[Recombinant vaccine and extracting vaccine against hepatitis B in patients with kidney insufficiency: comparative immunogenicity].
OBJECTIVE
Patients with chronic renal failure respond rather poorly to hepatitis B vaccines. A better response could be expected from recombinant vaccines including both the S and the pre-S2 antigens. We therefore prospectively compared the immunogenicity of plasma-derived Hevac B vaccine (H) with that of recombinant GenHevac B vaccine (G).


METHODS
Vaccinations were performed in 120 non-dialyzed patients with chronic renal failure. The patients were randomly divided into two groups. Group G included 60 patients (24 males, mean age 58 +/- 16 years, mean creatinine clearance 25.3 +/- 12.6 ml/min) who were given the Hevac B vaccine at the dose of 5 micrograms. Group H included 60 patients (31 males, mean age 60 +/- 15 years, mean creatinine clearance 24.4 +/- 11.1 ml/min) who were given GenHevac B vaccine at the dose of 20 micrograms. All vaccinations were repeated at 0, 1, 2, 4 and 12 months.


RESULTS
Following the fourth injection, seroconversion (anti-Hbs > or = 2 mlU/ml) was observed in 50/59 (85%) of the patients in group G versus 38/58 (67%) in group H (p < 0.02). Seroprotection (> or = 10 mlU/ml) was obtained in 42/59 (71%) vs 34/58 (59%), (NS) in the two groups respectively with a geometric mean titer of 112 versus 229 mlU/ml (NS) in responders. Following the booster injection at the 12th month, seroconversion was achieved in 48/51 (94%) vs 40/53 (76%) (p < 0.01) and seroprotection in 84% vs 70% (p = 0.053) respectively. The mean geometric titers were 879 and 1001 mlU/ml.


CONCLUSIONS
Recombinant GenHevac B vaccine elicits seroconversion and seroprotection in a higher proportion of patients with chronic renal failure than the plasma-derived Hevac B vaccine, with comparably high antibody titers in responders. Therefore, GenHevac B vaccine should be recommended for vaccinating patients with chronic renal failure against hepatitis B.
Jungers
P
P
Département de Néphrologie, Hôpital Necker, Paris.
Chauveau
P
P
Couroucé
A M
AM
Abbassi
A
A
Devillier
P
P
Marie
F N
FN
Bailleux
F
F
Excler
J L
JL
Cerisier
J E
JE
Saliou
P
P
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006508:Hepatitis Antibodies / Q000032:analysis; D006509:Hepatitis B / Q000209:etiology / Q000276:immunology / Q000517:prevention & control*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007110:Immunity, Active / Q000276:immunology*; D007676:Kidney Failure, Chronic / Q000150:complications*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000627:therapeutic use*
D006508:Hepatitis Antibodies; D017325:Hepatitis B Vaccines; D014614:Vaccines, Synthetic
Vaccin recombinant et vaccin d'extraction contre l'hépatite B chez l'insuffisant rénal: immunogénicité comparée.