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IMMUNOGENICITY AND SAFETY OF BERNA-YF COMPARED WITH TWO OTHER 17D YELLOW FEVER VACCINES IN A PHASE 3 CLINICAL TRIAL

MARKUS PFISTERBerna Biotech Ltd., Berne, Switzerland; Hesperion, Allschwil, Switzerland; Robert Koch Institute, Berlin, Germany

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OLIVER KÜRSTEINERBerna Biotech Ltd., Berne, Switzerland; Hesperion, Allschwil, Switzerland; Robert Koch Institute, Berlin, Germany

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HELENE HILFIKERBerna Biotech Ltd., Berne, Switzerland; Hesperion, Allschwil, Switzerland; Robert Koch Institute, Berlin, Germany

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DIDIER FAVREBerna Biotech Ltd., Berne, Switzerland; Hesperion, Allschwil, Switzerland; Robert Koch Institute, Berlin, Germany

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PETER DURRERBerna Biotech Ltd., Berne, Switzerland; Hesperion, Allschwil, Switzerland; Robert Koch Institute, Berlin, Germany

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ABDALLAH ENNAJIBerna Biotech Ltd., Berne, Switzerland; Hesperion, Allschwil, Switzerland; Robert Koch Institute, Berlin, Germany

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JOHANNA L’AGE-STEHRBerna Biotech Ltd., Berne, Switzerland; Hesperion, Allschwil, Switzerland; Robert Koch Institute, Berlin, Germany

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ACHIM KAUFHOLDBerna Biotech Ltd., Berne, Switzerland; Hesperion, Allschwil, Switzerland; Robert Koch Institute, Berlin, Germany

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CHRISTIAN HERZOGBerna Biotech Ltd., Berne, Switzerland; Hesperion, Allschwil, Switzerland; Robert Koch Institute, Berlin, Germany

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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.

Author Notes

Reprint requests: Christian Herzog, Berna Biotech Ltd., Rehagstrasse 79, CH-3018 Berne, Switzerland.
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