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 Wanja
and
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
Diarrhea - bacterial
Malaria
Dengue fever
Gonorrhea / chlamydia
Chikungunya virus
Rift Valley fever virus
Leptospirosis
HIV/AIDS
Meningococcal
CCHF virus
Brucellosis
Diarrhea - protozoal
Sand fly fever virus
Hepatitis E virus
Onyong-nyong virus
Schistosomiasis
Sindbis virus
HFRS
Visceral Leishmaniasis
Diarrhea - cholera
Spotted fever grp Typhus
TBE
Scrub Typhus
Japanese encephalitis
Murine Typhus
Q fever
Oropouche virus
Plague
VEE
Cutaneous Leishmaniasis
Tularemia
American Trypanosomiasis
West Nile fever
Lassa fever
Muco Leishmaniasis
African Trypanosomiasis
Avian flu
HPS
Lyme disease
Mayaro virus
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;
0
1000
2000
3000
4000
Global Risk-Severity Index
5000
6000
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 Force
Product Development Process
User Needs
Technology Opportunities & Resources
MDD
DoD
ICD
Research
6.1
6.2
A
B
Materiel ICD
Solution
Technology
Analysis
Development
6.3
CDD
Program
Initiation
C
Engineering &
Manufacturing
Development
6.4
6.5
CPD
Production & Deployment
Procurement
6.7
Operations
& Support
OMA
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
Militarily Important
Arthropod-borne
Threat Agents
Disease/Pathogen
Rank
Malaria
Dengue virus
Rift Valley fever virus
Chikungunya virus
CCHF virus
Sand fly fever virus
Onyong-nyong virus
Sindbis virus
Scrub typhus
Leishmaniasis, visceral
Spotted fever Rickettsia
Tick-borne encephalitis virus
Japanese Encephalitis
Murine typhus
Plague
VEE virus
Oropouche virus
Leishmaniasis, cutaneous
Tularemia
Trypanosomiasis, Gambian
West Nile Virus
Leishmaniasis, Mucocutaneous
Trypanosomiasis, Rhodesiensis
Lyme Disease
Mayaro virus
1
3
4
6
10
13
16
17
19
20
21
23
24
25
27
28
29
30
31
32
33
35
36
39
40
Vector
Type pathogen
Mosquito
Plasmodium sps.
Mosquito
Flavivirus
Mosquito
Phlebovirus
Mosquito
Alphavirus
Tick
Nairovirus
Sand fly
Phlebovirus
Mosquito
Alphavirus
Mosquito
Alphavirus
Mite
Orientia tsutsugamushi
Sand fly
Leishmania sps.
Tick
Rickettsia spp.
Tick
Flavivirus
Mosquito
Flavivirus
Fleas
Rickettsia typhi
Fleas
Yersinia pestis
Mosquito
Alphavirus
Midge
Bunyavirus
Sand fly
Leishmania sps.
Tick
Francisella tularensis
Tsetse Fly Trypanosoma brucei
Mosquito
Flavivirus
Sand fly
Leishmania sps.
Tsetse Fly Trypanosoma brucei
Tick
Borrelia sps.
Mosquito
Alphavirus
Geographic Region
Asia/Africa/South/Cental America
World-wide
Africa/Middle East
Africa/Asia/Pacific Islands
Asia/Africa/Middle East/Europe
Europe/Middle East/Asia/North Africa
Africa
Africa/Middle East/Australia/Phillipines
Asia/Pacific Region
Asia/Europe/Africa/South/Central America
South/Central America/Europe
Europe/Asia
Asia/Australia
World-wide
World-wide
South/Central America
South/Central America
South/Central America/Africa/Asia
America/Europe/Asia
Africa
America/Europe/Africa/Middle East
South/Central America
Africa
America/Europe
South/Central America
USAMRMC – Protect the Warrior, Sustain the Force
Desired Assays
# Targets
AV-RDD Kit
Priority per Test
Malaria
1
2
Dengue virus
2
1
Sand fly pathogen
3
2
Rift Valley fever virus
4
1
Old-world Leishmania
5
3
West Nile virus
6
1
Tick-borne Pathogens (1)
7
4
Tick-borne pathogens (2)
8
2
African Mosquito Arbovirus
9
4
Asian Mosquito Arbovirus
10
4
New-world Leishmania
11
4
Tick-borne pathogens (3)
12
2
Mite Pathogens
13
1
American Mosquito Arbovirus 14
4
Sand fly fever
15
3
Flea-borne Pathogens
16
2
Biting Midge Pathogens
17
1
African trypanosomiasis
18
2
Status
Disease/Pathogen
Fielded Vivax and falciparum malaria
Ongoing Dengue virus
Ongoing Leishmania (all) and Sand fly fever virus (all)
Ongoing Rift Valley fever virus
Ongoing L. major , L. tropica and L. donovani -complex
Fielded West Nile virus
CCHF, Lyme Disease, Spotted fever Rickettsia, Tularemia
Tick-borne and Russian Spring-Summer encephalitis viruses
Rift Valley fever, Onyong-nyong, Sindbis & Chikungunya viruses
Japanese encephalitis, Chikungunya, West Nile and Dengue viruses
L. mexicana , L. braziliensis , L. panamensis and L. chagasi
Lyme Disease, Tularemia
Scrub typhus
VEE, Dengue, Mayaro, and West Nile viruses
Naples, Sicilian, and Toscana Sand fly fever viruses
Murine typhus, Plague
Oropouche virus
Gambian and Rhodesian Trypanosomiasis
USAMRMC – Protect the Warrior, Sustain the Force
Proposed Fielding Plan
Fielding Plan
No.
Total
No.
AV-RDD MES's Total
Required
Kits per
to
Kits in Central
Total Kits
each
AV-RDD Kit
Priority MES Outfit* MES's Stockpile Training Required
Year
Malaria
1
2
288
576
350
74
1000
500
Dengue virus
2
2
288
576
350
74
1000
500
Sand fly pathogen
3
1
288
288
100
12
400
200
Rift Valley fever virus
4
1
288
288
100
12
400
200
Old-world Leishmania
5
1
288
288
100
12
400
200
West Nile virus
6
0
0
0
100
100
50
Tick-borne Pathogens (1)
7
0
0
0
100
100
50
Tick-borne pathogens (2)
8
0
0
0
100
100
50
African Mosquito Arbovirus
9
0
0
0
100
100
50
Asian Mosquito Arbovirus
10
0
0
0
100
100
50
New-world Leishmania
11
0
0
0
100
100
50
Tick-borne pathogens (3)
12
0
0
0
100
100
50
Mite Pathogens
13
0
0
0
100
100
50
American Mosquito Arbovirus
14
0
0
0
100
100
50
Sand fly fever
15
0
0
0
100
100
50
Flea-borne Pathogens
16
0
0
0
100
100
50
Biting Midge Pathogens
17
0
0
0
100
100
50
African trypanosomiasis
18
0
0
0
100
100
50
Total
7
1440 2016
2300
184
4500
2250
* Includes 286 Entomology Collecting Kit (PVNTMED Dets) and 2 Endemic Disease Microbiology Kit (AML)
USAMRMC – Protect the Warrior, Sustain the Force
PhasedinFielding
Phased
Fielding
RDT&E (Cost $K)
AV-RDD
Start Fiel FY10 FY11 FY12 FY13 FY14 FY15 FY16 FY17 FY18 FY19 FY20 FY21 FY22 FY23 FY24 FY FY FY Total
Malaria
1995 2003
0
West Nile virus
1998 2003
0
Rift Valley fever virus
2006 2011 500 500
1,000
Dengue virus
2005 2012 350 500 500
1,350
Sand fly pathogen
2008 2013 350 350 500 500
1,700
Old-world Leishmania
2008 2013 350 350 500 500
1,700
Tick-borne Pathogens (1)
2010 2014 100 350 350 500 500
1,800
Tick-borne pathogens (2)
2011 2015
100 350 350 500 500
1,800
African Mosquito Arbovirus 2012 2016
100 350 350 500 500
1,800
Asian Mosquito Arbovirus
2013 2017
100 350 350 500 500
1,800
New-world Leishmania
2014 2018
100 350 350 500 500
1,800
Mite Pathogens
2015 2019
100 350 350 500 500
1,800
Tick-borne pathogens (3)
2016 2020
100 350 350 500 500
1,800
American Mosquito Arbovirus 2017 2021
100 350 350 500 500
1,800
Sand fly fever
2018 2022
100 350 350 500 500
1,800
Flea-borne Pathogens
2019 2023
100 350 350 500 500
1,800
Biting Midge Pathogens
2020 2024
100 350 350 500 500
1,800
African trypanosomiasis
2021 2025
100 350 350 500 500
1,800
Total RDT&E Cost ($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
USAMRMC – Protect the Warrior, Sustain the Force
Desired Attributes of AV-RDD
Attribute
Threshold Objective
Comments
AV-RDD
Attributes
Cost
<$10/target
<$5/target Cost/kit
= # targets/test * 25 tests/kit)
No. of Target/Test
Sensitivity
Specificity
Assay Time
1/test
>70%
>80%
30 mins
2-5/test
>90%
>95%
15 mins
Shelf-Life
1 yr at 32oC 2 yrs at 32oC
Volume
Weight
<1 ft3/kit
<3 lbs/kit
<0.5 ft3/kit
<1 lb/kit
Compared to gold-standard non-molecular tests
Compared to gold-standard non-molecular tests
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 Immunochromatographic 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