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Efficacy With Hepatitis B Immune Globulin in Prevention of Perinatal Hepatitis B Virus Transmission

Cladd E. Stevens, MD; Patricia E. Taylor, PhD; Myron J. Tong, MD; Pearl T. Toy, MD; Girish N. Vyas, PhD; Prem V. Nair, MD; Joy Y. Weissman, MD; Saul Krugman, MD

JAMA. 1987;257(19):2612-2616.

Abstract
A yeast-recombinant hepatitis B vaccine was licensed recently by the Food and Drug Administration and is now available. To assess the efficacy of the yeast-recombinant vaccine, we administered the vaccine in combination with hepatitis B immune globulin to high-risk newborns. If infants whose mothers were positive for both hepatitis B surface antigen and the e antigen receive no immunoprophylaxis, 70% to 90% become infected with the virus, and almost all become chronic carriers. Among infants in this study who received hepatitis B immune globulin at birth and three 5-µg doses of yeast-recombinant hepatitis B vaccine, only 4.8% became chronic carriers, a better than 90% level of protection and a rate that is comparable with that seen with immune globulin and plasmaderived hepatitis B vaccine. These data suggest that, in this high-risk setting, the yeast-recombinant vaccine is as effective as the plasma-derived vaccine in preventing hepatitis B virus infection and the chronic carrier state.

(JAMA 1987;257:2612-2616)

Author Affiliations
From the Wolf Szmuness Laboratory of Epidemiology, Lindsley F. Kimball Research Institute of The New York Blood Center (Drs Stevens and Taylor), and the Department of Pediatrics, New York University College of Medicine (Dr Krugman), New York; the Department of Laboratory Medicine, University of California at San Francisco (Drs Toy and Vyas); and the Liver Center, Huntington Memorial Hospital, Pasadena, Calif (Drs Tong, Nair, and Weissman).

Footnotes
Reprint requests to The New York Blood Center, 310 E 67th St, New York, NY 10021 (Dr Stevens).

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