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A controlled clinical trial of the efficacy of the hepatitis B vaccine (heptavax B): A final report
Author(s) -
Szmuness Wolf,
Stevens Cladd E.,
Zang Edith A.,
Harley Edward J.,
Kellner Aaron
Publication year - 1981
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.1840010502
Subject(s) - medicine , hbsag , asymptomatic , hepatitis b vaccine , antibody , virology , hepatitis b virus , placebo , clinical trial , vaccination , immunology , randomized controlled trial , hepatitis b , antigen , virus , pathology , alternative medicine
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.