The combined hexavalent
diphtheria-
tetanus-acellular
pertussis-
hepatitis B-inactivated
polio Haemophilus influenzae type b (
DTPa-HBV-IPV/Hib) vaccine produces similar
hepatitis B responses as the HBV monovalent
vaccine. Booster vaccination of immunocompetent individuals primed against
hepatitis B in infancy is currently not recommended. We investigated persisting immunity to
hepatitis B in 4-6 (Study A; 106745) and 7-9 (Study B; 106744) year-old children primed in infancy and boosted in the second year of life with
DTPa-HBV-IPV/Hib. Immunity was assessed by measuring persisting anti-HBs
antibodies and evaluating the response to a challenge dose of HBV
vaccine. At 4-6 years of age 86.0% of 186 subjects had persisting anti-HBs > or =10 mIU/ml increasing to 98.4% after the challenge. At 7-9 years of age, 78.0% of 186 subjects continued to have anti-HBs antibody concentrations > or =10 mIU/ml, increasing to 98.9% after the challenge. In both studies anti-HBs antibody GMC rose >80-fold. An anamnestic response to the HBV challenge was observed in 95.7% and 98.9% of subjects in Studies A and B, respectively. In both studies, 87% of 38 subjects with initially undetectable circulating anti-HBs
antibodies (>3.3 IU/ml) achieved the 10 mIU/ml threshold after challenge; > or =97.0% of subjects with detectable
antibodies before the challenge at least quadrupled their concentration. Post-vaccination anti-HBs concentrations were directly related to persisting antibody concentrations and the concentrations achieved after the booster dose in the second year of life. The HBV
vaccine challenge dose was well tolerated. These studies show that primary and booster vaccination with combined
DTPa-HBV-IPV/Hib (
Infanrix hexa) induces sustained immune memory against
hepatitis B up to age 9 years.