**A. Background Information**

The National Institute of Allergy and Infectious Diseases (NIAID)
conducts and supports basic and applied research to better understand,
treat, and ultimately prevent infectious, immunologic, and allergic
diseases. For more than 50 years, NIAID research has led to new
therapies, vaccines, diagnostic tests, and other technologies that have
improved the health of millions of people in the United States and
around the world.

The Malaria Vaccine Development Branch (MVDB) within NIAID has been
commissioned to develop processes for producing recombinant proteins and
introducing them into vaccine formulations for safety and efficacy
testing. The MVDB currently has eight potential vaccines available as
clinical grade antigens poised for Phase 1 and 2 clinical trials.
Ongoing Phase 1 vaccine trials have already occurred with one current
Phase 2 vaccine trial in progress. Such work involves collaborations
with Principal Investigators in endemic locations such as Mali, West
Africa. To facilitate these collaborations, programmatic meetings are
conducted to develop long-range strategy plans for the deployment of
vaccine clinical studies.

Under this order, the contractor will independently provide support
services to satisfy the overall operational objectives of
NIAID/DIR/MVDB. The primary objective is to attend joint training
sessions and collaborative meetings to further define program goals and
objectives with peers and partners.

# **Purpose and Objectives of Procurement** 

The goal of the MVDB vaccine program is to develop a malaria vaccine
that will reduce morbidity and mortality due to malaria. The goal at the
present time is to perform Phase 2 trials of MVDB vaccines in children
living in West Africa in order to assess their efficacy. This includes
Phase 1 testing of these vaccines to populations living in
malaria-endemic areas, first in healthy adults, followed by testing in
young children; Phase 2 testing in children living in endemic areas; and
continuous development of vaccine testing sites in malaria-endemic
areas, including extensive background epidemiologic studies in the
target population in Mali, West Africa.

To do this, five Malian collaborators will join MVDB staff at two
training sessions to update one another on current Phase 2 trial
activities and results. Project planning will occur for the following 3
months with longer range planning of 24 months. Each of the five
collaborators will have subsistence expenses during these programmatic
meetings and training sessions. The five collaborators include: Boubacar
Traore, MD; Alassane Dicko, MD; Issaka Sagara, MD; Sory Diawara, MD; and
Mohamed Niambele, MD.

# **Contractor Requirements/Substance**

Collaborative services regarding assay and immunological development
will be performed during the scientists visit working under the
supervision of Dr. Susan K. Pierce and Dr. Louis H. Miller. The visitors
will receive hands-on training in assays for memory B cells and in a
project management training session for Phase 1 and 2 Clinical Trials.
During this period, the visitors will also be attending and presenting
at the ASTMH 55^th^ Annual Meeting in Atlanta, GA. Subsistence will also
be required during this period for all necessary expenses indicated
below for each visitor. The hotel selection for Atlanta, GA should be
the conference hotel, the Atlanta, Marriott Marquis. If this facility is
not available the selected hotel should be within walking distance to
the conference, dining, and all conference activities. The hotel
selection for Rockville, MD should be within walking distance to the
Twinbrook Complex of NIH or Metro accessible within 3 metro-rail stops
of the Twinbrook Metro Station. Vendor should provide evidence of
exceptional past performance as well as working relationship with the
NIH. Disbursement of monies for all expenses should come with clear
precise instructions addressed to each traveler on where to and how to
obtain funds from a financial center.

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| **[Necessary Expenses per Visitor]{.underline}**                      |
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|   **Atlanta, GA**         *                                           |
| *Dates:**   **11/11/2006**                 **thru**    **11/16/2006** |
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|   **[ ]{.unde                                                         |
| rline}**                                                              |
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|   **Items**                                                           |
|              **Units**                                                |
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|   ** **                                                               |
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|   **Hotel --                                                          |
| GA (Would    6                                                        |
|   prefer best                                                         |
|  available                                                            |
|   rate)**                                                             |
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|   Hotel Tax                                                           |
|              6                                                        |
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|   Meals                                                               |
|              7                                                        |
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|   Taxi from a                                                         |
| irport       2                                                        |
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|   Misc. Groun                                                         |
| d            1                                                        |
|   Transportat                                                         |
| ion                                                                   |
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|   **Rockville, MD**       **Dates:**   **                             |
| [11/17/2006]{.underline}**   **thru**    **[11/22/2006]{.underline}** |
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|   **[ ]{.unde                                                         |
| rline}**                                                              |
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|   **Items**                                                           |
|              **Units**                                                |
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|   ** **                                                               |
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|   **Hotel --                                                          |
| MD (Would    5                                                        |
|   prefer best                                                         |
|  available                                                            |
|   rate)**                                                             |
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|   Hotel Tax                                                           |
|              5                                                        |
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|   Meals                                                               |
|              6                                                        |
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|   Taxi from a                                                         |
| irport       2                                                        |
|                                                                       |
|   Misc. Groun                                                         |
| d            1                                                        |
|   Transportat                                                         |
| ion                                                                   |
|   ----------------------- ------------ ----                           |
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**D. Government Responsibilities**

The Government, i.e. the Malaria Vaccine Development Branch, NIAID,
located in Twinbrook I, Room 1103, will provide the facilities,
personnel, and instrumentation required to perform this work.

**E. Reporting Requirements and Deliverables**

Since work is to be performed in government facilities, i.e. within the
MVDB laboratory and associated subcontractor facilities, written
protocols and other daily data being generated serves as deliverables
and traceable records.

**F. Program Management and Control Requirements**

The existing internal program management will be utilized for this work.
Well-established standard operating procedures for writing protocols
will suffice for the management of this contract.

**G.** **Inspection and Acceptance Criteria**

LIG Chief, Susan K. Pierce, and MVDB Chief, Louis H. Miller will inspect
all services for quality. The criteria for acceptance will be measured
by completed developmental protocols and project planning.