Abstract Background A two-dose hepatitis B vaccination schedule is highly immunogenic in children aged ≥1 year, but data for infants are scarce. Our goal was to compare the immunogenicity of two- and three-dose hepatitis B vaccination schedules in this population. Methods Children in the experimental group were recruited at 2 months of age and randomized to receive a homologous (Infanrix-hexa/Infanrix-hexa) or heterologous (Infanrix-hexa/Twinrix) two-dose schedule at 2 and 12 months. Children in the control group were recruited at 18 months and had received a homologous three-dose schedule (Infanrix-hexa/Infanrix-hexa/Infanrix-hexa) at 2, 4 and 18 months. All groups received a challenge dose (Twinrix) three years later. Results One month after the primary series, seroprotection rates (anti-HBs ≥10 mIU/mL) were high and similar among the three groups (heterologous two-dose, 91.7%; homologous two-dose, 90.9%; three-dose, 94.2%). Geometric mean titers (GMTs) were lower in the two-dose groups than in the three-dose group. Post-challenge dose, the majority exhibited an anamnestic response, similar across all three groups (heterologous two-dose, 97.2%; homologous two-dose, 95.5%; three-dose, 92.7%). GMTs were numerically higher in the heterologous two-dose group (9380.5 mIU/mL) than in the three-dose group (6900.6 mIU/mL) (p=0.4). The proportion exhibiting local reactions was significantly lower after the heterologous two-dose schedule than after the homologous two-dose schedule. Conclusion The anamnestic response three years after two- (2, 12 months) and three-dose (2, 4, 18 months) hepatitis B vaccination schedules was similar. The heterologous two-dose schedule was more immunogenic and less reactogenic than the homologous two-dose schedule.
Kegbevi et al. (Tue,) studied this question.