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Environmental Factor, June 2012

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Upcoming workshop on Leptospira vaccine potency testing

By Debbie McCarley and Cathy Sprankle

The National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods logo

An upcoming workshop will focus on improved methods and approaches for Leptospira vaccine potency testing that may also help reduce, refine, and replace animal use. The "International Workshop on Alternative Methods for Leptospira Vaccine Potency Testing: State of the Science and the Way Forward" will take place Sept. 19-21 at the U.S. Department of Agriculture (USDA) Center for Veterinary Biologics at the National Centers for Animal Health in Ames, Iowa.

The National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) at NIEHS is organizing the workshop in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and partner organizations in the International Cooperation on Alternative Test Methods. The organizing committee for the workshop includes scientists from the National Institute of Allergy and Infectious Diseases (NIAID) and the Centers for Disease Control and Prevention, as well as from the USDA and other U.S. and international government agencies.

Leptospirosis is a neglected tropical and zoonotic disease

Leptospirosis is a bacterial zoonotic disease caused by spirochetes of the genus Leptospira. More than 500,000 human cases of leptospirosis occur worldwide each year, with a fatality rate of up to 25 percent in some regions. Designated as a neglected tropical disease by the NIH and a neglected zoonotic disease by the World Health Organization, leptospirosis is a global research and public health priority. According to Suman Mukhopadhyay, Ph.D., bacterial zoonoses program officer, NIAID is currently funding several major leptospirosis research grants, which include investigations of mechanisms involved in the infectious cycle, enhanced tools for clinical diagnosis, and target identification for therapeutic intervention and development of potential vaccines for humans.

In the U.S., Leptospira vaccines are used in cattle, swine, and dogs to protect them from disease and to reduce the risk of animal-to-human transmission. Human vaccines are also available in some countries outside the U.S. Manufacturers test the potency of vaccine lots prior to their release to ensure their effectiveness. However, methods currently used to test the potency of Leptospira vaccines involve large numbers of laboratory animals. Many of these animals experience significant unrelieved pain and distress, with Leptospira vaccine testing accounting for over one‑third of the animals reported to the USDA in this category.

NICEATM and ICCVAM promote the translation of innovative science and technology into improved alternative methods that are more efficient and that can also reduce, refine (enhance animal well-being and lessen or avoid pain and distress), and replace animal use. One of their highest priorities is promoting development and use of improved alternative test methods for vaccine potency and safety testing. NICEATM, ICCVAM, and their international partners recently identified Leptospira vaccines as a top priority.

About the workshop

This workshop will bring together international scientific experts from government, industry, and academia to review recent advances in science and technology, in addition to available methods and approaches for Leptospira vaccine potency testing. The main focus of the workshop will be on improved methods and approaches and that may provide improved accuracy, efficiency, and worker safety, and that are more humane and use fewer or no animals. Participants will develop a strategy to achieve global acceptance and implementation of scientifically valid alternative methods. A poster session will feature presentations on current research, development, and validation of alternative methods for Leptospira vaccine potency testing.

For more information

Registration information and a workshop program will soon be available on the NICEATM-ICCVAM website. NICEATM and ICCVAM also invite the submission of abstracts for scientific posters to be displayed during this workshop. Abstracts should be submitted by August 13.

(Debbie McCarley is a special assistant to Rear Adm. William Stokes, D.V.M., director of NICEATM. Cathy Sprankle is a communications specialist with ILS, Inc., support contractor for NICEATM.)

Members of the ICCVAM Interagency Biologics Working Group at the 2010 workshop

The upcoming workshop was an activity recommended by participants at a workshop on alternative methods for vaccine testing organized by NICEATM and ICCVAM in 2010. Members of the ICCVAM Interagency Biologics Working Group pictured here at the 2010 workshop include, back row from left, Juan Arciniega, D.Sc., U.S. Food and Drug Administration (FDA); Marlies Halder, V.M.D., European Union Reference Laboratory for Alternatives to Animal Testing; Janet Skerry, U.S. Department of Defense; Richard Isbrucker, Ph.D., Health Canada; Hajime Kojima, Ph.D., Japanese Center for the Validation of Alternative Methods; Warren Casey, Ph.D., NIEHS; front row from left, Geetha Srinivas, D.V.M., Ph.D., U.S. Department of Agriculture (USDA); Jodie Kulpa-Eddy, D.V.M., USDA; Richard McFarland, M.D., Ph.D., FDA; William Stokes, D.V.M., NIEHS.

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