RECOMBINANT AND PLASMA-DERIVED VACCINES A GAINST HEPATITIS-B IN PATIENTS WITH CHRONIC-RENAL-FAILURE - COMPARATIVE IMMUNOGENICITY

Objectives: Patients with chronic renal failure respond rather poorly to hepatitis B vaccines. A better response could be expected from reco mbinant vaccines including both the S and the pre-S2 antigens. We ther efore prospectively compared the immuno genicity of plasma-derived Hev ac B vaccine (H) with that of recombinant GenHevac B vaccine (G). Meth ods : Vaccinations were performed in 120 non-dialyzed patients with ch ronic renal failure. The patients were randomly divided into two group s. Group G included 60 patients (24 males, mean age 58 +/- 16 years, m ean creatinine clearance 25.3 +/- 12.6 ml/min) who were given the Heva c B vaccine at the dose of 5 mu g. Group II included 60 patients (31 m ales, 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 mu g. Al l vaccinations were repeated at 0, 1, 2, 4 and 12 months. Results: Fol lowing the fourth injection, seroconversion (anti-Hbs greater than or equal to 2 mIU/ml) was observed in 50/59 (85 %) of the patients in gro up G versus 38/58 (67 %) in group H (p < 0.02). Seroprotection (greate r than or equal to 10 mIU/ml) was obtained in 42/59 (71 %) vs 34/58 (5 9 %), (NS) in the two groups respectively with a geometric mean titer of 112 versus 229 mIU/ml (NS) in responders. Following the booster inj ection 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 = 0.0 53) respectively. The mean geometric titers were 879 and 1001 mIU/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 again ts hepatitis B.