University of Southern California


RFA-AI-20-029: Clinical Trials in Organ Transplantation in Children and Adults (CTOT-CA) (U01 Clinical Trial Optional)

Slots:                                        2

Internal Deadline:                      June 26, 2020

LOI:                                          30 days prior to the application due date

External Deadline:                      October 9, 2020

Award Information:                   Type: Cooperative Agreement

Estimated Number of Awards: 5-7 awards

Anticipated Amount: NIAID intends to commit $17 million in FY 2021 to fund 5-7 awards and includes $4 million annually to support an Ancillary Studies Fund.

Process for Limited Submissions: PIs must submit their application as a Limited Submission through the Office of Research Application Portal:


Materials to submit include:

(1) 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.

(2) CV – (5 pages maximum)


Who May Serve as PI:                  The PD/PI (or one of the PDs/PIs in the case of multiple PDs/PIs) must be a physician with substantial experience in the specific area of allotransplantation addressed by the application, and in the design, implementation, and evaluation of clinical trials, as evidenced by clinical experience and publication in peer-reviewed journals. Thus, applications for studies including pediatric subjects must have a pediatrician PD(s)/PI(s) or co-investigator; applications for studies addressing an infectious disease outcome must have an infectious disease specialist as a PD(s)/PI(s) or co-investigator.

Purpose:                                   The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications to participate in a clinical studies/clinical trials program to improve outcomes of recipients of thoracic or abdominal organ transplants, vascularized composite allografts (VCA), or cell replacement allografts (e.g., pancreatic islet or hepatocyte transplants). The goals of this research will be to improve our understanding of immune-mediated causes of morbidity and mortality in transplant recipients, evaluate interventions to address them, and ultimately improve transplant outcomes. The Clinical Trials in Organ Transplantation in Children and Adults (CTOT-CA) program will be a merger and renewal of two existing NIAID-sponsored consortia, the Clinical Trials in Organ Transplantation consortium (CTOT) and the Clinical Trials in Organ Transplantation in Children consortium (CTOT-C), and will support a cooperative, multi-institutional consortium for the conduct of interventional trials (Phase 1, 2, or 3) or observational clinical studies in allotransplantation. Each clinical study must include associated mechanistic studies that focus on immune-mediated pathologic processes in allotransplantation, including, but not limited to: mechanisms of immune activation and quiescence; biomarkers of immune activation, rejection, or tolerance; the interplay of alloimmunity and pathogen response; and mechanisms of susceptibility to/protection from infection that are particularly relevant to transplant recipients.


Visit our Institutionally Limited Submission webpage for more updates and other announcements.