ALTEX :: Alternatives to Animal Experiments

1998, Supplement

Detection of Extraneous Virus in Live Vaccines

Beate Kraemer, Petra Ruebmann, Karin Duchow, and Klaus Cussler

Paul-Ehrlich-Institut, D-Langen

SUMMARY

In the study of in vitro alternatives to a nonvalidated and harmful animal test for the absence of extraneous virus in live vaccines were investigated. For evaluation of a suitable in vitro method, the porcine herpes virus (Aujeszkyvirus, Pseudorabiesvirus) was used as a model virus. In artificially contaminated live vaccines, the aujeszkyvirus could be detected by molecular, genetical and cellular methods. Regarding the threshold values of virus detection, in vitro tests showed to be more efficacious than animal testing.

Meanwhile the European Pharmacopoeia Commission deleted the animal test for extraneous virus from two monographs. The discussion, if respective animal testing can be cancelled for the other live vaccines as well, is still ongoing. The study was supported by the German Ministry of Education, Science, Research, and Technology.

Keywords: Aujeszkyvirus, veterinary vaccines, live vaccines, extraneous virus, virus contamination, in vitro testing