RFA-AI-20-020: Tuberculosis Research Units (U19 Clinical Trial Optional)
Internal Deadline: May 22, 2020, noon PT
LOI: 30 days prior to the application due date
External Deadline: September 28, 2020
Award Information: Type: Cooperative Agreement
Estimated Number of Awards: NIAID intends to commit $10 million in FY 2020 to fund 2-3 awards.
Anticipated Amount: Applicants may propose a recommended budget of up to $1.8 million per year in direct costs.
Submission Process: PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://research.usc.edu/usc-grants/.
Materials to submit:
- Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
- CV – (5 pages maximum)
Who May Serve as PI:
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
The purpose of this FOA is to support the establishment of multidisciplinary Tuberculosis (TB) Research Units (TBRUs) that will operate as a collaborative network to improve understanding of Mycobacterium tuberculosis (Mtb)-host interactions through characterization of bacterial and host determinants that are relevant during stages of infection and disease, and analyses of bacterial and host heterogeneity on disease outcomes.
Each TBRU will be established as part of a multi-disciplinary consortium of investigators and institutions with expertise in clinical research, animal models, microbiology, epidemiology, pharmacology, immunology as well as data and statistical management. Each Unit will be overseen by a Project Director(s)/Principal Investigator(s) (PDs/PIs) who will coordinate and oversee its multidisciplinary research and ensure that the individual research projects synergize to advance the goals of this FOA to characterize bacterial and host determinants that are relevant during stages of infection, disease and transmission, as well as the impact of bacterial and host heterogeneity on disease outcomes. Investigators are encouraged to develop pathogen specific tools and incorporate systems biology, imaging and computational modeling approaches. To facilitate the understanding of the spectrum of TB infection and disease and enable the translation of research findings into clinical applications, each application must include at least one clinical research project and one animal research project. This combination may help facilitate the development of more predictive, targeted and interpretable animal models through “back-translation” of clinical findings.
Examples of potential research areas include, but are not limited to:
- Functional characterization of essential virulence factors of Mtb that are relevant during various stages of infection and disease progression
- Comprehensive studies to determine the impact of phenotypic or genotypic diversity within the infecting bacterial population on bacterial persistence, disease progression and disease outcome
- Studies to understand how bacterial metabolic or other physiologic changes mediate the evolution of resistance and persistence
- Identification of bacterial-specific markers that correlate with latency, progression to active disease, persistence or high-transmission potential, to enable the development of tools to better measure and predict TB outcomes
- Studies to determine effects of heterogeneity of host responses, co-morbidities and lung inflammation on the mechanism(s) associated with infection and disease progression
- Development of animal models that correlate with human disease/pathology to assess host-pathogen interactions during disease stages of TB and the effect of metabolic changes and inflammation in the host on disease progression
Applications proposing the following topics will be considered non-responsive and will not be reviewed:
- Applications that do not include both a clinical and an animal research project
- Immunological studies aimed at identifying correlates of protection or immunologic targets that can be used to improve TB vaccine strategies
- Impact of HIV/SIV and Nontuberculous Mycobacteria infections on relevant immune responses to Mtb infection or TB vaccines
- Impact of substance abuse (e.g. opioids, cannabinoids, cocaine, methamphetamines and alcohol) on TB transmission, progression and disease
- Research with a primary focus on epidemiologic studies
- Psychosocial or behavioral research
Please note that it is expected that some animal models that are developed by the TBRUs will be suitable for product development and evaluation. NIAID may request transfer of the protocols for these animal models to DMID’s preclinical services programs to be made available as a service to the community.
Visit our Institutionally Limited Submission webpage for updates and other announcements.