ABX203, a novel therapeutic vaccine for chronic hepatitis B patients

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.

Five-year Follow-up of Chronic Hepatitis B Patients Immunized by Nasal Route with the Therapeutic Vaccine HeberNasvac

“…The viral load determinations were carried out using the HBV in-house PCR system developed and validated at the Center for Genetic Engineering and Biotechnology and Institute of Tropical Medicine “Pedro Kouri,” Havana. 1718 This system has a detection limit of 20 copies/ mL.…”

A critical review of the prospects and challenges of Hepatitis B therapeutic vaccines

“…Several therapeutic vaccine candidates have shown promise in preclinical and clinical trials like GS-4774, developed by Dynavax [53] , which aims to induce strong T-cell responses against HBV. Assembly Biosciences' ABX203 targets the viral capsid assembly [54] , and nanoparticle therapeutic vaccine for immune activation [55] . Therapeutic vaccines aim to stimulate the patient's immune system to attack and clear the virus.…”