September 19-21, 2012
U.S. Department of Agriculture Center for Veterinary Biologics
National Centers for Animal Health
Ames, Iowa USA
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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.
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 USDA in
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.
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:
Questions discussed in breakout groups
Draft summary document:
"The Economic Burden of Leptospirosis"
View list of references relevant to Workshop topics