Immunogenicity of two paediatric doses of monovalent hepatitis B or combined hepatitis A and B vaccine in 8–10-year-old children

Hepatitis A and B vaccines are highly immunogenic in three-dose schedules. To obtain an equivalent result in children with two paediatric doses would be of significant benefit. The purpose of this study was to measure the immunogenicity of a two-dose schedule in children with two licensed recombinant HBsAg containing vaccines given at paediatric doses, one of them combined with hepatitis A. Seven-hundred and four healthy school children aged 8–10 years were recruited in an open label study to receive either Twinrix Pediatric (360 El.U HAV antigen; 10 μg HBsAg) or Recombivax (2.5 μg HBsAg) vaccine intramuscularly 6 months apart. The seroconversion (≥1 mIU/ml for anti-HBs antibodies and ≥33 mIU/ml for anti-HAV antibodies), seroprotection (anti-HBs ≥10 mIU/ml) rates and the geometric mean titers (GMTs) were determined 4–8 weeks after the second dose. The anti-HBs seroconversion rate was 97.1% with Twinrix and 97.2% with Recombivax. The seroprotection rates were 96.5 and 94.4%, respectively (P = 0.17). The GMT was higher with Twinrix than with Recombivax (3248 mIU/ml versus 742 mIU/ml, P < 0.0001). All the children vaccinated with Twinrix seroconverted to HAV and the GMT was 5168 mIU/ml. The obtained results suggest that two paediatric doses of hepatitis vaccines are highly immunogenic in 8–10-year-old children. This schedule could facilitate a greater vaccine acceptance and the addition of hepatitis A vaccine to existing adolescent universal hepatitis B virus immunization programs.