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.

RCT Entities:   Population Interventions Outcomes