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June 1990

A Randomized Double-blind Clinical Trial of a Mammalian Cell-Derived Recombinant DNA Hepatitis B Vaccine Compared With a Plasma-Derived Vaccine

Author Affiliations

From the Canadian Liver Foundation Epidemiology Unit, Department of Preventive Medicine and Biostatistics, Faculty of Medicine, University of Toronto (Canada) (Drs Halliday, Rankin, Coates, and Corey and Ms Bristow), and the Department of Occupational Health, Toronto (Canada) General Hospital (Dr Strickler).

Arch Intern Med. 1990;150(6):1195-1200. doi:10.1001/archinte.1990.00390180039006

• Eight hundred volunteers from health care and emergency fields participated in a randomized double-blind clinical trial of a new experimental mammalian cell—derived recombinant DNA hepatitis B vaccine (Betagen) compared with a licensed plasmaderived vaccine (Heptavax-B). Vaccine injections (20 μg) were administered intramuscularly at 0, 1, and 6 months, and sera were tested at 0,1, 2, 3,6, 7, and 12 months for hepatitis B surface antigen, antibody to hepatitis B surface antigen, and antibody to hepatitis B core antigen. Data from 745 vaccinees (93.1%), analyzed at the 7th month of follow-up, showed no significant difference in the seroconversion rates for Betagen (94.4%) vs Heptavax-B (97.3%), but the geometric mean titer of antibody was significantly higher for Heptavax-B (11 833 mlU/L) than for Betagen (4628 mlU/mL). The antibody response of Betagen was significantly and independently related to age and sex, while that of Heptavax-B was related to age only. Reported side effects from both vaccines were minor and mild, with approximately one fourth of all vaccinees reporting at least one side effect. Vaccinees, who had a protective level of antibody at the 7th month, were tested for antibodies at the 12th month. Of those in the Betagenvaccinated group and those in the Heptavax-B-vaccinated group, 99.0% and 100%, respectively, were still protected. There was a proportionately larger decline in the geometric mean titers of antibody to hepatitis B surface antigen for Heptavax-B than for Betagen.

(Arch Intern Med. 1990;150:1195-1200)

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