Alternative methods to reduce the animal use in quality controls of inactivated BTV8 Bluetongue vaccines
The acceptance of serology data instead of challenge for market release of new batches of commercial vaccine is under evaluation by regulatory agencies in order to reduce the use of animals and costs for manufacturers. In this study two vaccines for Bluetongue virus serotype 8 were submitted to qual...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Luciani, Mirella [verfasserIn] Di Febo, Tiziana [verfasserIn] Ronchi, Gaetano Federico [verfasserIn] Sacchini, Flavio [verfasserIn] Rossi, Emanuela [verfasserIn] Ulisse, Simonetta [verfasserIn] Di Pancrazio, Chiara [verfasserIn] Antonucci, Daniela [verfasserIn] Salini, Romolo [verfasserIn] Teodori, Liana [verfasserIn] Podaliri Vulpiani, Michele [verfasserIn] Tittarelli, Manuela [verfasserIn] Di Ventura, Mauro [verfasserIn] |
|---|
| Format: |
E-Artikel |
|---|---|
| Sprache: |
Englisch |
| Erschienen: |
2020 |
|---|
| Schlagwörter: |
|---|
| Übergeordnetes Werk: |
Enthalten in: Preventive veterinary medicine - Amsterdam [u.a.] : Elsevier Science, 1982, 176 |
|---|---|
| Übergeordnetes Werk: |
volume:176 |
| DOI / URN: |
10.1016/j.prevetmed.2020.104923 |
|---|
| Katalog-ID: |
ELV003806782 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | ELV003806782 | ||
| 003 | DE-627 | ||
| 005 | 20230524122215.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 230501s2020 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.prevetmed.2020.104923 |2 doi | |
| 035 | |a (DE-627)ELV003806782 | ||
| 035 | |a (ELSEVIER)S0167-5877(19)30728-7 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rda | ||
| 041 | |a eng | ||
| 082 | 0 | 4 | |a 630 |q DE-600 |
| 100 | 1 | |a Luciani, Mirella |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Alternative methods to reduce the animal use in quality controls of inactivated BTV8 Bluetongue vaccines |
| 264 | 1 | |c 2020 | |
| 336 | |a nicht spezifiziert |b zzz |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 520 | |a The acceptance of serology data instead of challenge for market release of new batches of commercial vaccine is under evaluation by regulatory agencies in order to reduce the use of animals and costs for manufacturers. In this study two vaccines for Bluetongue virus serotype 8 were submitted to quality controls required by the European Pharmacopoeia and tested on sheep in comparison with a commercial inactivated vaccine. Body temperature, antibody titres and viraemia of vaccinated and controls sheep were recorded. In addition IL4 and IFNγ in sera and supernatant derived from in vitro stimulation of blood cells were also quantified using two commercial ELISA kit. The outer-capsid protein VP2 contained in vaccine formulations was quantified using a home-made capture-ELISA. Results obtained indicates that in-lab evaluation of cell-mediated and humoral immune response are useful parameters to predict the efficacy of BTV inactivated vaccines avoiding the challenge phase required to release new batches of vaccines with proven clinical efficacy and safety. The correlation observed between serology data and VP2 protein concentration of final product could be useful in-process control to predict if a new vaccine batch of BTV must be discarded or released to the market. | ||
| 650 | 4 | |a Bluetongue virus serotype 8 | |
| 650 | 4 | |a Cytokines quantification | |
| 650 | 4 | |a Inactivated vaccine | |
| 650 | 4 | |a ELISA | |
| 650 | 4 | |a VP2 quantification | |
| 650 | 4 | |a 3R | |
| 650 | 4 | |a Quality controls | |
| 700 | 1 | |a Di Febo, Tiziana |e verfasserin |4 aut | |
| 700 | 1 | |a Ronchi, Gaetano Federico |e verfasserin |4 aut | |
| 700 | 1 | |a Sacchini, Flavio |e verfasserin |4 aut | |
| 700 | 1 | |a Rossi, Emanuela |e verfasserin |4 aut | |
| 700 | 1 | |a Ulisse, Simonetta |e verfasserin |4 aut | |
| 700 | 1 | |a Di Pancrazio, Chiara |e verfasserin |4 aut | |
| 700 | 1 | |a Antonucci, Daniela |e verfasserin |4 aut | |
| 700 | 1 | |a Salini, Romolo |e verfasserin |4 aut | |
| 700 | 1 | |a Teodori, Liana |e verfasserin |4 aut | |
| 700 | 1 | |a Podaliri Vulpiani, Michele |e verfasserin |4 aut | |
| 700 | 1 | |a Tittarelli, Manuela |e verfasserin |4 aut | |
| 700 | 1 | |a Di Ventura, Mauro |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Preventive veterinary medicine |d Amsterdam [u.a.] : Elsevier Science, 1982 |g 176 |h Online-Ressource |w (DE-627)320473171 |w (DE-600)2008793-7 |w (DE-576)263808270 |x 1873-1716 |7 nnns |
| 773 | 1 | 8 | |g volume:176 |
| 912 | |a GBV_USEFLAG_U | ||
| 912 | |a SYSFLAG_U | ||
| 912 | |a GBV_ELV | ||
| 912 | |a SSG-OLC-PHA | ||
| 912 | |a GBV_ILN_20 | ||
| 912 | |a GBV_ILN_22 | ||
| 912 | |a GBV_ILN_23 | ||
| 912 | |a GBV_ILN_24 | ||
| 912 | |a GBV_ILN_31 | ||
| 912 | |a GBV_ILN_32 | ||
| 912 | |a GBV_ILN_40 | ||
| 912 | |a GBV_ILN_60 | ||
| 912 | |a GBV_ILN_62 | ||
| 912 | |a GBV_ILN_63 | ||
| 912 | |a GBV_ILN_65 | ||
| 912 | |a GBV_ILN_69 | ||
| 912 | |a GBV_ILN_70 | ||
| 912 | |a GBV_ILN_73 | ||
| 912 | |a GBV_ILN_74 | ||
| 912 | |a GBV_ILN_90 | ||
| 912 | |a GBV_ILN_95 | ||
| 912 | |a GBV_ILN_100 | ||
| 912 | |a GBV_ILN_105 | ||
| 912 | |a GBV_ILN_110 | ||
| 912 | |a GBV_ILN_151 | ||
| 912 | |a GBV_ILN_224 | ||
| 912 | |a GBV_ILN_252 | ||
| 912 | |a GBV_ILN_370 | ||
| 912 | |a GBV_ILN_602 | ||
| 912 | |a GBV_ILN_702 | ||
| 912 | |a GBV_ILN_2004 | ||
| 912 | |a GBV_ILN_2005 | ||
| 912 | |a GBV_ILN_2025 | ||
| 912 | |a GBV_ILN_2034 | ||
| 912 | |a GBV_ILN_2044 | ||
| 912 | |a GBV_ILN_2048 | ||
| 912 | |a GBV_ILN_2049 | ||
| 912 | |a GBV_ILN_2050 | ||
| 912 | |a GBV_ILN_2056 | ||
| 912 | |a GBV_ILN_2059 | ||
| 912 | |a GBV_ILN_2061 | ||
| 912 | |a GBV_ILN_2064 | ||
| 912 | |a GBV_ILN_2068 | ||
| 912 | |a GBV_ILN_2111 | ||
| 912 | |a GBV_ILN_2113 | ||
| 912 | |a GBV_ILN_2129 | ||
| 912 | |a GBV_ILN_2143 | ||
| 912 | |a GBV_ILN_2153 | ||
| 912 | |a GBV_ILN_2336 | ||
| 912 | |a GBV_ILN_2522 | ||
| 912 | |a GBV_ILN_4251 | ||
| 912 | |a GBV_ILN_4305 | ||
| 912 | |a GBV_ILN_4313 | ||
| 912 | |a GBV_ILN_4323 | ||
| 912 | |a GBV_ILN_4324 | ||
| 912 | |a GBV_ILN_4326 | ||
| 912 | |a GBV_ILN_4333 | ||
| 912 | |a GBV_ILN_4334 | ||
| 912 | |a GBV_ILN_4335 | ||
| 951 | |a AR | ||
| 952 | |d 176 | ||
| author_variant |
m l ml f t d ft ftd g f r gf gfr f s fs e r er s u su p c d pc pcd d a da r s rs l t lt v m p vm vmp m t mt v m d vm vmd |
|---|---|
| matchkey_str |
article:18731716:2020----::lentvmtosoeuehaiauenultcnrloiatvt |
| hierarchy_sort_str |
2020 |
| publishDate |
2020 |
| allfields |
10.1016/j.prevetmed.2020.104923 doi (DE-627)ELV003806782 (ELSEVIER)S0167-5877(19)30728-7 DE-627 ger DE-627 rda eng 630 DE-600 Luciani, Mirella verfasserin aut Alternative methods to reduce the animal use in quality controls of inactivated BTV8 Bluetongue vaccines 2020 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier The acceptance of serology data instead of challenge for market release of new batches of commercial vaccine is under evaluation by regulatory agencies in order to reduce the use of animals and costs for manufacturers. In this study two vaccines for Bluetongue virus serotype 8 were submitted to quality controls required by the European Pharmacopoeia and tested on sheep in comparison with a commercial inactivated vaccine. Body temperature, antibody titres and viraemia of vaccinated and controls sheep were recorded. In addition IL4 and IFNγ in sera and supernatant derived from in vitro stimulation of blood cells were also quantified using two commercial ELISA kit. The outer-capsid protein VP2 contained in vaccine formulations was quantified using a home-made capture-ELISA. Results obtained indicates that in-lab evaluation of cell-mediated and humoral immune response are useful parameters to predict the efficacy of BTV inactivated vaccines avoiding the challenge phase required to release new batches of vaccines with proven clinical efficacy and safety. The correlation observed between serology data and VP2 protein concentration of final product could be useful in-process control to predict if a new vaccine batch of BTV must be discarded or released to the market. Bluetongue virus serotype 8 Cytokines quantification Inactivated vaccine ELISA VP2 quantification 3R Quality controls Di Febo, Tiziana verfasserin aut Ronchi, Gaetano Federico verfasserin aut Sacchini, Flavio verfasserin aut Rossi, Emanuela verfasserin aut Ulisse, Simonetta verfasserin aut Di Pancrazio, Chiara verfasserin aut Antonucci, Daniela verfasserin aut Salini, Romolo verfasserin aut Teodori, Liana verfasserin aut Podaliri Vulpiani, Michele verfasserin aut Tittarelli, Manuela verfasserin aut Di Ventura, Mauro verfasserin aut Enthalten in Preventive veterinary medicine Amsterdam [u.a.] : Elsevier Science, 1982 176 Online-Ressource (DE-627)320473171 (DE-600)2008793-7 (DE-576)263808270 1873-1716 nnns volume:176 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_252 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2025 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2336 GBV_ILN_2522 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 AR 176 |
| spelling |
10.1016/j.prevetmed.2020.104923 doi (DE-627)ELV003806782 (ELSEVIER)S0167-5877(19)30728-7 DE-627 ger DE-627 rda eng 630 DE-600 Luciani, Mirella verfasserin aut Alternative methods to reduce the animal use in quality controls of inactivated BTV8 Bluetongue vaccines 2020 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier The acceptance of serology data instead of challenge for market release of new batches of commercial vaccine is under evaluation by regulatory agencies in order to reduce the use of animals and costs for manufacturers. In this study two vaccines for Bluetongue virus serotype 8 were submitted to quality controls required by the European Pharmacopoeia and tested on sheep in comparison with a commercial inactivated vaccine. Body temperature, antibody titres and viraemia of vaccinated and controls sheep were recorded. In addition IL4 and IFNγ in sera and supernatant derived from in vitro stimulation of blood cells were also quantified using two commercial ELISA kit. The outer-capsid protein VP2 contained in vaccine formulations was quantified using a home-made capture-ELISA. Results obtained indicates that in-lab evaluation of cell-mediated and humoral immune response are useful parameters to predict the efficacy of BTV inactivated vaccines avoiding the challenge phase required to release new batches of vaccines with proven clinical efficacy and safety. The correlation observed between serology data and VP2 protein concentration of final product could be useful in-process control to predict if a new vaccine batch of BTV must be discarded or released to the market. Bluetongue virus serotype 8 Cytokines quantification Inactivated vaccine ELISA VP2 quantification 3R Quality controls Di Febo, Tiziana verfasserin aut Ronchi, Gaetano Federico verfasserin aut Sacchini, Flavio verfasserin aut Rossi, Emanuela verfasserin aut Ulisse, Simonetta verfasserin aut Di Pancrazio, Chiara verfasserin aut Antonucci, Daniela verfasserin aut Salini, Romolo verfasserin aut Teodori, Liana verfasserin aut Podaliri Vulpiani, Michele verfasserin aut Tittarelli, Manuela verfasserin aut Di Ventura, Mauro verfasserin aut Enthalten in Preventive veterinary medicine Amsterdam [u.a.] : Elsevier Science, 1982 176 Online-Ressource (DE-627)320473171 (DE-600)2008793-7 (DE-576)263808270 1873-1716 nnns volume:176 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_252 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2025 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2336 GBV_ILN_2522 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 AR 176 |
| allfields_unstemmed |
10.1016/j.prevetmed.2020.104923 doi (DE-627)ELV003806782 (ELSEVIER)S0167-5877(19)30728-7 DE-627 ger DE-627 rda eng 630 DE-600 Luciani, Mirella verfasserin aut Alternative methods to reduce the animal use in quality controls of inactivated BTV8 Bluetongue vaccines 2020 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier The acceptance of serology data instead of challenge for market release of new batches of commercial vaccine is under evaluation by regulatory agencies in order to reduce the use of animals and costs for manufacturers. In this study two vaccines for Bluetongue virus serotype 8 were submitted to quality controls required by the European Pharmacopoeia and tested on sheep in comparison with a commercial inactivated vaccine. Body temperature, antibody titres and viraemia of vaccinated and controls sheep were recorded. In addition IL4 and IFNγ in sera and supernatant derived from in vitro stimulation of blood cells were also quantified using two commercial ELISA kit. The outer-capsid protein VP2 contained in vaccine formulations was quantified using a home-made capture-ELISA. Results obtained indicates that in-lab evaluation of cell-mediated and humoral immune response are useful parameters to predict the efficacy of BTV inactivated vaccines avoiding the challenge phase required to release new batches of vaccines with proven clinical efficacy and safety. The correlation observed between serology data and VP2 protein concentration of final product could be useful in-process control to predict if a new vaccine batch of BTV must be discarded or released to the market. Bluetongue virus serotype 8 Cytokines quantification Inactivated vaccine ELISA VP2 quantification 3R Quality controls Di Febo, Tiziana verfasserin aut Ronchi, Gaetano Federico verfasserin aut Sacchini, Flavio verfasserin aut Rossi, Emanuela verfasserin aut Ulisse, Simonetta verfasserin aut Di Pancrazio, Chiara verfasserin aut Antonucci, Daniela verfasserin aut Salini, Romolo verfasserin aut Teodori, Liana verfasserin aut Podaliri Vulpiani, Michele verfasserin aut Tittarelli, Manuela verfasserin aut Di Ventura, Mauro verfasserin aut Enthalten in Preventive veterinary medicine Amsterdam [u.a.] : Elsevier Science, 1982 176 Online-Ressource (DE-627)320473171 (DE-600)2008793-7 (DE-576)263808270 1873-1716 nnns volume:176 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_252 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2025 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2336 GBV_ILN_2522 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 AR 176 |
| allfieldsGer |
10.1016/j.prevetmed.2020.104923 doi (DE-627)ELV003806782 (ELSEVIER)S0167-5877(19)30728-7 DE-627 ger DE-627 rda eng 630 DE-600 Luciani, Mirella verfasserin aut Alternative methods to reduce the animal use in quality controls of inactivated BTV8 Bluetongue vaccines 2020 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier The acceptance of serology data instead of challenge for market release of new batches of commercial vaccine is under evaluation by regulatory agencies in order to reduce the use of animals and costs for manufacturers. In this study two vaccines for Bluetongue virus serotype 8 were submitted to quality controls required by the European Pharmacopoeia and tested on sheep in comparison with a commercial inactivated vaccine. Body temperature, antibody titres and viraemia of vaccinated and controls sheep were recorded. In addition IL4 and IFNγ in sera and supernatant derived from in vitro stimulation of blood cells were also quantified using two commercial ELISA kit. The outer-capsid protein VP2 contained in vaccine formulations was quantified using a home-made capture-ELISA. Results obtained indicates that in-lab evaluation of cell-mediated and humoral immune response are useful parameters to predict the efficacy of BTV inactivated vaccines avoiding the challenge phase required to release new batches of vaccines with proven clinical efficacy and safety. The correlation observed between serology data and VP2 protein concentration of final product could be useful in-process control to predict if a new vaccine batch of BTV must be discarded or released to the market. Bluetongue virus serotype 8 Cytokines quantification Inactivated vaccine ELISA VP2 quantification 3R Quality controls Di Febo, Tiziana verfasserin aut Ronchi, Gaetano Federico verfasserin aut Sacchini, Flavio verfasserin aut Rossi, Emanuela verfasserin aut Ulisse, Simonetta verfasserin aut Di Pancrazio, Chiara verfasserin aut Antonucci, Daniela verfasserin aut Salini, Romolo verfasserin aut Teodori, Liana verfasserin aut Podaliri Vulpiani, Michele verfasserin aut Tittarelli, Manuela verfasserin aut Di Ventura, Mauro verfasserin aut Enthalten in Preventive veterinary medicine Amsterdam [u.a.] : Elsevier Science, 1982 176 Online-Ressource (DE-627)320473171 (DE-600)2008793-7 (DE-576)263808270 1873-1716 nnns volume:176 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_252 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2025 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2336 GBV_ILN_2522 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 AR 176 |
| allfieldsSound |
10.1016/j.prevetmed.2020.104923 doi (DE-627)ELV003806782 (ELSEVIER)S0167-5877(19)30728-7 DE-627 ger DE-627 rda eng 630 DE-600 Luciani, Mirella verfasserin aut Alternative methods to reduce the animal use in quality controls of inactivated BTV8 Bluetongue vaccines 2020 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier The acceptance of serology data instead of challenge for market release of new batches of commercial vaccine is under evaluation by regulatory agencies in order to reduce the use of animals and costs for manufacturers. In this study two vaccines for Bluetongue virus serotype 8 were submitted to quality controls required by the European Pharmacopoeia and tested on sheep in comparison with a commercial inactivated vaccine. Body temperature, antibody titres and viraemia of vaccinated and controls sheep were recorded. In addition IL4 and IFNγ in sera and supernatant derived from in vitro stimulation of blood cells were also quantified using two commercial ELISA kit. The outer-capsid protein VP2 contained in vaccine formulations was quantified using a home-made capture-ELISA. Results obtained indicates that in-lab evaluation of cell-mediated and humoral immune response are useful parameters to predict the efficacy of BTV inactivated vaccines avoiding the challenge phase required to release new batches of vaccines with proven clinical efficacy and safety. The correlation observed between serology data and VP2 protein concentration of final product could be useful in-process control to predict if a new vaccine batch of BTV must be discarded or released to the market. Bluetongue virus serotype 8 Cytokines quantification Inactivated vaccine ELISA VP2 quantification 3R Quality controls Di Febo, Tiziana verfasserin aut Ronchi, Gaetano Federico verfasserin aut Sacchini, Flavio verfasserin aut Rossi, Emanuela verfasserin aut Ulisse, Simonetta verfasserin aut Di Pancrazio, Chiara verfasserin aut Antonucci, Daniela verfasserin aut Salini, Romolo verfasserin aut Teodori, Liana verfasserin aut Podaliri Vulpiani, Michele verfasserin aut Tittarelli, Manuela verfasserin aut Di Ventura, Mauro verfasserin aut Enthalten in Preventive veterinary medicine Amsterdam [u.a.] : Elsevier Science, 1982 176 Online-Ressource (DE-627)320473171 (DE-600)2008793-7 (DE-576)263808270 1873-1716 nnns volume:176 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_252 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2025 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2336 GBV_ILN_2522 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 AR 176 |
| language |
English |
| source |
Enthalten in Preventive veterinary medicine 176 volume:176 |
| sourceStr |
Enthalten in Preventive veterinary medicine 176 volume:176 |
| format_phy_str_mv |
Article |
| institution |
findex.gbv.de |
| topic_facet |
Bluetongue virus serotype 8 Cytokines quantification Inactivated vaccine ELISA VP2 quantification 3R Quality controls |
| dewey-raw |
630 |
| isfreeaccess_bool |
false |
| container_title |
Preventive veterinary medicine |
| authorswithroles_txt_mv |
Luciani, Mirella @@aut@@ Di Febo, Tiziana @@aut@@ Ronchi, Gaetano Federico @@aut@@ Sacchini, Flavio @@aut@@ Rossi, Emanuela @@aut@@ Ulisse, Simonetta @@aut@@ Di Pancrazio, Chiara @@aut@@ Antonucci, Daniela @@aut@@ Salini, Romolo @@aut@@ Teodori, Liana @@aut@@ Podaliri Vulpiani, Michele @@aut@@ Tittarelli, Manuela @@aut@@ Di Ventura, Mauro @@aut@@ |
| publishDateDaySort_date |
2020-01-01T00:00:00Z |
| hierarchy_top_id |
320473171 |
| dewey-sort |
3630 |
| id |
ELV003806782 |
| language_de |
englisch |
| fullrecord |
<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">ELV003806782</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230524122215.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">230501s2020 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1016/j.prevetmed.2020.104923</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)ELV003806782</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(ELSEVIER)S0167-5877(19)30728-7</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rda</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="082" ind1="0" ind2="4"><subfield code="a">630</subfield><subfield code="q">DE-600</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Luciani, Mirella</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Alternative methods to reduce the animal use in quality controls of inactivated BTV8 Bluetongue vaccines</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2020</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">nicht spezifiziert</subfield><subfield code="b">zzz</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">The acceptance of serology data instead of challenge for market release of new batches of commercial vaccine is under evaluation by regulatory agencies in order to reduce the use of animals and costs for manufacturers. In this study two vaccines for Bluetongue virus serotype 8 were submitted to quality controls required by the European Pharmacopoeia and tested on sheep in comparison with a commercial inactivated vaccine. Body temperature, antibody titres and viraemia of vaccinated and controls sheep were recorded. In addition IL4 and IFNγ in sera and supernatant derived from in vitro stimulation of blood cells were also quantified using two commercial ELISA kit. The outer-capsid protein VP2 contained in vaccine formulations was quantified using a home-made capture-ELISA. Results obtained indicates that in-lab evaluation of cell-mediated and humoral immune response are useful parameters to predict the efficacy of BTV inactivated vaccines avoiding the challenge phase required to release new batches of vaccines with proven clinical efficacy and safety. The correlation observed between serology data and VP2 protein concentration of final product could be useful in-process control to predict if a new vaccine batch of BTV must be discarded or released to the market.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Bluetongue virus serotype 8</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Cytokines quantification</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Inactivated vaccine</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">ELISA</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">VP2 quantification</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">3R</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Quality controls</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Di Febo, Tiziana</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Ronchi, Gaetano Federico</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Sacchini, Flavio</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Rossi, Emanuela</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Ulisse, Simonetta</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Di Pancrazio, Chiara</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Antonucci, Daniela</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Salini, Romolo</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Teodori, Liana</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Podaliri Vulpiani, Michele</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Tittarelli, Manuela</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Di Ventura, Mauro</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">Enthalten in</subfield><subfield code="t">Preventive veterinary medicine</subfield><subfield code="d">Amsterdam [u.a.] : Elsevier Science, 1982</subfield><subfield code="g">176</subfield><subfield code="h">Online-Ressource</subfield><subfield code="w">(DE-627)320473171</subfield><subfield code="w">(DE-600)2008793-7</subfield><subfield code="w">(DE-576)263808270</subfield><subfield code="x">1873-1716</subfield><subfield code="7">nnns</subfield></datafield><datafield tag="773" ind1="1" ind2="8"><subfield code="g">volume:176</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_USEFLAG_U</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SYSFLAG_U</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ELV</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SSG-OLC-PHA</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_20</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_22</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_23</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_24</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_31</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_32</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_40</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_60</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_62</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_63</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_65</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_69</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_70</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_73</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_74</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_90</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_95</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_100</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_105</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_110</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_151</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_224</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_252</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_370</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_602</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_702</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2004</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2005</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2025</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2034</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2044</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2048</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2049</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2050</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2056</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2059</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2061</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2064</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2068</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2111</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2113</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2129</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2143</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2153</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2336</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2522</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4251</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4305</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4313</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4323</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4324</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4326</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4333</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4334</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4335</subfield></datafield><datafield tag="951" ind1=" " ind2=" "><subfield code="a">AR</subfield></datafield><datafield tag="952" ind1=" " ind2=" "><subfield code="d">176</subfield></datafield></record></collection>
|
| author |
Luciani, Mirella |
| spellingShingle |
Luciani, Mirella ddc 630 misc Bluetongue virus serotype 8 misc Cytokines quantification misc Inactivated vaccine misc ELISA misc VP2 quantification misc 3R misc Quality controls Alternative methods to reduce the animal use in quality controls of inactivated BTV8 Bluetongue vaccines |
| authorStr |
Luciani, Mirella |
| ppnlink_with_tag_str_mv |
@@773@@(DE-627)320473171 |
| format |
electronic Article |
| dewey-ones |
630 - Agriculture & related technologies |
| delete_txt_mv |
keep |
| author_role |
aut aut aut aut aut aut aut aut aut aut aut aut aut |
| collection |
elsevier |
| remote_str |
true |
| illustrated |
Not Illustrated |
| issn |
1873-1716 |
| topic_title |
630 DE-600 Alternative methods to reduce the animal use in quality controls of inactivated BTV8 Bluetongue vaccines Bluetongue virus serotype 8 Cytokines quantification Inactivated vaccine ELISA VP2 quantification 3R Quality controls |
| topic |
ddc 630 misc Bluetongue virus serotype 8 misc Cytokines quantification misc Inactivated vaccine misc ELISA misc VP2 quantification misc 3R misc Quality controls |
| topic_unstemmed |
ddc 630 misc Bluetongue virus serotype 8 misc Cytokines quantification misc Inactivated vaccine misc ELISA misc VP2 quantification misc 3R misc Quality controls |
| topic_browse |
ddc 630 misc Bluetongue virus serotype 8 misc Cytokines quantification misc Inactivated vaccine misc ELISA misc VP2 quantification misc 3R misc Quality controls |
| format_facet |
Elektronische Aufsätze Aufsätze Elektronische Ressource |
| format_main_str_mv |
Text Zeitschrift/Artikel |
| carriertype_str_mv |
cr |
| hierarchy_parent_title |
Preventive veterinary medicine |
| hierarchy_parent_id |
320473171 |
| dewey-tens |
630 - Agriculture |
| hierarchy_top_title |
Preventive veterinary medicine |
| isfreeaccess_txt |
false |
| familylinks_str_mv |
(DE-627)320473171 (DE-600)2008793-7 (DE-576)263808270 |
| title |
Alternative methods to reduce the animal use in quality controls of inactivated BTV8 Bluetongue vaccines |
| ctrlnum |
(DE-627)ELV003806782 (ELSEVIER)S0167-5877(19)30728-7 |
| title_full |
Alternative methods to reduce the animal use in quality controls of inactivated BTV8 Bluetongue vaccines |
| author_sort |
Luciani, Mirella |
| journal |
Preventive veterinary medicine |
| journalStr |
Preventive veterinary medicine |
| lang_code |
eng |
| isOA_bool |
false |
| dewey-hundreds |
600 - Technology |
| recordtype |
marc |
| publishDateSort |
2020 |
| contenttype_str_mv |
zzz |
| author_browse |
Luciani, Mirella Di Febo, Tiziana Ronchi, Gaetano Federico Sacchini, Flavio Rossi, Emanuela Ulisse, Simonetta Di Pancrazio, Chiara Antonucci, Daniela Salini, Romolo Teodori, Liana Podaliri Vulpiani, Michele Tittarelli, Manuela Di Ventura, Mauro |
| container_volume |
176 |
| class |
630 DE-600 |
| format_se |
Elektronische Aufsätze |
| author-letter |
Luciani, Mirella |
| doi_str_mv |
10.1016/j.prevetmed.2020.104923 |
| dewey-full |
630 |
| author2-role |
verfasserin |
| title_sort |
alternative methods to reduce the animal use in quality controls of inactivated btv8 bluetongue vaccines |
| title_auth |
Alternative methods to reduce the animal use in quality controls of inactivated BTV8 Bluetongue vaccines |
| abstract |
The acceptance of serology data instead of challenge for market release of new batches of commercial vaccine is under evaluation by regulatory agencies in order to reduce the use of animals and costs for manufacturers. In this study two vaccines for Bluetongue virus serotype 8 were submitted to quality controls required by the European Pharmacopoeia and tested on sheep in comparison with a commercial inactivated vaccine. Body temperature, antibody titres and viraemia of vaccinated and controls sheep were recorded. In addition IL4 and IFNγ in sera and supernatant derived from in vitro stimulation of blood cells were also quantified using two commercial ELISA kit. The outer-capsid protein VP2 contained in vaccine formulations was quantified using a home-made capture-ELISA. Results obtained indicates that in-lab evaluation of cell-mediated and humoral immune response are useful parameters to predict the efficacy of BTV inactivated vaccines avoiding the challenge phase required to release new batches of vaccines with proven clinical efficacy and safety. The correlation observed between serology data and VP2 protein concentration of final product could be useful in-process control to predict if a new vaccine batch of BTV must be discarded or released to the market. |
| abstractGer |
The acceptance of serology data instead of challenge for market release of new batches of commercial vaccine is under evaluation by regulatory agencies in order to reduce the use of animals and costs for manufacturers. In this study two vaccines for Bluetongue virus serotype 8 were submitted to quality controls required by the European Pharmacopoeia and tested on sheep in comparison with a commercial inactivated vaccine. Body temperature, antibody titres and viraemia of vaccinated and controls sheep were recorded. In addition IL4 and IFNγ in sera and supernatant derived from in vitro stimulation of blood cells were also quantified using two commercial ELISA kit. The outer-capsid protein VP2 contained in vaccine formulations was quantified using a home-made capture-ELISA. Results obtained indicates that in-lab evaluation of cell-mediated and humoral immune response are useful parameters to predict the efficacy of BTV inactivated vaccines avoiding the challenge phase required to release new batches of vaccines with proven clinical efficacy and safety. The correlation observed between serology data and VP2 protein concentration of final product could be useful in-process control to predict if a new vaccine batch of BTV must be discarded or released to the market. |
| abstract_unstemmed |
The acceptance of serology data instead of challenge for market release of new batches of commercial vaccine is under evaluation by regulatory agencies in order to reduce the use of animals and costs for manufacturers. In this study two vaccines for Bluetongue virus serotype 8 were submitted to quality controls required by the European Pharmacopoeia and tested on sheep in comparison with a commercial inactivated vaccine. Body temperature, antibody titres and viraemia of vaccinated and controls sheep were recorded. In addition IL4 and IFNγ in sera and supernatant derived from in vitro stimulation of blood cells were also quantified using two commercial ELISA kit. The outer-capsid protein VP2 contained in vaccine formulations was quantified using a home-made capture-ELISA. Results obtained indicates that in-lab evaluation of cell-mediated and humoral immune response are useful parameters to predict the efficacy of BTV inactivated vaccines avoiding the challenge phase required to release new batches of vaccines with proven clinical efficacy and safety. The correlation observed between serology data and VP2 protein concentration of final product could be useful in-process control to predict if a new vaccine batch of BTV must be discarded or released to the market. |
| collection_details |
GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_252 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2025 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2336 GBV_ILN_2522 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 |
| title_short |
Alternative methods to reduce the animal use in quality controls of inactivated BTV8 Bluetongue vaccines |
| remote_bool |
true |
| author2 |
Di Febo, Tiziana Ronchi, Gaetano Federico Sacchini, Flavio Rossi, Emanuela Ulisse, Simonetta Di Pancrazio, Chiara Antonucci, Daniela Salini, Romolo Teodori, Liana Podaliri Vulpiani, Michele Tittarelli, Manuela Di Ventura, Mauro |
| author2Str |
Di Febo, Tiziana Ronchi, Gaetano Federico Sacchini, Flavio Rossi, Emanuela Ulisse, Simonetta Di Pancrazio, Chiara Antonucci, Daniela Salini, Romolo Teodori, Liana Podaliri Vulpiani, Michele Tittarelli, Manuela Di Ventura, Mauro |
| ppnlink |
320473171 |
| mediatype_str_mv |
c |
| isOA_txt |
false |
| hochschulschrift_bool |
false |
| doi_str |
10.1016/j.prevetmed.2020.104923 |
| up_date |
2024-07-06T20:52:01.226Z |
| _version_ |
1803864371339722752 |
| fullrecord_marcxml |
<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">ELV003806782</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230524122215.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">230501s2020 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1016/j.prevetmed.2020.104923</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)ELV003806782</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(ELSEVIER)S0167-5877(19)30728-7</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rda</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="082" ind1="0" ind2="4"><subfield code="a">630</subfield><subfield code="q">DE-600</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Luciani, Mirella</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Alternative methods to reduce the animal use in quality controls of inactivated BTV8 Bluetongue vaccines</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2020</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">nicht spezifiziert</subfield><subfield code="b">zzz</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">The acceptance of serology data instead of challenge for market release of new batches of commercial vaccine is under evaluation by regulatory agencies in order to reduce the use of animals and costs for manufacturers. In this study two vaccines for Bluetongue virus serotype 8 were submitted to quality controls required by the European Pharmacopoeia and tested on sheep in comparison with a commercial inactivated vaccine. Body temperature, antibody titres and viraemia of vaccinated and controls sheep were recorded. In addition IL4 and IFNγ in sera and supernatant derived from in vitro stimulation of blood cells were also quantified using two commercial ELISA kit. The outer-capsid protein VP2 contained in vaccine formulations was quantified using a home-made capture-ELISA. Results obtained indicates that in-lab evaluation of cell-mediated and humoral immune response are useful parameters to predict the efficacy of BTV inactivated vaccines avoiding the challenge phase required to release new batches of vaccines with proven clinical efficacy and safety. The correlation observed between serology data and VP2 protein concentration of final product could be useful in-process control to predict if a new vaccine batch of BTV must be discarded or released to the market.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Bluetongue virus serotype 8</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Cytokines quantification</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Inactivated vaccine</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">ELISA</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">VP2 quantification</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">3R</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Quality controls</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Di Febo, Tiziana</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Ronchi, Gaetano Federico</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Sacchini, Flavio</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Rossi, Emanuela</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Ulisse, Simonetta</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Di Pancrazio, Chiara</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Antonucci, Daniela</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Salini, Romolo</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Teodori, Liana</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Podaliri Vulpiani, Michele</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Tittarelli, Manuela</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Di Ventura, Mauro</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">Enthalten in</subfield><subfield code="t">Preventive veterinary medicine</subfield><subfield code="d">Amsterdam [u.a.] : Elsevier Science, 1982</subfield><subfield code="g">176</subfield><subfield code="h">Online-Ressource</subfield><subfield code="w">(DE-627)320473171</subfield><subfield code="w">(DE-600)2008793-7</subfield><subfield code="w">(DE-576)263808270</subfield><subfield code="x">1873-1716</subfield><subfield code="7">nnns</subfield></datafield><datafield tag="773" ind1="1" ind2="8"><subfield code="g">volume:176</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_USEFLAG_U</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SYSFLAG_U</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ELV</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SSG-OLC-PHA</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_20</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_22</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_23</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_24</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_31</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_32</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_40</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_60</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_62</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_63</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_65</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_69</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_70</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_73</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_74</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_90</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_95</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_100</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_105</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_110</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_151</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_224</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_252</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_370</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_602</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_702</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2004</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2005</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2025</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2034</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2044</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2048</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2049</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2050</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2056</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2059</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2061</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2064</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2068</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2111</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2113</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2129</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2143</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2153</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2336</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2522</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4251</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4305</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4313</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4323</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4324</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4326</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4333</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4334</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4335</subfield></datafield><datafield tag="951" ind1=" " ind2=" "><subfield code="a">AR</subfield></datafield><datafield tag="952" ind1=" " ind2=" "><subfield code="d">176</subfield></datafield></record></collection>
|
| score |
7.400791 |