The efficacy of hepatitis B (HB) vaccine alone or combined with hepatitis B immunoglobulin (HBIg) in preventing hepatitis B virus (HBV) infection was studied in a controlled trial. Recombinant HB vaccine (Engerix-B, 20 micrograms) was given to 40 susceptible health-care workers within three days of exposure (Group B). In another group of 37 medical professionals a single dose of HBIg (0.06 mg/kg) was administered intramuscularly within three days of exposure, followed immediately by the first dose of vaccine (20 micrograms dose) (Group A). In both groups the next doses of recombinant vaccine were administered one, two and six months later. One month after the fourth dose of vaccine the percentage of incidence of antibody to hepatitis B virus surface antigen (anti-HBs) was 94.6% in group A and 95% in group B with geometric mean titer of antibodies of 340 and 380 mIU/ml, respectively. A control group consisted of 34 persons who did not receive any specific immunoprophylaxis (Group C). All subjects were followed for at least ten months. The protective value of immunization, both active alone and combined passive and active, was clearly effective since none of the recipients developed acute symptomatic HBV infection compared with two (6%) of 34 not immunized persons (Fisher's exact test p = 0.01). Thus, in the absence of evidence of lesser efficacy for the use of HB vaccine alone after exposure to HBsAg-positive blood, this schedule would seem to be the treatment of choice in adult persons.

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The results of the analysis of vaccination against hepatitis B performed in 2,000 persons of high-risk groups in Croatia are described. All susceptible non-immunocompromised persons (HBsAg, anti-HBs, and anti-HBc negative) received either plasma-derived vaccine (HB-Vax MSD, 20 micrograms per dose) or recombinant HB vaccine (ENGERIX-B, SKB, 20 micrograms per dose) according to a 0.1 and 6-month schedule. Hemodialysis patients received four doses of HB vaccine (40 micrograms per dose). Seroconversion occurred in 98% of health care workers, 98.5% of family members of HBsAg chronic carriers, 98% of infants born to HBsAg carrier-mothers and 92% of hemodialysis patients. The percentage of poor-responders (titer of anti-BHs = 1-10 mIU/ml) for the groups was 2, 2, 8 and 20%, respectively, while low-responders (titer of anti-BHs = 10.1-100 mIU/ml) were 5, 4.5, 12 and 26%, respectively. A significant prevalence of non-responders, poor-responders and low-responders among male health care workers was noticed (p = 0.01, 0.026 and 0.002, respectively). Females significantly prevailed among excellent-responders (p = 0.0039). In hemodialysis patients, there were 8% non-responders, 19.5% poor-responders, and 26% low-responders. A significant difference between the percentage of good-responders (titer of anti-HBs = 101-1,000 mIU/ml) and excellent-responders (titer of anti-HBs over 1,000 mIU/ml) among health care workers and hemodialysis patients was documented (91% versus 46.5%, p < 0.0001). The combined passive-active immunization (hyperimmune hepatitis B globulin + hepatitis B vaccine) was effective in 98% of infants born to HBsAg carrier-mothers, and only one boy developed subclinical HBV infection (HBsAg and anti-HBc positive findings with normal ALT-values).(ABSTRACT TRUNCATED AT 250 WORDS)

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