Development of Vaccine Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections, and Emerging Infectious Diseases

Development of Vaccine Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections, and Emerging Infectious Diseases Request for Information (RFI) Solicitation Number: HHS-NIH-NIAID-BAA2024-1 Introduction: This is an RFI only and does not constitute a commitment, implied or otherwise, that the Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), will take procurement action in this matter. This is NOT a solicitation for proposals, applications, proposal abstracts or quotations. The purpose of this RFI is to obtain knowledge and information to assess the current - state of the science in the field of vaccines. Further, neither DHHS/NIH/NIAID nor the government will be responsible for any cost incurred in furnishing this information. Purpose: This is a time-sensitive RFI, the purpose of which is to gather information on vaccine candidates in the areas identified below. This RFI is being issued for the purpose of obtaining knowledge and information for project planning and market research purposes. Broadly protective coronavirus vaccines (BPCVs) that target beta-coronaviruses, provide durable protection and/or immunity (superior to licensed vaccines for SARS-CoV-2) as well as breadth of immunity (i.e., high titer binding and neutralizing antibodies against recently circulating SARS-CoV-2 Variants of Concern, and SARS-CoV-1) and utilize technology platforms that are suitable for rapid pandemic response. Vaccine candidates should incorporate novel immunogens or delivery platforms and must elicit mucosal immunity. Alphaviruses (excludes Chikungunya) Filoviruses: Sudan ebolavirus, Marburg virus, Bundibugyo virus, especially vaccine candidates that demonstrate efficacy after a single dose in a relevant animal model. Flaviviruses (except Zika, Dengue) Orthopoxviruses: next generation vaccines for smallpox suitable for all ages and the immunocompromised that also protect against MPOX and that are not Modified Vaccinia Ankara (MVA)-based technologies. ESKAPE pathogens (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter spp) Group A and Group B Streptococcus Improved vaccines for S. pneumoniae and B. pertussis. Vaccines to prevent Mycobacterium tuberculosis infection and/or tuberculosis disease. Valley Fever (Coccidioidomycosis) Optimal Valley fever vaccine candidates should align with specific criteria outlined in NIAID's published strategy for Coccidioidomycosis (https://www.niaid.nih.gov/sites/default/files/niaid-strategic-plan-for-research-to-develop-a-valley-fever-vaccine9.9.22.pdf) Influenza vaccines designed to be protective against a broad array of Influenza A and/or B strains (e.g., - universal influenza vaccines), pandemic influenza vaccines, seasonal influenza vaccines that offer significant improvements over currently licensed seasonal influenza vaccines. Quadrivalent Shigella vaccines Combination Salmonella vaccines Neisseria gonorrhoeae vaccines Vibrio cholerae with a focus on 2nd generation vaccines Campylobacter jejuni Combination vaccines to protect against two or more enteric bacterial pathogens, i.e., ETEC, Campylobacter, Shigella, Vibrio, Salmonella (iNTS, paratyphi A.) Background: Research supported by the National Institutes of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), and the Department of Health and Human Services (DHHS), strives to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. NIAID also has a key role in the development of new medical countermeasures (MCMs) against potential agents of bioterrorism, drug-resistant pathogens, and emerging and re-emerging infectious diseases. Through a variety of research grants and contracts, NIAID's Division of Microbiology and Infectious Diseases (DMID) supports basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics targeting multiple pathogens, including NIAID Emerging Infectious Diseases/Pathogens which encompass Category A, B, and C priority pathogens (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens). Information requested: Organizations are invited to describe their research efforts involving vaccine candidates against any of the listed pathogens. Your comments may include but are not limited to: a) vaccine platform and antigen components, such as the development status, manufacturing capabilities, results of proof of concept immunogenicity and efficacy studies in relevant animal models, and the design and the results of any completed Phase 1 clinical trial(s); b) adjuvant component, if applicable, including development status of the adjuvant component, i.e. preclinical studies, clinical trial(s), and manufacturing capabilities; and c) the planned clinical indication(s) for use for the vaccine candidate. The Government is also interested in the manufacturing status of potential vaccine candidates and likelihood that a Phase 1 or Phase 2 trial could be completed within 5 years. Organizations are invited to describe briefly the status of manufacturing processes including Good Manufacturing Practice (GMP), scalability, and ability to complete and submit an IND. Disclaimer: This Notice shall not be construed as a solicitation or funding opportunity; a contract, grant, cooperative agreement, or other transaction; or as an obligation on the part of the Federal Government and the NIH to provide support for any ideas identified in response to it. Submitting a request for these materials does not guarantee support for current or future studies. NIAID does not provide feedback on submitted responses. Submitting a Response: Responses should be limited to 3 pages for any given vaccine candidate, not including cover page, cover letter and table of contents. Any proprietary information should be clearly identified as such and will be kept confidential as allowed by relevant federal law. Submitted data and information will not be returned. RFI responses must include: 1) Name and title of the primary point of contact for the response; 2) Name and address of the Institution or Company; 3) Email address and phone number of the primary point of contact. Responses are due by 5 p.m. EDT on October 18, 2023. Please label the subject of your RFI Response email as follows: - RFI Response - NIAID-BAA2024-1 Development of Vaccine Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections, and Emerging Infectious Diseases. A companion RFI is released in the NIH Guide. Inquiries & Responses: Please direct all inquiries and RFI Responses to: Alexandra J. Buck, J.D. Contracting Officer alexandra.buck@nih.gov Research Contracts Branch-A (MIDRCB-A) Office of Acquisitions, DEA, NIAID, NIH, HHS