New Russian Trivalent Hepatitis B vaccine (Bubo®-Unigep): Phase I Clinical Study Results and Perspectives of Further Investigations Aiming Registration in Russia
https://doi.org/10.31631/2073-3046-2019-18-6-45-52
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.
The aim of 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.
About the Authors
R. Yo. Maksvitis
«R&DPharma», Moscow
Russian Federation
Russian Federation
Roman Y. Maksvitis – medical research director
st. Ugreshskaya 2, building 57, office 412, Moscow, 115088.
+7 926 526 96 68
R. V. Ivanov
«R&DPharma», Moscow
Russian Federation
Russian Federation
Roman V. Ivanov – general director
+7 926 531 61 39A. V. Amelin
«R&DPharma», Moscow
Russian Federation
Russian Federation
Artem V. Amelin – lead manager of preclinical research and registration
+7 926 526 96 59A. V. Goncharova
«R&DPharma», Moscow
Russian Federation
Russian Federation
Anastasiya V. Goncharova – manager of medical research
+7 915 074 96 41A. S. Andreeva
«UROMED», Moscow
Russian Federation
Russian Federation
Alla S. Andreeva – doctor-clinical pharmacologist
+7 910 788 56 45I. A. Grinyov
«UROMED», Moscow
Russian Federation
Russian Federation
Ivan A. Grinyov – head physician
+7 910 783 13 13References
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Review
For citations:
Maksvitis R.Y., Ivanov R.V., Amelin A.V., Goncharova A.V., Andreeva A.S., Grinyov I.A. New Russian Trivalent Hepatitis B vaccine (Bubo®-Unigep): Phase I Clinical Study Results and Perspectives of Further Investigations Aiming Registration in Russia. Epidemiology and Vaccinal Prevention. 2019;18(6):45-52. (In Russ.) https://doi.org/10.31631/2073-3046-2019-18-6-45-52
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