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Re-evaluating the LD50 requirements in the codified potency testing of veterinary vaccines containing Leptospira (L.) serogroup Icterohaemorrhagiae and L. serogroup Canicola in the United States.
Walker, Angela; Olsen, Renee; Toth, Mindy; Srinivas, Geetha.
Afiliación
  • Walker A; Center for Veterinary Biologics, Animal and Plant Health Inspection Service, United States Department of Agriculture, P.O Box 844, Ames, IA, 50010, USA. Electronic address: Angela.M.Walker@aphis.usda.gov.
  • Olsen R; Center for Veterinary Biologics, Animal and Plant Health Inspection Service, United States Department of Agriculture, P.O Box 844, Ames, IA, 50010, USA.
  • Toth M; Center for Veterinary Biologics, Animal and Plant Health Inspection Service, United States Department of Agriculture, P.O Box 844, Ames, IA, 50010, USA.
  • Srinivas G; Center for Veterinary Biologics, Animal and Plant Health Inspection Service, United States Department of Agriculture, P.O Box 844, Ames, IA, 50010, USA.
Biologicals ; 56: 13-18, 2018 Nov.
Article en En | MEDLINE | ID: mdl-30126631
Approximately one-third of the reportable USDA Category D and E laboratory animals in the United States are expended on the potency testing of leptospiral vaccines by the codified hamster vaccination-challenge assay. Valid tests require ≥80% of challenge controls to succumb to disease and an LD50 between 10 and 10,000. This work evaluates the risk associated with the removal of LD50 limits; thereby, eliminating back-titration hamsters from in vivo potency assays for Leptospira (L.) serogroups Canicola and Icterohaemorrhagiae. The impact was assessed through 1) retrospective analysis of industry and CVB serial release data from July 2011-April 2015 and 2) evaluation through vaccination-challenge assays. For the initial vaccination-challenge assays (n = 3/serogroup), one group received potent bacterin (PB) and six groups received subpotent bacterins (SB1-SB6). PB and SB1 were challenged with a single dilution of Leptospira between 10 and 10,000 LD50. SB2-SB6 received serial dilutions of more concentrated challenge. Based on the retrospective analysis and in vivo assays, 80% of the challenge controls succumbing to disease reasonably ensured the minimal LD50 was administered. Subpotent vaccines were not at increased risk for being deemed potent when challenged with >10,000 LD50, but potent vaccines were at risk of being deemed subpotent when challenged with >10,000 LD50.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vacunas Bacterianas / Vacunación / Drogas Veterinarias / Leptospira interrogans serovar icterohaemorrhagiae / Potencia de la Vacuna / Leptospira interrogans serovar canicola / Leptospirosis Tipo de estudio: Observational_studies / Risk_factors_studies Límite: Animals País/Región como asunto: America do norte Idioma: En Revista: Biologicals Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2018 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vacunas Bacterianas / Vacunación / Drogas Veterinarias / Leptospira interrogans serovar icterohaemorrhagiae / Potencia de la Vacuna / Leptospira interrogans serovar canicola / Leptospirosis Tipo de estudio: Observational_studies / Risk_factors_studies Límite: Animals País/Región como asunto: America do norte Idioma: En Revista: Biologicals Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2018 Tipo del documento: Article Pais de publicación: Reino Unido