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Diabetes Care, Vol 20, Issue 2 148-151, Copyright © 1997 by American Diabetes Association

ARTICLES

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

C Douvin, D Simon, MA Charles, L Deforges, P Bierling, V Lehner, A Budkowska and D Dhumeaux
Department of Hepatology and Gastroenterology, Henri Mondor Hospital, Creteil, France.

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 i.u./l at month 4, a fourth injection of vaccine was given. A positive response was defined by anti-HBs titer > or = 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 HbA1c 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-S2 antigen) appears to have little influence, if any, on the response rate.
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M. Mancuso, M. Caruso-Nicoletti, S. Bianca, G. Granata, G. Li Volti, and S. Li Volti
Immune Responses to Hepatitis B Vaccine With and Without the Pre-S2 Antigen in Children With Type 1 Diabetes
Diabetes Care, October 1, 2001; 24(10): 1841 - 1842.
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Copyright © 1997 by the American Diabetes Association.