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减毒活疫苗QazCOVID-Live预防冠状病毒感染COVID-19的安全性和免疫原性:临床前研究结果

Safety and Immunogenicity of the Live Attenuated Vaccine QazCOVID-Live Against Coronavirus Infection COVID-19: Pre-Clinical Study Results.

作者信息

Kutumbetov Lespek, Myrzakhmetova Balzhan, Tussipova Aiganym, Zhapparova Gulzhan, Tlenchiyeva Talshyngul, Bissenbayeva Karina, Zhapar Kuanysh, Zhugunissov Kuandyk, Nurabayev Sergazy, Kerimbayev Aslan

机构信息

Research Institute for Biological Safety Problems, Gvardeiskiy 080409, Kazakhstan.

出版信息

Vaccines (Basel). 2024 Dec 12;12(12):1401. doi: 10.3390/vaccines12121401.

Abstract

The research conducted in this preclinical study assesses QazCovid-live, a live attenuated COVID-19 vaccine created in Kazakhstan, by conducting preclinical evaluations of safety, immunogenicity, and allergenicity in various animal models, including mice, rats, hamsters, and guinea pigs. The vaccine, developed by attenuating SARS-CoV-2 via numerous Vero cell passages, had no significant adverse effects in acute and subacute toxicity assessments, even at elevated dosages. Allergenicity testing indicated the absence of both immediate and delayed hypersensitivity reactions. Immunogenicity evaluations revealed strong virus-neutralizing antibody responses, especially following intranasal and intratracheal delivery. Studies on reversibility and transmission further validated the vaccine's stability and non-pathogenicity. The data indicate that QazCovid-live is safe, immunogenic, and prepared for clinical trials, presenting a potential strategy for COVID-19 prevention.

摘要

这项临床前研究开展的研究,通过在包括小鼠、大鼠、仓鼠和豚鼠在内的各种动物模型中进行安全性、免疫原性和致敏性的临床前评估,对哈萨克斯坦研发的减毒活新冠疫苗QazCovid-live进行了评估。该疫苗通过对严重急性呼吸综合征冠状病毒2(SARS-CoV-2)进行多次Vero细胞传代培养而减毒制成,即使在高剂量情况下,在急性和亚急性毒性评估中也没有显著的不良反应。致敏性测试表明既没有速发型也没有迟发型超敏反应。免疫原性评估显示出强烈的病毒中和抗体反应,尤其是在经鼻和经气管给药后。关于可逆性和传播性的研究进一步证实了该疫苗的稳定性和非致病性。数据表明,QazCovid-live是安全的、具有免疫原性的,并且已准备好进行临床试验,为预防新冠病毒疾病(COVID-19)提供了一种潜在策略。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e0b1/11728456/9bfd3420339b/vaccines-12-01401-g001.jpg

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