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

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          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.

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          Most cited references28

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          Development of a fluorescent antibody virus neutralisation test (FAVN test) for the quantitation of rabies-neutralising antibody.

          A microtest named the FAVN test (fluorescent antibody virus neutralisation test), which is an adaptation of the original rapid fluorescent focus inhibition test (RFFIT) has been developed and evaluated. One hundred percent specificity was estimated using 414 sera from dogs sampled in rabies-free areas or from non-vaccinated animals. The accuracy as determined by the agreement between observed and expected values using sera of known titres was satisfactory. Serum samples from unvaccinated and vaccinated dogs (using sera with titres near 0.5 IU/ml) were assayed for rabies antibody by the FAVN test, the RFFIT and the mouse neutralisation test (MNT): comparative results obtained on the same sera with the three tests showed good agreement. Furthermore, distinguishing negative sera from positive sera with low titres is much easier with the FAVN test than with the RFFIT.
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            Infectious rabies viruses from cloned cDNA.

            The generation of infectious rabies virus (RV), a non-segmented negative-stranded RNA virus of the Rhabdoviridae family, entirely from cloned cDNA is described. Simultaneous intracellular expression of genetically marked full-length RV antigenome-like T7 RNA polymerase transcripts and RV N, P and L proteins from transfected plasmids resulted in formation of transcriptionally active nucleocapsids and subsequent assembly and budding of infectious rabies virions. In addition to authentic RV, two novel infectious RVs characterized by predicted transcription patterns were recovered from modified cDNA. Deletion of the entire non-translated pseudogene region, which is conserved in all naturally occurring RVs, did not impair propagation of the resulting virus in cell culture. This indicates that non-essential genetic material might be present in the genomes of non-segmented RNA viruses. The introduction of a functional extra cistron border into the genome of another virus resulted in the transcription of an additional polyadenylated mRNA containing pseudogene sequences. The possibility of manipulating the RV genome by recombinant DNA techniques using the described procedure--potentially applicable also for other negative-stranded viruses--greatly facilitates the investigation of RV genetics, virus-host interactions and rabies pathogenesis and provides a tool for the design of new generations of live vaccines.
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              A rapid reproducible test for determining rabies neutralizing antibody.

              Rabies neutralizing antibody levels in human and animal sera were tested by a rapid fluorescent focus inhibition technique, in which BHK-21 cells were infected with tissue-culture-adapted rabiesvirus. The results, obtained in 24 hours, were comparable with those of the standard mouse neutralization test.
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                Author and article information

                Contributors
                Journal
                Front Vet Sci
                Front Vet Sci
                Front. Vet. Sci.
                Frontiers in Veterinary Science
                Frontiers Media S.A.
                2297-1769
                18 May 2018
                2018
                : 5
                : 91
                Affiliations
                [1] 1IDT Biologika GmbH , Dessau-Rosslau, Germany
                [2] 2Institute of Molecular Virology and Cell Biology, Friedrich-Loeffler-Institute , Greifswald, Germany
                Author notes

                Edited by: Zhenhai Chen, Yangzhou University, China

                Reviewed by: Kuldeep Dhama, Indian Veterinary Research Institute (IVRI), India; Konstantia E. Tasioudi, Hellenic Ministry of Rural Development and Food, Greece

                Data Availability Statement: The datasets for this manuscript are not publicly available as being confidential proprietary information of IDT Biologika GmbH. However, reasonable requests to access the datasets can be directed to the corresponding author (ad.vos@idt-biologika.de).

                Specialty section: This article was submitted to Veterinary Infectious Diseases, a section of the journal Frontiers in Veterinary Science

                Article
                369056
                10.3389/fvets.2018.00091
                5968751
                29868616
                d86e0853-d9d1-47c4-8a17-bb02a7f7368f
                Copyright © 2018 Ortmann, Kretzschmar, Kaiser, Lindner, Freuling, Kaiser, Schuster, Mueller and Vos

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 28 February 2018
                : 13 April 2018
                Page count
                Figures: 0, Tables: 3, Equations: 0, References: 32, Pages: 8, Words: 5806
                Categories
                Veterinary Science
                Original Research

                rabies,spbn gasgas,red fox,raccoon dog,oral vaccination
                rabies, spbn gasgas, red fox, raccoon dog, oral vaccination

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