National Toxicology Program

National Toxicology Program

Workshop on Alternatives for Leptospira Vaccine Testing

Leptospira Workshop Poster September 19-21, 2012
U.S. Department of Agriculture Center for Veterinary Biologics
National Centers for Animal Health
Ames, Iowa  USA

Workshop proceedings available: Biologicals Volume 41 Issue 5 (2013)
View articles on Science Direct website

View workshop summary 

View final workshop program 

This workshop brought together over 80 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 was on methods and approaches that will provide improved accuracy, efficiency, and worker safety, and that are more humane and use fewer or no animals, with the goal of developing a strategy to achieve global acceptance and implementation of scientifically valid alternative methods.

View workshop presentations

Workshop Overview

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 NIH and a Neglected Zoonotic Disease by the World Health Organization, leptospirosis is a global research and public health priority. For example, the National Institute of Allergy and Infectious Diseases is currently funding several major leptospirosis research grants, which include investigations on mechanisms involved in the infectious cycle, enhanced tools for clinical diagnosis, and identification of immunogenic sites for improved immune response.

In the United States, 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 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 animals reported to the U.S. Department of Agriculture in this category.

This workshop brought scientists from around the world together to consider improved methods and approaches for Leptospira vaccine potency testing that may also help reduce, refine, and replace animal use. The workshop was organized by NICEATM in collaboration with ICCVAM and partner organizations in the International Cooperation on Alternative Test Methods. The U.S. Department of Agriculture Center for Veterinary Biologics and the International Alliance for Biological Standardization were sponsors of the workshop. 

Poster Session

A poster session at the workshop featured presentations on current research, development, and validation of alternative methods for Leptospira vaccine potency testing.

View abstracts of posters:

Additional Information

Questions discussed in breakout groups

Draft summary document: "The Economic Burden of Leptospirosis"

List of references relevant to Workshop topics

NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.