Hepatitis B immune globulin: Final report of a controlled, multicenter trial of efficacy in prevention of dialysis-associated hepatitis

Alfred M. Prince, Wolf Szmuness, Margaret K. Mann, Girish N. Vyas, George F. Grady, Fred L. Shapiro, Wadi N. Suki, Eli A. Freidman, Morell M. Avram, Kurt H. Stenzel

Research output: Contribution to journalArticle

38 Scopus citations

Abstract

In a randomized, double-blind multicenter trial, 284 patients and 282 staff members of renal dialysis units who lacked detectable hepatitis B surface antigen (HBsAg) and antibody to HBsAg (anti-HBs) were randomly assigned to receive two 3 ml injections of immune serum globulin with high, intermediate, or low titers of anti-HBs four months apart. The incidence of infection with hepatitis B and of development of HBsAg was significantly lower in both patients and staff who received the high-titer material than in subjects who received the low-titer preparation eight but not 12 months after randomization (P<0.01 for patients and P<0.04 for staff, low-titer vs. high-titer at eight months). The high-titer hepatitis B immune globulin preparation did not appear to affect the severity of the cases of hepatitis that did occur, the proportion of subjects who developed persistent antigenemia, or the magnitude or timing of primary anti-HBs responses.

Original languageEnglish (US)
Pages (from-to)131-144
Number of pages14
JournalJournal of Infectious Diseases
Volume137
Issue number2
DOIs
StatePublished - Jan 1 1978

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

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