NIH – RFA-AI-13-006 CLINICAL TRIALS IN ORGAN TRANSPLANTATION (CTOT) (U01)
Nomination per School: One (Proposals may not be submitted directly by the PI; nominations are submitted by the School’s Research Dean’s Office.)
LOI: October 19, 2013 (Not Required)
Internal Deadline: August 26, 2013
External Deadline: November 19, 2013
Type: New/ Renewal
Estimated Number of Awards: NIAID intends to commit $9.5 million yearly, to make 3 to 4 awards.
Anticipated Amount: Application budgets are limited to $1.75M in direct costs per year. Budgets need to reflect the actual needs of the proposed project. The maximum project period is 7 years.
Materials to Office of Research: Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt).
Link to Award: http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-13-006.html
Purpose: The National Institute of Allergy and Infectious Diseases (NIAID) invites new or renewal applications from groups of two (2) or more institutions to participate in a clinical studies program to improve the long-term outcome of recipients of thoracic or abdominal organ transplants or vascularized composite allografts (VCA). The Clinical Trials in Organ Transplantation (CTOT) program will support a cooperative, multi-institutional consortium for the conduct of interventional trials (Phase 1, 2, or 3) or observational clinical studies in transplantation. Each clinical study must include associated mechanistic studies that focus on immune-mediated pathologic processes in allotransplantation or on mechanisms of immune activation and quiescence. The goals of this research will be to further our understanding of and ultimately reduce immune-mediated morbidity and mortality in thoracic and abdominal organ and VCA transplant recipients.
Objective and Scope:
The objective of this FOA is to support multi-center interventional clinical trials and/or observational studies in adult candidates for and recipients of organ or vascularized composite allotransplantation. All clinical trials and studies must include associated studies of immunologic mechanisms performed on samples from study subjects and, if appropriate, human controls. These mechanistic studies may include cellular assays (ELISPOT, flow cytometry, etc.), antibody assays, gene expression studies, genomic studies, studies of the microbiome, or any other assays that will contribute to the scientific goals of the proposed studies.
Examples of clinical trials, observational studies and associated mechanistic studies include, but are not limited to, the following:
- evaluation of improved, less toxic or more specific immunosuppressive agents or regimens;
- protocols designed to minimize pharmacologic immune suppression;
- interventions in the donor that will result in improved recipient outcomes;
- identification and validation of biomarkers that will:
(1) enable accurate non- or minimally-invasive monitoring of the recipient’s immunoreactive state, so that therapy can be individualized and proactive, or
(2) act as reliable surrogates for important clinical transplant outcomes;
- studies designed to improve understanding of pathogen-specific immune reconstitution or heterologous immunity in transplant recipients;
- implementing and validating strategies to improve surveillance, diagnosis, prophylaxis and/or treatment of infections in transplant recipients.
This FOA will NOT support research involving:
- hematopoietic stem cell or mesenchymal stem cell transplant, except as a component of a study of organ transplantation or VCA;
- pancreatic islet transplantation for treatment of type I diabetes;
- autologous reconstructive surgery;
- investigations in animal models, unless mechanistic assays specifically linked to a clinical study require the use of animals, e.g., a mouse footpad assay; protocols for which the primary target population is pediatric transplant recipients.