New Russian Trivalent Hepatitis B Vaccine (Bubo<sup>®</sup>-Unigep): Clinical Study Results

Abstract

Relevance. Currently, there is no registered vaccine against the hepatitis B virus (HBV) mutant G145R worldwide, which justifies the need to develop a new generation of vaccines due to large-scale immunization against hepatitis B and the accumulation of escape mutants of the virus.The aim of the study was a comparative assessment of the immunogenicity, reactogenicity and safety of Bubo®-Unigep (trivalent hepatitis B recombinant yeast vaccine) and the drug Hepatitis B recombinant yeast vaccine.Materials and methods. To assess the main characteristics of the new trivalent vaccine Bubo®-Unigep (CJSC NPC «COMBIOTECH»), a doubleblind, comparative, randomized, multicenter clinical trial was conducted in two parallel groups in previously unvaccinated individuals in an adult healthy population (n = 166) according to a protocol developed by the contract research organization «R&D Pharma».Results. The assessment of hematological and biochemical parameters during screening and the administration of vaccine preparations showed that in the individuals included in the study, the studied indicators were within the boundaries of the normal range. According to the criteria for assessing safety and efficacy, both drugs had low reactogenicity, no serious adverse events were registered. The results of a comparative analysis of the concentrations of antibodies to HBsAg determined after a full course of immunization with Bubo®-Unigep vaccine or recombinant yeast Hepatitis B vaccine showed that both drugs effectively induced a humoral immune response (anti-HBs) with seroprotection rates of 96.3% and 92.6%.Conclusion. The inclusion of the relevant HBV serotypes (ay and ad) and the mutant antigen G145R in the composition of the new polyvalent vaccine Bubo®-Unigep contributes to the expansion of the spectrum of specificity of the immune response, and, consequently, more effective vaccination of hepatitis B.