New Russian Trivalent Hepatitis B Vaccine (Bubo®­-Unigep): Reactogenicity, Safety and Immunological Efficacy

Abstract

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.