title: Immunogenicity and safety of BERNA-YF compared with two other 17D yellow fever vaccines in a phase 3 clinical trial.
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 > 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.
authors.affiliation: Berna Biotech Ltd., Berne, Switzerland. markus.pfister@bernabiotech.com
authors.forename: Markus
authors.initials: M
authors.lastname: Pfister
authors.forename: Oliver
authors.initials: O
authors.lastname: Kürsteiner
authors.forename: Helene
authors.initials: H
authors.lastname: Hilfiker
authors.forename: Didier
authors.initials: D
authors.lastname: Favre
authors.forename: Peter
authors.initials: P
authors.lastname: Durrer
authors.forename: Abdallah
authors.initials: A
authors.lastname: Ennaji
authors.forename: Johanna
authors.initials: J
authors.lastname: L'Age-Stehr
authors.forename: Achim
authors.initials: A
authors.lastname: Kaufhold
authors.forename: Christian
authors.initials: C
authors.lastname: Herzog
mesh_terms: D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009500:Neutralization Tests; D018579:Patient Selection; D012449:Safety; D012727:Sex Characteristics; D015004:Yellow Fever / Q000276:immunology*; D022341:Yellow Fever Vaccine
chemical_list: D000914:Antibodies, Viral; D022341:Yellow Fever Vaccine