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Am. J. Trop. Med. Hyg., 72(3), 2005, pp. 339-346
Copyright © 2005 by The American Society of Tropical Medicine and Hygiene

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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 PFISTER, OLIVER KÜRSTEINER, HELENE HILFIKER, DIDIER FAVRE, PETER DURRER, ABDALLAH ENNAJI, JOHANNA L’AGE-STEHR, ACHIM KAUFHOLD, AND CHRISTIAN HERZOG
Berna Biotech Ltd., Berne, Switzerland; Hesperion, Allschwil, Switzerland; Robert Koch Institute, Berlin, Germany

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.

Received April 15, 2004. Accepted for publication October 20, 2004.

Acknowledgments: We thank J. Signer, D. Buchs, and E. Kehrli-Gygax for their excellent technical assistance and R. Ibanéz for his valuable help in conducting this study.

Disclosure: The authors wish to disclose that Markus Pfister, Oliver Kursteiner, Helene Hilfiker, Didier Favre, Peter Durrer, Achim Kaufhold, and Christian Herzog are employees of Berna Biotech Ltd., the company that proposes to market Flavimun®. This statement is made in the interest of full disclosure and not because the authors consider this to be a conflict of interest.

Authors’ addresses; Markus Pfister, Oliver Kürsteiner, Helene Hilfiker, Didier Favre, Peter Durrer, Achim Kaufhold, and Christian Herzog, Berna Biotech Ltd., Rehagstrasse 79, CH-3018 Berne, Switzerland, Telephone: 41-31-980-6111, Fax: 41-31-980-6775, E-mails: markus.pfister{at}bernabiotech.com, liver.kuersteiner{at}bernabiotech.com, helene.hilfiker{at}bernabiotech.com, didier.favre{at}bernabiotech.com, peter.durrer{at}bernabiotech.com, achim.kaufhold{at}bernabiotech.com, and christian.herzog{at}bernabiotech.com. Abdallah Ennaji, Hesperion, Gewerbestrasse 16, CH-4123 Allschwil, Switzerland, Telephone: 41-61-487-1648, Fax: 41-61-487-1401, E-mail: abdallah. ennaji{at}hesperion.com. Johanna l’Age-Stehr, Robert Koch Institute, Nordufer 20, PO Box 65 02 61, D-13302 Berlin, Germany, Telephone: 499 (0)1888 754 0, Fax: 49-188-754-2328, E-mail: LageStehr{at}aol.com.

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




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Copyright © 2005 by the American Society of Tropical Medicine and Hygiene.