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

Por: Parreño, V.
Colaborador(es): López, M. V | Rodriguez, D | Vena, M. M | Izuel, M | Filippi, J | Romera, A | Faverin, C | Bellinzoni, R | Fernandez, F | Marangunich, L.
ISSN: 0264-410X.Tipo de material: Artículos y capítulos. Recurso electrónico.Tema(s): BOHV-1 | CATTLE | GUINEA PIG | IBR | INTER-SPECIES CONCORDANCE ANALYSIS | LABORATORY ANIMAL MODEL | LIVESTOCK | VACCINE POTENCY | VETERINARY VACCINE | WEIGHTED KAPPA | BOVINE HERPES VIRUS VACCINE | UNCLASSIFIED DRUG | VIRUS ANTIBODY | VIRUS ANTIGEN | VIRUS VACCINE | ANIMAL EXPERIMENT | BOVINE HERPES VIRUS | CALF [BOVINE] | CONTROLLED STUDY | DISEASE SEVERITY | DOSE RESPONSE | DRUG POTENCY | EXPERIMENTAL MODEL | GUINEA PIG | NONHUMAN | PRIORITY JOURNAL | STATISTICAL ANALYSIS | VACCINATION | VALIDATION PROCESS | VIRUS SHEDDING | ANIMALS | ANTIBODIES, NEUTRALIZING | ANTIBODIES, VIRAL | CATTLE | DISEASE MODELS, ANIMAL | DOSE-RESPONSE RELATIONSHIP, IMMUNOLOGIC | ENZYME-LINKED IMMUNOSORBENT ASSAY | FEMALE | GUINEA PIGS | HERPESVIRUS 1, BOVINE | INFECTIOUS BOVINE RHINOTRACHEITIS | MALE | NEUTRALIZATION TESTS | REPRODUCIBILITY OF RESULTS | SEVERITY OF ILLNESS INDEX | UNITED STATES | VIRAL VACCINES | VIRUS SHEDDING | Recursos en línea: Haga clic para acceso en línea | LINK AL EDITOR. En: Vaccine Vol. 28, no. 13 (2010) 2539-2549Resumen: 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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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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