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.


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.
Douvin
C
C
Department of Hepatology and Gastroenterology, Henri Mondor Hospital, Créteil, France.
Simon
D
D
Charles
M A
MA
Deforges
L
L
Bierling
P
P
Lehner
V
V
Budkowska
A
A
Dhumeaux
D
D
D000328:Adult; D000368:Aged; D015331:Cohort Studies; D003920:Diabetes Mellitus / Q000276:immunology* / Q000503:physiopathology; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006509:Hepatitis B / Q000276:immunology / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000097:blood* / Q000276:immunology; D006514:Hepatitis B Surface Antigens / Q000008:administration & dosage / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000737:chemistry / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011498:Protein Precursors / Q000008:administration & dosage / Q000276:immunology*; D013997:Time Factors; D014611:Vaccination / Q000379:methods; D014614:Vaccines, Synthetic / Q000737:chemistry / Q000276:immunology*; D014759:Viral Envelope Proteins / Q000008:administration & dosage / Q000276:immunology
D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D011498:Protein Precursors; D014614:Vaccines, Synthetic; D014759:Viral Envelope Proteins; C050807:presurface protein 2, hepatitis B surface antigen