H_Redacted_J&A.docx

Justification for Other than Full and Open Competition at or Below the Simplified Acquisition Threshold

Project Title: Custom Sanger Sequencing

I. Identification of the agency and contracting activity

DHHS, NIH, NIAID, VRC

II. Description of the project, and supplies or services required to meet the agency’s needs (including the estimated value) A. Type of action. Check the appropriate box:

New requirement: 1957659 ☒ Follow-on B. Project Background:

Our mission here at the Vaccine Research Center (VRC) is to determine the immune correlates of protection against emerging infectious diseases. One of the specific aims of the Human Immunology Section is to understand processes that determine the course of human diseases in which the immune system plays a central role in their pathogenesis and outcome. We use the knowledge gained from studies on human disease directly in humans, with as little in vitro manipulation as possible to initiate clinical studies of new therapeutic and vaccine approaches.

The human immunology section is involved in several projects that require the generation of genomic sequences to determine the T cell receptor usage by HIV-specific CD8 T cells as well as the gene expression analysis of T and B cells after vaccination or in an infection setting. Also, this research will gain further understanding in the HIV quasispecies that are present in a variety of tissues. With this knowledge, we are better able to understand the immunologic response that must be generated during a vaccine regimen aiding in the protection of persons against known pathogens. The current clinical study is evaluating the ability of eOD-GT8 to stimulate naïve B cells towards the development of VRC01 signature bNabs.

This study was first initiated in FY 2018 and is currently in the first phase of the required Federal Drug Administration’s (FDA) clinical testing. This trial consists of a randomized, double-blind, placebo-controlled dosage escalation trial to evaluate the safety and immunogenicity of eOD-GT8 60mer Vaccine. This testing will be performed in two volunteer groups to include: Adjuvanted in HIV-uninfected adults and healthy adult. This is a first in human exploratory trial (G001) to evaluate the safety and tolerability of eODGT8 60mer and its ability to generate immune responses that initiate the engagement of B cells to generate VRC01-class broadly neutralizing antibodies. For the G001 protocol, 24 trial participants, are recruited at the George Washington University (GWU) clinic, with a peripheral blood Mononuclear cell (PBMC) samples being sent to the VIP. Another 24 participants are being recruited at the Fred Hutchinson Cancer Research Center (FHCRC).” These samples generated from these participants will be sent to the FDA approval vendor, Genewiz Inc., for testing and quarterly results submittal.

C. Description of the supplies or services to be purchased This request is for a standing order with Genewiz, the FDA approved testing lab, for sanger sequencing services. Services will include sequencing of 801 samples.

III. Identification of the statutory authority permitting other than full and open competition (SELECT ONE) (

· 41 USC 253(c)(1) and FAR Part 6.302-1: Only one responsible source

IV. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

A. Name and address of the proposed contractor(s) Genewiz Inc.

115 Corporate Boulevard South Plainfield, NJ 07080

B. Describe why only the requested supply/service will meet the government’s needs This standing order is needed to generate data for our phase 1 clinical trial evaluating the ability of eOD-GT8 to stimulate naïve B cells towards the development of VRC01 signature bNabs. This service is required for the FDA approved clinical trial. The results will need to be submitted quarterly to the FDA or the trial will be discontinued, and the approval withdrawn.

C. Describe why only the proposed contractor is capable of providing the requested supply/service:

Genewiz Inc, will be able to provide this service because the sponsor of the trial - International AIDS Vaccine Initiative (IAVI), located in New York, performed an audit of the sequencing company called GENEWIZ® located at 733 Concord Avenue in Cambridge, MA 02138, in preparation of the use of their sequencing services in the G00l trial. The audit occurred on August 21st & 22nd, 2018. IAVI found the services of the vendor GENEWIZ® to be acceptable and the FDA approved vaccine trial was approved with this vendor providing the results. If any of the FDA approved processes are changed the FDA will withdraw the approval and shut down the trial. This would severely hinder the research mission of the VRC and cost the government a great monetary loss of the funding spent to start the clinical trial.