HBIG prophylaxis for perinatal HBV infections--final report of the Taiwan trial

A randomized double blind placebo controlled efficacy trial of hepatitis B immunoglobulin (HBIG) for prevention of the mother to infant transmitted HBsAg carrier state was conducted in Taiwan where the carrier rate in the general population is 15% to 20%. HBIG was given immediately after birth to infants of e antigen positive HBsAg carrier mothers and all infants were followed for at least 15 months. Among 61 placebo recipients the carrier rate was 92%; compared with 26% among 57 infants who received 0.5 ml HBIG at birth, three months and six months and 54% among 67 infants who received a single 1.0 ml dose of HBIG at birth only. Efficacy was 71% and 42% respectively for the two treatment schedules. The most common response of HBIG-treated infants was passive-active immunization which was 27% in single dose group and 61% in three doses group. Some of the infants who became carriers were probably infected as HBIG protection waned and we expect that higher efficacy can be achieved by HB vaccine in conjunction with HBIG.