A new research initiative supports discovery and validation research for biomarkers and biomarker signatures that can identify tuberculosis (TB) infection in children under five years of age and predict those more likely to progress to active TB disease, which will allow for targeted treatment of those at risk of progression.
Researchers can apply through the request for applications (RFA) Biomarker Signatures of TB Infection in Young Children With and Without HIV (R01, Clinical Trial Not Allowed).
Research Objectives and Scope
Biomarker signatures predictive of TB disease progression have not been extensively evaluated in children, and the different immune responses to TB in children could result in biomarkers that are different than those identified in adults. Such biomarker signatures, if identified, could translate to simple, easy to use, point-of-care-based tools and allow targeted TB preventive chemoprophylaxis in children.
For this RFA, NIAID invites research applications that include the following features in their research design:
- A biomarker discovery approach leveraging state-of-the-art laboratory techniques such as single cell multi-omics technologies and similar approaches to perform unbiased, high-resolution biomarker profiling
- Additional approaches to confirm or refine biomarker signatures identified in the biomarker discovery approach, e.g., model systems, animal models, or other activities to evaluate biomarkers
- Children under five years of age as the target population, including children living with HIV and children at risk for TB through suspected/documented exposure or living in high TB incidence settings
- Access to well-characterized biobanks and datasets from the target population or access to ongoing, prospective, longitudinal, or observational cohorts of young children at risk for TB acquisition
- Rigorous methodological approaches—appropriate controls and accounting for confounders, sound diagnostic approaches, and rigorous classification of active TB disease and TB infection cases
Read the RFA linked above for full descriptions of these priority research parameters.
Examples of Nonresponsive Applications
NIAID will consider applications that include the following approaches to be nonresponsive and not review them:
- Absence of an unbiased, comprehensive profiling approach for biomarker discovery
- Newly established cohorts that have not obtained final IRB approval at the time of submission
- Developing a point-of-care diagnostic assay or evaluating existing diagnostic platforms
- Clinical trials, as defined by NIH
Award and Deadline Information
Application budgets are limited to $700,000 in annual direct costs. The maximum project period is five years.
Non-domestic entities are eligible to apply. Foreign components are allowed.
Applications are due by June 8, 2022, at 5 p.m. local time of the applicant organization.
Submit inquiries to Dr. Tania Lombo, NIAID’s scientific/research contact listed for this initiative at 301-761-7612 or tania.lombo@nih.gov. The peer review contact is Dr. Dimitrios Vatakis, whom you can reach at 301-761-7176 or dimitrios.vatakis@nih.gov.