February 23, 2023
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National Institute of Allergy and Infectious Diseases (NIAID)
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. The NIAID, has a requirement for assessment of HIV immunogens-adjuvants formulations to allow better prediction of immune response prior to transitioning into clinical trials. Contractors supported through the R-CASA program will be expected to: 1) generate standardized protocols and endpoint assays for rational and systematic vaccine formulation screening and 2) apply those protocols and assays to screen immunogens and adjuvants formulations, and 3) screen additional immunogens and adjuvants at the direction of NIAID. The efforts will delineate a standardized set of assays, algorithms and signatures that can identify correlates of protection (immune biomarker(s) associated with vaccine efficacy), and which maximize the successful transition of immunogen-adjuvant formulations from the pre-clinical testing to First-in-Humans (FIH) trials. Henceforth, the goal would be to select adjuvants via qualified parameters and not by convenience or availability.
Contractors supported through the R-CASA program will be expected to: 1) generate and propose standardized protocols and endpoint assays for rational and systematic down-screening of HIV immunogen-adjuvant formulations, 2) apply those protocols and assays to screen HIV immunogen-adjuvant formulations, and 3) screen additional immunogens and adjuvants at the direction of NIAID. The efforts will delineate a standardized set of assays for biochemical and immunologic characterization of HIV immunogen-adjuvant formulations, down-selection workflow and go-no-go criteria to maximize the successful transition of immunogen-adjuvant formulations from the pre-clinical testing to First-in-Humans (FIH) trials. Henceforth, the overarching goal is to select HIV immunogen-adjuvant formulations via qualified parameters and not by convenience or availability.
It is anticipated that one to two cost reimbursement, completion type contracts will be awarded for a 5-year period of performance beginning on or about June 3, 2024 through June 2, 2029.
NIAID estimates making one to two awards with an average annual total cost (direct and indirect costs combined) of $2 million for each award. However, 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 which shall be considered by the Agency. This BAA will be available electronically on/about February 21, 2023 and may be accessed through 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."
Kishan Patel, Contracting Officer
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5157
Email: Patelki@niaid.nih.gov
and Human Services (HHS)
