Prevention of hepatitis B virus infection in children born to HBsAg positive/HBeAg positive mothers. Preliminary results of active and passive-active immunization.

In Taiwan the Hepatitis B virus (HBV) carrier rate is 15% to 20%. Mother infant transmission plays the most important role in the endemy resulting in 20% of the children being HBsAg carrier at 4 years of age. A large proportion of HBV carriers will develop a chronic hepatitis leading to cirrhosis and ultimately to primary hepatocellular carcinoma. Children born to HBsAg +/HBeAg + mothers (7% of neonates) have an estimated risk of 90% to become HBsAg chronic carriers. A plan for control of Hepatitis B in Taiwan will aim to solve the problem of these children, as a priority. A Hepatitis B vaccine trial has been undertaken in Taiwan since October 1981 in a selected population of children born to HBsAg +/HBeAg + mothers. The purpose of the study was to determine the efficacy of Hepatitis B vaccine alone or in combination with Hepatitis B immunoglobulin in preventing maternal infant transmission of HBV infection. A three way prophylactic regimen comparison was carried out. Subjects consisted of children born to HBsAg +/HBeAg + mothers. Only mature and apparently healthy neonates were included with the parents' formal consent based on real knowledge and understanding. Babies were randomly included in four different groups of study.