NICEATM-ICCVAM International Workshop on Alternative Methods for Leptospira Vaccine Potency Testing: Sept. 19-21, 2012

The National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces an "International Workshop on Alternative Methods for Leptospira Vaccine Potency Testing: State of the Science and Planning the Way Forward" on September 19-21, 2012. The workshop will be hosted by the U.S. Department of Agriculture Center for Veterinary Biologics at the National Centers for Animal Health in Ames, Iowa. NICEATM is organizing the workshop in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and partner organizations in theInternational Cooperation on Alternative Test Methods.

This workshop will bring together international scientific experts from government, industry, and academia to recent advances in science and technology, in addition to available methods and approaches for Leptospira vaccine potency testing. A poster session will feature presentations on current research, development, and validation of alternative methods for Leptospira vaccine potency testing.

Background

Leptospirosis is a bacterial zoonotic disease caused by spirochetes of the genus Leptospira. An estimated 500,000 human cases of leptospirosis occur worldwide each year with a fatality rate of up to 25% in some regions. Designated as a Neglected Tropical Disease by the U.S. National Institutes of Health and a Neglected Zoonotic Disease by the World Health Organization, leptospirosis is a global public health priority.

In the United States and other countries, 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 alsoavailable in some countries outside the United States. 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 that experience significant pain and distress, accounting for over one third of the animalsreported to the USDA in this category. Accordingly, NICEATM, ICCVAM, and its international partners recently identified Leptospira vaccines as one of its top three priorities for development, validation, and implementation of improved alternatives.

About the Workshop

The upcoming workshop will focus on methods and approaches that will 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.

Registration information and a draft workshop agenda are now available on the NICEATM-ICCVAM website. If you are planning to attend the workshop, you must preregister by September 7, 2012; walk-in registration on the day of the workshop will not be available.

NICEATM and ICCVAM also invite the submission of abstracts for scientific poster presentations on current research, development, and validation of alternative methods for Leptospira vaccine potency testing. Abstracts should be submitted by August 13, 2012. Abstract submission guidelines are available on the workshop webpage.

If you have questions about the workshop or would like more information, please contact NICEATM.

About NICEATM and ICCVAM

ICCVAM is an interagency committee composed of representatives from 15 U.S. Federal regulatory and research agencies that require, use, generate, or disseminate toxicological and safety testing information. ICCVAM conducts technical evaluations of new, revised, and alternative safety testing methods with regulatory applicability. ICCVAM also promotes the scientific validation and regulatory acceptance of safety testing methods that more accurately assess the safety and health hazards of chemicals and products and that reduce, refine, or replace animal use.
The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l–3) established ICCVAM as a permanent interagency committee of the NIEHS under NICEATM. NICEATM administers ICCVAM and provides scientific and operationalsupport for ICCVAM technical evaluations and related activities. NICEATM also conducts independent validation studies to assess the usefulness and limitations of new, revised, and alternative test methods and strategies.

NICEATM, ICCVAM, and the ICCVAM member agencies have contributed to the approval or endorsement of over 50 alternative safety testing methods by Federal regulatory agencies and international organizations. Appropriate use of these test methods can significantly reduce animal use and improve animal welfare. Critical research, development, and validation efforts needed to further advance numerous other alternative methods have also been identified.

NICEATM and ICCVAM welcome nominations and submissions of alternative safety testing methods for validation studies and/or technical evaluations. Nominations and submissions are welcome from any individual or organization. Please contact NICEATM at niceatm@niehs.nih.gov for more information or to discuss a possible nomination or submission.

Additional information about other NICEATM and ICCVAM activities can be found on the NICEATM-ICCVAM website.