新型俄罗斯三价乙型肝炎疫苗(Bubo®-Unigep):反应原性、安全性和免疫效力

V. N. Borisova, R. Y. Maksvitis, R. V. Ivanov, T. A. Semenenko
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摘要

相关性。在俄罗斯,国产三价疫苗 Bubo®-Unigep 的第三阶段临床试验已经完成,该疫苗含有保护性抗原,可预防 "野生 "乙型肝炎病毒亚型 ay 和 ad 以及带有 G145R 突变的血清型 ay 的决定簇。Аim.评估新型乙型肝炎重组多联疫苗 "Bubo-Unigep "对成年健康人群中以前未接种过疫苗者的生命功能和实验室指标的影响。材料和方法。为评估 Bubo®-Unigep(CJSC NPC "COMBIOTECH")在既往未接种过疫苗的健康成人(n = 166)中的反应原性、安全性和免疫原性,进行了一项随机多中心临床研究。研究按照合同研究组织 "R&D Pharma "制定的方案在俄罗斯联邦的八个临床中心进行。结果与讨论对整个研究过程中的研究参数(不良反应的频率和严重程度、志愿者的体格检查数据(包括生命体征评估)、实验室检测结果等)进行分析后发现,Bubo®-Unigep 疫苗具有很高的安全性。结论Bubo®-Unigep 疫苗具有广泛的免疫反应特异性、高安全性和反应原性,其生产可通过完整的技术周期进行,无需使用进口物质,这将提高乙型肝炎的预防效果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
New Russian Trivalent Hepatitis B Vaccine (Bubo®­-Unigep): Reactogenicity, Safety and Immunological Efficacy
Relevance. In Russia, phase III of clinical trials of the domestic trivalent vaccine Bubo®-Unigep, containing protective antigens that provide protection against “wild” forms of the hepatitis B virus subtypes ay and ad, as well as the determinant of serotype ay with the G145R mutation, has been completed. Аim. Evaluation of the effect of the new recombinant polyvaccine against hepatitis B «Bubo-Unigep» on vital functions and laboratory parameters in previously unvaccinated individuals in an adult healthy population. Materials and methods. A randomized multicenter clinical study was conducted to assess the reactogenicity, safety and immunogenicity of Bubo®-Unigep (CJSC NPC «COMBIOTECH») in previously unvaccinated healthy adults (n = 166). The study performed according to the protocol developed by the contract research organization «R&D Pharma» at eight clinical centers located in Russian Federation. Results and discussion. Analysis of the studied parameters throughout the study (frequency and severity of adverse events, physical examination data of volunteers with assessment of vital signs, laboratory test results, etc.) made it possible to establish a high safety profile of Bubo®-Unigep vaccine, which turned out to be virtually areactogenic without causing development of targeted local and systemic post-vaccination adverse events. Conclusion. The wide range of specificity of the immune response, along with the high safety and reactogenicity of the Bubo®-Unigep vaccine, the production of which can be carried out through a full technological cycle without the use of imported substances, will increase the effectiveness of hepatitis B prevention.
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