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PEDIATRICS Vol. 103 No. 6 June 1999, pp. 1243-1247

Hepatitis B Vaccine Administered to Children and Adolescents at Yearly Intervals

Received Dec 3, 1997; accepted Dec 10, 1998.

Neal A. Halsey*, Lawrence H. Moulton*, J. Crossan O'DonovanDagger , J. Ronald Walcher§, Mary Lou Thoms*, Harold S. Margolis, and David S. Krauseparallel

From the * Department of International Health, Johns Hopkins University School of Hygiene and Public Health, Baltimore, Maryland; Dagger  Drs. O'Donovan, Ahluwalia and Fertsch, Baltimore, Maryland; § Private Practice, Towson, Maryland;  Hepatitis Branch, Division of Viral and Rickettsial Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; and parallel  SmithKline Beecham Pharmaceuticals, Collegeville, Pennsylvania.

Objective.  Hepatitis B vaccines are usually administered on a schedule of 0, 1 to 2, and 6 months. Longer intervals between the second and third doses have been studied, but the effectiveness of hepatitis B vaccine administered at intervals of >2 months between the first and second doses have not been studied. Our objective was to compare the antibody response in recipients of Engerix-B hepatitis B vaccine administered at 12-month intervals to the response to vaccine administered at 0-, 1-, and 6-month intervals.

Methods.  A total of 389 children, 5 through 16 years of age, were randomized to receive Engerix-B (10 mg) at a schedule of either 0-, 1-, and 6-month intervals or 0-, 12-, and 24-month intervals. Blood was drawn before and 1 month after the third dose.

Results.  Immediately before the third dose of vaccine, 92.3% of children who received vaccine on the 0-, 1-, and 6-month schedule and 88.8% of children who received the 0-, 12-, and 24-month schedule had antibody to hepatitis B surface (anti-HBs) antigen concentrations >= 10 mIU/mL. Of the children in the 0-, 1-, and 6-month schedule, 95% received the third dose according to protocol versus 90% of those in the 0-, 12-, 24-month schedule. The geometric mean anti-HBs concentration just before the third dose for recipients of the 0-, 1-, and 6-month schedule (117.9 mIU/mL) was somewhat lower than that for the children who had received vaccine on the 0-, 12-, and 24-month schedule (162.1 mIU/mL). One month after the third dose, >98% of all children had anti-HBs concentrations >= 10 mIU/mL and high geometric mean antibody concentrations were observed in both groups: 5687 mIU/mL for children on the 0-, 1-, and 6-month schedule and 3159 mIU/mL for children on the 0-, 12-, and 24-month schedule. Body mass index was correlated inversely with final antibody concentration, but age was not a factor after adjustment for body mass index.

Discussion.  Engerix-B administered on a 0-, 12-, and 24-month schedule is highly immunogenic. Providers should consider this alternate immunization schedule for children who are at low risk of immediate exposure to hepatitis B infections.vaccine, hepatitis B, hepatitis B vaccine, antigen, dose, schedule, immunization, adolescent. .


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