(R01 Clinical Trial Not Allowed)
Funding Opportunity Announcement (FOA) Numbers: PAR-19-079
(R21 Clinical Trial Not Allowed)
Funding Opportunity Purpose
The purpose of this Funding Opportunity Announcement (FOA) is to advance the experimental validation and functional characterization of genetic variants in coding or non-coding genomic regions that result in inborn errors of immunity/primary immunodeficiency diseases and to elucidate the molecular, cellular, and immunological mechanisms of these disorders. Understanding the genetic basis of primary immunodeficiency disorders is essential for their diagnosis, prognosis, and the development of precision therapeutics.
Research Objectives and Scope
Research areas supported by this FOA include, but are not limited to, the experimental validation and immunological characterization of:
- Single nucleotide variants (inherited or de novo) in coding or non-coding regions of the genome that cause inborn errors of immunity;
- Insertions or deletions (indels) in coding or non-coding regions of the genome that cause inborn errors of immunity;
- Digenic/polygenic mutations that cause inborn errors of immunity;
- Structural variations (large insertions or deletions, translocations, inversions, or copy-number variations) that cause inborn errors of immunity.
State-of-the-art technologies and approaches (e.g., iPSC technology, CRISPR/Cas9 gene editing, multi-omics such as transcriptomics, proteomics, epigenetics etc) used to accomplish the objectives of this FOA are strongly encouraged.
The prioritization of putative disease-causing variant(s) is expected to be finalized by the time applications are submitted. For the genetic variant(s) that are chosen to be investigated further according to the objectives of this FOA, preliminary data should be presented to support causality between the variant(s) and disease phenotype.
The clinical and laboratory phenotype of the patients should be well defined and relevant medical history should be available. Information about the patient cohort(s) or family pedigree(s) should be provided. For single patient studies, adherence to the guidelines established for genetic studies in single patients is strongly encouraged.
Utilization of relevant cell types isolated from the patient(s) and appropriate controls (e.g., unaffected family members, healthy subjects of the same ethnic origin etc.) are strongly encouraged for the delineation of the functional consequences of the mutations under investigation. If animal models are used to elucidate the mechanism of disease, a clear correlation between human and animal disease phenotypes should be established. In all cases, preliminary data should demonstrate that the genotype/phenotype correlation recapitulates the patient’s clinical disease.
Eligibility
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions.
Award Budget
PAR-19-078
Application budgets are not limited but need to reflect the actual needs of the proposed project.
PAR-19-079
The combined budget for direct costs for the two-year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.
Award Project Period
PAR-19-078
The total project period for an application submitted in response to this FOA may not exceed 5 years.
PAR-19-079
The total project period for an application submitted in response to this FOA may not exceed 2 years.
Key Dates
PAR-19-078
Open Date (Earliest Submission Date): January 04, 2019
PAR-19-079
Open Date (Earliest Submission Date): January 16, 2019
Letter of Intent Due Date(s): N/A
*Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Expiration Date: January 8, 2022
Deadline
Application Due Date(s)
PAR-19-078
The first standard application due date for this FOA is February 05, 2019.
Standard dates apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.
PAR-19-079
The first standard application due date for this FOA is February 16, 2019.
Standard dates apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.
