Hepatitis B immunization in high risk neonates born from HBsAg positive mothers: Comparison between plasma derived and recombinant DNA vaccine

Abstract

A half dose recombinant hepatitis B vaccine (HBVax II®, MSD, 5 μg) was investigated for efficacy in the prevention of perinatal hepatitis B virus (HBV) transmission in high risk neonates born from e-antigen positive HBsAg carrier mothers as compared to the half-standard dose regimen of plasma derived hepatitis B vaccine (HBVax,® MSD, 10 μg). Forty infants born to carrier mothers were given hepatitis B immune globulin (HBIG) 100 IU intramuscularly immediately after birth, combined with either the recombinant or plasma derived hepatitis B vaccine. The infants were randomly divided into two groups of 20 infants each. The plasma derived vaccine (10 μg) was given to group I, while infants in group II received the recombinant vaccine (5 μg) at birth, 1 and 6 months of age. There were no statistically significant differences in the efficacy and the seroconversion rate of these two combined prophylaxis regimens. The protective efficacy rate of both kinds of HBV vaccine was found to be 94.6 and 89.2 percent in group I and group II respectively. At twelve months of age, the anti-HBs seroconversion rates were 95.0 percent in group I and 84.2 percent in group II. However, the geometric mean titres in group I (179.55 mIU/ml) was significantly higher than those in group II (42.2 mIU/ml) but the anti-HBs titre was still above protective level (10 mIU/ml) in most of the infants. It is concluded that a half dose (5 μg) of the recombinant hepatitis B vaccine (HBVax II®, MSD) could be used as effectively as the half-standard dose (10 μg) of plasma derived vaccine (HBVax,® MSD) in the prevention of perinatal HBV transmission in high risk neonates born from e-antigen positive HBsAg carrier mothers. A booster dose of HBV vaccine at twelve months of age is recommended to ensure long lasting protection.