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October 28, 1996

Immunogenicity of a Recombinant Hepatitis B Vaccine in Adults

Author Affiliations

From the Institute for Medical Microbiology and Hygiene, Universität Regensburg, Regensburg, Germany (Dr Jilg); SmithKline Beecham Pharma, München, Germany (Drs Bock, Clemens, and Sänger and Mr Höbel); and the Department of Medical Virology and Immunology, Universitätsklinikum Essen, Essen, Germany (Dr Kruppenbacher).

Arch Intern Med. 1996;156(19):2226-2231. doi:10.1001/archinte.1996.00440180088011

Objectives:  To evaluate the immunogenicity and reactogenicity of a recombinant hepatitis B vaccine in health care staff under routine use and unselected conditions and to investigate factors that influence the response to vaccination.

Methods:  This prospective postmarketing surveillance study was performed in unselected health care staff and their relatives (age range, 12-60 years) at 58 hospitals. Overall, 880 subjects were administered a 20-μg dose of a vaccine at 0, 1, and 6 months according to the prescribing information and under routine hospital practice, and they were tested for antibody to hepatitis B surface antigen after the third dose at the hospitals' routine laboratory. The principal outcome measures were antibody to hepatitis B surface antigen titers that were expressed as the seroprotection rate (SPR) (SPR [given as a percentage], ≥10 mlU/ mL), spontaneously reported adverse events, and geometric mean titers (in milli—international units per milliliter).

Results:  The compliance to the 3-dose schedule under routine hospital practice was 98.1%. The immune response was good in all age groups, and the overall SPR was 97.8% at 1 month after the third dose in field conditions with unselected health care workers. The SPR in vaccinees (age range, 40-59 years) was close to 95%. Age (P<.001), smoking (≥10 cigarettes per day) (P<.001), Broca index (>110%) (P<.001), antibody to hepatitis B surface antigen testing (>8 weeks after the last dose) (P=.03), chronic underlying disease (P=.04), and male gender (P=.04) were factors associated with lower geometric mean titers in routine vaccine use. No serious adverse events were reported.

Conclusion:  The large immune response that was elicited by this hepatitis B vaccine in adults under daily routine field conditions reflected reality, with a high SPR also found in elderly and other persons with risk factors associated with a lower immune response.Arch Intern Med. 1996;156:2226-2231