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

被引:41
作者
Goris, N.
Merkelbach-Peters, P.
Diev, V. I.
Verloo, D.
Zakharov, V. M.
Kraft, H.-P.
De Clercq, K.
机构
[1] Veterinary and Agrochemical Research Centre, Virology Department, Section of Epizootic Diseases, 1180 Brussels
[2] Bayer HealthCare, Animal Health, 50739 Köln
[3] Federal Governmental Institution Federal Centre for Animal Health, Biological and Technical Control Department, Vladimir
[4] European Food Safety Authority, 43100 Parma
关键词
foot-and-mouth disease; vaccine potency; variability;
D O I
10.1016/j.vaccine.2006.12.049
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
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 01 Manisa vaccine batch indicate that the obtained potency of a vaccine with an overall 50% protective dose (PD50) value of 9.99 may vary from 4.59 to 24.25 PD50. (c) 2007 Elsevier Ltd. All rights reserved.
引用
收藏
页码:3373 / 3379
页数:7
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