PEDIATRICS Vol. 76 No. 5 November 1985, pp. 713-718
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Prevention of Perinatal Acquisition of Hepatitis B Virus Carriage Using Vaccine: Preliminary Report of a Randomized, Double-Blind Placebo-Controlled and Comparative Trial

Zhi-Yi Xu MD1, Chung-Bo Liu MD1, Donald P. Francis MD, DSc1, Robert H. Purcell MD1, Zhi-Li Gun PhD1, Shu-Cheng Duan MD1, Ru-Jun Chen MD1, Harold S. Margolis MD1, Chen-Hsiang Huang MD1, James E. Maynard MD, PhD1, and the United States-China Cooperative Study Group on Hepatitis B

1 From the Department of Epidemiology, Pediatric Hospital, and Gynecologic and Obstetric Hospital, Shanghai First Medical College, Shanghai, People's Republic of China; Institute of Virology, National Center of Preventive Medicine, Beijing, and Beijing Institute of Vaccine and Serum, Beijing, People's Republic of China; Hepatitis Branch, Division of Viral Diseases, Centers for Disease Control, Atlanta; and Hepatitis Viruses Section, National Institute of Allergy and Infectious Disease, Bethesda, Maryland

Hepatitis B is a serious disease of global significance. In developing countries, hepatitis B virus (HBV) infection and its sequelae rank among the public health problems of highest priority. Infants born to mothers who are chronic carriers of HBV are at particularly high risk of acquiring infection and becoming chronic HBV carriers. The efficacy of hepatitis B vaccine alone in preventing the transmission of HBV to infants born to HBV carrier mothers was determined in a double-blind placebo-controlled trial. Infants received plasma-derived vaccine at birth, 1 month, and 6 months of age. Of 180 infants born to hepatitis B surface antigen (HBs Ag)-positive mothers, equal numbers received National Institute of Allergy and Infectious Disease (NIAID) vaccine, Beijing Institute of Vaccine and Serum (BIVS) vaccine, and placebo. The cumulative seroconversion to the vaccines at 1 year of age was 95% and 75%, respectively. Vaccine efficacy as measured by the prevention of HBs Ag-positive events was 88% for the NIAID vaccine and 51% for the BIVS vaccine. Vaccine efficacy was similar among infants born to hepatitis Be antigen-positive mothers. Because of the low efficacy of the BIVS vaccine, an additional group of 28 infants was given vaccine and hepatitis B immune globulin at birth. The resulting efficacy was 83%. The results of this trial indicate that hepatitis B vaccine alone can substantially reduce perinatally acquired HBV infection and the resulting chronic carrier state.

Key Words: hepatitis B • vaccine • childhood vaccination • perinatal infection

Submitted on May 31, 1985
Accepted on July 23, 1985




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