Tularemia Vaccine Development Contract: Technical Report
Period: 12/01/2005 to 12/30/2005
Due Date: 1/15/2006 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. Rick Lyons, Barbara Griffith, Vicki Pierson and Marlene Hammer have focused their
b.
c.
d.
e.
f.
g.
h.
efforts on the SOWs for each of the 4 subcontracting institutions and the SOWs are
approximately 99% completed and in text format in Word.
The major Milestones (Exhibit A) have been condensed to a 2 page table with due dates
adjusted for a 2/1/2006 initiation date.
The schedule of Reports and Meetings (Exhibit E) has been revised to remove most
NIAID and FDA references.
The Financial Reports by Milestone will show total costs per milestone and percent effort,
rather than broken down by expenditure categories.
Michelle Matteucci, accountant for Dr. Lyons, is creating the Financial Reports by
Milestone templates, under Barbara Griffith’s direction.
The timeline report template in MS Project is in progress.
The Data Sharing Plan has been prepared by Pat Briggs.
UNM and CSC/DVC have an executed NDA. LBERI and UTSA have NDAs with DVC.
ASU’s NDA with CSC has been signed by ASU and is awaiting CSC/DVC’s signature.
Cerus’ legal representative is in correspondence with CSC/DVC’s Conrad Celestial.
2. Significant decisions made or pending
Barbara is preparing the customized timeline report template in MS Project and the expense
report template by milestone is in preparation by Michelle Matteucci. Work on these has been
delayed by the higher priority of revising the Milestones and the SOWs.
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 revised subcontracts by
1/21/06. UNM plans to have negotiated, signed contracts by the subcontractors by 2/1/2006.
4. Deliverables completed
Revised Statements of Work are complete for 4 subcontractors. Revised Exhibit A and Exhibit E
are completed.
5. Quality of performance
Good
6. Percentage completed
80%
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Tularemia Vaccine Development Contract: Technical Report
Period: 12/01/2005 to 12/30/2005
Due Date: 1/15/2006 and Prepared by: Barbara Griffith
7. Work plan for upcoming month
UNM plans to send final subcontracts to ASU, Cerus, LRRI and UTSA during the week of
1/21/06. UNM will work on UNM’s two SOWs, one for scientific work and a second for
management. These can be two sections in one SOW.
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 March or April 2006.
9. Upcoming Contract Authorization (COA) for subcontractors
None You could mention all COAs, travel, etc. here and call this Milestone an “admin” category.
This helps you cpture some of the work you’re doing but not taking credit for. For example, the
COA for ASU’s computer equipment has been approved- you can take credit for that. And you
should take credit for submitting the COA for LRRI’s telemetry equipment. Also a good place to
mention that a COA for LRRI’s biobubble will be coming soon.
Milestone 2
Milestone description: Vaccinations performed on relevant personnel
Institution: UNM/LRRI
1. Work performed and progress including data and preliminary conclusions
NIAID is working on the IAA with USAMRIID and discussions regarding funding transfers are in
progress.
2. Significant decisions made or pending
a. As of 1/9/06, Ross is waiting for Martin Crumrine, a DMID Program 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? The legal concern is actually the other way around:
no one can be coerced into taking an investigational product as a condition of
employment. That is why the addition of the biobubble is important regardless of whether
or when the vaccinations are available. We need to provide workers with a safe
alternative to vaccination.
3. Problems or concerns and strategies to address
a. NIAID has ruled out the option of a CRDA.
b. LBERI estimates 3-4 months to design, purchase and install a biobubble as additional
protective equipment. The cost of a biobubble is pending LBERI negotiations with vendor.
b. UNM has notified NIAID that if vaccinations are not administered by February 2006, or no later
than June 2006, additional protective equipment will be necessary to prevent a stoppage of work.
c. Rick has understood that vaccinated staff may need to remain at USAMRIID for 1-2weeks post
vaccination. If Vicki confirms this duration, then additional per diem expense would result for 25
or more scientists, since Rick budgeted for a 2 night stay over.
4. . . . Deliverables completed
None
5. Quality of performance
Good
6. Percentage completed
10%
7. Work plan for upcoming month
a. Ross Kelley will continue to monitor the progress of Martin Crumrine’s IAA between
NIAID and USAMRIID and will inform UNM when and whether the TVD Contractors can
be vaccinated under this IAA.
b. Dr. Sherwood of LBERI is obtaining a quote for a biobubble
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Tularemia Vaccine Development Contract: Technical Report
Period: 12/01/2005 to 12/30/2005
Due Date: 1/15/2006 and Prepared by: Barbara Griffith
c.
Vicki will verify the USAMRIID 1 or 2 week stay for staff receiving the LVS vaccination at
USAMRIID.
8. Anticipated travel
None in the next month; travel could occur in any month between February and June 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. UNM has received 160 vials of LVS and has requested 100 vials of SCHU S4.
b. Barbara faxed the Form 2 (transfer of select agent form) to Stephen Matthews on 1/10/06
as part of the request for the SCHU S4 vials.
4. Significant decisions made or pending
a. Vicki has stated that LVS lot#16 will be available to UNM and UNM’s subcontractors and
that we will obtain the vials through NIAID (DVC/CSC) rather than through BEI. If
insufficient vials of lot#16 exist over time, Dr. Lyons is prepared to complete bridging
studies for lot #16 and lot#18.
5. Problems or concerns and strategies to address
a. Barbara is in contact with Stephen Matthews regarding the delivery date for the vials of
SCHU S4.
6. Deliverables completed receiving materials is not really a deliverable. This is already
captured in item 3 above, work performed.
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
3%
9. Work plan for upcoming month
Obtain vials of SCHU S4 from CSC/DVC
10. Anticipated travel
None
11. Upcoming Contract Authorization (COA) for subcontractors
None
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