The protective efficacy of recombinant hepatitis B vaccine in newborn infants of hepatitis B e antigen-positive-hepatitis B surface antigen carrier mothers

Recombinant hepatitis B vaccine has been shown to be as safe and effective as plasmaderived vaccines. However, its efficacy in the prevention of perinatal infection has not been fully evaluated in an endemie area. We recruited 110 high risk infants born to hepatitis B e antigen-positive-hepatitis B surface antigen (HBsAg) carrier mothers in a study of recombinant vaccine efficacy. They were randomized into 2 groups, A (54 infants) and B (56 infants), to receive 4 doses of vaccine, containing 20 or 10 μg of surface antigen, respectively, at 0, 1,2 and 12 months of age. An additional 60 high risk infants were recruited later (Group C) and received three 20-μg doses of vaccine at 0, 1 and 6 months of age. AH infants also received a dose (145 IU) of hepatitis B immunoglobulin soon after birth. Sera were collected at 0, 1, 2, 3, 6, 12 and 14 months of age to assay HBsAg and anti-HBs.At 12 months of age the HBsAg carrier rates were 7.4 and 1.8%, in Groups A and B, respectively. In Group C the HBsAg-positive rate was 3.3%. HBsAg was invariably first observed be-tween 0 and 2 months of age.Virtually ail noncarrier infants developed substantial titers of anti-HBs at 12 months of age. No serious adverse effect was observed after vaccination.