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You are here: Home / Journal Articles / In Vivo Safety Studies With SPBN GASGAS in the Frame of Oral Vaccination of Foxes and Raccoon Dogs Against Rabies / About

In Vivo Safety Studies With SPBN GASGAS in the Frame of Oral Vaccination of Foxes and Raccoon Dogs Against Rabies

By Steffen Ortmann, Antje Kretzchmar, Christiane Kaiser, Thomas Linder, Conrad Freuling, Christian Kaiser, Peter Schuster, Thomas Mueller, Ad Vos

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Category Journal Articles
Abstract

In order to obtain Marketing Authorization for an oral rabies vaccine in the European Union, not only safety studies in the target species, red fox and raccoon dog, are required. Since baits are distributed unsupervised in the environment, specific safety studies in selected non-target species are compulsory. Furthermore, oral rabies vaccines are based on live, replication-competent viruses and thus distinct safety studies in the target species for such type of vaccines are also mandatory. Here, the results of these safety studies in target and selected non-target species for a 3rd generation oral rabies virus vaccine construct, SPBN GASGAS (Rabitec), are presented. The studies included the following species; red fox, raccoon dog, domestic dog, domestic cat, domestic pig, wild rodents. The following safety topics were investigated; overdose, repeated dose, dissemination, shedding, horizontal and vertical transmission. It was shown that SPBN GASGAS did not cause disease or any other adverse reaction in vaccinated animals and naïve contact animals. The vaccine did not disseminate within the host beyond the site of entry. No horizontal transmission was observed in wild rodents. In the target species, there was evidence that in a few cases horizontal transmission of vaccine virus could have occurred under these experimental conditions; most likely immediately after vaccine administration. The vaccine construct SPBN GASGAS meets therefore the latest revised minimal safety requirements as laid down in the European Pharmacopoeia.

Submitter

Katie Osborn

Publication Title Frontiers in Veterinary Science
ISBN/ISSN 1663-4365
Publisher Frontiers
DOI doi.org/10.3389/fvets.2018.00091
URL https://www.frontiersin.org/articles/10.3389/fvets.2018.00091/full
Cite this work

Researchers should cite this work as follows:

  • Steffen Ortmann; Antje Kretzchmar; Christiane Kaiser; Thomas Linder; Conrad Freuling; Christian Kaiser; Peter Schuster; Thomas Mueller; Ad Vos (2018), "In Vivo Safety Studies With SPBN GASGAS in the Frame of Oral Vaccination of Foxes and Raccoon Dogs Against Rabies," http://habricentral.org/resources/63031.

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Tags
  1. Animal roles
  2. Dogs
  3. Foxes
  4. open access
  5. peer-reviewed
  6. Rabies
  7. vaccination
  8. Wild animals
Badges
  1. open access
  2. peer-reviewed