USAMRMC – Protect the Warrior, Sustain the Force

Agenda

• What?• Who? • Why?• How?

USAMRMC – Protect the Warrior, Sustain the Force

Program Overview:Rapid Vector Diagnostics for Military Deployments.

COL Russell Coleman, CPT Elizabeth Wanjaand

Professor Michael Faulde

The opinions or assertions contained herein are the private views of the author, and are not to be construed as official, or as reflecting true views

of the Department of the Army or the Department of Defense.

USAMRMC – Protect the Warrior, Sustain the Force

0 1000 2000 3000 4000 5000 6000

Mayaro virusLyme disease

HPSAvian flu

African TrypanosomiasisMuco Leishmaniasis

Lassa fever West Nile fever

American TrypanosomiasisTularemia

Cutaneous LeishmaniasisVEE

PlagueOropouche virus

Q feverMurine Typhus

Japanese encephalitisScrub Typhus

TBESpotted fever grp Typhus

Diarrhea - choleraVisceral Leishmaniasis

HFRSSindbis virus

SchistosomiasisOnyong-nyong virus

Hepatitis E virus Sand fly fever virusDiarrhea - protozoal

BrucellosisCCHF virus

MeningococcalHIV/AIDS

LeptospirosisRift Valley fever virus

Chikungunya virusGonorrhea / chlamydia

Dengue feverMalaria

Diarrhea - bacterial

Global Risk-Severity Index

0 1000 2000 3000 4000 5000 6000

Mayaro virusLyme disease

HPSAvian flu

African TrypanosomiasisMuco Leishmaniasis

Lassa fever West Nile fever

American TrypanosomiasisTularemia

Cutaneous LeishmaniasisVEE

PlagueOropouche virus

Q feverMurine Typhus

Japanese encephalitisScrub Typhus

TBESpotted fever grp Typhus

Diarrhea - choleraVisceral Leishmaniasis

HFRSSindbis virus

SchistosomiasisOnyong-nyong virus

Hepatitis E virus Sand fly fever virusDiarrhea - protozoal

BrucellosisCCHF virus

MeningococcalHIV/AIDS

LeptospirosisRift Valley fever virus

Chikungunya virusGonorrhea / chlamydia

Dengue feverMalaria

Diarrhea - bacterial

Global Risk-Severity Index

Why Vector Diagnostics? • Medical mission is preserve the

fighting force;• Threat is not the arthropods but the diseases they carry;• Knowing what diseases are present and where allows for targeted vector control;

USAMRMC – Protect the Warrior, Sustain the Force

USAMRMC – Protect the Warrior, Sustain the Force

CONOPS• Part of integrated effort (collect, ID arthropod,

pathogen detection, control)• Two-tiered System

– Hand-held assays used by BCT PM staff or PVNTMED Det;

– Molecular assays used by laboratory (AML, FDPMU, AF BAT, CSH, CHPPM…)

• Negative results minimal value, positive results tremendous value– Allow for targeted control efforts;– Get action from non-medical types;

USAMRMC – Protect the Warrior, Sustain the ForceD

oD

Procurement6.3 OMA

A

6.4

Operations & Support

Engineering & Manufacturing Development Production & Deployment

TechnologyDevelopment

ProgramInitiation

B C

Materiel Solution Analysis

6.1 6.2 6.5

Research

User Needs

Technology Opportunities & Resources

MDD

6.7

ICD CDDICD CPD

Product Development Process

CAPABILITY DEVELOPMENT DOCUMENT (CDD)  ARTHROPOD VECTOR RAPID DIAGNOSTIC DEVICES (AV-RDD)

 Increment: I ACAT: III

 Validation & Approval Authority: HQDA Milestone Decision Authority: CG, USAMRMC

 Draft Version 1.8 23 December 2009

USAMRMC – Protect the Warrior, Sustain the Force

Disease/Pathogen Rank Vector Type pathogen Geographic Region

Malaria 1 Mosquito Plasmodium sps. Asia/Africa/South/Cental AmericaDengue virus 3 Mosquito Flavivirus World-wideRift Valley fever virus 4 Mosquito Phlebovirus Africa/Middle EastChikungunya virus 6 Mosquito Alphavirus Africa/Asia/Pacific IslandsCCHF virus 10 Tick Nairovirus Asia/Africa/Middle East/EuropeSand fly fever virus 13 Sand fly Phlebovirus Europe/Middle East/Asia/North AfricaOnyong-nyong virus 16 Mosquito Alphavirus AfricaSindbis virus 17 Mosquito Alphavirus Africa/Middle East/Australia/PhillipinesScrub typhus 19 Mite Orientia tsutsugamushi Asia/Pacific RegionLeishmaniasis, visceral 20 Sand fly Leishmania sps. Asia/Europe/Africa/South/Central AmericaSpotted fever Rickettsia 21 Tick Rickettsia spp. South/Central America/EuropeTick-borne encephalitis virus 23 Tick Flavivirus Europe/AsiaJapanese Encephalitis 24 Mosquito Flavivirus Asia/AustraliaMurine typhus 25 Fleas Rickettsia typhi World-widePlague 27 Fleas Yersinia pestis World-wideVEE virus 28 Mosquito Alphavirus South/Central AmericaOropouche virus 29 Midge Bunyavirus South/Central AmericaLeishmaniasis, cutaneous 30 Sand fly Leishmania sps. South/Central America/Africa/AsiaTularemia 31 Tick Francisella tularensis America/Europe/AsiaTrypanosomiasis, Gambian 32 Tsetse Fly Trypanosoma brucei AfricaWest Nile Virus 33 Mosquito Flavivirus America/Europe/Africa/Middle EastLeishmaniasis, Mucocutaneous 35 Sand fly Leishmania sps. South/Central AmericaTrypanosomiasis, Rhodesiensis 36 Tsetse Fly Trypanosoma brucei AfricaLyme Disease 39 Tick Borrelia sps. America/EuropeMayaro virus 40 Mosquito Alphavirus South/Central America

Militarily Important Arthropod-borne Threat Agents

USAMRMC – Protect the Warrior, Sustain the Force

AV-RDD Kit Priority# Targets per Test Status Disease/Pathogen

Malaria 1 2 Fielded Vivax and falciparum malariaDengue virus 2 1 Ongoing Dengue virusSand fly pathogen 3 2 Ongoing Leishmania (all) and Sand fly fever virus (all)Rift Valley fever virus 4 1 Ongoing Rift Valley fever virusOld-world Leishmania 5 3 Ongoing L. major , L. tropica and L. donovani -complexWest Nile virus 6 1 Fielded West Nile virusTick-borne Pathogens (1) 7 4 CCHF, Lyme Disease, Spotted fever Rickettsia, TularemiaTick-borne pathogens (2) 8 2 Tick-borne and Russian Spring-Summer encephalitis virusesAfrican Mosquito Arbovirus 9 4 Rift Valley fever, Onyong-nyong, Sindbis & Chikungunya virusesAsian Mosquito Arbovirus 10 4 Japanese encephalitis, Chikungunya, West Nile and Dengue virusesNew-world Leishmania 11 4 L. mexicana , L. braziliensis , L. panamensis and L. chagasiTick-borne pathogens (3) 12 2 Lyme Disease, TularemiaMite Pathogens 13 1 Scrub typhusAmerican Mosquito Arbovirus 14 4 VEE, Dengue, Mayaro, and West Nile virusesSand fly fever 15 3 Naples, Sicilian, and Toscana Sand fly fever virusesFlea-borne Pathogens 16 2 Murine typhus, PlagueBiting Midge Pathogens 17 1 Oropouche virusAfrican trypanosomiasis 18 2 Gambian and Rhodesian Trypanosomiasis

Desired Assays

USAMRMC – Protect the Warrior, Sustain the Force

Fielding PlanAV-RDD Kit Priority

No. AV-RDD Kits per

MES

Total MES's

to Outfit*

Total Kits in MES's

Central Stockpile Training

Total Kits Required

No. Required

each Year

Malaria 1 2 288 576 350 74 1000 500Dengue virus 2 2 288 576 350 74 1000 500Sand fly pathogen 3 1 288 288 100 12 400 200Rift Valley fever virus 4 1 288 288 100 12 400 200Old-world Leishmania 5 1 288 288 100 12 400 200West Nile virus 6 0 0 0 100 100 50Tick-borne Pathogens (1) 7 0 0 0 100 100 50Tick-borne pathogens (2) 8 0 0 0 100 100 50African Mosquito Arbovirus 9 0 0 0 100 100 50Asian Mosquito Arbovirus 10 0 0 0 100 100 50New-world Leishmania 11 0 0 0 100 100 50Tick-borne pathogens (3) 12 0 0 0 100 100 50Mite Pathogens 13 0 0 0 100 100 50American Mosquito Arbovirus 14 0 0 0 100 100 50Sand fly fever 15 0 0 0 100 100 50Flea-borne Pathogens 16 0 0 0 100 100 50Biting Midge Pathogens 17 0 0 0 100 100 50African trypanosomiasis 18 0 0 0 100 100 50Total 7 1440 2016 2300 184 4500 2250* Includes 286 Entomology Collecting Kit (PVNTMED Dets) and 2 Endemic Disease Microbiology Kit (AML)

Proposed Fielding Plan

USAMRMC – Protect the Warrior, Sustain the Force

Phased in FieldingAV-RDD Start Fiel FY10 FY11 FY12 FY13 FY14 FY15 FY16 FY17 FY18 FY19 FY20 FY21 FY22 FY23 FY24 FY FY FY Total

Malaria 1995 2003 0West Nile virus 1998 2003 0Rift Valley fever virus 2006 2011 500 500 1,000Dengue virus 2005 2012 350 500 500 1,350Sand fly pathogen 2008 2013 350 350 500 500 1,700Old-world Leishmania 2008 2013 350 350 500 500 1,700Tick-borne Pathogens (1) 2010 2014 100 350 350 500 500 1,800Tick-borne pathogens (2) 2011 2015 100 350 350 500 500 1,800African Mosquito Arbovirus 2012 2016 100 350 350 500 500 1,800Asian Mosquito Arbovirus 2013 2017 100 350 350 500 500 1,800New-world Leishmania 2014 2018 100 350 350 500 500 1,800Mite Pathogens 2015 2019 100 350 350 500 500 1,800Tick-borne pathogens (3) 2016 2020 100 350 350 500 500 1,800American Mosquito Arbovirus 2017 2021 100 350 350 500 500 1,800Sand fly fever 2018 2022 100 350 350 500 500 1,800Flea-borne Pathogens 2019 2023 100 350 350 500 500 1,800Biting Midge Pathogens 2020 2024 100 350 350 500 500 1,800African trypanosomiasis 2021 2025 100 350 350 500 500 1,800Total RDT&E Cost ($K) 1,650 2,150 2,300 2,300 1,800 1,800 1,800 1,800 1,800 1,800 1,800 1,800 1,700 1,350 1,000 500 0 0 27,350

RDT&E (Cost $K)

Phased Fielding

USAMRMC – Protect the Warrior, Sustain the Force

AV-RDD AttributesAttribute Threshold Objective Comments

Cost <$10/target <$5/target Cost/kit = # targets/test * 25 tests/kit)No. of Target/Test 1/test 2-5/testSensitivity >70% >90% Compared to gold-standard non-molecular testsSpecificity >80% >95% Compared to gold-standard non-molecular testsAssay Time 30 mins 15 mins

Shelf-Life 1 yr at 32oC 2 yrs at 32oC

Volume <1 ft3/kit <0.5 ft3/kitWeight <3 lbs/kit <1 lb/kit

Desired Attributes of AV-RDD

USAMRMC – Protect the Warrior, Sustain the Force

Current Status of AV-RDD• Malaria (falciparum and vivax): Fielded• North American Arboviruses

(WN, WEE, SLE, EEE): Fielded• Rift Valley fever virus (Ph II SBIR): Field

studies• Dengue (Ph II SBIR): Lab studies• Leishmaniasis (Ph II SBIR): Lab studies• Sand fly fever virus (Ph II SBIR): Lab studies• Tick-borne pathogen multiplex

(CCHF/TBE/Rickettsia, Ph 1 SBIR): Lab studies

USAMRMC – Protect the Warrior, Sustain the Force

Current Status of AV-RDD

• All previous and current efforts are Immuno-chromatographic wicking assays developed by Dr. Kirti Dave, currently VecTOR Test Systems;

• Diagnostic technology rapidly changing and could be incorporated into this program.

USAMRMC – Protect the Warrior, Sustain the Force

Use of AV-RDD during Deployments

• Malaria VecTEST Assay widely used in Iraq and Afghanistan. – Iraq: Few anophelines, few assays run, no positives.

In 2003/2004 negative data assisted in decision to remove requirement for mandatory malaria chemoprophylaxis;

– Afghanistan: More anophelines, more assays run, a number of positives. Data helped shaped control programs;

• Comments/Thoughts???

USAMRMC – Protect the Warrior, Sustain the Force

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