Demostración de la seguridad, inmunogenicidad y evidencias de la eficacia del candidato vacunal HeberNasvac y caracterización de las poblaciones de pacientes con hepatitis B crónica

Chronic hepatitis B remains as a major public health problem, with more than 350 million people infected worldwide. Available therapies have limited efficacy and require long-term continuous treatments, further encouraging the development of therapeutic vaccines as a promising approach. In this sense, a new vaccine formulation called HeberNasvac was developed, which is based on the combined administration of the HBV nucleocapsid (HBcAg) and surface (HBsAg) antigens by the intranasal and the subcutaneous routes. In this work, we present some of the achievements of HeberNasvac clinical development studies, particularly summarized data from Phase I and II clinical trials. Altogether, our results demonstrated the good safety and immunogenicity profiles of the HeberNasvac vaccine, providing it as a novel and competitive treatment against chronic hepatitis B. In parallel, the chronic hepatitis B infected populations in Cuba and Bangladesh were characterized, attending to virological, serological, biochemical and histological parameters. This research granted the 2014 Award of the Cuban National Academy of Sciences.