AECOM Sole Source Justification 03092022.WRJ_Final_Rd.pdf

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Research Center (NMRC), Silver Spring, MD, on behalf of the Navy to meet Navy Expeditionary Medical Research requirements.

2. Nature and/or description of the action.

The nature of the work is summarized as following:

1. To recombine genes of envelope (E), pre-membrane (PrM), and non-structural protein-1

(NS1) of dengue-2 into the Herpes Simplex virus vector Δg(GJDI)-2::attB vector to make three recombinant E, PrM, and NS1 vaccine.

2. To deliver the E, PrM, and NS1 recombinant vaccines into cell lines and determine the expression of proteins in cell lines.

3. To deliver the recombinant E, PrM, and NS1 vaccines to mice and determine the immune responses in mice. The vaccines need to be tested in C57/BL mice to determine immune responses after vaccination. The best vaccine needs to be tested in AG129-

IFNRalpha/gamma knock out mice to assess the efficacy of protection.

The technical specification, requirement, and deliverables/time lines of the contract are detailed in the State of Work (SOW). The end product is an effective dengue NS1 vaccine that elicits good immunogenicity and can protect mice from lethal infection. Briefly, we seek a contractor who is able to provide a Herpes simplex virus vector containing a deletion of the US4-US7 genes, resulting in a recombinant Δg(GJDI)::attB-2-DENV-NS1 vaccine.

The proposed contracting agency is Albert Einstein College of Medicine, 1300 Morris Park

Avenue, Bronx, New York 10461. This contract will award the College $168K per year for two years for their service. The terms of funding award are defined in the SOW.

3. Description of Supplies or Services:

A. The contractor is required to do the following:

a) Generate Bxb1 attP plasmids expressing dengue NS1, E24-NS1, E, and PrM from the

DENV-2 serotype using different signal sequences and transmembrane domains and evaluate cell surface expression of the Dengue proteins on transfected cells.

b) Using optimally expressed Dengue genes in the Bxb1 attP plasmid vectors, generate

Δg(GJDI)-2::attB recombinant virus strains using the Bxb1 integration system and test for surface expression of Dengue proteins in virus-infected cells.

c) Breed AG129 (IFNAR crossed with interferon-γ receptor knockout) mice and IFNAR mice as models for testing the protective efficacy of recombinant viruses expressing DENV proteins against challenges with DENV strains provided by NMRC.

d) Immunize wild-type C57BL/6J mice, Interferon-alpha receptor knock-out (IFNAR) mice, and AG129 mice with recombinant HSV strains expressing DENV-2 antigens and test for immunogenicity by assaying antibody binding to the purified proteins provided by NMRC.

e) Challenge immunized IFNAR or AG129 mice and appropriate controls with lethal doses of

DENV stock intraperitoneally, and monitor these mice for weight loss and survival.

f) Generate cell lines to measure ADCC by co-expressing DENV targets with a fluorescent marker, such as red fluorescent protein (RFP), and measuring cytotoxicity from added immunized sera and effector cells with loss of fluorescence.

4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10

U.S.C. 2304(c)(1) and FAR 6.302-1 sole source acquisitions.

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

This contract is to develop and test a novel dengue virus non-structural protein-1 (NS-1) vaccine.

which is fundamentally different from other existing vaccines. The potential mechanism of protection of the NS1 vaccine involves a novel mechanism, antibody-dependent cell cytotoxicity.

The Herpes simplex virus vector Δg(GJDI)-2 is the most suitable vector since this vector can elicit antibodies with IgG2c subtype and antibody-dependent cell cytotoxicity.

The group led by Prof. William Jacobs in the Department of Microbiology and Immunology, Albert Einstein College of Medicine has the ability to take on this contract as this group invented and optimized this vector. To allow highly efficient cloning of transgenes into the Δg(GJDI)-2 virus, they incorporated the Bxb1 mycobacteriophage integrase-mediated recombination system

Δg(GJDI)-2::attB to generate recombinant viral vectors quickly and reliably. This is the only group having access to the proposed recombinant vector.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Market research was performed. This is the only laboratory who is in possession of the

Δg(GJDI)-2::attB vector.

7. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made.

8. Description of the market survey conducted and the results, or a statement of the reasons a market survey was not conducted.

Market research was conducted. We researched the internet for commercial availability of the vector Δg(GJDI)-2::attB, and we did not find any commercial vendor. We searched research groups which have the vector Δg(GJDI)-2::attB by searching literatures in Pubmed using the term “delta g(GJDI)-2 of HSV for vaccine”. The search returned zero item.

9. Other facts supporting the use of other than full and open competition.

The proposed lab is the sole source. The lab is the inventor of the vector. This is proprietary vector.

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other labs or commercial vendors can be found to have the HSV vector Δg(GJDI)-

2::attB. Therefore, no writing acquisition could be done.

11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203.

12. Point of Contact.

The point of contact at the Naval Medical Research Center, Silver Spring, MD, regarding the contents of the sole source justification is, Deborah M. Sharpe, who may be reached at (301)

319-6471.

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY NAVSUP 4200.83 series

I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

Technical Cognizance

Name Phone Date

Title

Department/Command

Requirements Cognizance

Name Phone Date

Title

Department/Command

CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge.

Deborah M. Sharpe Phone Date Contracting Officer

Edilberto P. Calma Phone Date Contracting Officer