September 2022 DMID Council-Approved Concepts

Concepts represent early planning stages for program announcements, requests for applications, notices of special interest, or solicitations for Council's input. If NIAID publishes an initiative from one of these concepts, we link to it below. To find initiatives, go to Opportunities & Announcements.

Note: Council approval does not guarantee that a concept will become an initiative.

Table of Contents

Fiscal Year (FY) 2023 Concepts

FY 2024 Concepts

Scientific and Technical Staff and Services Contract to Support NIAID Collaboration with UVRI on Emerging Infectious Diseases

Justification for Other Than Full and Open Competition—proposed FY 2023 initiative

Contact:
Rosemary Gomes
rosemary.gomes@nih.gov
240-669-5374

Objectives: Emerging/re-emerging zoonotic diseases are a major global health problem. Linking comprehensive pathogen surveillance of arthropod/vector populations in Uganda with public health surveillance at the regional and international level will make an important contribution to human and animal health in East Africa and the ‘One World One Health’ concept in general. In this new project we propose to focus on vector-borne pathogens potentially causing disease in humans, wildlife, and livestock. A more comprehensive understanding of the ecology of known and unknown vector-borne zoonotic pathogens is essential for a risk assessment for local and global human and animal health.

  • Identification and research program for vector-borne microbiology. Further definition of the spectrum of viral/bacterial pathogens harbored by vector populations with a focus on rodent, tick, and mosquito populations to gain insight in the role of these vectors in the possible transmission and spread of pathogens to humans, wildlife, and livestock.
  • Surveillance for vector-borne disease exposure in local populations. Using the well-established Rakai Community Cohort Study to perform surveillance of vector-borne disease exposure to identify and prioritize pathogens currently circulating in local populations.
  • Characterization of vector-borne pathogens. Isolation and characterization of clinically relevant bacteria/viruses derived from rodent populations in cell culture systems and animal models.
  • Development of countermeasures. Development of potential intervention strategies (vaccines, therapeutics, improved diagnostics), based on ecological and laboratory-based studies.
  • Laboratory capacity building. Establishment of a state-of-the-art laboratory at Uganda Virus Research Institute (UVRI) to perform molecular microbiology and serology, as well as mobile laboratory capacity allowing for more rapid and independent support for field studies.
  • Training and education. Provision of training of Ugandan researchers to include graduate and postgraduate students, as well as more senior researchers.

Description: We propose to establish a research program on vector-borne pathogens in Uganda that will include ecological studies, pathogen characterization, disease modeling in animals, and development of countermeasures. For this, we will establish a state-of-the art microbiology laboratory at the UVRI, which will function as the laboratory for all field research activities. Field research teams consisting of local scientists in partnership with NIAID personnel will also deploy mobile laboratory units to perform limited analyses in field locations. Teams will consist of NIAID and local scientists, as well as researchers from other international research institutions, based on mutual agreement. Training of Ugandan scientists will be a major component of this project.

Limited Competition: Resources and Workforce Development for the Regional Biocontainment Laboratories

For the published request for applications, check the December 14, 2022 Guide announcement, Limited Competition: Resources and Workforce Development for the Regional Biocontainment Laboratories (UC7, Clinical Trial Not Allowed).

Sexually Transmitted Infections (STI) Cooperative Research Centers (CRC): Vaccine Development

For the published request for applications, check the February 9, 2023 Guide announcement, Sexually Transmitted Infections (STI) Cooperative Research Centers (CRC)—Vaccine Development (U01, Clinical Trial Not Allowed)

Advancing Development of Diagnostics for Congenital and Acquired Syphilis

Request for Applications—proposed FY 2024 initiative

Contact:
Jonathan Glock
jglock@niaid.nih.gov
240-627-3258

Objective: To enhance development of new diagnostics for congenital and acquired syphilis infections by leveraging recent advances in T. pallidum basic research and broader infectious disease diagnostic innovations.

Description: This initiative will support academic collaboration with industry in a way that will rapidly move promising technologies such as nucleic acid amplification tests (NAAT), antibody, metabolomics, transcriptomics, and genomics through the product development pipeline towards the development of new diagnostics for syphilis. This initiative would be focused on translational diagnostic development research that would not allow clinical trials but would allow collection and use of clinical samples. Applications concerning congenital syphilis would be of highest programmatic priority.

Preclinical Models of Infectious Diseases

For the published request for proposals, check the February 15, 2023 solicitation Pre-Clinical Models of Infectious Diseases.

Genomics Centers for Infectious Diseases

For the published request for applications, check the February 24, 2023 Guide announcement, Genomics Centers for Infectious Diseases (U19 Clinical Trial Not Allowed).

Therapeutics for Eliminating Hepatitis B Virus cccDNA

For the published request for applications, check the October 3, 2022 Guide announcement, Therapeutics for Eliminating Hepatitis B Virus cccDNA (R21/R33 Clinical Trial Not Allowed).

Development of Medical Countermeasures for Biodefense and Emerging Infectious Diseases

Broad Agency Announcement—proposed FY 2024 initiative

Contact:
Swee Teo
swee.teo@nih.gov
240-669-5173

Objective: To advance the development of candidate medical countermeasure products, devices, and platform technologies from preclinical studies through early phase clinical trials, thereby building a data set to reduce risk for advanced development and regulatory approval and/or gain efficiencies/speed for future use. Supports medical countermeasures for biodefense, emerging infectious diseases, antimicrobial resistance, and pandemic preparedness and response.

Description: This program supports the preclinical and early clinical development of candidate vaccines, therapeutics, diagnostics, and platform technologies for NIAID priority biodefense and emerging infectious diseases pathogens (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens). Contract funding will support vaccine and therapeutic development through candidate testing, manufacture, preclinical or nonclinical toxicology testing, and early clinical studies which may include Phase 1 and Phase 2 clinical trials. Diagnostics can be most critically supported in the planning, design, development, and verification phases of product development. This program reduces risk and enables candidate medical countermeasures to transition to other funding to support advanced clinical development (Phase 2b and beyond), large-scale manufacturing, and regulatory approval. Proposed focus areas include, but are not limited to, the following:

Vaccines

  1. Improved and/or new plug-and-play platforms, dose-sparing formulations, and/or delivery systems that can be rapidly manufactured and deployed for pandemic response and are applicable to more than one pathogen
  2. Pan-coronavirus vaccines
  3. Prototype pathogens from RNA viral families of pandemic potential
  4. Combating antibiotic resistant bacteria
  5. Fungal pathogens
  6. Influenza
  7. Mucosal or T-cell based platforms
  8. Vaccines that block transmission

Therapeutics

  1. Novel strategies for combating antibiotic resistant bacteria
  2. Influenza
  3. Emerging viral diseases
  4. Direct-acting antivirals in support of NIAID’s Antiviral Program for Pandemics (APP)
  5. Host-directed antivirals
  6. Novel monoclonal antibody strategies
  7. Nontraditional and small molecule approaches for toxins

Diagnostics

  1. Faster nucleic acid and protein sequencing for agnostic diagnoses
  2. Earlier bacterial identification and antimicrobial resistance characterization during sepsis onset
  3. More sensitive and faster rapid antigen testing for emerging infectious diseases

Notice of Special Interest (NOSI)—Advancing Research Needed to Develop a Coccidioidomycosis (Valley Fever) Vaccine

For the published notice of special interest, check the February 23, 2023 Guide notice, Notice of Special Interest (NOSI)—Advancing Research Needed to Develop a Coccidiodomycosis (Valley Fever) Vaccine.

Notice of Special Interest (NOSI)—Halting Tuberculosis (TB) Transmission

For the published notice of special interest, check the September 20, 2022 Guide notice, Notice of Special Interest (NOSI)—Halting Tuberculosis (TB) Transmission.

 

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