February 2013 DAIT Council-Approved Concepts
Concepts represent early planning stages for program announcements, request for applications, or solicitations for Council's input. If NIAID publishes an initiative from one of these concepts, we link to it below. To find initiatives, go to the Opportunities and Announcements portal.
NB: Council approval does not guarantee that a concept will become an initiative.
Table of Contents
Human Immunology Project Consortium
Request for Applications
Contact: Helen Quill
Objective: This initiative will support a consortium of human immune profiling research centers that will 1) identify and characterize diverse states of the human immune system at rest and following infection, vaccination against infectious diseases, or treatment with vaccine adjuvants and 2) create a database of human immune profiles and accompanying data analysis tools as a new bioinformatics resource for the scientific community.
Description: This initiative will support human immune profiling projects through the analysis of well-characterized human cohorts and use a variety of modern analytical tools. The centers will work collaboratively to establish standardized assays and data management and analysis tools to facilitate cross-study comparisons and data consolidation to increase study power.
In addition, the initiative will support the further development and implementation of a centralized, publically accessible database and analysis resource that presents human immune profiles determined under a variety of conditions as well as novel data mining and analysis tools to facilitate use of the data by outside investigators.
A steering committee will serve as the governing body for Human Immunology Project Consortium (HIPC) activities, with one principal investigator from each awarded center serving as a voting member.
NIAID will establish an opportunities fund to support novel experimental approaches and new scientific opportunities not available at the time of award. The steering committee will direct the use of these funds to support the overall program objectives. Use of the opportunities fund will require NIAID program officer approval in addition to steering committee approval. Changes from the initial funding period include separate competitions and awards for development of the central HIPC database and analysis resource (one U01 award) and for the data-generating immune profiling research projects (multiple U19 awards). This approach ensures that development of the central HIPC database proceeds optimally from the beginning of the funding period and avoids the need to build a database team from within the funded research centers.
Another change will be to require the research centers to adopt standardized assay conditions and data standards over the funding period to facilitate harmonization of results and strengthen the results obtained within the consortium. This process will be directed by the HIPC steering committee.
DAIT Statistical and Clinical Coordinating Center
Request for Applications
Contact: James McNamara
Objective: To recompete the biostatistical, data management, and clinical trial operations awards as a comprehensive and consolidated project that supports clinical research studies and trials in allergy and asthma, autoimmunity, and transplantation.
Description: The DAIT Statistical and Clinical Coordinating Center will provide complete biostatistical and operational support for clinical trials in the area of allergy and asthma, autoimmune diseases, and transplantation. Research consortia currently being supported through separate awards include:
- Immune Tolerance Network and Asthma and Allergic Diseases Cooperative Research Centers
- Atopic Dermatitis Research Network
- Inner-City Asthma Consortium
- Consortium of Food Allergy Research
- Organ Transplantation (Clinical Trials in Organ Transplantation, Clinical Trials in Organ Transplantation in Children, Genomics of Transplantation Cooperative Research Program)
- Autoimmunity Centers of Excellence and autologous stem cell studies for autoimmune disease
Support for consortia and other clinical trials supported by the Division will include: 1) statistical leadership for the design and analysis of clinical trials, including periodic safety and administrative reports, data and safety monitoring board reports, and final analyses and reports; 2) data collection, management, and quality assurance programs; 3) clinical site monitoring and training; 4) pharmacovigilance, including serious adverse event data collection, evaluation, and report preparation; 5) distribution and quality control of study products; and 6) support for technical and administrative functions of the clinical trial consortia.
HLA Region Genomics in Immune-Mediated Diseases
Request for Applications
Contact: Jeffrey Rice
Objective: The goal of the HLA Region Genomics in Immune-Mediated Diseases program is to define the association between variations in human leukocyte antigen (HLA) and natural killer cell immunoglobulin-like receptor (KIR) genetic regions and immune-mediated diseases, including risk and severity of disease, and organ, tissue, and cell transplantation outcomes. The program will continue to generate high-quality HLA- and KIR-disease association data, correlated with patient phenotypes that will be submitted to publically accessible databases.
Description: This program will support retrospective or prospective studies to investigate the relationship between genetic variation in the HLA region and immune-mediated diseases. Areas of research may include:
- The role of donor/recipient HLA and KIR matching in transplantation outcome, graft-versus-host disease, or rate of leukemic relapse following bone marrow transplant.
- Association of HLA region genes with susceptibility to and progression of immune-mediated diseases and disease phenotype.
- Discovery of novel HLA region genes associated with immune-mediated diseases or transplantation outcome.
- Mechanistic studies into the basis of HLA region disease associations.
No changes were made in the scope or mechanism of the support activities.