Roxann Motroni, DVM, PhD AAAS Fellow Agriculture Defense Branch Chemical and Biological Defense Division Science and Technology Directorate International Foot-and- Mouth Disease Vaccine and Diagnostic Field Trial Global Foot and Mouth Disease Research Alliance Scientific Meeting October 2015
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Roxann Motroni, DVM, PhD AAAS Fellow Agriculture Defense Branch Chemical and Biological Defense Division Science and Technology Directorate International.
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Roxann Motroni, DVM, PhD
AAAS Fellow Agriculture Defense BranchChemical and Biological Defense DivisionScience and Technology Directorate
International Foot-and-Mouth Disease Vaccine and Diagnostic Field Trial
Global Foot and Mouth Disease Research Alliance Scientific Meeting
October 2015
Agricultural Defense Mission
The Agricultural Defense mission is to enhance current capabilities and develop state-of-the-art countermeasures for
high-priority foreign animal diseases (FAD). This includes near- and long-term research and development for vaccines and
diagnostics, in coordination with internal and external stakeholders.
HSPD-9 Paragraph 23: The Secretaries of [DHS, USDA, HHS, EPA…] in consultation with the Director of the Office of Science and Technology Policy, will accelerate and expand development of current and new countermeasures against the intentional introduction or natural occurrence of catastrophic animal, plant, and zoonotic diseases. The Secretary of Homeland Security will coordinate these activities.
Minimum Protective Dose (MPD) Studies:•14 days post single dose vaccination (n=34 vaccinates)
94 % SVN positive 97% protection against generalized disease 91% protection against plasma viremia (VI, rRT-PCR)
•7 days post single dose vaccination (n=10 vaccinates) 50% SVN positive 100% protection against generalized disease 90% protection against plasma virema (VI, rRT-PCR)
•Product release dose (‘normal potency’) is 15.8 X MPD
• 100% (12/12) protected against generalized disease and viremia following direct contact challenge at 1 week post-single dose vaccination (Grubman, MJ, et. al. 2010. Future Virol. 5(1):51-64.)
• 88% (91/104) of the vaccinated animals tested from the Field Safety Study had positive FMDV SVN titers (>0.9 log10) at approximately 12 months post-single dose vaccine administration
2. 9 AdFMD vaccine candidates have been identified for master seed virus production• 4 MSVs have CVB approval, 1 is very near approval and 4 will be
submitted in the next quarter for approval.
3. AdFMD candidates for 6 of 7 major serotypes• Multiple, serotype A candidates• Multiple serotype O candidates• Includes vaccine candidates for most recent outbreaks in S. Korea
(O/South Korea/2010) and Egypt (SAT2/Egypt/2012)
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The question remains, how will this vaccine and companion
diagnostic platform perform in an endemic and/or outbreak
situation?
International Vaccine and Diagnostic Trial Objectives
Demonstrate effectiveness of Ad5 vectored, multivalent developmental vaccine in an outbreak and/or endemic situation Critical to establishing efficacy and promoting commercial potential.
Demonstrate process for using vaccine and companion Differentiating Infected from Vaccinated Animals (DIVA) diagnostic in a disease situation
Build international partnerships to facilitate future trials in endemic settings
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Overarching Goal
Identify and foster the development of collaborative opportunities for international
partnerships to further advance the state of the art for FAD vaccines and diagnostics
12Build enduring partnerships for the future
Tasks
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1 - Workshop(s) to identify partner countries and detailed plan for case-control study and validating 3B DIVA diagnostic assay in endemic countries2 - Production of additional master seed viruses needed for the bi- or tri-valent vaccine
Analysis of data and final report
Procurement of required vaccine and diagnostic kits
Begin field study, initial study period of 6 months
If vaccine efficacious at 6 months, continue study to 12 and 18 mo. time points to obtaininformation related to duration of immunity, effect of boostering, and serological response to vaccine
Future possibility of additional trials with African or Classical Swine Fever vaccines, or additional FMD vector platforms in other countries
Begin in country planning for vaccine trial
A series of meetings/workshops to establish a common understanding of DHS goals and objectives
Discuss logistical considerations and how to best succeed at the execution of an international with Adenovirus Vectored vaccine and the companion 3B ELISA (short term)
Establish general recommendations for international field trials
Identify potential field trial locations and partners for current and future collaborations (Notice of Intent to CRADA)
Release an “Expression of Interest” for potential partners to respond to once the study requirements and design are established
Vaccine and Diagnostic Trial Approach
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Defining Requirements for International Field Trials for Conventional and Next-Generation Foot and Mouth Disease Virus (FMDV) Vaccines and Diagnostics
Washington, DC June 10-12th, 2014
The project working groups have reevaluated all of the recommendations made at the workshop and made revisions where necessary.
Preference for a cluster randomized trial and baseline epidemiologic study in partner country prior to the field trial to better inform the study design.
Finalized the criteria for country selection and developed a country outreach strategy. Also, developing the expression of interest to go to partner countries.
Starting to work through regulatory requirements but will need more input when a partner country is selected.
Project Progress to Date
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Questions?
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If interested in additional information please contact;Roxann Motroni DVM, PhDAAAS Fellow, Agricultural DefenseChemical and Biological Defense DivisionHomeland Security Advanced Research Projects AgencyScience and Technology [email protected]