Hepatitis B Vaccination in Diabetic Patients: Randomized trial comparing recombinant vaccines containing and not containing pre-S2 antigen
- Catherine Douvin, MD,
- Dominique Simon, MD, PHD,
- Marie Aline Charles, MD,
- Lionel Deforges, MD,
- Philippe Bierling, MD, PHD,
- Valérie Lehner, PHD,
- Agata Budkowska, PHD and
- Daniel Dhumeaux, MD
- Department of Hepatology and Gastroenterology, Pasteur Institute, Henri Mondor Hospital Créteil
- Department of Diabetology, Henri Mondor Hospital Créteil
- Department of Bacteriology and Virology, Henri Mondor Hospital Créteil
- Blood Transfusion Center, Henri Mondor Hospital Créteil
- INSERM U-21 Villejuif
- Smith-Kline and Beecham Laboratory Nanterre
- Microbial Immunology Unit, Pasteur Institute Paris, France
- Address correspondence and reprint requests to Dominique Simon, MD, Service de Diabétologie, Hôpital Henri Mondor, 94010 Créteil, France. E-mail: u21{at}lorelei.vjf.inserm.fr
Abstract
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 <10 IU/1 at month 4, a fourth injection of vaccine was given. A positive response was defined by anti-HBs titer ≥ 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.
- Received April 29, 1996.
- Revision received September 12, 1996.
- Accepted September 12, 1996.
- Copyright © 1997 by the American Diabetes Association
