Inital_TO_SOW.pdf

National Cancer Institute Task Order #1

Statement of Work

National Cancer Institute Task Order No.: T.B.D Page 1 of 4

1.0 TITLE

Task Order #1 - Droplet Digital PCR (ddPCR) Assays of RNA SIV Gag In Plasma Samples and Purified and Tittered stocks of attenuated recombinant poxviruses with titer of 1010 PFU

2.0 BACKGROUND

The Vaccine Branch (VB) is a research branch of the Center for Cancer Research (National Cancer Institute, Bethesda, Maryland). The Animal Models and Retroviral Vaccines section (AMRVS) of the VB conducts research on two retroviruses, HTLV-1 and HIV, that respectively cause cancer and neuropathology, and acquired immunodeficiency syndrome (AIDS).

2.1 OBJECTIVE

The main purpose of the AMRVS is preventing HTLV-1 and HIV infection by developing effective vaccines, testing them in preclinical and clinical studies and analyzing the immune responses elicited by immunizations. In order to achieve this goal, the AMRVS requires to produce different reagents/immunogens with a purity/quality grade suitable for preclinical studies in non-human primates. Additionally, the AMRVS requires to conduct immunological and virological assays on samples collected from non-human primates and humans that have been vaccinated.

3.0 SCOPE

The Contractor shall provide all labor, material, facilities, and personnel required to perform thirty (30) Droplet Digital PCR (ddPCR) assays of RNA SIV gag in plasma, and provide one (1) purified and tittered stock of attenuated recombinant poxviruses with titer of 1010 PFU. All task will be performed in accordance with the terms and conditions of the parent IDIQ.

3.1 TASK ORDER REQUIREMENTS

The Contractor shall perform task following:

TASK #1 - IDIQ Task #3.1: The Contractor shall conduct Droplet Digital PCR (ddPCR) assays of RNA SIV gag in 30 plasma samples collected from non-human primate.

The contractor, upon receiving cryopreserved plasma from the AMRVS, shall purify and quantitate RNA in plasma of non-human primates by ddPCR. Quantification of the viral RNAs of SIV shall be conducted using primers recognizing the gag region of SIV. The sequence of the primers may be provided by the AMRVS and/or may be provided by the Contractor. The ddPCR for viral RNAs shall be sensitive to 15 copies/ml plasma or less.

The Contractor shall, upon completion of virological assays, document the results

National Cancer Institute Task Order No.: T.B.D Page 2 of 4 achieved and report data in sufficient detail. The results and report data shall be provided within the due date provided in the table at point 8.0. The Contractor shall provide raw data (as provided by the instrument utilized during the assay) as well as report data in a Microsoft Office format (e.g., Excel, Word, etc.) or any appropriate format depending on the type of analysis. The Contractor shall document in sufficient detail each step taken in performing the task and provide data collected to the specific NCI investigator, as requested.

TASK #2 - IDIQ Task #6: The Contractor shall provide one (1) purified and titered stocks of attenuated recombinant poxviruses with titer of 1010 PFU.

The contractor, upon receiving cryopreserved ALVAC-SIV vcp2438 from the AMRVS, shall use the virus as inoculum for the production and amplification of the viral stock.

Following production and purification the viral stock shall have a purity/quality grade suitable for preclinical studies in non-human primates. The Contractor shall aliquot the viral stock in 1.8ml vials containing 108 PFU of virus in a volume of 1ml each. The stocks of recombinant virus shall be stored at -80 until shipped to AMRVS.

Additionally, the Contractor shall provide to AMRVS quality control for the expression of heterologous genes by Western Blot. The Contractor shall document in sufficient detail each step taken in performing the task and provide data to the AMRVS confirming that the stock is of the quantity required and meet the specifications of purity and biological activity. Report shall be in Microsoft Office format (e.g., Excel, Word, etc.).

3.2 RETURN SHIPPING

Upon completion of all work associated with this Task Order, the Contractor shall ensure that all unused or residual sample materials provided by the Government are properly handled and packaged so as to facilitate their safe return to the Government. Return shipping of samples must be coordinated with the NCI’s Technical Point of Contact (TPOC).

4.0 TYPE OF ORDER

This is a firm fixed price task order for Laboratory Services. The services under this order are severable services. Funds are only available for use for the contract line-item number (CLIN) to which they are obligated. Unused funds from one CLIN or order period may not rollover for use in other periods or CLINs.

5.0 PERIOD OF PERFORMANCE

The period of performance of the initial task orders shall be from 12/01/2023 to 01/31/2024, according to the table below at point 8.0.

National Cancer Institute Task Order No.: T.B.D Page 3 of 4

6.0 PLACE OF PERFORMANCE

Services shall be provided at the Contractor’s facilities.

8.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

Pursuant to FAR clause 52.212-4, all work to be delivered under this task order is subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the Technical Point of Contact (TPOC)(See Section 9.0 below), who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor.

NCI shall have 30 days in which to review and accept the deliverables provided by the Contractor. If no comments or request for revisions are provided within 30 days, the deliverables shall be considered acceptable.

DELIVERABLE

DELIVERABLE DESCRIPTION / FORMAT

REQUIREMENTS

DUE DATE

TASK #1

Droplet Digital PCR (ddPCR) assays of RNA SIV gag in plasma (30 samples): Instrument readouts and in Microsoft Office format (e.g., Excel, Word, etc.)

01/15/2024

TASK #2

Viral Stock Preparation (10^10 pfu ALVAC-SIV vcp2438): Microsoft Office format (e.g., Excel, Word, etc.)

01/31/2024

Any deliverable created as a direct result of this procurement shall be the sole propriety of NCI and shall not be shared or distributed without written consent of the Executive Officer, NCI.

Regardless of format, all digital content or communications materials produced as a deliverable under this contract, shall conform to applicable Section 508 Standards to allow Federal employees and members of the public with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by Federal employees or by members of the public who are not individuals with disabilities. Remediation of any materials that do not comply with the applicable Section 508 requirements as set forth below, shall be the responsibility of the Contractor.

HHS guidance regarding accessibility of documents can be found at:

https://www.hhs.gov/web/section-508/additional-resources/index.html.

Federal Government-wide guidance regarding accessibility of documents can be found at:

National Cancer Institute Task Order No.: T.B.D Page 4 of 4 https://www.section508.gov, including the documents describing the preferred method of authoring and testing documents produced in Microsoft Word 2013 or later, Microsoft Excel, and files formatted as PDF.

9.0 TECHNICAL POIN OF CONTACT

The Technical points of contact for this order are:

Name:

Email:

Phone: ________ and

Name:

Email:

Phone: _________