Preclinical development of a next-generation, pan-genotypic chimeric vaccine candidate against Hepatitis B Virus, including vaccine escape variants
- HepBpanVac -
(PN-IV-P7-7.1-PED-2024-2210)
Duration
09/01/2025 – 31/12/2026
Budget
783.335,00 lei
(33.335,00 lei own budget)
Funding
Ministry of Research, Innovation and Digitization, CCCDI UEFISCDI
Hepatitis B Virus (HBV) represents a major global health concern, with 296 million chronically infected individuals and 1.5 million new infections/year. Up to 40% of the chronic HBV infected patients develop severe liver diseases as fibrosis, cirrhosis and hepatocellular carcinoma which are associated with high mortality (820,000 deaths/year). The clinically approved therapeutics, although reducing viral replication and disease progression, are not curative, while vaccination remains the most cost-effective approach to limit HBV spreading. However, 10% of vaccinated adults with current HBV vaccine are low- or non- responders, a major concern in highly endemic areas. Moreover, the genomic diversity between the 9 HBV genotypes together with selected HBV variants resistant to conventional vaccine limit the protection coverage. In this context, WHO set up the goal for the elimination of hepatitis B as a major health concern by 2030. To address the current HBV vaccines challenges, we will advance our previous results (obtained within GreenVac and SmartVac projects) that demonstrate the feasibility to produce functional chimeric HBV-derived antigens with improved immunogenicity compared to standard vaccines and able to induce neutralising antibodies against the same genotype. Given the impact of HBV genetic variability on vaccination coverage, we propose to develop a next-generation, pan-genotypic chimeric vaccine candidate against HBV, including vaccine escape variants.
Objectives
Objective 1
Production of novel S/preS1 antigens exposing preS1 epitopes covering the main HBV genotypes.
Objective 2
Investigating the HBV-specific immune response induced by the novel S/preS1 in animal model
Objective 3
Validation of the cross-genotype infection neutralisation capacity of antibodies induced by vaccination with the novel S/preS1
Address
(+4).021.223.90.69
Institute of Biochemistry
Splaiul Independentei 296
060031, Bucharest 17
Romania