June 2019 DMID Council-Approved Concepts

Concepts represent early planning stages for program announcements, requests for applications, 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.

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

Table of Contents

Fiscal Year 2021 Concepts

Tuberculosis Research Units

Request for Applications—proposed FY 2021 initiative

Contact: Katrin Eichelberg

Objective: This initiative will support studies to determine the impact of Mycobacterium tuberculosis (Mtb) physiology, virulence, and pathogenicity as well as host factors on tuberculosis (TB) disease progression and outcomes in humans and animal models. These studies are expected to inform the development of more effective therapeutic strategies and biomarkers.

Description: This initiative will support the establishment of up to four TB Research Units (TBRUs) that will operate as a collaborative network. It is expected that each TBRU center will include expertise in clinical research, animal modeling, microbiology, pharmacology, immunology, as well as data and statistical management.

A considerable amount of research in TB is focused on host immune mechanisms underlying infection, latency, and progression to active disease. The causative agent of TB, Mtb, has adapted to evade and survive in various host environments, and its virulence factors during the different phases of disease are not well understood. The objective of the TBRU program is to inform the development of more effective therapeutic strategies and diagnostics through improved understanding of how bacterial physiology, heterogeneity, and host-pathogen interactions drive TB disease outcomes. This initiative will support integrated, multidisciplinary programs using animal and human samples with an emphasis on microbial physiology and host-pathogen interactions. Investigators are also encouraged to develop pathogen-specific tools, predictive animal and ex vivo models, and incorporate systems biology and computational modeling approaches.

Examples of potential research areas include but are not limited to:

  • Functionally characterize Mtb virulence factors that play a role in infection, transmission, and disease as well as establishment and maintenance of latency.

  • Define host factors and their influence/role on susceptibility to infection, transmission, and progression to TB disease
  • Identify bacterial-specific markers that correlate with latency, progression to active disease, persistence or high-transmission potential to measure and predict success of therapy or potential for relapse, as well as for the development of rapid, point-of-care diagnostics.

  • Determine impact of Mtb phenotypic diversity, changes in pathogen biochemical pathways, and metabolism on bacterial persistence, disease progression, and outcome.

Centers of Excellence for Influenza Research and Response

Broad Agency Announcement—proposed FY 2021 initiative

Contact: Daniel Bresnahan

Objective: To support an international and domestic basic and clinical influenza research program focused on the study of the natural history, transmission, and pathogenesis of influenza in humans and at interspecies interfaces, including the provision of critical infrastructure for emergency response.

Description: The overall goal of this program is to conduct integrated basic and clinical research to advance knowledge of host and viral factors that determine influenza emergence, transmission, and protection against influenza to accelerate development of new and improved control measures including vaccines and therapeutics. The program will provide information and public health tools and strategies needed to control and lessen the impact of epidemic influenza and the increasing threat of pandemic influenza.

To that end, Centers of Excellence for Influenza Research and Response (CEIRR) will carry out a host of activities, including cohort studies and human and animal sampling to further understanding of influenza infection, transmission, and vaccination; identifying immunological factors that determine disease outcome in the response to influenza infection and vaccination; and studies to determine how influenza viruses evolve, adapt, and transmit between humans and at interspecies interfaces. Together, these activities lay the groundwork for the development of new and improved control measures for emerging and reemerging influenza viruses. The program will continue to perform nonhuman surveillance but will focus these efforts at interspecies interfaces and geographic regions at high-risk for spillover of influenza into humans.

The CEIRR program will build upon strengths of the previous Centers of Excellence for Influenza Research and Surveillance program, including the study of influenza at the interspecies interface but will more strongly emphasize the study of influenza in humans. The CEIRR will address knowledge gaps that can advance universal influenza vaccine research and development through longitudinal human studies while continuing to provide the international research infrastructure needed to address zoonotic influenza outbreaks in humans or a pandemic.

Given the potential for the emergence of a new influenza pandemic, network sites must be prepared to redirect their work to address an urgent public health emergency involving the emergence and rapid spread of influenza in humans, as requested by NIAID. This will allow NIAID to maintain a network of dedicated influenza labs that could be able to quickly respond to a public health emergency.

Influenza Data Processing and Communication Center

Request for Proposals—proposed FY 2021 initiative

Contact: Huran Ali

Objective: To continue to support a robust, state of the art, influenza data processing center that provides appropriate processing for data collected and generated by the NIAID Centers of Excellence for Influenza Research and Response (CEIRR; separate FY 2021 initiative). The Influenza Data Processing and Communication Center (iDPCC) will also serve as a central resource for other NIAID Universal Influenza Vaccine initiatives.

Description: The iDPCC will collect and process the diverse influenza data sets generated by NIAID’s CEIRR to facilitate the management and transfer to other appropriate databases. The main objectives of the iDPCC include:

  • Maintaining robust cloud-based data management systems and software tools to facilitate collecting, tracking, and updating diverse influenza data sets generated and collected across the CEIRR network. The data types managed by iDPCC may include genome sequences, immunology and serology data, animal and human surveillance data, viral isolate data, clinical and human cohort data (including relevant metadata), and network-generated reagents.
  • Assisting the CEIRR network with managing and processing the data they generate, and facilitating data transfer to the appropriate publicly-accessible databases, including the NIAID-funded Bioinformatics Resources Centers, National Center for Biotechnology Information resources, or other relevant databases for wide dissemination.
  • Maintaining and updating influenza-specific data and metadata standards for diverse data types generated by CEIRR.
  • Developing and facilitating implementation of CEIRR network-wide bioinformatics activities including data analysis, uniform annotation processes, and interoperability.
  • Providing training for data analysis, management, and transfer.
  • Developing and maintaining a publicly accessible website that serves as a central portal for DMID’s universal influenza resources, including cataloging and publicizing reagents and other resources (e.g., virtual human cohort sample repository) for the influenza research community.
  • Creating and distributing informational material for DMID’s universal influenza research efforts to ensure consistent messaging, branding, and access to division-wide resources.

Multidisciplinary Studies To Improve Understanding of Influenza Transmission

Request for Applications—proposed FY 2021 initiative

Contact: Teresa Hauguel

Objective: To improve understanding of influenza transmission between humans.

Description: This initiative will support coordinated, multidisciplinary research to further understanding of the dynamics and drivers of influenza transmission between humans. Specifically, this initiative will support research to:

  1. Develop innovative devices and/or improve existing methods for the efficient detection and sampling of influenza viral particles from the air.

  2. Develop novel assays for characterizing viral particles collected from the air, including assessments of infectivity and viability.

  3. Refine and optimize animal study designs to more closely mimic human-to-human influenza transmission and address physical and environmental variables (e.g., route, timing, and length of exposure; airflow and ventilation; temperature and humidity; distance to aerosol source).

  4. Conduct and integrate animal and human studies and data to comprehensively evaluate viral, host, physical, and environmental factors that facilitate efficient human-to-human influenza transmission.

Applicants should propose well-integrated, cross-disciplinary research teams with expertise in pathogen biology, host genetics, immunology, and computational biology as well as aerobiology, biological engineering, environmental health, physical science, and behavioral science.

Partnerships for Countermeasures Against Select Pathogens

Request for Applications—proposed FY 2021 initiative

Contact: Michael Schaefer

Objective: Expand the product development pipeline by supporting preclinical development of countermeasures against select pathogens.

Description: This initiative will support milestone-driven projects focused on advancing candidate therapeutics and vaccines against select pathogens. Responsive projects must include preliminary data that demonstrates proof-of-principle for target candidate products. Participation with industrial laboratories will be required to facilitate appropriate and affirmed product development activities. Clinical trials will not be supported under this program.

Therapeutics and Immunotherapeutics: Development of new or improved therapeutics against NIAID priority pathogens is of great importance. Projects must focus on well-characterized leads and/or targets. Priority will be given to projects aligned with either of the following therapeutic strategies:

  • Nontraditional Therapeutics That Limit Antibacterial Resistance

    Nontraditional therapeutics have the potential to transform treatment of patients infected with antibiotic-resistant bacteria, reduce the spread of resistance, and reinvigorate the dwindling pipeline of antibacterial agents. A nontraditional therapeutic is an antibacterial agent/approach that is characterized by a mechanism that differs from traditional small-molecule antibiotics that directly kill or inhibit growth of bacteria. Included within the nontraditional therapeutic category are small molecules or biotherapeutics that do not directly target bacterial viability or growth but instead modulate virulence or pathogenicity. Also included are biological interventions such as bacteriophage, therapeutic bacteria (individual or combinations), or biologicals capable of modifying or restoring microbial communities for the purpose of treating or preventing infections. Responsive projects will target bacterial pathogens for which antibiotic resistance is a significant clinical concern and antibiotic use in clinical settings contributes to pathogen spread and infection.

  • Broad-Spectrum Antiviral Therapeutics Against RNA Viruses

    Broad-spectrum antivirals have the potential to improve treatment options for patients infected with RNA viral pathogens. Responsive projects will focus on developing an antiviral that targets at least two select RNA viral pathogens. Emphasis will be placed on therapeutics that show greater effectiveness than licensed antivirals and provide a longer treatment window for delayed therapy initiation.

Vaccines: Development of vaccines against NIAID priority pathogens or vaccine technologies should focus on proven immunogens. Projects are expected to include proof-of-concept in animal models, preclinical evaluation, and if warranted, scale-up production under Good Manufacturing Practice to provide sufficient quantities for preclinical FDA-required animal studies. Responsive projects must focus on developing targeted vaccine strategies aligned with one of the following priorities:

Partnerships for the Development of Universal Influenza Vaccines

Request for Applications—proposed FY 2021 initiative

Contact: Jennifer Gordon

Objective: The objective of this initiative is to ensure an ongoing, steady flow of promising universal influenza vaccine candidates that protect against both influenza A and B viruses entering the preclinical development pipeline.

Description: The proposed Partnerships initiative will include milestone-driven translational and early preclinical studies supporting the development of universal influenza vaccines that protect against both influenza A and B viruses. Specifically, the aims of this proposed initiative are to

  • Stimulate innovative, potentially high-risk approaches that support the discovery and early development of universal influenza vaccines

  • Encourage the development and/or characterization of influenza B (IBV) components to complement existing influenza A (IAV) vaccine candidates that target both influenza A and B viruses

The proposed initiative supports implementation of NIAID’s Strategic Plan for Universal Influenza Vaccine Development, Research Area 3: Support Rational Design of Universal Influenza Vaccines.

Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases

Request for Proposals—proposed FY 2021 initiative

Contact: Chase Sullivan

Objective: To provide comprehensive statistical, data management and analysis support activities for DMID clinical research studies and trials.

Description: This initiative will support a Statistical and Data Coordinating Center to provide comprehensive and consistent statistical and data management support for DMID clinical research studies and trials spanning a wide range of infectious diseases and candidate products, including vaccines, diagnostics, biologics, devices, and therapeutics. These services are provided at multiple domestic/international sites.

Specifically, the program will provide a comprehensive array of statistical and data management support services, including web-based data collection, management, and quality control; statistical consultation, design, and analysis; assistance in study materials development with related web-based reports and training; assistance with site management; electronic specimen tracking; and data reports to support safety/regulatory requirements.

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