Humoral immune response to a yeast-derived hepatitis B vaccine in patients with type 1 diabetes mellitus.

The immune response following vaccination with a recombinant hepatitis B vaccine was investigated in 32 patients with Type 1 diabetes mellitus and compared with the outcome in 32 healthy age- and sex-matched volunteers. Participants were vaccinated at 0, 30, and 180 days and in vivo immune response was determined at 30, 60, 90, 180, and 210 days. The number of responders (anti-HBs greater than 1 IU l-1) was significantly lower (p less than 0.05) among patients at 30 (2 vs 11), 60 (17 vs 26), 90 (20 vs 28) and 180 (22 vs 29) days. The number of patients protected (anti-HBs greater than 10 IU l-1) was lower (p less than 0.05) than the number of protected volunteers at 60 (5 vs 14), 90 (10 vs 19), 180 (15 vs 24), and 210 days (24 vs 31). After the complete course of vaccination 8 out of 32 patients were still unprotected against hepatitis B (p less than 0.05). The anti-HBs titre of responders at 210 days was 251 (20, 3162) (geometric mean (-SD, +SD] IU l-1 in patients and 1259 (126, 12589) IU l-1 in control subjects (p less than 0.05). The HLA-antigen DQw1 frequency in the diabetic low responders (anti-HBs less than 100 IU l-1) was 0.27 compared with 0.86 in diabetic adequate responders. No relation between anti-HBs production and concentration of HbA1c could be demonstrated.