European Pharmacopoeia foot-and-mouth disease vaccine potency testing in cattle: between test variability and its consequences

N Goris; P Merkelbach-Peters; V I Diev; D Verloo; V M Zakharov; H-P Kraft; K De Clercq

doi:10.1016/j.vaccine.2006.12.049

European Pharmacopoeia foot-and-mouth disease vaccine potency testing in cattle: between test variability and its consequences

Vaccine. 2007 Apr 30;25(17):3373-9. doi: 10.1016/j.vaccine.2006.12.049. Epub 2007 Jan 16.

Authors

N Goris¹, P Merkelbach-Peters, V I Diev, D Verloo, V M Zakharov, H-P Kraft, K De Clercq

Affiliation

¹ Veterinary and Agrochemical Research Centre, Virology Department, Section of Epizootic Diseases, Groeselenberg 99, 1180 Brussels, Belgium. negor@var.fgov.be

PMID: 17227691
DOI: 10.1016/j.vaccine.2006.12.049

Abstract

In the event of a foot-and-mouth (FMD) outbreak in a densely populated livestock area within the European Community, emergency vaccination will most likely be employed. The objective of the present study was to support the European FMD control policy by evaluating the between test variability of the European accepted method for assessing the potency, a major determinant in vaccine choice, of an FMD vaccine batch. The test system suffers from low in vivo repeatability and reproducibility (67.6 and 58.8%, respectively). Consequently, the results of 10 identical, individual vaccine potency tests using an FMD virus O1 Manisa vaccine batch indicate that the obtained potency of a vaccine with an overall 50% protective dose (PD(50)) value of 9.99 may vary from 4.59 to 24.25 PD(50).

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Animals
Cattle
Dose-Response Relationship, Immunologic
Europe
Foot-and-Mouth Disease Virus / immunology*
Male
Pharmacopoeias as Topic*
Reproducibility of Results
Viral Vaccines / immunology*

Substances

Viral Vaccines