Immunoprophylaxis against Hepatitis B Virus Infection: A Controlled Trial in Infants Born to HBeAg-Negative HBsAg Carrier Mothers in Taiwan

To determine the strategy of interruption of perinatal transmission of hepatitis B virus (HBV) infection in infants born to hepatitis B e antigen (HBeAg) negative (or antibody to HBeAg positive), hepatitis B surface antigen (HBsAg) carrier mothers in Taiwan, infants were randomized into three groups. Group Ⅰ initially received three 5 μg doses of vaccine beginning in the first week after birth by the subcutaneous route with one-month interval between doses. A booster dose was given at one year of age. Group Ⅱ received the identical schedule of vaccine plus one dose (0.5 ml) of hepatitis B hyperimmune globulin (HBIG) at birth. Group Ⅲ was the control group and comprised of infants whose parents refused vaccination. In Group Ⅰ, 3/21 (14.3%) developed antibody to HBsAg (anti-HBs) within one month of age after the first dose of vaccine in contrast to 95.8% (23/24) of infants in Group Ⅱ. Anti-HBs was detected in the serum of 76.2% of Group Ⅰ infants and 91.7% in Group Ⅱ at 6 months of age. 100% and 95.8% of the infants in Group Ⅰ and Ⅱ respectively developed anti-HBs 2 months after having given the booster dose of HBV vaccine. Only one of nineteen infants in the control group had anti-HBs response at 14 months of age. None of the infants except one (5.3%) in the control group became an HBsAg carrier at 14 months of age. These results indicate that the HBV vaccine alone or in conjunction with HBIG at birth provides good protection for infants born to HBeAg-negative, HBsAg carrier mothers and protects against postnatal HBV infection.