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.
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).
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.
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