Comparative study of the immunogenicity and safety of two dosing schedules of hepatitis B vaccine in neonates.

Healthy Egyptian neonates born to hepatitis B surface antigen (HBsAg)-seronegative mothers were randomly enrolled in one of three vaccination schedules. A dose of 2.5 micrograms of recombinant HB vaccine was given at birth, two, and six months of age (group A) or two, four, and nine months of age (group B). These two groups and a third control group (group C) also were given the other routine childhood vaccines (BCG, DPT, polio, and measles). Blood samples were taken one month after the third vaccine dose in groups A (seven months of age) and B (10 months of age), and a second follow-up blood sample was taken at the age of 18 months for all three groups. Sera were tested for HBsAg and antibody to hepatitis B core antigen, and quantitatively for antibody to hepatitis B surface antigen (anti-HBs) using commercial enzyme immunoassay kits. The vaccine was well tolerated and side effects were limited to local soreness, redness, or temporary swelling. Among 590 infants who were followed-up, good (51-300 mIU anti-HBs/ml) or excellent (> 300 mIU/ml) immune responses occurred in 85% of the infants in group A and in 96% in group B. Geometric mean titers of anti-HBs at the first and second follow-up were 306 and 55 mIU/ml in group A, and 1,492 and 147 mIU/ml in group B. The recombinant HB vaccine is safe and immunogenic when given in three doses of 2.5 micrograms in either regimen, but delay of the booster dose of the vaccine until nine months after birth produced a higher immune response.