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.  The NIAID, Division of Allergy, Immunology, and Transplantation has a requirement for the development of vaccine adjuvants towards licensure for human use.

Description

The purpose of this Broad Agency Announcement (BAA) is to solicit proposals for the pre-clinical development of novel vaccine adjuvants towards licensure for human use.  The proposal must describe a milestone-driven program to support the pre-clinical development and optimization of a single lead vaccine adjuvant for use in vaccines to prevent or treat human disease caused by non-HIV infectious pathogens or to treat immune-mediated diseases (e.g., allergic diseases, autoimmune diseases).  The lead adjuvant may be a single entity (e.g., a single TLR agonist) or a combination adjuvant (e.g., a TLR agonist combined with a saponin based adjuvant).  Adjuvants may be chemical, biological, or genetic adjuvants.  Adjuvants must have previously demonstrated in an in vivo model system the ability to augment, potentiate, or modulate an immune response to an antigen, resulting in enhanced protective efficacy or drive therapeutic efficacy.  The adjuvant must be studied and further developed toward human licensure with currently licensed or as new investigational vaccines and may not be developed as a stand-alone agent.  The choice of the target non-HIV pathogen or immune-mediated disease is left to the Offeror, who may choose the best vaccine target to advance the development of the adjuvant given the properties of the adjuvant.  Vaccines may be prophylactic or therapeutic vaccines.  Offerors may choose to develop the adjuvant within the context of a single vaccine or as multiple vaccine candidates each targeting different pathogens or immune-mediated diseases.  The vaccine target(s) must be well justified, and the choice of antigen(s) strongly supported by preliminary or published data.  The BAA will not support the discovery of new or novel antigens.  Offerors may choose to develop the adjuvant within the context of a single or multiple vaccine platform technologies (e.g., recombinant protein, RNA, split vaccine), though the choice of vaccine platform(s) used must be well justified.  Activities supported by the BAA include, but are not limited to: Formulation activities, in vivo immunogenicity and efficacy studies in appropriate animal models, pharmacology and toxicology, vaccine stability studies, and manufacturing of the adjuvant.

It is anticipated that multiple cost reimbursement, completion type contracts will be awarded for a five-year period of performance beginning on or about September 2023.   

NIAID estimates that the average annual total cost (direct and indirect costs combined) is $1-2 million per award per year.  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 five (5) years.

Any responsible offeror may submit a proposal which shall be considered by the Agency.   This BAA will be available electronically on/about April 13, 2022, and may be accessed through SAM.gov (https://sam.gov/content/home).  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 via the NIAID electronic Contract Proposal Submission (eCPS) website. 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."