Immunogenicity of a recombinant hepatitis B vaccine in adults

Objectives: To evaluate the immunogenicity and reactogencity 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 year) at 58 hospitals. Overall, 880 subjects were administered a 20-[mu]g 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], [greater than or equal to] 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 (P110%) (P8 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.