New Russian Trivalent Hepatitis B vaccine (Bubo<sup>®</sup>-Unigep): Phase I Clinical Study Results and Perspectives of Further Investigations Aiming Registration in Russia

Abstract

Relevance.The absence of a registered vaccine against G145R escape mutant determines the need to develop a drug for the prophylaxis of infectious hepatitis caused by the hepatitis B virus.Theaimof the study was to evaluate the safety and reactogenicity of a new hepatitis B recombinant Bubo®-Unigep yeast vaccine in healthy volunteers.Materials & Methods.To confirm the safety of the new trivalent Bubo®-Unigep vaccine, an open, single- center, nonrandomized clinical trial was conducted in healthy male volunteers at the clinical base of «Uromed» (Smolensk) according to the protocol developed by the contract research organization R&D Pharma.Results and discussions.Safety and reactogenicity assessment was carried out throughout the study period. In the safety assessment, one adverse event was reported that was not related to the use of Bubo®-Unigep vaccine. No serious adverse events have been reported. There were no local reactions at the injection site throughout the observation period. The results indicate a high safety and areactogenicity of Bubo®-Unigep vaccine.Conclusions:The confirmed safety and areactogenicity of a new Bubo®-Unigep vaccine in a phase I clinical trial allows to proceed to the next stage and to conduct a registration study in which immunogenicity, safety and reactogenicity will be studied during the full course of vaccination. The introduction of such a vaccine on the market will contribute to a more effective vaccination against those serotypes of the hepatitis B virus that are endemic and prevail in the Russian Federation. Due to the created complete immunity, the infection threshold rises and the number of cases of hepatitis B among the already vaccinated population decreases.