Tularemia Vaccine Development Contract: Technical Report
Period: 11/01/2005 to 11/30/2005
Due Date: 12/15/2005 and Prepared by: Barbara Griffith
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 Milestone
Active milestones: 1, 2, 5
Inactive milestones: 3, 4, 6-30, 31-54
Milestone 1
Milestone description: Subcontracts finalized
Institution: UNM/All subcontractors
1. Work performed and progress including data and preliminary conclusions
a. Ross Kelley, NIAID Contract Officer, approved the subcontracts, pending SOW review by
Vicki Pierson, NIAID Project Officer.
b. Virginia Henning, UNM Financial Services, emailed a draft of each subcontract to the
c.
d.
e.
f.
g.
h.
business officials at each collaborating institution (with copies to Drs. Johnston and
Sykes at ASU, Dr. Bob Sherwood at LRRI, for Dr. Karl Klose at UTSA, and Dr. Justin
Skoble at Cerus). The subcontracts were submitted in draft form on 12/01/05 for the
purpose of legal review only and will not be signed until the statement of work, and other
exhibits (i.e., the schedule of reports and the report formats), are finalized and made
available to the subcontractors in final form.
Milestones as the SOW in Microsoft Project were sent to Vicki, Marlene and Ross on
11/11/05 by email and UNM received Vicki’s comments by fax and by teleconference on
12/1/2005.
Based on Vicki’s requests of 12/1/05 UNM further revised the Milestones as the
Statement of Work and included
i. more dependencies
ii. include organizational titles
iii. submilestones, go/no go, and endpoints for UNM and LRRI
iv. more deliverables or endpoints for ASU and Cerus
The re-revised Milestones in MS Project were emailed to Vicki, Ross, and Marlene on
12/12/2005. The Subcontracts cannot be sent to the 4 Subcontracting institutions for
signatures, until the SOW is completed and approved by the NIAID Contract Officer and
the NIAID Project Officer.
Budgets by milestone are being edited to show animal costs as an expense category for
UNM, LRRI and Cerus.
Virginia Henning revised the Invoice templates to include an expenditure category for
animal costs in the Cerus, UNM, LRRI and UTSA invoices.
Barbara Griffith is creating 3 customized reporting templates for each participating
institution. The customized technical report templates are completed. The timeline
report template in MS Project and the expense report template by milestone are pending.
These documents will be described in the subcontract but the final forms will be sent to
the subcontractors, separately, to avoid delaying submission of the subcontracts to the
subcontractors.
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Tularemia Vaccine Development Contract: Technical Report
Period: 11/01/2005 to 11/30/2005
Due Date: 12/15/2005 and Prepared by: Barbara Griffith
i.
Times and dates for the Weekly Technical Calls and for Meeting/Visits will be included in
the subcontract.
The Data Sharing Plan is pending. UNM’s Financial Services is drafting a memo
agreement to acknowledge acceptance of the plan by UNM and its collaborating
subcontractors. Pat Briggs, under Rena Vinyard’s supervision, is preparing the
acceptance agreement that will accompany the Data Sharing Plan. The Data Sharing
Plan will be referenced in the subcontracts but will not be part of the subcontracts and
compliance with the plan is mandated as a condition of each subcontract..
k. In the subcontracts, UNM included language for confidential sharing of information and
for confidential sharing of materials.
l. UNM and CSC/DVC have a nearly executed NDA; CSC/DVC has signed and only the
UNM signature is pending. Barbara Griffith has communicated with Stephen Matthews
regarding NDAs between CSC/DVC and UNM’s subcontractors and regarding NDAs
between UNM and CSC/DVC’s subcontractors. UTSA and LRRI have emailed Stephen
Matthews regarding an NDA. Barbara will remind ASU and Cerus to email Stephen
regarding an NDA.
j.
2. Significant decisions made or pending
Barbara is preparing the customized timeline report template in MS Project and the expense
report template by milestone. Work on these has been delayed by the higher priority of revising
the Milestones as the SOW.
3. Problems or concerns and strategies to address
The subcontracts were not completed and signed by 11/18/2005, as indicated in the “Immediate
Action Items” from the Kick off meeting. UNM anticipates sending the subcontracts during the
week of 12/19, pending the Project Officer’s review and approval. UNM plans to have
negotiated, signed contracts by the subcontractors by 1/19/2005.
4. Deliverables completed
Revised Milestones as the SOW were submitted to Vicki on 12/12/05.
5. Quality of performance
Good
6. Percentage completed
80%
7. Work plan for upcoming month
UNM plans to send final subcontracts to ASU, Cerus, LRRI and UTSA during the week of
12/19/05, pending Project Officer review and approval.
8. Anticipated travel
None for this specific milestone, but UNM and 4 subcontracting institutions may travel for a joint
CSC/DVC, NIAID and UNM meeting in February or March 2006.
9. Upcoming Contract Authorization (COA) for subcontractors
None
Milestone 2
Milestone description: Vaccinations performed on relevant personnel
Institution: UNM/LRRI
1. Work performed and progress including data and preliminary conclusions
Ross Kelley has investigated options of an MOU, CRADA or IAA between NIAID and USAMRIID
to allow USAMRIID to provide LVS vaccinations to approximately 25 scientists and technical staff
at UNM and LRRI, as an additional safety precaution.
2. Significant decisions made or pending
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Tularemia Vaccine Development Contract: Technical Report
Period: 11/01/2005 to 11/30/2005
Due Date: 12/15/2005 and Prepared by: Barbara Griffith
a.
As of 12/13/05, Ross is waiting for Martin Crumrod, another Contract Officer, to provide
an update on the status of the IAA between NIAID and USAMRIID.
b. Since the LVS vaccinations were included in the Contract proposal submitted and
approved for funding, would a legal concern arise if staff were unable to receive the LVS
vaccination and were accidentally exposed in the laboratory? Could litigation arise due to
not providing the LVS vaccinations?
3. Problems or concerns and strategies to address
a. UTSA has a CRDA recently approved by both USAMRIID and UTSA, so 3 members of Dr.
Kose’s staff can receive LVS vaccinations required for a separate RCE funded project. Should a
CRDA be initiated between UNM and USAMRIID for the TVD contract?
b. If the IAA between NIAID and USAMRIID is not awarded, and a CRDA would require 7-10
months, UNM can proceed without the LVS vaccinations and with the usage of existing protective
facilities and personal protective equipment. LRRI would at least need a biobubble for additional
containment in order to proceed with the LVS aerosol exposures.
b. UNM/LRRI want the IAA in place so that vaccinations may be administered by February 2006,
or no later than June 2006
c. Rick has understood that vaccinated staff may need to remain at USAMRIID for 1 week post
vaccination. If Vicki confirms this duration, then additional per diem expense would result for 25
scientists, since Rick budgeted for a 2 night stayover.
4. . Deliverables completed
None
5. Quality of performance
Good
6. Percentage completed
10%
7. Work plan for upcoming month
a. Ross Kelley will determine whether Martin Crumrod’s IAA between NIAID and USAMRIID
is awarded and whether the TVD Contractors can be vaccinated under this IAA.
b. At our January Contract meeting, we will discuss the CRDA route if the IAA is not closer
to resolution.
c. Dr. Sherwood of LBERI is obtaining a quote for a biobubble and will determine the
timeline to purchase and receive a biobubble from the vendor.
d. Vicki will verify the USAMRIID 1 week stay for staff receiving the LVS vaccination at
USAMRIID.
8. Anticipated travel
None in the next month; travel could occur in February 2006
9. Upcoming Contract Authorization (COA) for subcontractors
Not at this time.
Milestone 5
Milestone description: Species tested for sensitivity to LVS & generation of immunity against a
pulmonary challenge of Schu4
Institution: UNM
1. Date started: 12/12/2005
2. Date completed: pending
3. Work performed and progress including data and preliminary conclusions
a. Vicki Pierson arranged for CSC/DVC to send LVS vials to UNM. UNM received 160 vials
of lot#16 of LVS to be distributed to UNM and the appropriate subcontracting institutions.
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Tularemia Vaccine Development Contract: Technical Report
Period: 11/01/2005 to 11/30/2005
Due Date: 12/15/2005 and Prepared by: Barbara Griffith
b. Stephen Matthews communicated to Barbara that the Schu4 is undergoing testing and
will be ready to ship in January 2006
4. Significant decisions made or pending
a. UNM will determine the number of vials of Schu4 needed for the 1st yr of the TVD
contract
b. Regarding LVS, Stephen Matthews conveyed that only lot #18 is available through BEI
currently and that future sharing of LVS vials will be through BEI.
c. Please request that Vicki provide comments as well. I believe she thought we would all
be using the same lot of LVS throughout the entire project. We may need a bridging
study to confirm similarity and behavior of lots, if we need to use lot #16 in year 1 and
#18 in future years.
5. Problems or concerns and strategies to address
a. Barbara will ask UNM and the subcontractors to estimate the number of vials of LVS
needed in years 2-5 so that Stephen Matthews may research the ability for our TVD team
to use Lot#16 in years 2-5, rather than lot#18.
b. Barbara is contacting Vicki Pierson for advice on the potential use of 2 lots of LVS.
6. Deliverables completed
UNM received 160 vials of LVS at 1-2x 108/vial, with concentration based on testing at Baylor
University. 160 vials was the estimate of required vials for year 1 of the TVD Contract.
7. Quality of performance
Good
8. Percentage completed
2%
9. Work plan for upcoming month
Barbara will obtain estimate of the number of LVS vials needed for years 2-5 and number of vials
of Schu4 needed currently.
10. Anticipated travel
None
11. Upcoming Contract Authorization (COA) for subcontractors
none
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