A 3-week hepatitis B vaccination schedule provides rapid and persistent protective immunity: a multicenter, randomized trial comparing accelerated and classic vaccination schedules.

Hepatitis B (HB) vaccinations given once weekly for 3 weeks can provide early seroprotection. This study compared immune responses induced by the accelerated (A; days 0, 10, 21) and classic (C; days 0, 28, 56) HB vaccination schedules. Two hundred seventy healthy subjects (95 men, 175 women) with a mean age of 23.8 years received 3 doses of GenHevac B, a recombinant vaccine produced in mammalian cells. The subjects were randomly assigned to schedules A or C. A booster dose was given 1 year later. One month after the third dose, 70% (schedule A) and 92% (schedule C) of the subjects were seroprotected and 100% (A) and 99% (C) had developed anti-pre-S2 antibodies. Before booster injections, 93% (A) and 95% (C) of the subjects were seroprotected, and 1 month after the booster, almost all subjects were seroprotected. A 3-week HB vaccination schedule with GenHevac B can confer early protective immunity lasting up to 1 year.

Randomised placebo-controlled trial of recombinant interleukin-2 in chronic uraemic patients who are non-responders to hepatitis B vaccine.

Natural interleukin-2 at low dose has been reported to overcome the non-responsiveness of patients with chronic uraemia to hepatitis B vaccine. Therefore, we revaccinated 52 previous such non-responders (24 on maintenance dialysis) with 20 micrograms of recombinant preS2-containing hepatitis B vaccine with human recombinant interleukin-2 (1 MU) or placebo (randomly allocated). Seroconversion rates (74 vs 80%, respectively) and proportion of patients who elicited anti-HBs titres of 10 mlU/mL or more (56 vs 68%) were similar in both groups. Our results do not confirm local injection of interleukin-2 as an effective immunoadjuvant to hepatitis B vaccine in uraemic patients.

[Recombinant vaccine and extracting vaccine against hepatitis B in patients with kidney insufficiency: comparative immunogenicity]. / Vaccin recombinant et vaccin d'extraction contre l'hépatite B chez l'insuffisant rénal: immunogénicité comparée.

OBJECTIVES: 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.

Three-week hepatitis B vaccination provides protective immunity.

To determine whether a 3-week hepatitis B (HB) vaccination could achieve protective immunity, 89 healthy non-immunized young adults received three doses of 20 micrograms each of HBs antigen (GenHevac B, Pasteur) and were randomly assigned to schedule A (n = 44): two doses at day 0, one dose at day 21; or schedule B (n = 45): one dose at days 0, 10 and 21. Seroprotection rates (anti-HBs > or = 10 mIU ml-1) for groups A and B respectively were: 23 and 40% at day 21; and 77 and 91% at day 82 (not significant). Anti-HBs geometric mean titres were higher in group B than in group A (p < 0.05) at days 21 (6.4 versus 3.8) and 82 (77.6 versus 33.5). One year after primary vaccination, the seroprotection rate remained as high as 90% in the vaccinees of group B; after boosting all vaccinees had protective levels of anti-HBs antibodies. Thus 3-week HB vaccination with GenHevac B allowed early and durable protective immunity.