ABX203, a novel therapeutic vaccine for chronic hepatitis B patients

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Abstract

Despite the existence of effective prophylactic vaccines, chronic hepatitis B remains a major public health problem, with more than 350 million people infected   worldwide.  Chronic  infection   increases the  risk of serious  liver diseases  such  as cirrhosis and  hepatocellular carcinoma.  Available therapies for chronic  hepatitis  B  have  limited  efficacy and require  long-term   continuous  treatments;  that  is why the  development of therapeutic vaccines has been  investigated as  promising  approach.  In this sense, a novel  vaccine  formulation  called ABX203 (HeberNasvac), based  on  the  combination of the hepatitis B virus nucleocapsid and surface antigens, was developed. ABX203 has been studied in phase I, phase II and phase III clinical trial in treatment-naïve chronically infected  patients  in Bangladesh  and  in healthy  volunteers  in Cuba with promising  results. In the present work we reviewed the main preclinical and   clinical  results  of  ABX203 development. Altogether, the data demonstrates safety and immunogenicity of ABX203 vaccine and support  its use as a novel and competitive treatment alternative for chronic hepatitis B. The vaccine has been granted marketing authorization in Cuba.

About the authors

Y. Lobaina Mato

Center for Genetic Engineering and Biotechnology, Havana

Email: fake@neicon.ru
Lobaina Mato Yadira – PhD, Researcher, Hepatitis B therapeutic vaccine Project, Vaccine Department, Biomedical Research Unit Cuba

J.C. Aguilar Rubido

Center for Genetic Engineering and Biotechnology, Havana

Email: fake@neicon.ru
Aguilar Rubido Julio Cesar – PhD, Senior Researcher, Head of Hepatitis B therapeutic vaccine Project, Vaccine Department, Biomedical Research Unit Cuba

G.E. Guillén Nieto

Center for Genetic Engineering and Biotechnology, Havana

Author for correspondence.
Email: gerardo.guillen@cigb.edu.cu

Guillen Nieto Gerardo Enrique – PhD, Member of the Cuban Academy of Science, Senior Researcher, Biomedical Research Director.

31 Avenue, P.O. Box 6162, Havana 6, 10 600, Cuba. Tel: (53-7) 250 44 95. E-mail: gerardo.guillen@cigb.edu.cu

Cuba

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Copyright (c) 2016 Lobaina Mato Y., Aguilar Rubido J., Guillén Nieto G.

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