Improved prevention of perinatal hepatitis B transmission HBV by employing the Bio-Hep-B PreS1/PreS2/S HBV vaccine in new born babies from HBV positive mothers

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As HBV prevalence is high in the Palestinian population with elevated mother to child transmission in spite of vaccination, we will perform the following: 1. Determine the prevalence of HBV infection in pregnant Palestinian women, by screening for anti-HBc antibodies, HBsAg and anti-HBs. 2. Characterise the state of HBV infection in HBsAg positive mothers (HBeAg and HBV DNA load). 3. In the newborn babies of HBsAg positive mothers, we will compare the efficacy of the conventional Engerix B vaccine that contains only the S-HBsAg protein with an alternative licensed PreS1, PreS2, S-containing vaccine (Bio-Hep-B that includes all three HBsAg proteins). 4. Determine the failure rate of vaccination in this particular setting by following the vaccinated children for at least one year. They will be tested for HBsAg, HBV DNA, anti-HBc, anti-HBs and if positive for anti-HBc for further HBV markers. 5. Investigate the major reason for vaccination failures: is it related to a breakthrough of wild type HBV or escape mutants? For this purpose we will employ molecular biology tools to amplify and sequence the preS/S gene region of all HBV DNA positive mothers and infants. The genotyping data will be analysed and compared to known genotypes. The neutralising potential of vaccine-induced antibodies against HBV escape mutants shall be studied in vitro. 6. A final recommendation based on this research data should be a reference for the Palestinian health institution to consider the optimisation of the vaccination program and the type of vaccine to be used.