Comparison of a recombinant DNA hepatitis B vaccine alone or in combination with hepatitis B immune globulin for the prevention of perinatal acquisition of hepatitis B carriage.

The protective efficacy of a recombinant DNA yeast-derived hepatitis B vaccine was assessed alone or in combination with hepatitis B immune globulin (HBIg) in neonates born to surface antigen (HBsAg)-positive and e antigen (HBeAg)-positive mothers. Neonates received either a 10 micrograms dose of vaccine alone or the same dose of vaccine plus 0.5 ml HBIg within 12 h of birth. All infants subsequently received 10 micrograms of vaccine at 1, 2 and 12 months. Only two of the 58 (3.4%) newborns of HBsAg-positive/HBeAg-positive mothers receiving vaccine alone became chronically infected with hepatitis B virus (HBV) while all infants administered vaccine + HBIg were protected. These results indicate that although the administration of HBIg can increase the protection rate, the use of vaccine without concomitant administration of HBIg according to the above schedule could considerably reduce the risk of perinatal HBV transmission.