Leptospira

National Toxicology Program Interagency Interagency Coordinating Committee on Center for the Evaluation of Alternative the Validation of Alternative Methods Toxicological Methods

NICEATM

ICCVAM

Upcoming Leptospira Vaccine and Acellular Pertussis Vaccine Workshops
Jodie Kulpa-Eddy, DVM, USDA Richard McFarland, MD, PhD, FDA Co-Chairs, ICCVAM Biologics Working Group

SACATM MeetingSeptember 6, 2012 National Institute of Environmental Health Sciences Research Triangle Park, NC

Workshop on Alternative Methods for Leptospira Vaccine Potency Testing
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September 19-21, 2012 U.S. Department of Agriculture Center for Veterinary Biologics National Centers for Animal Health Ames, Iowa, USA Experts from government, academia and industry Plenary and BreakoutSessions Poster Session Workshop proceedings to be published in Biologicals

Further information is available at: http://iccvam.niehs.nih.gov/restrict/leptowksp/leptowksp.htm

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NICEATM-ICCVAM - Advancing Public Health and Animal Welfare

Leptospirosis

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Bacterial zoonotic disease caused by spirochetes of the genus Leptospira with a worldwide distributionLeptospira has greater than 200 pathogenic serovars, and divides into 25 serogroups More than 500,000 human cases of severe leptospirosis occur worldwide each year with a fatality rate of 1% – 25% There are no widely used human Leptospiral vaccines; disease is controlled by antibiotic treatment Mainly a disease of dogs, cattle, sheep, goats and swine. Vaccines have been available for use in animalsfor several decades ‑  Typically 4-5 serovars often in combination with other viral or bacterial vaccines

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Potency testing requires large numbers of laboratory animals (hamsters)
-  Many experience significant unrelieved pain and distress

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Leptospira spp. Vaccine PotencyTesting: ICCVAM Priority Activity
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At the September 2010 workshop1, Leptospiral spp. vaccines were identified as one of the three highest priorities for future research, development, and validation efforts because: -  -  Many serials are produced annually for use in multiple veterinary species Potency tests use large numbers of laboratory animals
•  •  48,015 hamsters (pain and no drug used) –all testing (2010)2 38,412 (80%) are estimated to be used in vaccine testing

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Challenge test involves significant unrelieved pain and distress Vaccine challenge tests requiring live bacteria are hazardous to laboratory workers 3Rs implementation of humane endpoints and in vitro ELISA development for Leptospira potency testing has resulted in refinement and replacement of hamster usage 

~45,000 in 2002 to ~33,000 in 20093

Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions, September 14-16, 2010, Bethesda, MD, USA. 2USDA 2010 Annual Report Animal Usage. 3Kulpa-Eddy, J. Development of in vitro Leptospira Potency Test. Langen, Germany. December 1-3, 2010.1International

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NICEATM-ICCVAM - Advancing Public Health and Animal Welfare

Leptospira Vaccine Potency Testing: Refinement Methods
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Serology
‑  Ph.Eur. Monograph 447 (Multi-component Canine Leptospirosis vaccine) and Ph.Eur. Monograph 1939 (Multicomponent Bovine Leptospirosis vaccine) •  Last revision 01/2008

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NICEATM

Leptospira Vaccine Potency Testing: Replacement Methods
Replacement Methods - In vitro
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1990-2000 - ELISA methods developed by the USDA in the 1990’s and Supplemental Assay Methods (SAMs) published in 2000 2005-2009 - CVB validated the Reference vaccines in the host animal (dogs, pigs) and correlated to the hamster challenge model. ELISA assays were...