The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is soliciting research proposals under a 2021 Broad Agency Announcement to advance biodefense medical countermeasures research and development (R&D).
This solicitation contains multiple distinct Research Areas. Offerors may submit a proposal in response to
one, or more, of the Research Areas.
Research Area 1 – Advanced Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases
Research Area 1 seeks to advance vaccine technologies and platforms that have sufficient proof of concept data and/or clinical data to support vaccine development through manufacturing, toxicology testing, and testing in phase 1 or 2 clinical trials. The goal of Research Area 1 is to advance vaccine technologies and platforms which could be deployed against agents important for biodefense and/or emerging pathogens to protect human health and well-being. The development of these platforms and technologies to rapidly progress into Phase 1 clinical trials will provide critical data to reduce the risk for future development of these technologies into approved therapies and vaccines.
One objective of Research Area 001 is to develop vaccines to address anti-microbial resistant (AMR) organisms including biodefense, gram negative, gram positive and fungal pathogens; vaccines focused on antimicrobial resistant gram-negative organisms; vaccines focused on multi drug resistant gram-positive bacteria; and vaccines focused on fungal pathogens.
Pathogens of particular interest include (but are not limited to):
- Burkholderia spp
- Francisella tularensis
- Yersinia pestis
- Pseudomonas aeruginosa
- Escherichia coli
- Staphylococcus aureus
- Candida auris
NIAID is specifically excluding vaccines for Bacillus anthracis.
A second objective is to support development of vaccines for emerging viruses and pandemic
preparedness. Targets of particular interest include:
- Vaccines that target coronaviruses with pandemic potential
- Development of pan-coronavirus (pan-CoV) vaccine candidates that provide durable protective immunity to multiple CoV strains.
- Eastern equine encephalitis virus (EEEV)
- Tick borne viruses
- Non-Zaire Ebolaviruses/filoviruses (such as SUDV, MARV)
NIAID will exclude, specifically for this BAA, vaccine candidates that only protect against SARS-CoV-2 alone, Ebola Zaire, Lassa, Chikungunya, Zika and Nipah.
The candidate product(s) may also include adjuvant(s) that enhances the immune responses. Preference will be given to novel adjuvants that have not previously been in clinical trials or have demonstrated enhanced immunogenicity appropriate for the associated antigen and disease. Additionally, where feasible, vaccines providing protection with a single dose with adjuvant are also preferred over multi-dose administrations.
Novel delivery platforms that reduce logistical requirements, are readily scalable and/or provide other benefits such as generation of potent mucosal immunity may be developed as well. Crosscutting technologies applicable to more than one vaccine component are also of interest.
Research Area 2 – Development of Therapeutic Products for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases
The objective of Research Area 2 is the development of promising new therapeutics to address infections caused by NIAID Category A, B, and C priority pathogens and select bacterial and fungal infections identified in the 2019 CDC Antibiotic Resistance Threats Report. For the purposes of this solicitation, therapeutic activity is defined as the cure or mitigation of disease, preferably, once signs and symptoms of infection are evident. A therapeutic candidate refers to an advanced lead series, optimized leads, or product candidate, and is either a small molecule (synthetic or natural product) or a biological product (e.g. monoclonal antibodies, recombinant proteins).
Research Area 2 will support lead optimization, pre-clinical (IND enabling) studies and clinical trials that include Phase 1 and Phase 2 studies or confirmatory trials no greater than 120 subjects.
- Synthesize lead compounds from selected lead scaffolds: new analogs with improved potency, reduced off-target activities, and physiochemical/metabolic properties suggestive of reasonable in vivo pharmacokinetics.
- Conduct non-GLP in vivo toxicity in accordance with the product’s intended use.
- Demonstrate in vivo activity and potential for efficacy consistent with the product’s intended use (i.e. dose, schedule, duration, route of administration).
- Initiate experiments to identify PK/PD relationships and define efficacious exposure targets for further pre-clinical and clinical studies.
- Select lead candidate and initiate IND-enabling studies.
Pre-Clinical (IND Enabling) Studies
- Demonstrate acceptable ADME characteristics and/or immune responses in non-GLP animal studies as necessary for IND filing.
- Conduct GLP non-clinical studies for toxicology, pharmacology, and immunogenicity (as appropriate).
- Continue development of animal models for determining efficacy and defining PK/PD relationships for further pre-clinical and clinical studies.
- Develop a scalable and reproducible manufacturing process amenable to GMP.
- Manufacture GMP-compliant pilot lots.
- Initiate development of in-process assays and analytical methods for product characterization and release, including assessments of potency, purity, identity, strength sterility, and quality as appropriate.
- Prepare and submit IND package to FDA.
Research Area 3 – Advanced Development of Sequencing- Based Diagnostics for Biothreats and Emerging Infectious Diseases
NIAID is interested in supporting the development of promising sequencing-based diagnostics for biothreat pathogens as well as pathogens causing emerging and re-emerging infectious diseases. Specifically, the objective of Research Area 3 is to advance the research and development of nucleic acid and protein sequencing solutions on established commercial platforms for the targeted and agnostic detection of bio-threat and naturally emerging infectious pathogens. It is not required to complete the development and FDA clearance of the diagnostic during the project period; however, the targeted metrics for the final diagnostic product should include:
- Turnaround time – pathogen ID within 1-2 hours of specimen collection
- Throughput – minimum of 10 patient samples processed per sequencing run
- Sensitivity – analytical sensitivity of > 97% for infectious pathogen detection
- Specificity – limited off- target detection of < 3%
- Ease of use – automated nucleic acid or protein extraction and sample preparation; simplified transfer to sequencing system; data analyses operated and interpreted with minimal training
- Regulatory – FDA pre-EUA and/or 510(k) clearance
- System utility – other commercially sustainable assays cleared or in development or in planning on same or equivalent system
Development activities that are within the scope of this research area include:
- Nucleic acid or protein extraction method development
- Automated nucleic acid or protein preparation method development
- Sequencing assay development to detect one or more required pathogens
- Metagenomic sequencing assay development for agnostic detection of untargeted pathogens
- Internal and external controls development
- Integration of chemistry processing on automated platforms
- Software development, including database improvement for faster and/or more comprehensive analysis patient sample data
- Reagent scale-up for process validation and pilot manufacturing
- Establishment of clinical studies to validate performance
NIAID estimates that three or more awards may be issued across Research Areas 1 and 2. The total cost and duration for each award may vary depending upon the scope of the project and the technical objectives of the award(s). NIAID estimates a total FY22 budget of up to $11 million for the non-severable base work across all contracts in Research Areas 1 and 2.
NIAID estimates that one or more awards may be issued across Research Area 3 with a total FY22 budget of up to $4 million.
Additional details are available at beta.SAM.gov HHS-NIH-NIAID-BAA2021-1. The proposal deadline is May 24, 2021.