January 2009 DAIT Council-Approved Concepts

NB: Concepts represent early planning stages for PAs, RFAs, or solicitations for Council's input. Council approval does not guarantee that a concept will become an initiative.

If NIAID publishes an initiative from one of these concepts, we link to it below. For a full list of initiatives, go to NIH Funding Opportunities Relevant to NIAID.

Table of Contents

• Bioinformatics Integration Support Contract (BISC)
• Inner-City Asthma Consortium Statistical Coordinating Center
• HLA Region Genetics in Immune-Mediated Diseases
• Immunobiology of Xenotransplantation Cooperative Research Program
• Non-Human Primate Heart/Lung Transplantation Tolerance
• Centers for Medical Countermeasures Against Radiation
• Radiation/Nuclear Countermeasure Product Development Support Services Contract

Bioinformatics Integration Support Contract (BISC)

Request for Proposals

Contact: Bryan Jones
Phone: 301-451-3682
Email: jonesbry@niaid.nih.gov

Objective: To provide bioinformatics support to the DAIT-funded research community to advance the discovery and testing of new therapies for immune-mediated diseases and to further our understanding of innate and adaptive immunity by:

• Providing advanced computer support for managing scientific data.
• Providing analytical and statistical support.
• Disseminating best practices in scientific data management and analysis.
• Building a platform for integrated research and data sharing.

Description: This initiative will continue to support the ever changing bioinformatics needs and activities of the scientific research community through continued development, enhancement, and expansion of the existing Immport system. It has become clear that the data analysis and statistical support needs require expansion from that proposed in the original initiative. It is also anticipated that the number of users, data storage, analysis, and statistical support needs will grow over the next five years and therefore an expansion of the funding is requested.

Inner-City Asthma Consortium Statistical Coordinating Center

Request for Proposals

Contact: Brandon White
Phone: 301-451-3687
Email: whitebra@niaid.nih.gov

Objective: To renew the Statistical and Clinical Coordinating Center (SCCC) support for the NIAID Inner City Asthma Consortium (ICAC).

Description: The Statistical and Clinical Coordinating Center will be responsible for various functions in support of ICAC clinical trials. These include:

• Assisting in the development of protocols (design and statistical approaches).
• Developing manuals of operation and standard operating procedures.
• Developing clinical trial case report forms.
• Clinical site training and certification.
• Monitoring good clinical practice.
• Providing regulatory support for investigational new drug applications and FDA reports.
• Centralizing data collection, data cleaning, quality assurance, and analysis.
• Participating in publication of study findings.

HLA Region Genetics in Immune-Mediated Diseases

For the published initiative, see the July 31, 2009, Guide announcement, HLA Region Genomics in Immune-Mediated Diseases.

Request for Applications

Contact: Jeffrey Rice
Phone: 301-496-5598
Email: ricejs@niaid.nih.gov

Objective: The goal of the HLA-Region Genetics in Immune-Mediated Diseases program is to associate and catalog sequence variations in the HLA and natural killer (NK) cell immunoglobulin-like receptor (KIR) genetic regions that determine susceptibility to immune-mediated diseases, including autoimmune diseases, primary immunodeficiencies, graft-versus-host disease, and graft rejection in organ and cell transplantation.

Description: This program will support prospective or retrospective studies to investigate the role of sequence variations in HLA-region and/or KIR genes and associations with immune-mediated diseases.

Research projects may address the following areas:

1. Correlation of transplantation outcomes with the level of donor-recipient HLA and/or KIR matching or mismatching at the allele level.
2. Association of HLA-region or KIR genes with immune-mediated disease susceptibility, protection, progression and/or severity.
3. Discovery of new genes in the HLA or KIR regions associated with immune-mediated diseases.
4. Mechanistic basis of HLA-region or KIR gene-disease association.

No changes were made in the scope or mechanism of the supported activities. A budget increase is requested to allow larger-scale gene association studies.

Immunobiology of Xenotransplantation Cooperative Research Program

For the published initiative, see the August 11, 2009, Guide announcement, Immunobiology of Xenotransplantation.

Request for Applications

Contact: Nasrin Nabavi
Phone: 301-435-3567
Email: nnabavi@niaid.nih.gov

Objective: The goals of this initiative are to (1) delineate the cellular and molecular mechanisms of xenograft rejection and the induction of tolerance and accommodation; (2) develop effective strategies to improve xenograft survival and function; (3) characterize the physiological compatibility/limitations of xenografts; and (4) evaluate the risk and pathogenic consequences of cross-species infections in porcine to non-human primate (NHP) models of xenotransplantation. The long-term goal of this program is to develop novel and efficacious strategies for safe clinical application of xenotransplantation.

Description: This program will continue to address key immunologic and physiologic issues required to achieve safe and effective xenotransplantation. The research scope will include:

1. Elucidation of cellular and molecular mechanisms of xenograft rejection, accommodation, and/or tolerance induction.
2. Development of effective strategies to prolong xenograft survival and function.
3. Characterization of the biology of the xenograft post-transplantation.
4. Pathogenic consequences of xenogeneic infectious agents, immune responses to these agents, and strategies to circumvent the impact of these agents on the host.

No changes have been made in the mechanism. The scope is expanded to include investigations into pathogenic consequences of cross-species infection as a minor focus of the proposed research. A budget increase is requested if Special Statutory Type 1 Diabetes funds do not become available in FY 2010 to ensure sufficient funding for up to six applications and to allow collaborative core activities. Currently, only one other investigator-initiated multiproject grant using a large animal model of xenotransplantation is supported by NIH, and no U.S. industry supports this research.

Non-Human Primate Heart/Lung Transplantation Tolerance

For the published initiative, see the August 14, 2009, Guide announcement.

Request for Applications

Contact: Kristy Kraemer
Phone: 301-496-5598
Email: kkraemer@niaid.nih.gov

Objective: The goals of the NIAID and NIDDK Non-Human Primate Transplantation Tolerance Cooperative Study Group (NHPCSG) program are to: (1) develop donor-specific immune tolerance induction regimens; (2) evaluate the preclinical safety and efficacy of candidate regimens; and (3) elucidate the mechanisms of the induction, maintenance, and/or loss of tolerance in non-human primate (NHP) models of islet, kidney, heart, and lung transplantation. This solicitation will renew the heart and lung transplantation portion of the program.

Description: This initiative is a renewal of the NHP allogeneic heart and lung transplantation portion of the NHPCSG program (RFA AI-04-049). The research scope will include:

1. Developing novel, donor-specific tolerance induction regimens or refining existing regimens.
2. Assessing safety and efficacy of candidate immune tolerance regimens.
3. Defining the underlying mechanisms of action of tolerance regimens.
4. Developing and validating biomarkers for the induction, maintenance, and/or loss of immune tolerance and/or for the onset of acute or chronic graft rejection.

No changes will be made to the scope. A budget increase is requested to ensure sufficient funding for up to three applications.

Centers for Medical Countermeasures Against Radiation

For the published initiative, see the August 20, 2009, Guide announcement.

Request for Applications

Contact: Narayani Ramakrishnan
Phone: 301-451-3101
Email: nramakrishnan@niaid.nih.gov

Objective: To maintain a network of national research centers to develop effective and comprehensive medical responses applicable to all subsets of the civilian population in the event of radiological or nuclear emergencies. Multidisciplinary basic and translational research will produce new techniques and devices to measure radiation exposure in the human body and follow biomarkers of tissue damage and recovery and will develop novel therapies to minimize tissue damage, hasten tissue recovery, restore normal physiological function, and improve survival.

Description: The Centers for Medical Countermeasures Against Radiation (CMCR) will operate in a flexible, cooperative, and multidisciplinary manner to provide comprehensive research support to counter radiation damage. This program will support both basic and translational research. Funds will also be available for critical infrastructure needs, animal model development and utilization, pilot projects, and web-based informatics and database support. The following research areas will be supported:

• Practical biodosimetry devices and techniques, biomarker assays, and other automated diagnostic systems to rapidly assess levels of radiation exposure and assess tissue damage early after event and during the treatment and recovery phase.
• Therapeutic regimens using single or combinations of therapeutic drugs to treat radiation-induced hematopoietic, gastrointestinal, pulmonary, skin injuries with ultimate goal of increasing survival.
• Therapeutic regimens with emphasis on broadly effective activity, ease of administration, and safety.
• Mechanisms of radiation injury at the system, organ, cellular, and molecular levels with emphasis on hematopoietic, immunological, gastrointestinal, and pulmonary function.
• Identification and characterization of injury and therapy in pediatric, aged, immune compromised subpopulations that are at risk of radiation damage from even low doses that do not affect healthy adults.
• Study of long term medical effects that compromise health in radiation survivors.

Radiation/Nuclear Countermeasure Product Development Support Services Contract

For the published initiative, see the October 6, 2009, solicitation.

Request for Proposals

Contact: Deborah Blyveis
Phone: 301-594-7211
Email: blyveisd@niaid.nih.gov

Objective: To provide additional funds to continue and expand nonclinical and clinical efforts for product development of radiation/nuclear medical countermeasure candidate drugs and biodosimetry devices for inclusion in the Strategic National Stockpile for use during a radiation emergency.

Description: The initiative will provide funds to continue and expand product development of radiation countermeasure efforts of the current “Medical Countermeasures Against Radiological Threats: Product Development Support Services” contract. The contractor will provide a comprehensive and broad range of nonclinical and clinical support services. The program will support product development efforts for licensure of both candidate drugs and biodosimetry devices. The types of product development support services currently supported include: screening and efficacy evaluation of candidate drugs, GLP toxicology and safety pharmacology in animal models, cGMP manufacturing support, GLP pivotal animal efficacy studies, Phase I clinical safety and pharmacokinetic studies, and regulatory submission support for candidate drugs and biodosimetry devices.