A controlled clinical trial of the efficacy of the hepatitis B vaccine (heptavax B): A final report

Authors

  • Wolf Szmuness M.D.,

    Corresponding author
    1. The Lindsley F. Kimball Research Institute of the New York Blood Center
    2. The Division of Epidemiology, Columbia University School of Public Health, New York, New York 10021
    • The Lindsley F. Kimball Institute, The New York Blood Center, 310 K. 67th Street, New York, New York 10021
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  • Cladd E. Stevens,

    1. The Lindsley F. Kimball Research Institute of the New York Blood Center
    2. The Division of Epidemiology, Columbia University School of Public Health, New York, New York 10021
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  • Edith A. Zang,

    1. The Lindsley F. Kimball Research Institute of the New York Blood Center
    2. The Division of Epidemiology, Columbia University School of Public Health, New York, New York 10021
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  • Edward J. Harley,

    1. The Lindsley F. Kimball Research Institute of the New York Blood Center
    2. The Division of Epidemiology, Columbia University School of Public Health, New York, New York 10021
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  • Aaron Kellner

    1. The Lindsley F. Kimball Research Institute of the New York Blood Center
    2. The Division of Epidemiology, Columbia University School of Public Health, New York, New York 10021
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Abstract

A controlled, randomized, double-blind trial in 1,083 homosexual men from New York confirmed that a highly purified, formalin-inactivated vaccine against hepatitis B prepared from HBsAg positive plasma, is safe immunogenic, and highly efficacious. Over 95% of vaccinated subjects developed antibody against the surface antigen. Vaccine-induced antibody persisted for the entire 24-month follow-up period. The attack rate of all hepatitis B virus infections (excluding conversions of anti-HBc alone) was 3.2% in vaccine recipients compared with 25.6% in placebo recipients (p < 0.0001). In those who received all three doses of vaccine, of 40 μg each, the protective efficacy rate was close to 100%. The vaccine protects against acute hepatitis B, asymptomatic infection, and chronic antigenemia. There is reason to assume that the vaccine is also partially effective when given postexposure.

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