Tularemia Vaccine Development Contract: Semi-Annual Technical Report
Period: 4/01/2009 to 9/30/2009
Due Date: 10/15/2009 and Prepared by: C. Rick Lyons, Barbara Griffith, Terry Wu, Bob
Sherwood, Julie Wilder, Julie Hutt, Michelle Valderas, Trevor Brasel, Dana Pohlman, Mitch
Magee, Kathryn Sykes, Stephen Johnston, Karl Klose, Bernard Arulanandam, Justin Skoble
Contract No.
ADB Contract No.
HHSN266200500040-C
N01-AI-50040
Contract Title:
Tularemia Vaccine Development Team
Performance Period: 4/1/09 to 9/30/09
Contractor Name:
University of New Mexico Health Science Center
Contractor Address: Controller’s Office MSC-09-5220
1 University of New Mexico
Albuquerque, New Mexico 87131-0001
Authors:
C. Rick Lyons, MD, PhD and Barbara B. Griffith, MS
Date of submission: 10/14/2009
Semi-Annual
Technical Report:
Based on Contributions from ASU, Cerus/Aduro,
LBERI, UNM and UTSA
Page 1 of 11
Tularemia Vaccine Development Contract: Semi-Annual Technical Report
Period: 4/01/2009 to 9/30/2009
Due Date: 10/15/2009 and Prepared by: C. Rick Lyons, Barbara Griffith, Terry Wu, Bob
Sherwood, Julie Wilder, Julie Hutt, Michelle Valderas, Trevor Brasel, Dana Pohlman, Mitch
Magee, Kathryn Sykes, Stephen Johnston, Karl Klose, Bernard Arulanandam, Justin Skoble
Contract No. HHSN266200500040-C
ADB Contract No. N01-AI-50040
Section I: Purpose and Scope of Effort
The Tularemia Vaccine Development Contract will lead to vaccine candidates, two animal
models and cellular assays vital for testing vaccine efficacy.
Sections II and III: Progress and Planning Presented by Institution
Active milestones: 2, 8, 9, 10, 11(UNM/LBERI), 12/13(UNM/LBERI), 14, 17, 18, 19,
21(UNM/LBERI), 29 (UNM/LBERI), 35(ASU/UNM), 36, 49, 52, 53, 54, 55, 56, 57
Completed milestones: 1, 3, 4, 5, 6, 7, 16, 25, 26, 27, 28, 32, 33, 34 (UNM/ASU), 39, 40,
43 (UTSA), 48, 50, 51
Inactive milestones: 15, 20, 22, 23, 24, 30, 37, 38, 59
Milestones terminated after initiation: 41, 42, 44, 46, (MSCR will be written)
Milestones terminated before initiated: 43 (Cerus), 45, 47, 58, (MSCR will not be written)
See the attached 8 Powerpoint presentations annotated with minutes and 1 Word
document for “Year 5: What to Finish? What Resources to Use?”
1. UNM: Terry Wu- Fischer 344 Rat Model
2. LBERI: Bob Sherwood, Trevor Brasel, Michelle Valderas, Julie Wilder, Julie HuttNHP Model: SCHU S4 Natural History and Vaccination/Challenge
3. ASU: Kathryn Sykes and Mitch Magee- Progress toward identification of
Francisella tularensis subunit vaccine candidates using the proteome and
transcriptome approaches
4. UTSA: Karl Klose and Bernard Arulanandam- F. tularensis attenuated vaccine
strain construction and evaluation
5. Cerus/Aduro: Justin Skoble- Vaccine candidates: Ft antigens presented with
Listeria platform
6. Cerus/Aduro/ASU/UTSA: Justin Skoble, Kathryn Sykes, Mitch Magee, Karl
Klose-Selection of vaccine candidates from Proteome/Transcriptome/Genetic
Mutant Approaches
7. UNM/LBERI: Terry Wu and Julie Wilder- Update on Immunoassays and
Correlates of protection
8. UNM/LBERI: Terry Wu, Bob Sherwood, Julie Hutt, Michelle Valderas, Rick
Lyons, Julie Wilder- Models comparison: Mouse, Rat, NHP, Human-Protection,
Immunology, Pathology
9. Annual meeting “Year 5: What to finish? What resources to use?: Rick Lyons
Page 2 of 11
Tularemia Vaccine Development Contract: Semi-Annual Technical Report
Period: 4/01/2009 to 9/30/2009
Due Date: 10/15/2009 and Prepared by: C. Rick Lyons, Barbara Griffith, Terry Wu, Bob
Sherwood, Julie Wilder, Julie Hutt, Michelle Valderas, Trevor Brasel, Dana Pohlman, Mitch
Magee, Kathryn Sykes, Stephen Johnston, Karl Klose, Bernard Arulanandam, Justin Skoble
Sections IV: Contract Expenditures and Subcontractor Billing
1. % work completed vs. %cumulative costs incurred to date with regard to planned
effort and proposed budget
The active Milestones over the past 6 months have been: 2, 7, 8, 9, 10, 11(UNM &LBERI), 12/13 (UNM
&LBERI), 14, 17, 18, 19, 21 (UNM &LBERI), 29(UNM &LBERI), 35(UNM/ASU), 36, 49, 50, 52, 53, 54, 55,
56, 57. One active milestone (UNM 12/13) currently is over budget, though the budgets for many
Milestones have been adjusted as noted on the FRMs and/or notes below. The other five milestones that
are over budget are either terminated or 100% work completed.
To date, NIAID has been billed for scientific activity on Milestones 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12/13
(UNM &LBERI), 14, 16, 17,18, 19, 21 (UNM &LBERI), 25, 26, 27, 28, 29, 32, 33, 34(UNM/ASU),
35(UNM/ASU), 36, 39, 40, 41, 42, 43 (UTSA), 44, 46, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57.
Data associated with most current UNM invoice submitted to NIAID (parallels Financial Report by Milestone
and lags behind current Technical Report)
Milestone
% invoiced
2-UNM
2-LBERI
3- LBERI
4-LBERI
5-UNM
7-LBERI
8-LBERI
9-LBERI
10-LBERI
10-UNM
11-UNM
11-LBERI
12/13-UNM
12/13-LBERI
14-UNM
16-UTSA
17-UNM
18-UNM
19-UNM
21-UNM
21-LBERI
25-ASU
26-ASU
27-UNM
28-ASU
29-LBERI
0
87.4
100.8
82.4
100
89.8
83.6
3
0
0.9
59.5
33.2
100.1
70.5
11.4
100
0
0.2
94.9
82.9
10.9
100
100
100.1
103.9
1.2
% work
completed
77
76
100
100
100
100
70
45
2
3
66
50
80
91
5
100
0
5
27
74
8
100
100
100
100
16
Over
budget?
No
No
Yes
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
Yes
No
Discrepancy?
See explanation below #4
See explanation below #3
See explanation below #3
See explanations below #3
NA
See budget note below #3
See budget note below #3
See explanation below #3
See explanation below #3
NA
See budget note below #4.
See explanation & budget note below #3
See budget explanation below #4
See budget explanation below #3
See explanation below #4
See budget note below #5
See budget explanation #4 below
See explanation below #4
See explanation below #4
See budget explanation #4 below
NA
NA
See budget note below #1
See budget note below #4
See explanations below #1
See explanation below #3
Page 3 of 11
Tularemia Vaccine Development Contract: Semi-Annual Technical Report
Period: 4/01/2009 to 9/30/2009
Due Date: 10/15/2009 and Prepared by: C. Rick Lyons, Barbara Griffith, Terry Wu, Bob
Sherwood, Julie Wilder, Julie Hutt, Michelle Valderas, Trevor Brasel, Dana Pohlman, Mitch
Magee, Kathryn Sykes, Stephen Johnston, Karl Klose, Bernard Arulanandam, Justin Skoble
29-UNM
32-ASU
33-ASU
34-UNM
34-ASU
35-ASU
35-UNM
36-ASU
39-UTSA
40-Cerus
41-Cerus
42-Cerus
43-Cerus
43-UTSA
44-Cerus
45-Cerus
46-Cerus
47-Cerus
48-UTSA
49-UTSA
50-UTSA
51-UTSA
52-UTSA
53-UTSA
55-Cerus
56-Cerus
57-Cerus
58-Cerus
59-Cerus
27.3
100
100
100
100
96
27.8
0
100
100
104.2
110.9
0
100
144.3
0
100
0
100
90.8
96.7
94.6
55.1
28.2
77.2
58.2
33.7
0
0
25
100
100
100
100
90
35
15
100
100
85
25
0
100
5
0
53
0
100
96
100
100
68
23.5
65
45
25
0
0
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
NA
NA
NA
See budget note below #4
NA
See budget note below#4
NA
See explanation below #1
See budget below #5
NA
See explanation below #2
See explanation below #2
See explanation below #2
See budget note below #5
See explanation below #2
See explanation below #2
See explanation below #2
See explanation below #2
See budget note below #5
NA
See budget note below #5
See budget note below #5
NA
NA
See explanation below #2
See explanation below #2
See explanation below #2
See budget note below #2
See budget note below #2
Discrepancy Explanations
1. ASU
MS 26: This milestone was going over budget as of 11/26/07, until ASU moved $3,000 from MS28 to
MS26 on 11/26/07, $25,000 from MS35 to MS26 on 2/13/08 and $33,033 from MS38 to MS26 on 7/17/08
to increase the original budget for MS26 by $61,033 to a current total budget of $355,239. The original
budget for MS26 was $294,206. This milestone is 100% scientifically completed.
MS 28: This milestone was going over budget as of 2/13/08, partially due to ASU moving $3,000 from
MS28 to MS26 on 11/26/07. Later ASU moved $25,000 from MS35 to MS28 on 2/13/08. This increased
the original budget for MS28 by a net $22,000 to a current total budget of $771,572. The original budget
for MS28 was $749,572. MS 28 is over budget at 103.9% invoiced but the work is 100% completed.
MS 35: On 2/13/08, ASU retrospectively moved $50K from MS35 and put $25K into MS26 and $25K into
MS28 budgets since MS26&28 were approaching fully expensed without being 100% work completed.
$378,916 is the current budget for MS 35.
MS 36: This milestone has no budget as it was to be a decision point/integration of data. MS 36 is 15%
done and 0% invoiced.
Page 4 of 11
Tularemia Vaccine Development Contract: Semi-Annual Technical Report
Period: 4/01/2009 to 9/30/2009
Due Date: 10/15/2009 and Prepared by: C. Rick Lyons, Barbara Griffith, Terry Wu, Bob
Sherwood, Julie Wilder, Julie Hutt, Michelle Valderas, Trevor Brasel, Dana Pohlman, Mitch
Magee, Kathryn Sykes, Stephen Johnston, Karl Klose, Bernard Arulanandam, Justin Skoble
2. CERUS
MS 41, 42, 44, 46: These 4 Milestones were terminated for scientific reasons, outlined in subcontractor
modification 4r2 in the revised statement of work. The residual funding was moved into Cerus’ new
Milestones 55 through 59, which are developing the Listeria platform for Ft antigen vaccines. As of
9/10/09, as outlined in subcontractor modification 4r4 in the revised statement of work, funds were
returned to MS 41, 42, 44, and 46 to cover the expenses associated with Milestone Completion Reports.
With an upcoming adjustment to the budgets on these 4 milestones, they will no longer be over budget.
MS 43, 45 and 47: These 3 Milestones were never initiated and were terminated for scientific reasons,
outlined in subcontractor modification 4r2 in the revised statement of work. The residual funding was
moved into Cerus’ new Milestones 55 through 59, which are developing the Listeria platform for Ft
antigen vaccines.
MS 55, 56, 57: Cerus started Milestones 55, 56 and 57 originally with Anza as a service provider and
then continued with Aduro Biotech as the service provider. Anza Therapeutics ceased to exist due to the
economic downturn and the team of scientists on the TVDC project moved to Aduro Biotech. UNM
expects the % invoiced to reconcile with the % work completed, before the milestone technical work is
completed.
MS 58: This Milestone was never initiated and was terminated for scientific reasons, outlined in
subcontractor modification 4r4 in the revised statement of work. The residual funding was moved into
Cerus’ Milestones 55, 56, and 57 which are developing the Listeria platform for Ft antigen vaccines and
also to Milestones 40-47 to cover expenses associated with Milestone Completion Reports.
MS 59: This Milestone has not been opened but had the budget reduced for scientific reasons outlined in
subcontractor modification 4r4 in the revised statement of work. The some funding was moved into
Cerus’ Milestones 55, 56, and 57 which are developing the Listeria platform for Ft antigen vaccines and
also to Milestones 40-47 to cover expenses associated with Milestone Completion Reports
3. LBERI
MS 2: LBERI increased the MS 2 budget from $28,060 to $33060 in November 2008. The increase in
budget decreased the % completed from the prior 99% to the current 87.4%. There is no discrepancy
between the 87.4% invoiced and the 76% work completed. LBERI MS2 will reach 100% completed when
up to 9 more UNM and LBERI staff are vaccinated in 2009 to 2010.
MS 3: LBERI is slightly over budget by 0.8% on MS3. This milestone is completed and the milestone
completion report is in progress.
MS4 Bob Sherwood approved moving $50,000 from MS4 and into MS12/13 on 9/27/07. So the original
budget of $422,939 dropped to $372,939 on MS4. On 7/23/08, Bob Sherwood/Dana Pohlman approved
moving $50K from MS 7 and into MS4 so budget returned to the original budget of $422,939
On 8.28.08 Dana Pohlman approved moving $6K from MS11 and into MS4 so budget increased to
$428,939. On 11/10/08 Dana Pohlman requested moving $150,000 from MS 8 to MS 4, increasing the
budget of $428,939 to $578,939. MS 4 is completed and the MSCR is in progress. The though there is a
slight discrepancy between the 82.4% invoiced and the 100% work completed, the milestone is done.
MS 7: There is little discrepancy between the 89.8% invoiced and the 100% work completed, as the
ED50 of SCHU S4 aerosols in NHP work is completed. On 12/21/08 Dana Pohlman authorized $14,379
to be moved from MS3 into MS7 and moving $75K from MS11 into MS7. The budget for MS7 increased
Page 5 of 11
Tularemia Vaccine Development Contract: Semi-Annual Technical Report
Period: 4/01/2009 to 9/30/2009
Due Date: 10/15/2009 and Prepared by: C. Rick Lyons, Barbara Griffith, Terry Wu, Bob
Sherwood, Julie Wilder, Julie Hutt, Michelle Valderas, Trevor Brasel, Dana Pohlman, Mitch
Magee, Kathryn Sykes, Stephen Johnston, Karl Klose, Bernard Arulanandam, Justin Skoble
by $89,379, increasing the MS 7 contract amount to $378,863 and leaving a balance of $59,138. Prior to
the $89,379 increase, the MS 7 budget had been $289,484 on 12/2/08 and originally in 2005 the MS7
budget had been $324,484. On 03/24/09, the MS 7 budget $378863 was over spent ($134,999). Dr.
Lyons approved a transfer of $170,000 from MS 10 to MS 7, as LBERI requested. The current budget
with transfer is $548,863.
MS 8: There is little discrepancy between the 83.6% invoiced and the 70% work completed. On 11/10/08
Dana Pohlman requested moving $260,000 from MS 8 to MS 2, 3, 4, and 12. This reduced the budget of
$763,448 to $503,448. On 12/2/08, Bob and Dana authorized a $75,000 reduction in MS8 budget and
increase in MS 7 budget. So MS8 budget dropped from 504,448 to 428,448. At NIAID’s request, the
protective efficacy of 4 lots of LVS is being performed under MS8. The budget will be monitored through
this additional study on MS8C.
MS 9: LBERI appears under budget on MS 9 which is 3% invoiced and 45% work completed. Additional
work to tighten the SCHU S4 presented dose is likely to increase the funding spent, before reaching
100% work completed.
MS 10: LBERI started work on MS 10, with the understanding that testing other lots of LVS (e.g.
USAMMDA IND 157 lot) would be performed under MS10. The current NIAID Project Officer required
UNM to test the USAMMDA LVS under MS 8. So some work was reported on MS10 but then moved to
MS 8.
MS 11: LBERI’s natural history study under MS 11 has completed the non-telemetered arm and is nearly
complete for the telemetered arm of the study. MS 11 is at 33.2% invoiced and 50% work completed.
When the telemetered arm is completed, LBERI expects the % invoiced and % work completed to each
reach 100%. On 8.28.08 Dana Pohlman approved moving $6K from MS11 and into MS4 so budget
decreased to $831,752. On 12/21/08 Dana Pohlman approved moving $75K from MS11 to increase the
budget for MS7. The MS11 budget decreased to $756,752. The prior MS 11 budget had been $831,752
MS 12&13: This milestone was going over budget as of 9/27/07, until LBERI moved $50,000 from MS4 to
MS 12&13 on 9/27/07, $10,000 from MS 7 to MS12&13 on 6/6/08 and $50,000 from MS7 to MS 12&13
on 7/23/08 to increase the budget for MS 12&13 by $110,000 to a current total budget of $204,696. The
original budget for MS12&13 was $94,696. On 11/10/08, Dana Pohlman requested moving $100K from
MS8 to MS 12 increasing this budget of $204, 696 to $304,696. Please note that on the 10/14/08 semiannual report, 78.2% invoiced and 73% completed was reported for MS12&13. MS 12&13 are “assays
for detecting relevant immune responses in animals and humans developed and compared to those in
other species”. Dr. Lyons extended the duration of MS12&13 to 12/31/2009, due to the addition of the
microagglutination assay by NIAID Project Officer. Dr. Lyons wants to keep Dr. Wilder’s immunoassay
development under MS12&13.
MS 29: LBERI’s role on MS 29 is to provide cells from vaccinated NHP to UNM for testing ASU
polypeptides in an ELIspot assay. The discrepancy between 1.2% invoiced and 16% work completed will
diminish when the second LVS vaccinated NHP is boosted and harvested for the next round of screening
the ASU polypeptides in the T cell assay at UNM.
Page 6 of 11
Tularemia Vaccine Development Contract: Semi-Annual Technical Report
Period: 4/01/2009 to 9/30/2009
Due Date: 10/15/2009 and Prepared by: C. Rick Lyons, Barbara Griffith, Terry Wu, Bob
Sherwood, Julie Wilder, Julie Hutt, Michelle Valderas, Trevor Brasel, Dana Pohlman, Mitch
Magee, Kathryn Sykes, Stephen Johnston, Karl Klose, Bernard Arulanandam, Justin Skoble
4. UNM
MS 2- MS 2 has no budget and is 77% work completed. The expenses for MS 2 (LVS vaccinations for
relevant personnel) consist of the UNM administrative oversight of the LVS vaccinations and also the
travel and health screenings for the LVS vaccinees. The administrative costs are not covered under
Milestone budgets. The travel and health screening costs are included under the “Occupational Health”
expense category, which was not included in the Milestone budgets. In the past year, 33 LBERI and 4
UNM staff/scientists completed the one year post vaccination health screenings. Nine more potential
vaccinees are preparing for LVS vaccinations in November 2009 and January 2010.
MS 11: In April 2009, UNM moved $89,326 expense to MS 11 that had previously been charged to MS
17 incorrectly (charges added to Oct 08-March 09)-as per Dr. Lyons/Terry Wu 04/10/09.
MS12/13: On 6/11/09, UNM moved $12,631 from completed MS5 into MS 12/13. MS12/13 budget
increased to $149,163. So MS 12/13 is not over budget currently, but will go over budget with additional
development for the microagglutination assay.
MS 14: The discrepancy between the 11.4% invoiced and the 5% work completed is due to the
developmental nature of this milestone. UNM will reassess whether some milestones should be
consolidated.
MS 17: In April 2009, UNM moved $89,326 expense to MS 11 that had previously been charged to MS
17 incorrectly (charges added to Oct 08-March 09)-as per Dr. Lyons/Terry Wu 04/10/09. In November
2008, MS 17 was listed as 16% invoiced and 10% completed. This was corrected in April 2009.
MS 18: The discrepancy between the 0.2% invoiced and the 5% work completed is due to no additional
work on this milestone in 2009. UNM will reassess whether some milestones should be consolidated.
MS 19: UNM was developing assays with human alveolar macrophages from human donors. The
expenses to date, included the salary for the bronchoscopy nurse, who was recruiting the normal human
donors, and the pre-health screenings for potential bronchoscopy donors. The discrepancy between the
94.9% invoiced and 27% work completed was due to the developmental aspects of the assays as well as
the low number of donors recruited to date. MS 19 is ended, unless while writing a manuscript, UNM and
NIAID decide to perform more experiments.
MS 21: On 6/11/09, UNM moved $12,632 from completed MS5, into MS21. MS21 budget was increased
by $12,632 to reach $136,579. On 9/22/09 UNM moved $84,000 from MS20 to MS21 which brought
MS21 budget to $220,579. The MS 21 budget had been overspent by $39,262 and Terry/Andrew expect
3 more months at approx. $15,000 per month, $39,626 +$45,000 =$84,262 was needed in the MS21
budget.
MS 27: MS 27 was 100% work completed so UNM moved the residual $19,430 from MS27 and into
MS19 which had been overspent as of 4/13/09.
MS 34: MS 34 was 100% work completed so UNM moved the residual $14,254 from MS34 and into
MS19 which had been overspent as of 4/13/09.
Page 7 of 11
Tularemia Vaccine Development Contract: Semi-Annual Technical Report
Period: 4/01/2009 to 9/30/2009
Due Date: 10/15/2009 and Prepared by: C. Rick Lyons, Barbara Griffith, Terry Wu, Bob
Sherwood, Julie Wilder, Julie Hutt, Michelle Valderas, Trevor Brasel, Dana Pohlman, Mitch
Magee, Kathryn Sykes, Stephen Johnston, Karl Klose, Bernard Arulanandam, Justin Skoble
5. UTSA
MS 16, MS 39, MS 43, MS 48, and MS 51: These 5 milestones show 100% invoiced and 100% work
completed. After the technical work was 100% completed, residual budgeted funds were moved from
these 5 milestones in the fall of 2007 and into MS50 to support work on the intragastric route of
immunization. A combined total of $46,950 was moved from these 5 milestones and into the MS50
budget. The original budget for MS50 was $310,483 and the current MS50 budget is $357,433.
MS 50: A combined total of $46,950 was moved from MS 16, 39, 43, 48, and 51 and into the MS50
budget. The original budget for MS50 was $310,483 and the current MS50 budget is $357,433. MS50
became 100% work completed in September 2009 and is expected to be 100% spent soon.
To date, administrative costs have been billed to NIAID that are associated with Milestone 2 and with the
management of the scientific milestones 3, 4, 5, 6, 7, 8, 9, 10, 11, 12/13, 14, 16, 17,18, 19, 21, 25, 26,
27, 28, 29, 32, 33, 34, 35, 36, 39, 40, 41, 42, 43, 44, 46, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57.
2. Estimates of subcontractors expenses from prior month if subcontractor did not
submit a bill. List for each subcontractor. If subcontractors were not working or did not
incur any cost in current or prior month, then include a statement to this effect.
LBERI, Cerus, ASU and UTSA all submitted invoices to UNM in the prior month. The UNM invoice to
NIAID, being submitted on 10/15/09, includes subcontractor invoices from ASU, Cerus, LBERI and UTSA.
Page 8 of 11
Tularemia Vaccine Development Contract: Semi-Annual Technical Report
Period: 4/01/2009 to 9/30/2009
Due Date: 10/15/2009 and Prepared by: C. Rick Lyons, Barbara Griffith, Terry Wu, Bob
Sherwood, Julie Wilder, Julie Hutt, Michelle Valderas, Trevor Brasel, Dana Pohlman, Mitch
Magee, Kathryn Sykes, Stephen Johnston, Karl Klose, Bernard Arulanandam, Justin Skoble
Acronyms for Tech Reports 10/12/09
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ABSL3: Animal Biosafety Level 3 lab
AM: alveolar macrophages
ASU: Arizona State University
BLD: below limit of detection
BMDM: bone marrow derived macrophages
BP: base pair
BSL2: Biosafety Level 2 lab
BSL3: Biosafety Level 3 lab
C: centrigrade
cDNA: complimentary deoxyribonucleic acid
CDA: confidentiality and disclosure agreement
CDM: Chamberlains defined media
CFU: colony forming units
COA: contract officers authorization
CRDA: Cooperative research and development agreement
C-term: Carboxy terminus
DNA: deoxyribonucleic acid
DVC: Dynport Vaccine Company
ED50: Effective Dose, 50 % dead
ELISA: enzyme-linked immunosorbent assay
ELISpot: enzyme-linked immunospot assay
EOH: Employee Occupational Health
FDA: Federal Drug Administration
FF: formalin fixed
FSC: forward scatter, equivalent to cell size FT or Ft or F. tularensis: Francisella tularensis
GDP: genome directed primers
GI: gastrointestinal
GLP: good laboratory practice
KBMA: killed but metabolically active
HK: heat killed
HTP: high through put
IAA: interagency agreement
IACUC: Institutional animal care and use committee
ICS: Intracellular staining
Page 9 of 11
Tularemia Vaccine Development Contract: Semi-Annual Technical Report
Period: 4/01/2009 to 9/30/2009
Due Date: 10/15/2009 and Prepared by: C. Rick Lyons, Barbara Griffith, Terry Wu, Bob
Sherwood, Julie Wilder, Julie Hutt, Michelle Valderas, Trevor Brasel, Dana Pohlman, Mitch
Magee, Kathryn Sykes, Stephen Johnston, Karl Klose, Bernard Arulanandam, Justin Skoble
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ID: intradermal
IFNγ: interferon gamma
IL2: interleukin 2
IN: intranasal
IND: investigational new drug
IP: intraperitoneal
IRB: institutional review board
IRS: immune rat sera
IT: intratracheal
IVT: in vitro translation/transcription
KB: kilobase
L: liter
LAPT: Linear Amplification of Procaryotic Transpcript
LBERI: Lovelace Biomedical and Environmental Research Institute
LD50: Lethal dose 50% dead
LD99: lethal dose, 99% dead
LN: lymph node
LPS: lipopolysaccharide
LRRI: Lovelace Respiratory Research Institute
LVS: Live vaccine strain (tularemia)
NHP: nonhuman primate
MDM: monocyte derived macrophages
mL: milliliter
MLN: mesenteric lymph node
mM: Milli molar
MOI: multiplicity of infection
MS: Milestone
MSCR: Milestone Completion Report
MTA: material transfer agreement
MTS reagent: (3-(4,5-dimethylthiazol-2-yl)-5-(3-carboxymethoxyphenyl)-2-(4-sulfophenyl)-2Htetrazolium, inner salt
N: number
NIAID: National Institute of Allergy and Infectious Disease
NRS: normal rat sera
N-term: amino- terminus
OD: optical density
ORF: open reading frame
PBMC: peripheral blood mononuclear cells
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Tularemia Vaccine Development Contract: Semi-Annual Technical Report
Period: 4/01/2009 to 9/30/2009
Due Date: 10/15/2009 and Prepared by: C. Rick Lyons, Barbara Griffith, Terry Wu, Bob
Sherwood, Julie Wilder, Julie Hutt, Michelle Valderas, Trevor Brasel, Dana Pohlman, Mitch
Magee, Kathryn Sykes, Stephen Johnston, Karl Klose, Bernard Arulanandam, Justin Skoble
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PBS: phosphate buffered saline
PFA: paraformaldehyde
pM: pico Molar
pmol: picomole
PCR: polymerase chain reaction
QA: quality assurance
QC: quality control
qPCR: quantitative polymerase chain reaction
RNA: ribonucleic acid
SC: subcutaneous
SDS: sodium dodecyl sulfate
SCHU S4: virulent strain of Francisella tularensis
SIP: Special Immunizations Program at USAMRIID
SOP: standard operating procedure
SSC: side scatter, equivalent to cell density or granularity
TBLN: tracheobronchial lymph node
Tn: transposon
TNFα: tumor necrosis factor alpha
TVDC: Tularemia vaccine development contract
uL: microliter
UNM: University of New Mexico
USAMMDA: United States Army Medical Materiel Development Activity
USAMRIID: United States Army Medical Research Institute for Infectious Disease
UTSA: University of Texas at San Antonio
WT: wild type
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