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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 NIAID initiatives, go to Explore NIH Grant Opportunities.
Note: Council approval does not guarantee that a concept will become an initiative.
Table of Contents
Fiscal Year (FY) 2027 Division of Microbiology and Infectious Diseases (DMID) Concepts
- Infectious Diseases Clinical Trials Network (IDCTN)
- Clinical Research Network on Antimicrobial Resistance
- Tuberculosis Research Advancement Centers (TRACs)
- Coccidioidomycosis Collaborative Research Centers
- Accelerating Research and Development of Next Generation Vaccines Against Malaria—A Model for Mosquito-Borne Diseases
- Development of Medical Countermeasures for Biodefense and Emerging Infectious Diseases
Infectious Diseases Clinical Trials Network (IDCTN)
Request for Applications—proposed FY 2027 initiative
Contact:
Marina Lee
marina.lee@nih.gov
Objective: The objective of this initiative is to advance clinical and public health outcomes for NIAID scientific priorities in evaluating therapeutics, vaccines, biologics, diagnostics, and devices targeting infectious diseases, including emerging and chronic infections. This will be promoted by identifying experienced clinical trial sites and teams, engaging investigators and other scientific leaders in the field to solicit and generate innovative concepts for advancing public health, and providing opportunities for new clinical trialists.
Description: This initiative will support a clinical trials network to develop clinical trial concepts to address infectious diseases. The Infectious Diseases Clinical Trials Network (IDCTN) is comprised of the Clinical Trial Evaluation Units (CTEUs) and a Network Coordination Center (NCC), supporting the evaluation of therapeutics, vaccines, biologics, diagnostics, and devices targeting infectious diseases, including emerging and chronic infections. The CTEUs provide the clinical infrastructure for implementing clinical trials and studies and provide rapid response capabilities to studies of medical countermeasures in response to public health and disease threats. The NCC, comprised of leaders from the CTEU and in collaboration with NIAID, provides the scientific leadership and organizational framework for a collaborative and integrated network, engages with experts in the field to solicit and generate innovative clinical trial concepts for advancing public health while creating opportunities to advance investigators early in their careers and those new to the field. The initiative gives NIH the capabilities to rapidly implement clinical trials and studies for public health priorities that address the needs of the U.S. population.
Clinical Research Network on Antimicrobial Resistance
Request for Applications—proposed FY 2027 initiative
Contact:
Kyung Moon
kyung.moon@nih.gov
Objective: To support a Clinical Research Network (CRN) on Antimicrobial Resistance (AMR), which will design, prioritize, implement, and manage a clinical research program to address key clinical questions in AMR.
Description: This initiative aims to continue support for a CRN focused on AMR to address critical clinical research questions. The program will encompass four key components: Scientific Leadership Center, Clinical Operations Center, Laboratory Center, and Statistics and Data Coordination Center. The Scientific Leadership Center will oversee the network’s overarching research agenda on AMR and offer clinical research opportunities for early-stage investigators thereby fostering the next generation of clinical researchers in infectious diseases and AMR. The general areas of clinical research and activities may include:
- Clinical evaluation of new interventions, including alternatives such as bacteriophage therapy, monoclonal antibodies, and microbiome, to effectively treat and prevent AMR infections. The research will focus on the AMR priority lists from the CDC, including AMR fungal pathogens.
- Strategy trials to optimize the use of currently licensed antibacterials (e.g., dose, duration, clinical algorithms, and combinations) to reduce the risk of resistance.
- Research to identify biomarkers and develop rapid diagnostic tools for refining treatment strategies and reducing the misuse or overuse of antibiotics, and validate new diagnostic tests to support regulatory submissions.
- Clinical utility studies of diagnostic tests to determine their impact on patient and facility-level outcomes and prescribing behavior.
- Molecular epidemiological studies to provide data on the associations between patient characteristics, clinical outcomes, and resistant genotypes/phenotypes, informing future interventional therapeutics.
- Private and public partnerships to foster a robust community, guide optimal clinical trial designs, and enhance robust clinical trials to advance potential therapies in a timely manner.
Tuberculosis Research Advancement Centers (TRACs)
Request for Applications—proposed FY 2027 initiative
Contact:
Susana Mendez
susana.mendez@nih.gov
Objective: The objective of this initiative is to develop the next generation of tuberculosis (TB) researchers and to catalyze multidisciplinary and innovative TB science by providing expertise and resources to facilitate basic and clinical TB research.
Description: All TRACs will include a Developmental Core, at least two elective TB-specific Science Cores, and an Administrative Core that will support the management and operations of each center. The Development Core will provide short-term funding to support TB-specific pilot awards and other research activities and will develop and foster mentoring and training activities for early-career investigators and scientists wishing to enter the TB field. The Developmental Core will also identify and assist with evolving research opportunities and collaborative studies with other centers/programs. TB-specific Science Cores will vary in scope and can include a combination of Basic Science, Clinical, or Specialty Cores. The Basic Science cores will provide resources such as emerging technologies, laboratory services, disease models, and BSL-3 activities. The Clinical Science Core will provide resources for study design, protocols, regulatory support, access to clinical data or cohorts, and clinical research training and opportunities to consult with Community Advisory Board members in TB endemic areas. Specialty Core(s) may be proposed if they are unique and essential for advancing local TB research. The TRACs may also support research on other mycobacterial species beyond Mycobacterium tuberculosis (Mtb), the causative agent of TB, if properly justified.
Coccidioidomycosis Collaborative Research Centers
Request for Applications—proposed FY 2027 initiative
Contact:
Dona Love
dona.love@nih.gov
Objective: To establish Coccidioidomycosis Collaborative Research Centers (CCRCs) to conduct multidisciplinary research aligned with the priorities outlined in NIAID’s Strategic Plan for Research to Develop a Valley fever Vaccine. It is expected that the CCRCs will leverage unique research resources and patient populations from endemic regions to advance the field.
Description: This initiative will support collaborative research centers to conduct multidisciplinary research with clear relevance to the strategic priorities defined in the strategic plan, which encompasses three major research areas: 1) address gaps in Coccidioides basic research to support the development of a vaccine; 2) develop tools and resources to support vaccine development; and 3) develop and advance vaccines to prevent coccidioidomycosis. It is expected that the multidisciplinary centers will leverage unique research resources and patient populations from endemic regions to advance the field. Examples of multidisciplinary projects include discovery and validation of novel vaccine and/or immunomodulatory targets and pathways, identification and validation of correlates of immune protection, and diagnostic development to support vaccine testing. This initiative will not support clinical trials, but the CCRCs may leverage existing NIAID infrastructure such as the Early-Phase Clinical Trial Units for early-phase clinical trials and NIAID preclinical services. Each Center will support a Development and Research Program to help develop early-stage translational projects and bring new investigators to the field. Center directors and project principal investigators will meet yearly to exchange ideas, reagents, new techniques, and innovative approaches, and forge new collaborations to better understand and treat this complex disease.
Accelerating Research and Development of Next Generation Vaccines Against Malaria—A Model for Mosquito-Borne Diseases
Request for Applications—proposed FY 2027 initiative
Contact:
Annie Mo
moa@niaid.nih.gov
Objective: The objective of this initiative is to support research and/or preclinical development of highly efficacious malaria vaccines that capitalize on recent vaccine technological innovations, especially encouraging structure-based immunogen design, improved formulations, and combination vaccines.
Description: The overall goal of this initiative is to stimulate basic research, discovery, and/or preclinical development activities to enable and accelerate the generation of highly efficacious malaria vaccines against two major human parasites, Plasmodium falciparum and P. vivax, and potentially other mosquito-borne illness by encouraging cross-fertilization and collaboration across different scientific disciplines and/or with vaccine developers or product development partners. The initiative will specifically seek product candidates or concepts targeting pre-erythrocytic, blood, and/or sexual stages of Plasmodium parasites, as well as mosquito vector products to create a highly efficacious and effective vaccine to prevent infection, reduce disease burden, and/or block transmission of malaria and/or other mosquito-borne diseases. The initiative will emphasize structure-based immunogen design and improvement as well as combination vaccine design and formulation, calling for utilization of recent technological advances in vaccine platforms and other vaccinology innovations. Regardless of the stage of proposed research and development activities (discovery or preclinical development), proposed vaccine concepts should take into consideration downstream product feasibility aspects such as favorable product features (e.g., easily deployable formulations and straightforward immunization regimens) to address real world implementation demands. Partnership with product development partnerships or commercial developers is highly encouraged.
Development of Medical Countermeasures for Biodefense and Emerging Infectious Diseases
Broad Agency Announcement—proposed FY 2027 initiative
Contact:
Jonathan Bryan
jonathan.bryan@nih.gov
Objective: To advance the development of candidate medical countermeasure products, platform technologies, and devices from preclinical studies through early-phase clinical trials/validation, thereby building a data set to reduce risk for advanced development and regulatory approval and/or gain efficiencies/speed for future use.
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 disease 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/or 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.