[PDF][PDF] Immunogenicity and safety of BERNA-YF compared with two other 17D yellow fever vaccines in a phase 3 clinical trial

M Pfister, O Kursteiner, H Hilfiker, D Favre… - American Journal of …, 2005 - researchgate.net
M Pfister, O Kursteiner, H Hilfiker, D Favre, P Durrer, A Ennaji, J L'Age-Stehr, A Kaufhold…
American Journal of Tropical Medicine and Hygiene, 2005researchgate.net
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 …
Abstract
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 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.
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