A six-year survey of immunogenicity and efficacy of hepatitis B vaccine in infants born to HBsAg carriers.

ABSTRACT

Although the efficacy of hepatitis B vaccine is well documented, the duration of immunity of healthy infants after vaccination is unknown. 99 infants born to hepatitis B surface antigen (HBsAg)-carrier mothers were studied and found to have positive anti-HBs (titer greater than or equal to 10 mIU/mL) after a first injection of vaccine at the ages of 1 to 6 years. The infants were randomly divided into four groups of recipients treated with the vaccine of the National Institute of Allergy and Infectious Diseases (NIAID), U.S.A. or that of the Beijing Biological Products Research Institute (BBPRI), BBPRI vaccine in combination with hepatitis B immune globulin (HBIG) and placebo. The results showed that the protective efficacy dropped considerably after 5 years with NIAID vaccine, after 3 years with BBPRI vaccine and after 4 years with BBPRI vaccine plus HBIG. This suggests that a booster injection is needed 5 years after the first injection of NIAID vaccine, 3 years after BBPRI vaccine, and 4 years after BBPRI vaccine plus HBIG.