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Immunogenicity and safety of BERNA-YF compared with two other 17D yellow fever vaccines in a phase 3 clinical trial.
Am J Trop Med Hyg. 2005 Mar; 72(3):339-46.AJ

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+Show Affiliations

Pfister M
Berna Biotech Ltd., Berne, Switzerland. markus.pfister@bernabiotech.com
Kürsteiner O
No affiliation info available
Hilfiker H
No affiliation info available
Favre D
No affiliation info available
Durrer P
No affiliation info available
Ennaji A
No affiliation info available
L'Age-Stehr J
No affiliation info available
Kaufhold A
No affiliation info available
Herzog C
No affiliation info available

MeSH

AdultAntibodies, ViralFemaleHumansMaleMiddle AgedNeutralization TestsPatient SelectionSafetySex CharacteristicsYellow FeverYellow Fever Vaccine

Pub Type(s)

Clinical Trial
Clinical Trial, Phase III
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

15772332

Citation

Pfister, Markus, et al. "Immunogenicity and Safety of BERNA-YF Compared With Two Other 17D Yellow Fever Vaccines in a Phase 3 Clinical Trial." The American Journal of Tropical Medicine and Hygiene, vol. 72, no. 3, 2005, pp. 339-46.
Pfister M, Kürsteiner O, Hilfiker H, et al. Immunogenicity and safety of BERNA-YF compared with two other 17D yellow fever vaccines in a phase 3 clinical trial. Am J Trop Med Hyg. 2005;72(3):339-46.
Pfister, M., Kürsteiner, O., Hilfiker, H., Favre, D., Durrer, P., Ennaji, A., L'Age-Stehr, J., Kaufhold, A., & Herzog, C. (2005). Immunogenicity and safety of BERNA-YF compared with two other 17D yellow fever vaccines in a phase 3 clinical trial. The American Journal of Tropical Medicine and Hygiene, 72(3), 339-46.
Pfister M, et al. Immunogenicity and Safety of BERNA-YF Compared With Two Other 17D Yellow Fever Vaccines in a Phase 3 Clinical Trial. Am J Trop Med Hyg. 2005;72(3):339-46. PubMed PMID: 15772332.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety of BERNA-YF compared with two other 17D yellow fever vaccines in a phase 3 clinical trial. AU - Pfister,Markus, AU - Kürsteiner,Oliver, AU - Hilfiker,Helene, AU - Favre,Didier, AU - Durrer,Peter, AU - Ennaji,Abdallah, AU - L'Age-Stehr,Johanna, AU - Kaufhold,Achim, AU - Herzog,Christian, PY - 2005/3/18/pubmed PY - 2005/5/13/medline PY - 2005/3/18/entrez SP - 339 EP - 46 JF - The American journal of tropical medicine and hygiene JO - Am J Trop Med Hyg VL - 72 IS - 3 N2 - 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. SN - 0002-9637 UR - https://www.unboundmedicine.com/medline/citation/15772332/Immunogenicity_and_safety_of_BERNA_YF_compared_with_two_other_17D_yellow_fever_vaccines_in_a_phase_3_clinical_trial_ L2 - https://www.diseaseinfosearch.org/result/7583 DB - PRIME DP - Unbound Medicine ER -
Grapherence [↓16]

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