The safety and immunogenicity of a recombinant hepatitis B vaccine in neonates

A study to evaluate the safety and immunogenicity of a yeast derived recombinant DNA hepatitis B vaccine (Engerix-B) was conducted in healthy newborn infants born to low risk European mothers negative for hepatitis B surface antigen (HBsAg). The vaccination schedule using 20 micrograms doses was administered intramuscularly at 0, 1 and 6 months. The seroconversion rate was 99% (90 of 91 infants). The geometric mean titer of antibody to hepatitis B was 1259 mIU/mL one month after the third dose of vaccine. Possible side effects reported by the mothers were minor and uncommon. This vaccine is highly immunogenic and safe for use in infants.