Development and statistical validation of a guinea pig model for vaccine potency testing against Infectious Bovine Rhinothracheitis (IBR) virus
Abstract 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 valida...
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Published in | Vaccine Vol. 28; no. 13; pp. 2539 - 2549 |
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Abstract | Abstract 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 ≤ 20%). 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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AbstractList | 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 log
10
difference in its BoHV-1 concentration with very good repeatability and reproducibility (CV ≤ 20%). 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. 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 1log10difference in its BoHV-1 concentration with very good repeatability and reproducibility (CV<=20%). A regression analysis of the Ab titers obtained in guinea pigs and bovines at 30 and 60dpv, 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. 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 log sub(10) difference in its BoHV-1 concentration with very good repeatability and reproducibility (CV <= 20%). 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. 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 1log(10) difference in its BoHV-1 concentration with very good repeatability and reproducibility (CV < or = 20%). A regression analysis of the Ab titers obtained in guinea pigs and bovines at 30 and 60dpv, 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. Abstract 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 ≤ 20%). 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. 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 log 10 difference in its BoHV-1 concentration with very good repeatability and reproducibility (CV ≤ 20%). 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. |
Author | Vena, María Marta Faverin, Claudia Parreño, Viviana Romera, Alejandra Marangunich, Laura Izuel, Mercedes Fernandez, Fernando López, María Virginia Rodriguez, Daniela Filippi, Jorge Bellinzoni, Rodolfo |
AuthorAffiliation | d Universidad Nacional de Mar del Plata, Buenos Aires, Argentina e Universidad Nacional de Tres de Febrero, UNTREF, Buenos Aires, Argentina b Universidad de Buenos Aires, Facultad de Agronomía, Buenos Aires, Argentina a Instituto de Virología, CICV y A - INTA, Buenos Aires, Argentina c Biogénesis Bagó S.A., Buenos Aires, Argentina |
AuthorAffiliation_xml | – name: b Universidad de Buenos Aires, Facultad de Agronomía, Buenos Aires, Argentina – name: c Biogénesis Bagó S.A., Buenos Aires, Argentina – name: a Instituto de Virología, CICV y A - INTA, Buenos Aires, Argentina – name: d Universidad Nacional de Mar del Plata, Buenos Aires, Argentina – name: e Universidad Nacional de Tres de Febrero, UNTREF, Buenos Aires, Argentina |
Author_xml | – sequence: 1 fullname: Parreño, Viviana – sequence: 2 fullname: López, María Virginia – sequence: 3 fullname: Rodriguez, Daniela – sequence: 4 fullname: Vena, María Marta – sequence: 5 fullname: Izuel, Mercedes – sequence: 6 fullname: Filippi, Jorge – sequence: 7 fullname: Romera, Alejandra – sequence: 8 fullname: Faverin, Claudia – sequence: 9 fullname: Bellinzoni, Rodolfo – sequence: 10 fullname: Fernandez, Fernando – sequence: 11 fullname: Marangunich, Laura |
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CitedBy_id | crossref_primary_10_1016_S2095_3119_17_61661_7 crossref_primary_10_1016_j_vaccine_2015_07_106 crossref_primary_10_1016_j_vetmic_2015_10_017 crossref_primary_10_1016_j_jviromet_2010_07_014 crossref_primary_10_1016_j_vetmic_2024_110155 crossref_primary_10_1111_tbed_13591 crossref_primary_10_3390_vaccines12060615 crossref_primary_10_1016_j_ram_2014_12_004 crossref_primary_10_1016_j_rvsc_2013_11_004 crossref_primary_10_1007_s12250_013_3283_z crossref_primary_10_1016_j_virusres_2022_198899 crossref_primary_10_1038_srep17871 |
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Keywords | BoHV-1 Veterinary vaccine Laboratory animal model Guinea pig Cattle Inter-species concordance analysis IBR Livestock Vaccine potency Weighted kappa Animal model Farming animal Bovine Rodentia Vaccine Vertebrata Mammalia Artiodactyla Veterinary Ungulata |
Language | English |
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Snippet | Abstract Infectious Bovine Rhinothracheitis (IBR) caused by bovine herpesvirus 1 (BoHV-1) infection is distributed worldwide. BoHV-1 either alone or in... Infectious Bovine Rhinothracheitis (IBR) caused by bovine herpesvirus 1 (BoHV-1) infection is distributed worldwide. BoHV-1 either alone or in association with... |
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SubjectTerms | Agreements Allergy and Immunology Animal models Animals Antibodies, Neutralizing - blood Antibodies, Viral - blood Applied microbiology Biological and medical sciences BoHV-1 Bovine herpesvirus 1 Cattle Disease Models, Animal Dose-Response Relationship, Immunologic Enzyme-Linked Immunosorbent Assay Female Fetuses Fundamental and applied biological sciences. Psychology Guinea pig Guinea Pigs Herpesvirus 1, Bovine - immunology Herpesvirus 1, Bovine - pathogenicity IBR Immunization Infections Infectious Bovine Rhinotracheitis - immunology Infectious Bovine Rhinotracheitis - prevention & control Inter-species concordance analysis Laboratory animal model Livestock Male Manufacturers Microbiology Neutralization Tests Reproducibility of Results Severity of Illness Index United States Vaccine potency Vaccines Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Veterinary vaccine Viral infections Viral Vaccines - immunology Virus Shedding - immunology Viruses Weighted kappa |
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Title | Development and statistical validation of a guinea pig model for vaccine potency testing against Infectious Bovine Rhinothracheitis (IBR) virus |
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