Development and statistical validation of a guinea pig model for vaccine potency testing against Infectious Bovine Rhinothracheitis [IBR] virus

Infectious Bovine Rhinothracheitis [IBR] caused by bovine herpesvirus 1 [BoHV-1] infection is distributed worldwide. BoHV-1 either alone or in association with other respiratory cattle pathogens causes significant economic losses to the livestock industry. The aim of this work was to validate a guin...

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Detalles Bibliográficos
Otros Autores: Parreño, Viviana, López, María Virginia, Rodríguez, Daniela, Vena, María Marta, Izuel, Mercedes, Filippi, Jorge, Romera, Alejandra, Faverín, Claudia, Bellinzoni, Rodolfo, Fernández, Fernando, Marangunich, Laura
Formato: Artículo
Lenguaje:Inglés
Materias:
IBR
Acceso en línea:http://ri.agro.uba.ar/files/intranet/articulo/2010Parreno.pdf
LINK AL EDITOR
Aporte de:Registro referencial: Solicitar el recurso aquí
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245 1 0 |a Development and statistical validation of a guinea pig model for vaccine potency testing against Infectious Bovine Rhinothracheitis [IBR] virus 
520 |a Infectious Bovine Rhinothracheitis [IBR] caused by bovine herpesvirus 1 [BoHV-1] infection is distributed worldwide. BoHV-1 either alone or in association with other respiratory cattle pathogens causes significant economic losses to the livestock industry. The aim of this work was to validate a guinea pig model as an alternative method to the current BoHV-1 vaccine potency testing in calves. Guinea pigs were immunized with two doses of vaccine, 21 days apart and sampled at 30 days post vaccination [dpv]. BoHV-1 antibody [Ab] response to vaccination in guinea pigs, measured by ELISA and virus neutralization [VN], was statistically compared to the Ab response in cattle. The guinea pig model showed a dose-response relationship to the BoVH-1 antigen concentration in the vaccine and it was able to discriminate among vaccines containing 1 log10 difference in its BoHV-1 concentration with very good repeatability and reproducibility [CV less or equal than 20 percent]. A regression analysis of the Ab titers obtained in guinea pigs and bovines at 30 and 60 dpv, respectively, allowed us to classify vaccines in three potency categories: "very satisfactory", "satisfactory" and "unsatisfactory". Bovines immunized with vaccines corresponding to each of these three categories were experimentally challenged with BoVH-1 virus, the level of protection, as measured by reduction of virus shedding and disease severity, correlated well with the vaccine category used. Data generated by 85 experiments, which included vaccination of calves and guinea pigs with 18 reference vaccines of known potency, 8 placebos and 18 commercial vaccines, was subjected to statistical analysis. Concordance analysis indicated almost perfect agreement between the model and the target species for Ab titers measured by ELISA and almost perfect to substantial agreement when Ab titers were measured by VN. Taken together these results indicate that the developed guinea pig model represents a novel and reliable tool to estimate batch-to-batch vaccine potency and to predict efficacy of killed BoHV-1 veterinary vaccines. 
653 0 |a BOHV-1 
653 0 |a CATTLE 
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653 0 |a IBR 
653 0 |a INTER-SPECIES CONCORDANCE ANALYSIS 
653 0 |a LABORATORY ANIMAL MODEL 
653 0 |a LIVESTOCK 
653 0 |a VACCINE POTENCY 
653 0 |a VETERINARY VACCINE 
653 0 |a WEIGHTED KAPPA 
653 0 |a BOVINE HERPES VIRUS VACCINE 
653 0 |a UNCLASSIFIED DRUG 
653 0 |a VIRUS ANTIBODY 
653 0 |a VIRUS ANTIGEN 
653 0 |a VIRUS VACCINE 
653 0 |a ANIMAL EXPERIMENT 
653 0 |a BOVINE HERPES VIRUS 
653 0 |a CALF [BOVINE] 
653 0 |a CONTROLLED STUDY 
653 0 |a DISEASE SEVERITY 
653 0 |a DOSE RESPONSE 
653 0 |a DRUG POTENCY 
653 0 |a EXPERIMENTAL MODEL 
653 0 |a GUINEA PIG 
653 0 |a NONHUMAN 
653 0 |a PRIORITY JOURNAL 
653 0 |a STATISTICAL ANALYSIS 
653 0 |a VACCINATION 
653 0 |a VALIDATION PROCESS 
653 0 |a VIRUS SHEDDING 
653 0 |a ANIMALS 
653 0 |a ANTIBODIES, NEUTRALIZING 
653 0 |a ANTIBODIES, VIRAL 
653 0 |a CATTLE 
653 0 |a DISEASE MODELS, ANIMAL 
653 0 |a DOSE-RESPONSE RELATIONSHIP, IMMUNOLOGIC 
653 0 |a ENZYME-LINKED IMMUNOSORBENT ASSAY 
653 0 |a FEMALE 
653 0 |a GUINEA PIGS 
653 0 |a HERPESVIRUS 1, BOVINE 
653 0 |a INFECTIOUS BOVINE RHINOTRACHEITIS 
653 0 |a MALE 
653 0 |a NEUTRALIZATION TESTS 
653 0 |a REPRODUCIBILITY OF RESULTS 
653 0 |a SEVERITY OF ILLNESS INDEX 
653 0 |a UNITED STATES 
653 0 |a VIRAL VACCINES 
653 0 |a VIRUS SHEDDING 
700 1 |9 47867  |a Parreño, Viviana 
700 1 |9 23824  |a López, María Virginia 
700 1 |9 72307  |a Rodríguez, Daniela 
700 1 |a Vena, María Marta  |9 72308 
700 1 |a Izuel, Mercedes  |9 72309 
700 1 |a Filippi, Jorge  |9 72310 
700 1 |a Romera, Alejandra  |9 72311 
700 1 |a Faverín, Claudia  |9 44545 
700 1 |a Bellinzoni, Rodolfo  |9 72312 
700 1 |a Fernández, Fernando  |9 72313 
700 1 |a Marangunich, Laura  |9 72314 
773 |t Vaccine  |g vol.28, no.13 (2010), p.2539-2549 
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900 |a ^aParreño^bV.^tInstituto de Virología, CICV y A - INTA, Buenos Aires, Argentina 
900 |a ^aLópez^bM.V.^tUniversidad de Buenos Aires, Facultad de Agronomía, Buenos Aires, Argentina 
900 |a ^aRodriguez^bD.^tBiogénesis Bagó S.A., Buenos Aires, Argentina 
900 |a ^aVena^bM.M.^tUniversidad Nacional de Mar del Plata, Buenos Aires, Argentina 
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900 |a GUINEA PIG 
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900 |a Infectious Bovine Rhinothracheitis [IBR] caused by bovine herpesvirus 1 [BoHV-1] infection is distributed worldwide. BoHV-1 either alone or in association with other respiratory cattle pathogens causes significant economic losses to the livestock industry. The aim of this work was to validate a guinea pig model as an alternative method to the current BoHV-1 vaccine potency testing in calves. Guinea pigs were immunized with two doses of vaccine, 21 days apart and sampled at 30 days post vaccination [dpv]. BoHV-1 antibody [Ab] response to vaccination in guinea pigs, measured by ELISA and virus neutralization [VN], was statistically compared to the Ab response in cattle. The guinea pig model showed a dose-response relationship to the BoVH-1 antigen concentration in the vaccine and it was able to discriminate among vaccines containing 1 log10 difference in its BoHV-1 concentration with very good repeatability and reproducibility [CV less or equal than 20 percent]. A regression analysis of the Ab titers obtained in guinea pigs and bovines at 30 and 60 dpv, respectively, allowed us to classify vaccines in three potency categories: "very satisfactory", "satisfactory" and "unsatisfactory". Bovines immunized with vaccines corresponding to each of these three categories were experimentally challenged with BoVH-1 virus, the level of protection, as measured by reduction of virus shedding and disease severity, correlated well with the vaccine category used. Data generated by 85 experiments, which included vaccination of calves and guinea pigs with 18 reference vaccines of known potency, 8 placebos and 18 commercial vaccines, was subjected to statistical analysis. Concordance analysis indicated almost perfect agreement between the model and the target species for Ab titers measured by ELISA and almost perfect to substantial agreement when Ab titers were measured by VN. Taken together these results indicate that the developed guinea pig model represents a novel and reliable tool to estimate batch-to-batch vaccine potency and to predict efficacy of killed BoHV-1 veterinary vaccines. 
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