Develop Microbiome-Related Approaches To Advance Understanding of Radiation Injuries

The NIAID Radiation and Nuclear Countermeasures Program requests applications that 1) explore how the presence of resident microbiomes in the body might affect the severity of radiation injuries that would be sustained during a radiation or nuclear incident and how the microbiome itself is impacted by radiation exposure, and/or 2) develop medical countermeasures (MCMs) that target the microbiome to treat radiation injury.

Researchers can apply through the request for applications (RFA) Development of Microbiome-Related Approaches for Diagnosis/Mitigation/Treatment of Radiation Injuries (U01, Clinical Trial Not Allowed).

Research Objectives and Scope

To advance the state of the science and facilitate research on radiation and the microbiome, NIAID is interested in studies that propose any of the following areas of research:

• Projects addressing the role of microbiome(s) in radiation injury, and developing animal models to study the effect of irradiation on the microbiome in organs/tissues with relevance to a radiation emergency (e.g., gastrointestinal tract, oral mucosa, skin, lung), and its involvement in radiation pathogenesis in those tissues and organs affected by total and/or partial body radiation exposure
• Studies of the differing microbiome strains and species linked to susceptibility or resistance to radiation injury
• Developing MCMs targeting the microbiome to mitigate or treat radiation injuries, such as:
  • Probiotics or genetically modified bacteria, dietary modifications, prebiotics, vitamins, and minerals
  • Fecal microbiota transplant
  • Antibiotic approaches
  • Other products that exert an effect on the microbiome or the body’s immune response to changes in the microbiota
• Identifying and demonstrating efficacy of MCM candidates for use during a radiation public health emergency that target the microbiome or immune system interactions with the microbiome, with the following criteria:
  • Effective when administered at least 24 hours or later post-irradiation
  • Demonstrated ease-of-use in a mass casualty setting (e.g., route of administration is oral, subcutaneous, intramuscular, inhaled, topical, or transdermal)
  • Favorable safety profile
• Research on microbial changes following radiation exposure that could be used as biomarkers of injury/biodosimeters
• Ex vivo studies using human subject samples

Applications should include measurable, result-focused milestones that are appropriate for the scope of the project and reasonably attainable within the timeline provided.

Examples of Nonresponsive Applications

Applicants should note that NIAID will consider applications proposing research in the following areas to be nonresponsive and will not review them:

• Studies focused on administration of MCM candidates at times earlier than 21 hours post-irradiation, including pre-irradiation exposure
• Research that does not focus on the microbiome
• Work in radiation dose ranges or exposure parameters that are not relevant to a radiation accident or attack, e.g., studies using fractionated radiation exposures or very low radiation dose levels
• Studies focused on HIV/AIDS-related research
• Research looking at the role of the microbiome in radiation-induced carcinogenesis
• Applications that do not include milestones
• Clinical trials

Award and Deadline Information

Application budgets are limited to $350,000 in annual direct costs. The maximum project period is five years.

Applications are due by February 9, 2022, at 5 p.m. local time of the applicant organization.

Submit inquiries to Dr. Carmen I. Rios, NIAID’s scientific/research contact listed for this initiative at 240-627-3553 or carmen.rios@nih.gov. The peer review contact is Dr. Konrad Krzewski, whom you can reach at 240-747-7526 or konrad.krzewski@nih.gov.