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

2005; American Society of Tropical Medicine and Hygiene; Volume: 72; Issue: 3 Linguagem: Inglês

10.4269/ajtmh.2005.72.339

1476-1645

Markus Pfister, Oliver Kürsteiner, HELENE HILFIKER, Didier Favre, Peter Durrer, ABDALLAH ENNAJI, Johanna L'age‐Stehr, Achim Kaufhold, Christian Herzog,

Viral Infections and Vectors

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.