Background:
The mission of the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) is to ensure an end to the human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) epidemic by supporting research that can lead to the development of therapies, vaccines, and prevention strategies. Since the mid-1980's animal models have played an important role in the Institute's efforts to achieve its mission.
Animal models present the opportunity to test a variety of candidate HIV and other infectious disease vaccines. Preclinical studies, and in particular, nonhuman primates (NHP) studies are key to evaluate the immunogenicity, efficacy, and toxicity of vaccine candidates, de-risk the product/platform in costly GMP manufacturing, and also, help to inform and guide Phase 1 clinical trial studies. NIAID supports preclinical studies through both contract and grant assistance mechanisms. NIAID DAIDS supports NHP studies to evaluate the immunogenicity and efficacy of candidate AIDS vaccines through grants and contracts including the Simian Vaccine Evaluation Units (SVEU). The SVEU contracts conduct the studies: acquiring and housing the animals, developing the protocols, administering the vaccine, and collecting the samples.
NIAID DAIDS also supports for centralized laboratories to provide standardization of the assays and a common basis for comparability of results across different studies. These Core Laboratories conduct cellular and humoral immunology, virology, and functional genomics assays to comprehensively assess candidate vaccines and for potential identification of protective immune responses in efficacy studies. The current contract for the Functional Genomics Core Laboratory is held by University of Washington (HHSN272201800008C). Duke University holds the contract for the Humoral Immunology Core Laboratory (HHSN272201800004C), as well as the contract for the Virology Core Laboratory (HHSN272201800003C). Lastly, the Cellular Immunology Core Laboratory contract (HHSN272201700022C) is held by Tulane University.
Purpose and Objectives:
The Functional Genomics Core Laboratory has a period of performance of July 1, 2018, through June 30, 2025, and is the focus of this solicitation. The objective of Functional Omics Core Laboratory (FOCL)is to continue providing high quality assessment of the immunogenicity and efficacy of vaccines or other prevention strategies, and generate omics signatures of genes, epigenome, transcriptomes, and proteins to identify biomolecules expression and pathway profiles that could define correlates of protection and predict vaccine efficacy for HIV and other infectious diseases. To ensure standardization and validation of the assays and comparability of results across studies, assays and data analysis performed on fresh, cryopreserved, and fixed samples will follow good laboratory practice (GLP practices. For the purposes of this contract, GLP is defined as the application of the principles of Good Laboratory Practices Regulation, codified in CFR Title 21 Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies), but does not require external accreditation or official Food and Drug Administration (FDA) regulatory review of the laboratory. The conformance to GLP procedures for contract laboratory activities will be reviewed by an independent quality control assurance unit. Thus, the FOCL aims to provide high quality assessment on the immunogenicity and efficacy of vaccines or other prevention strategies.
Project requirements
The Contractor shall conduct, develop, acquire, improve, implement, validate, analyze and report data from state-of-the-art high-throughput functional omics assays (e.g., bulk, single-cell, and spatial RNA-seq, ATAC-seq and CITE-seq) and approaches (e.g., genomics, epigenomics, transcriptomics, and proteomics) for comprehensive characterization of immune responses in samples from in vivo or in vitro studies investigating simian immunodeficiency virus (SIV), simian-human immunodeficiency virus (SHIV), HIV and other infectious diseases. The assays will primarily focus on samples from animal models for HIV, however analysis of samples from human clinical trials with HIV or other infectious diseases maybe included to evaluate immunogenicity and efficacy of vaccines or other prevention strategies, as directed by the COR.
Specifically, the Contractor shall: 1) conduct validated functional omics assays using GLP-like processes; 2) perform omics data analysis using state-of-the-art bioinformatics and biocomputing tools, 3) receive, store, catalog, track, and maintain an inventory of the samples for evaluation; 4) manage, report, and deposit assay data; 5) perform project management activities related to contract activities; 6) conduct initial and final transition activities, as needed; and 7) perform option work described below, if required.
Anticipated Period of Performance:
It is anticipated that one (1) cost reimbursement, level-of-effort (term) type contract will be awarded. The period of performance will be for one (1) year (Base Period) plus six (6) one-year options (terms that may be exercised by the Government unilaterally), for a total possible performance period of 7 years, beginning on or about May 1, 2025. The performance requirement will be the delivery of 2.7 full time equivalents (FTEs) per year for the base period (Year 1) and option periods 1-6 (Year 2 through Year 7). Please note that the number of FTEs is exclusive of subcontractor and consultant effort.
In addition, the Government may exercise options to accommodate unanticipated increases in demand as follows:
Options 7 through 13: Increased Level of Effort: The Government may exercise options for increased level of effort that may result from unanticipated increases in demand for the activities supported by the base requirements of the contract. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 1.0 Full Time Equivalent (FTE) for each option exercised. These options may be exercised once per year during Years 1 through 7. The period of performance of an Option for increased level of effort for this purpose will not exceed the term of the Base Period or Option Period in which the Option is exercised. Please note that the number of FTEs is exclusive of subcontractor and consultant effort.
Options 14 through 27: Increased Level of Effort: The Government may exercise options for increased level of effort that may result from unanticipated increases in demand for the activities supported by the base requirements of the contract. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 0.5 Full Time Equivalent (FTE) for each option exercised. These options may be exercised up to twice a year during Years 1 through 7. The period of performance of an Option for increased level of effort for this purpose will not exceed the term of the Base Period or Option year in which the Option is exercised. Please note that the number of FTEs is exclusive of subcontractor and consultant effort.
Any responsible offeror may submit a proposal, which will be considered by the Agency. This RFP will be available electronically, on/about February 16, 2024, and may be accessed through SAM http://sam.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.
For this solicitation, the NIAID requires proposals to be submitted online via the NIH's electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov. Submission of proposals by facsimile or e-mail is not acceptable.
For directions on using eCPS, go to the website (https://ecps.nih.gov) and then click on "How to Submit."
