Hepatitis B vaccination in diabetic patients - Randomized trial comparing recombinant vaccines containing and not containing pre-S2 antigen

OBJECTIVE - To investigate the immunogenicity of two recombinant hepatitis B vaccines containing S antigen alone (Engerix B) or both S and pre-S2 antigens (GenHevac B) in diabetic patients. RESEARCH DESIGN AND METHODS - Of the adult diabetic patients, 71 (26 IDDM, 45 NIDDM) were randomized to receive Engerix B or GenHevac B at 0, 1, 2, and 12 months in a single-blind clinical trial; if the antibody to hepatitis B surface antigen (anti-HBs) titers were <10 IU/l at month 4, a fourth injection of vaccine was given, A positive response was defined by anti-HBs titer greater than or equal to 10 IU/l at month 13. RESULTS - The anti-HBs response rate and the titers of anti-HBs did not differ significantly between the two types of vaccine. Overall, >90% of the patients responded at month 13. In patients vaccinated with GenHevac B, anti-pre-S2 antibodies appeared earlier than anti-HBs. The anti-HBs response tended to decrease with age (P = 0.07) and tended to be higher in IDDM patients than in NIDDM patients (P = 0.06). Metabolic control, as assessed by HbA(1c) level, did not influence the response rate. The presence of the HLA DQ2 allele was associated with a low response. CONCLUSIONS - A large majority of diabetic patients can be efficiently vaccinated against the hepatitis B virus using a booster dose at month 4. The choice of the vaccine (with or without pre-SZ antigen) appears to have Little influence, if any, on the response rate.