The workshop was hosted by the National Center of Excellence for Zoonotic and Animal Disease Defense (ZADD), a Department of Homeland Security Science and Technology Center of Excellence that is co-led by Institute for Infectious Animal Diseases (IIAD) and the Center of Excellence for Emerging and Zoonotic Animal Diseases (CEEZAD). The groups this week released a report from the workshop titled "Defining Requirements for International Field Trials for Conventional and Next-Generation Foot and Mouth Disease (FMD) Virus Vaccines and Diagnostics."
Funding for this workshop was provided by the U.S. Department of Homeland Security Science and Technology Directorate, Homeland Security Advanced Research Projects Agency, Chemical and Biological Defense Division, Agricultural Defense Branch and 49 participants representing scientific and food-security organizations, universities and animal-health companies from around the world.
A primary objective of the workshop was to discuss how to best succeed at the execution of an international field trial of the conditionally licensed live adenovirus vectored vaccine (hAd5-FMD) and VRMD 3B enzyme linked immunosorbent assay (ELISA).
For safety reasons, most FMD vaccines currently in use around the world are killed-virus vaccines, which are useful in controlling the disease but have limitations, such as lack ability to confer cross-protection between and within serotypes, limited shelf life, need for re-vaccination every 4 to 12 months and possible interference with the ability to serologically differentiate infected from vaccinated animals.
However, according to the report, the second-generation hAd5-FMD vaccine for serotype A/subtype A24 Cruzeiro, which can be safely manufactured within the United States, has recently been developed and conditionally licensed by the USDA Centers for Veterinary Biologics. Numerous hAd5-FMD monovalent vaccine candidates for major serotypes A, O,Asia-1 and SAT2 have been tested in cattle in proof-of-concept safety and efficacy studies and have been shown to be as effective as conventional (normal- potency) vaccines against experimental FMD challenge.
Other objectives of the workshop included:
· Establish a common understanding of DHS goals and objectives for working with the global community on the further characterization of the FMD virus vaccine, live adenovirus vectored vaccine (hAd5-FMD) and VRMD 3B enzyme linked immunosorbent assay (ELISA).
· Develop an approach to keep all interested stakeholders informed of the project progress in a transparent and timely manner.
· Identify potential field trial locations and partners.
· Establish recommendations for performing international field trials to include, but not be limited to field trial processes, study protocols, test plans, evaluation, and regulatory requirements, validation requirements for companion diagnostics and concept of operations for testing.
· Develop a general understanding of the regulatory approval processes for vaccines and diagnostics in the U.S. and in countries potentially interested in collaborating on this project;
· Discuss and understand the best approach to incentivize participation at the country and individual producer level.
The full report is available online from IIAD.