Efficacy of Hepatitis B Immune Globulin for Prevention of Perinatal Transmission of the Hepatitis B Virus Carrier State: Final Report of a Randomized Double-Blind, Placebo-Controlled Trial

Authors

  • R. Palmer Beasley,

    Corresponding author
    1. University of Washington Medical Research Unit, Institute of Public Health, College of Medicine, National Taiwan University, and Maternity and Child Health Center of the Taiwan Provincial Junior College of Nursing, Taipei, Taiwan, Republic of China; Lindsley F. Kimball Research Institute of the New York Blood Center, New York, New York 10021; and U.S. Naval Medical Research Unit (NAMR U-2), Manila, Philippines
    • R. Palmer Beasley, M.D., University of Washington Medical Research Unit, 15–2 Kyuan Road, Taiwan, Republic of China.
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  • Lu-Yu Hwang,

    1. University of Washington Medical Research Unit, Institute of Public Health, College of Medicine, National Taiwan University, and Maternity and Child Health Center of the Taiwan Provincial Junior College of Nursing, Taipei, Taiwan, Republic of China; Lindsley F. Kimball Research Institute of the New York Blood Center, New York, New York 10021; and U.S. Naval Medical Research Unit (NAMR U-2), Manila, Philippines
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  • Cladd E. Stevens,

    1. University of Washington Medical Research Unit, Institute of Public Health, College of Medicine, National Taiwan University, and Maternity and Child Health Center of the Taiwan Provincial Junior College of Nursing, Taipei, Taiwan, Republic of China; Lindsley F. Kimball Research Institute of the New York Blood Center, New York, New York 10021; and U.S. Naval Medical Research Unit (NAMR U-2), Manila, Philippines
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  • Chia-Chin Lin,

    1. University of Washington Medical Research Unit, Institute of Public Health, College of Medicine, National Taiwan University, and Maternity and Child Health Center of the Taiwan Provincial Junior College of Nursing, Taipei, Taiwan, Republic of China; Lindsley F. Kimball Research Institute of the New York Blood Center, New York, New York 10021; and U.S. Naval Medical Research Unit (NAMR U-2), Manila, Philippines
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  • Fon-Jou Hsieh,

    1. University of Washington Medical Research Unit, Institute of Public Health, College of Medicine, National Taiwan University, and Maternity and Child Health Center of the Taiwan Provincial Junior College of Nursing, Taipei, Taiwan, Republic of China; Lindsley F. Kimball Research Institute of the New York Blood Center, New York, New York 10021; and U.S. Naval Medical Research Unit (NAMR U-2), Manila, Philippines
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  • Kwei-Yu Wang,

    1. University of Washington Medical Research Unit, Institute of Public Health, College of Medicine, National Taiwan University, and Maternity and Child Health Center of the Taiwan Provincial Junior College of Nursing, Taipei, Taiwan, Republic of China; Lindsley F. Kimball Research Institute of the New York Blood Center, New York, New York 10021; and U.S. Naval Medical Research Unit (NAMR U-2), Manila, Philippines
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  • Tsu-Shen Sun,

    1. University of Washington Medical Research Unit, Institute of Public Health, College of Medicine, National Taiwan University, and Maternity and Child Health Center of the Taiwan Provincial Junior College of Nursing, Taipei, Taiwan, Republic of China; Lindsley F. Kimball Research Institute of the New York Blood Center, New York, New York 10021; and U.S. Naval Medical Research Unit (NAMR U-2), Manila, Philippines
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  • Wolf Szmuness

    1. University of Washington Medical Research Unit, Institute of Public Health, College of Medicine, National Taiwan University, and Maternity and Child Health Center of the Taiwan Provincial Junior College of Nursing, Taipei, Taiwan, Republic of China; Lindsley F. Kimball Research Institute of the New York Blood Center, New York, New York 10021; and U.S. Naval Medical Research Unit (NAMR U-2), Manila, Philippines
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    • Deceased


Abstract

A randomized double-blind, placebo-controlled efficacy trial of hepatitis B immune globulin (HBIG) for prevention of the mother-to-infant transmitted HBsAg carrier state was conducted in Taiwan where the carrier rate in the general population is 15 to 20%. HBIG was given immediately after birth to infants of e antigen positive HBsAg carrier mothers, and all infants were followed for at least 15 months. Among 61 placebo recipients, the carrier rate was 92%; compared with 26% among 57 infants who received 0.5 ml HBIG at birth, 3 months, and 6 months, and 54% among 67 infants who received a single 1.0 ml dose of HBIG at birth only. Efficacy was 71 and 42%, respectively, for the two treatment schedules. The most common response of HBIG-treated infants was passive-active immunization which was 27% in the single-dose group and 61% in the three-dose group. Some of the infants who became carriers were probably infected as HBIG protection waned, and we expect that higher efficacy can be achieved by hepatitis B vaccine in conjunction with HBIG.

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