Bock, HL and Kruppenbacher, J and Sanger, R and Hobel, W and Clemens, R and Jilg, W (1996) Immunogenicity of a recombinant hepatitis a vaccine in adults. ARCHIVES OF INTERNAL MEDICINE, 156 (19). pp. 2226-2231. ISSN 0003-9926,
Full text not available from this repository.Abstract
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 relaties (age range, 12-60 years) 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 wer 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 (P<.001), smoking (greater than or equal to 10 cigarettes per day) (P<.001), Broca index (>110%) (P<.001), antibody to hepatitis B surface antigen resting (>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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | CONTROLLED CLINICAL-TRIAL; LONG-TERM IMMUNOGENICITY; B VACCINE; ANTIBODY-RESPONSE; IMMUNE-RESPONSE; EFFICACY; POPULATION; PREDICTOR; |
| Depositing User: | Dr. Gernot Deinzer |
| Last Modified: | 19 Oct 2022 08:34 |
| URI: | https://pred.uni-regensburg.de/id/eprint/51408 |
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