Adjuvant Comparison and Characterization   5

Introduction:

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. NIAID's Division of Allergy, Immunology and Transplantation (DAIT), Division of AIDS (DAIDS), and Division of Microbiology (DMID) have an interest in supporting the side-by-side comparison of adjuvants, which includes a comprehensive immune assessment to evaluate strength, quality, breadth, and durability of responses. The data generated from the comparative studies will be made available to the broader community, enabling the rational selection of adjuvants and the future development of stronger, more protective vaccines against infectious diseases, and new vaccines to treat allergic and autoimmune diseases.

Requirement:

The purpose of this Broad Agency Announcement (BAA) is to solicit proposals for a research program that includes the comparison of multiple adjuvants using various vaccine/antigen platforms. The comparative studies will establish immunological profiles ("immune fingerprints") of adjuvants that work through different mechanisms by employing a comprehensive immune assessment to evaluate strength, quality, breadth, and durability of responses using: 1. "omics" technology platforms such as genomics, epigenomics, transcriptomics, RNAi screens, proteomics, metabolomics, lipidomics, and glycomics; 2. T cell functional assays (e.g., cytotoxicity, cytokine production, epitope specificity); and 3. B cell and antibody profiles to include assessment of isotype, avidity, epitope fine-specificity, and systems serology.

It is anticipated that 3-5 cost-reimbursement, completion-type contracts will be awarded for a 12-month period of performance beginning on or about September 1, 2022. NIAID estimates that the average annual total cost (direct and indirect costs combined) of this entire program will be $7.5 million, of which $5.5 million is dedicated to fund projects that include non-HIV vaccines/antigens, and $2 million to fund project(s) that include the HIV envelope antigen. It is anticipated that the total cost for the award(s) may vary depending upon the scope of the project and the technical objectives of the award(s). The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research. In no event shall the period of performance proposed by an offeror exceed 5 years.

Any responsible offeror may submit a proposal to be considered by the Agency. This BAA will be available electronically around March 30, 2021 via SAM.gov at https://beta.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.

The BAA is governed by Federal Acquisition Regulation (FAR) 6.102(d)(2) and FAR 35.016, as well as the NIH Policy Manual, Manual Chapter 6035, Broad Agency Announcements. A BAA may be used as a solicitation mechanism for basic and applied research directed toward advancing the state-of-the-art or increasing knowledge or understanding and that part of development not related to the development of a specific system or hardware procurement. BAAs are general in nature, identifying areas of research interest, and shall only be used when meaningful proposals with varying technical/scientific approaches can be reasonably anticipated.

Offers submitted in response to this BAA will be required to present separate detailed technical and business proposals designed to meet the Technical Objectives described for each Research Area proposed. The Statement of Work (SOW), including the specific technical requirements and performance specifications, shall be developed and proposed by the Offeror, not the Government.

Submission of Proposals:

All responsible offerors may submit a proposal. NIAID requires proposals be submitted only online via the NIAID electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov/NIAID.

For directions on using eCPS, go to the eCPS website and click on "How to Submit."