Preclinical Studies of the Specific Activity of the Live Culture Vaccine VACD6 against Smallpox and other Orthopoxvirus Infections

S. Shchelkunov, S. N. Yakubitskiy, A. E. Nesterov, I. Kolosova, A. Sergeev, А. V. Zaykovskaya, A. S. Kabanov, Е. A. Nechaeva, M. P. Bogryantseva, S. V. Usova, N. S. Kutserubova, T. V. Tregubchak, E. Gavrilova, R. Maksyutov
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Abstract

Relevance. The epidemiological situation in the world is characterized by an increase in the incidence of orthopoxvirus infections in humans and animals. In this regard, it is necessary to develop new safe vaccines against these infections.Aim. Conducting preclinical studies on the specific activity of the live vaccine against smallpox and other orthopoxvirus infections VACΔ6 based on the vaccinia virus (VACV) with six deleted virulence genes are presented.Matherials and methods. The studies were performed in accordance with the requirements of the Guidelines for conducting preclinical studies of drugs (immunobiological preparations), the State Pharmacopoeia XIII and the European Pharmacopoeia 7.0.Results and discussion. The vaccine strain VACΔ6 VACV showed significantly reduced neurovirulence in the model of intracerebral administration to suckling mice, and reduced inflammatorynecrotic activity in the model of intradermal administration to rabbits compared to the classical first­generation smallpox live vaccine approved for use in Russia. Preclinical studies of three series of the finished dosage form of the VAC∆6 vaccine showed its authenticity, thermal stability, non­pyrogenicity and safety. Double intradermal vaccination of rabbits at a dose of 106 PFU/animal, a 100% protective effect was provided against the intranasal infection of rabbits with VACV strain HB­-92 at a dose of 1995 LD50 and a double intradermal vaccination of mice at a dose of 106 PFU/animal, full protection was provided against the intranasal infection of mice with ectromelia virus strain K1 at a dose of 56 LD50.Conclusion. Based on the conducted complex of studies, it can be concluded that the created vaccine of the fourth generation VACΔ6 is safer compared to the live smallpox vaccine of the first generation and is not inferior to it in immunogenic and protective properties.
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活疫苗VACD6抗天花和其他正痘病毒感染特异性活性的临床前研究
的相关性。世界流行病学形势的特点是人类和动物中正痘病毒感染发生率增加。在这方面,有必要开发针对这些感染的新的安全疫苗。基于6个缺失毒力基因的牛痘病毒(VACV),进行了针对天花和其他正痘病毒感染VACΔ6的活疫苗特异性活性的临床前研究。材料和方法。研究是按照药物临床前研究指南(免疫生物学制剂)、国家药典XIII和欧洲药典7.0的要求进行的。结果和讨论。与俄罗斯批准使用的经典第一代天花活疫苗相比,疫苗株VACΔ6 VACV在哺乳小鼠脑内给药模型中显示出显著降低的神经毒力,在兔皮内给药模型中显示出降低的炎症坏死活性。三个系列的VAC∆6疫苗成品剂型的临床前研究表明,该疫苗具有真实性、热稳定性、无热原性和安全性。以106 PFU/只的剂量双次皮内接种兔对1995 LD50和106 PFU/只的双次皮内接种兔对HB—92疫苗株的鼻内感染有100%的保护作用,对56 LD50的小鼠鼻内感染有充分的保护作用。根据所进行的综合研究,可以得出结论,第四代疫苗VACΔ6与第一代天花活疫苗相比更安全,并且在免疫原性和保护性能方面并不逊色。
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