C1-cell expressed receptor-binding domain (C1-RBD) SARS-CoV-2 vaccine, bound to aluminum hydroxide (Alhydrogel ® ‘85’), following repeated intramuscular (IM) injections, in New Zealand White (NZW) rabbits.…”

Section: Introductionmentioning

confidence: 99%

Toxicity and Local Tolerance of a Novel Spike Protein RBD Vaccine Against SARS-CoV-2, Produced Using the C1 Thermothelomyces Heterothallica Protein Expression Platform

Ramot

Kronfeld²,

Ophir

et al. 2022

Toxicol Pathol

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Coronavirus disease 2019 (COVID-19) has caused the ongoing COVID-19 pandemic and there is a growing demand for safe and effective vaccines. The thermophilic Thermothelomyces heterothallica filamentous fungal host, C1-cell, can be utilized as an expression platform for the rapid production of large quantities of antigens for developing vaccines. The aim of this study was to evaluate the local tolerance and the systemic toxicity of a C1-cell expressed receptor-binding domain (C1-RBD) vaccine, following repeated weekly intramuscular injections (total of 4 administrations), in New Zealand White rabbits. The animals were sacrificed either 3 days or 3 weeks following the last dose. No signs of toxicity were observed, including no injection site reactions. ELISA studies revealed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific immunoglobulin G antibodies in the sera of C1-RBD-treated animals starting from day 13 post injection, that were further elevated. Histopathology evaluation and immunohistochemical staining revealed follicular hyperplasia, consisting of B-cell type, in the spleen and inguinal lymph nodes of the treated animals that were sustained throughout the recovery phase. No local or systemic toxicity was observed. In conclusion, the SARS-CoV-2 C1-RBD vaccine candidate demonstrated an excellent safety profile and a lasting immunogenic response against receptor-binding domain, thus supporting its further development for use in humans.

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SARS-CoV-2 inactivated vaccine (Vero cells) shows good safety in repeated administration toxicity test of Sprague Dawley rats

Cited by 14 publications

References 26 publications

An overview on inactivated and live‐attenuated SARS‐CoV‐2 vaccines

An overview on inactivated and live‐attenuated SARS‐CoV‐2 vaccines

Variants of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Vaccine Effectiveness

Toxicity and Local Tolerance of a Novel Spike Protein RBD Vaccine Against SARS-CoV-2, Produced Using the C1 Thermothelomyces Heterothallica Protein Expression Platform

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