Immune Responses to Hepatitis B Vaccine With and Without the Pre-S2 Antigen in Children With Type 1 Diabetes

This study involved 20 patients (10 males and 10 females) with type 1 diabetes who were seronegative for hepatitis B surface-antigen (HBsAg) and other hepatitis B (HB) viral markers and had no diabetic complications. As patients were recruited over a period of several months, each patient was alternatively assigned to one of two vaccination groups (A or B). There was no significant difference between groups A and B in terms of age, sex, duration of diabetes, and levels of HbA1c. Written informed parental consent was obtained for all patients. Patients in groups A (mean age 12.7 ± 2.6 years, mean duration of diabetes 5.1 ± 2.6 years, mean HbA1c level 8.6 ± 0.7%) received three doses of 10 or 20 μg (the lower dose was given to patients aged <10 years, as recommended by the manufacterer) of a recombinant DNA HB vaccine (Engerix B; Smith-Kline Beecham, Rixensart, Belgium) by intramuscular injections in the left thigh at 0, 1, and 2 months. Patients in group B (mean age 13.8 ± 5.7 years, mean duration …