Immunogenicity and safety of BERNA-YF compared with two other 17D yellow fever vaccines in a phase 3 clinical trial.
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.
Pfister
Markus
M
Berna Biotech Ltd., Berne, Switzerland. markus.pfister@bernabiotech.com
Kürsteiner
Oliver
O
Hilfiker
Helene
H
Favre
Didier
D
Durrer
Peter
P
Ennaji
Abdallah
A
L'Age-Stehr
Johanna
J
Kaufhold
Achim
A
Herzog
Christian
C
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
D000914:Antibodies, Viral; D022341:Yellow Fever Vaccine