IMMUNOGENICITY AND SAFETY OF BERNA-YF COMPARED WITH TWO OTHER 17D YELLOW FEVER VACCINES IN A PHASE 3 CLINICAL TRIAL
| العنوان: | IMMUNOGENICITY AND SAFETY OF BERNA-YF COMPARED WITH TWO OTHER 17D YELLOW FEVER VACCINES IN A PHASE 3 CLINICAL TRIAL |
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| المؤلفون: | Achim Kaufhold, Oliver Kürsteiner, Helene Hilfiker, Christian Herzog, Didier Favre, Johanna L’Age-Stehr, Abdallah Ennaji, Markus F. Pfister, Peter Durrer |
| المصدر: | The American Journal of Tropical Medicine and Hygiene. 72:339-346 |
| بيانات النشر: | American Society of Tropical Medicine and Hygiene, 2005. |
| سنة النشر: | 2005 |
| مصطلحات موضوعية: | Adult, Male, Yellow fever vaccine, Antibodies, Viral, Neutralization Tests, Virology, Yellow Fever, Humans, Medicine, Neutralizing antibody, Sex Characteristics, biology, business.industry, Patient Selection, Immunogenicity, Yellow Fever Vaccine, Yellow fever, Antibody titer, Middle Aged, medicine.disease, Vaccination, Titer, Infectious Diseases, Immunology, biology.protein, Female, Parasitology, Safety, Antibody, business, medicine.drug |
| الوصف: | BERNA-YF (Flavimun) is a live, attenuated yellow fever (YF) vaccine of the 17D strain produced by Berna Biotech Ltd. following a transfer of technology from the Robert Koch Institute (RKI) in Berlin, Germany. In this phase 3 bridging study, the immunogenicity and safety of BERNA-YF were compared with the original RKI YF vaccine (RKI-YF) and to a current, commercially available YF vaccine, Stamaril (AP-YF; Aventis Pasteur, Lyon, France), in 304 healthy, adult volunteers. All three vaccines elicited an effective immune response with seroprotection achieved in 100% of individuals in each vaccine group at a neutralizing antibody titer > or = 1:10. BERNA-YF was shown to be comparable to the other two vaccine products, and subgroup analysis showed no differences in immune response between three consecutive production batches. The immune response to BERNA-YF and RKI-YF was very similar, with no significant difference in antibody titer between the two groups (P = 0.4634). However, AP-YF vaccination resulted in a significantly lower antibody titer (P < 0.0001 versus BERNA-YF). Males exhibited a higher antibody response than females to both BERNA-YF and RKI-YF, but not to AP-YF. All three vaccines were well tolerated and no serious adverse events were reported. |
| تدمد: | 1476-1645 0002-9637 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9ed0f0ff5c0b30aee6080163993c123fTest https://doi.org/10.4269/ajtmh.2005.72.339Test |
| رقم الانضمام: | edsair.doi.dedup.....9ed0f0ff5c0b30aee6080163993c123f |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14761645 00029637 |
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