ЛИЦЕНЗИРОВАННЫЕ СИБИРЕЯЗВЕННЫЕ ВАКЦИНЫ И ЭКСПЕРИМЕНТАЛЬНЫЕ ПРЕПАРАТЫ НА СТАДИИ КЛИНИЧЕСКИХ ИССЛЕДОВАНИЙ

Q3 Medicine Zhurnal mikrobiologii, epidemiologii, i immunobiologii Pub Date : 2017-08-28 DOI:10.36233/0372-9311-2017-4-112-126

Н. И. Микшис, П. Ю. Попова, А. П. Семакова, Владимир Кутырев

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引用次数: 2

Abstract

High pathogenicity of anthrax agent combined with unique insensitivity of its spore forms to environmental stresses class it among extremely dangerous biological agents. Registered and effectively used anthrax vaccines made invaluable contribution to the improvement of epidemiological situation around the world. Nevertheless, neglect of non-specific prophylaxis may result in dramatic scenarios and require large-scale measures on rectification of the consequences. Efforts on the development of next-generation vaccines are aimed at safety build-up, decrease in frequency of administration, and enhancement of manufacturing technologies. The review contains the key information on licensed anthrax vaccines designed for medical use, both in the territory of the Russian Federation and abroad. Among multiple experimental developments emphasized have been preparations manufactured by various biopharmaceutical companies in compliance with GMP standards, at different phases of clinical trials in 2016.

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西伯利亚有执照的疫苗和临床试验药物

炭疽菌的高致病性及其孢子形式对环境胁迫的不敏感性使其成为极为危险的生物制剂之一。注册和有效使用的炭疽疫苗为改善世界各地的流行病学状况作出了宝贵的贡献。然而，忽视非特异性预防可能导致严重的情况，需要采取大规模措施纠正后果。开发下一代疫苗的努力旨在提高安全性，减少给药频率，并提高生产技术。审查载有在俄罗斯联邦境内和国外获得许可的用于医疗用途的炭疽疫苗的关键信息。在多项实验进展中，2016年各生物制药公司按照GMP标准生产的制剂处于临床试验的不同阶段。

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