Daniel Rotrosen, M.D., Director
Dr. Rotrosen announced the following new staff members and scientific activities:
STAFFING/ORGANIZATIONAL CHANGES
Yvonne Morrison Ms. Morrison joined the Transplantation Immunology Branch in May 2004 as a Health Specialist. She earned her bachelor’s degree in Health Science Education from the University of Florida, and is currently a candidate for a Master of Science in Biotechnology degree at Johns Hopkins University. Prior to joining the Division, she was a Protocol Monitor/Data Manager at the EMMES Corporation, working on kidney transplantation studies.
Adeira Greene, R.N., B.S.N. Ms. Greene joined the Transplantation Immunobiology Branch in August 2004 as a Nurse Consultant. Mrs. Greene received her bachelor’s degree in Nursing from the University of South Carolina. Before joining the Division, Adeira worked as a Research Nurse Specialist with the National Heart, Lung, and Blood Institute/Hematology Branch bone marrow transplant program.
Elizabeth Schneider Ms. Schneider joined the Transplantation Immunobiology Branch in June 2004 as a Health Specialist. She received her bachelor’s degree in Physical Therapy from the University of Connecticut, and is currently pursuing a Master of Management in Health Care Administration degree at the University of Maryland. Prior to joining the Transplantation Immunobiology Branch, she was a project manager in the DAIT Office of Clinical Applications.
Lynda Chiodetti, Ph.D. Dr. Chiodetti joined the Basic Immunology Branch as a Program Officer in July 2004. She received her Ph.D. from the Department of Microbiology and Immunology at George Washington University. Prior to joining the Division, Dr. Chiodetti was an investigator for the NIAID intramural, where her research was focused on T cell activation and tolerance.
Gary Rathbun, Ph.D. Dr. Rathbun joined the Basic Immunology Branch as a Program Officer in August 2004. He received his Ph.D. at the University of Texas Health Science Center at Dallas. Prior to joining the Division Dr. Rathbun was on the faculty in the Department of Pediatrics at Harvard Medical School, where he investigated regulation, function and signaling pathways of cell cycle checkpoint components critical in cellular DNA repair programs.
Narayani Ramakrishnan, Ph.D. Dr. Ramakrishnan joined the Basic Immunology Branch in July 2004 as a Program Officer. Before joining the Division she was the Assistant Director in the Division of Receipt and Referral, Center for Scientific Review. Dr. Ramakrishnan has held appointments at the Armed Forces Radiobiology Research Institute, and the Case Western Reserve University. Her research expertise includes immediate and late effects of radiation to hematopoietic system, radioprotection and treatment of radiation injuries.
James McNamara, M.D. Dr. McNamara joined the Clinical Immunology Branch in August 2004 as Chief. He has worked for NIAID for over 12 years in the Division of AIDS, most recently as Chief of the Pediatric Medicine Branch in the Therapeutics Research Program and has extensive clinical trials experience. He received his M.D. degree from the University of Vermont College of Medicine and trained in Pediatrics and Allergy/Clinical Immunology as well as basic immunology research and the Yale University School of Medicine. Prior to joining the Division, Dr. McNamara was on the pediatric faculty at Yale.
Julia Goldstein, M.D. Dr. Goldstein joined the Office of Clinical Applications in July 2004 as a Senior Regulatory Affairs Officer. She received her M.D. degree from Universidad de Buenos Aires, Argentina. She did a Fogarty postdoctoral fellowship at CBER/FDA and where she later was a staff scientist with responsibility as a researcher/reviewer. Prior to joining the Division, she was Director of Regulatory Affairs, at MedImmune, Inc.
Nancy Englar, M.H.L., B.S.N., R.N., C.C.T.C., Ms. Englar joined the Office of Clinical Applications in August 2004 as a Project Manager. She received her Masters in Health Law from Shepard Broad Law School at Nova Southeastern University. Before joining the Division, Ms. Englar was a transplant coordinator for kidney/pancreas and islet cells Transplant Autoimmunity Branch, in NIDDK.
Allison Girouard Ms. Girouard joined the Office of Clinical Applications Branch in August 2004 as a Project Manager. Ms. Girouard received her bachelor’s degree in Environmental Science from Lehigh University. She previously was a Program Specialist in the Office of Clinical Applications.
Patricia Woltz, R.N. Ms. Woltz joined the Clinical Immunology Branch in August 2004 as a Project Manager. She received her Bachelors degree in nursing from the University of Delaware. Before joining the Division, Ms. Woltz was a clinical site coordinator in the NIAID Laboratory of Host Defenses.
SCIENTIFIC INITIATIVES
Biodefense and Emerging Infectious Disease Research Opportunities - PA-04-119: This PA is intended to encourage the submission of investigator-initiated research grant applications in biodefense. The goal is to expedite research leading to the diagnosis, prevention and treatment of diseases caused by potential bioterrorism agents.
Regional Biocontainment Laboratories (RBL) Construction Program - RFA-AI-04-032: Cooperative Agreement (UC6) funds to support the construction of new Regional Biocontainment Laboratories (RBLs) to be used for biomedical research and research training. Funds will be provided to program, design, construct, and commission comprehensive state-of-the-art laboratories that will support research on the NIAID Category A, B and C priority pathogens and emerging infectious diseases. At a minimum, the facility must include biosafety level-3 (BSL-3) and biosafety level-2 (BSL-2) biomedical research laboratories, a vivarium for small animals, and support space for research, administration, and building operations
The participating Institutes and Centers of the National Institutes of Health (NIH) along with the Office of Research on Women’s Health announces a continuing program for administrative supplements to research grants to support individuals with high potential to reenter an active research career after taking time off to care for children or attend to other family responsibilities. The aim of these supplements is to encourage such individuals to reenter research careers within the missions of all the program areas of NIH. This program will provide administrative supplements to existing NIH research grants for the purpose of supporting full-time or part-time research by these individuals in a program geared to bring their existing research skills and knowledge up to date. It is anticipated that at the completion of the supplement, the reentry scientist will be in a position to apply for a career development (K) award, a research award, or some other form of independent research support.
SBIR Advanced Technology - PA-04-127: This PA invites grant applications for SBIR advanced technology projects that require a longer award period and greater award amount than those routinely allowed under the SBIR program. For this PA, "advanced technology" is defined as a product or service that will require approval of the Food and Drug Administration (FDA) and is in one of the following three research areas.
- Development of vaccines, biologics, drugs and prevention strategies for infectious and immunologic diseases, allergy, and transplantation.
- Development of vaccine, biologic and drug delivery systems.
- Development of assays and therapeutic monitoring systems for clinical and vaccine trials and for improved diagnosis of infectious, allergic, and immunologic diseases.
Immunobiology of Xenotransplantation - RFA-AI-04-042: The purpose of this RFA is to solicit applications from single institutions or consortia of institutions to establish cooperative interdisciplinary research programs for development of pre-clinical, porcine to non-human primate (NHP)models of xenotransplantation. The goals of this program are (1) to delineate the cellular and molecular mechanisms of xenograft rejection and the induction of tolerance and accommodation; (2) to develop effective strategies to improve xenograft survival; and (3) to characterize the physiological compatibility/limitations of xenografts. The long-term goal of this program is to develop novel and efficacious strategies for broad application of xenotransplantation in the clinic.
Non-Human Primate Heart and Lung Transplantation Tolerance – RFA-AI-04-049: NIAID invites applications to expand the scope of the Non-Human Primate Immune Tolerance Cooperative Study Group (NHPCSG) to include models of heart and lung transplantation. The current program was established in 1999 and expanded in 2002 and is limited to kidney and islet non-human primate transplantation models. The purpose of this program is to develop and evaluate tolerance-induction regimens that will result in long-term graft survival in clinical transplantation.
Food Allergy Research Consortium and Statistical Center- RFA-AI-04-034: The NIAID invites applications to establish the Food Allergy Research Consortium, a collaborative research program designed to develop new approaches to treat and prevent food allergy. Applications are also invited to establish a Statistical and Clinical Coordinating Center to support the clinical research projects undertaken by the Consortium. The goals of the program are to: (1) develop immune intervention strategies for preventing and treating food allergy; (2) identify the mechanisms of development, loss and re-emergence of oral tolerance; (3) determine the molecular and functional characteristics of food allergens; and (4) determine the role of the gastrointestinal tract in development and loss of oral tolerance. This RFA will fund cooperative agreement grants.
Extramural Research Facilities Improvement Program - PAR-04-122: The National Center for Research Resources is authorized under Sections 481A and 481B of the Public Health Services Act, as amended by Sections 303 and 304 of Public Law (PL) 106-505, to "make grants or contracts to public and nonprofit private entities to expand, remodel, renovate, or alter existing research or animal facilities or construct new research or animal facilities." The facilities will be used for basic and clinical biomedical and behavioral research and research training.
Change in Direct Cost Limitations on Solicited Applications - NOT-OD-04-040: NIH announces a revision of its policy on direct cost limitations on solicited applications published after this notice. Applications in response to those Program Announcements (PAs) and Requests for Applications (RFAs) that include a limitation on direct costs are to exclude from that limit the facilities and administrative (F&A) costs requested by consortium participants. The F&A costs requested by the consortium will be reflected in the PHS 398 application according to current instructions, and F&A costs awarded under these programs will continue to be awarded under the current practice. However, these consortium F&A costs will not be counted as a direct cost when determining if an applicant is in compliance with a direct cost limitation on a solicited application.
NIAID Career Development Awards in Epidemiology and Outcomes Research NOT-AI-04-033: To announce that NIAID will support Mentored Research Scientist Development (K01) awards (see http://grants.nih.gov/grants/guide/pa-files/PA-00-019.html) in the research areas presented in this notice. To encourage submission of Mentored Research Scientist Development Award (K01) and Independent Scientist Development Award (K02) (see http://grants.nih.gov/grants/guide/pa-files/PA-00-020.html) applications in clinical research in the areas of: Epidemiology, Modeling Techniques, and Outcomes Research.
NIAID Primary Caregiver Technical Assistance Supplements - NOT-AI-04-035: To encourage submission of applications for the NIAID Primary Caregiver Technical Assistance Supplements (PCTAS). NIAID recognizes that postdoctoral scientists with young children or ailing parents are sometimes unable to focus completely on their research activities because of primary caregiver responsibilities. As a result productivity can be seriously compromised during this critical period of a young scientist’s career. Thus, NIAID has created the PCTAS program to provide technical support to postdocs who have primary caregiver responsibilities.
Announcing the High Priority, Short-Term Project Award (R56)- NOT-OD-04-047: The R56 Award will provide limited, interim research support based on the merit of a pending application. The R56 will enable an applicant to gather additional data for revision of a new or competing renewal application. R56 funding will end after one or two years or when the applicant succeeds in obtaining traditional project funding. The High Priority, Short-Term Project Awards will underwrite highly meritorious applications with funds that can range up to initial review group recommended levels.
Hyperaccelerated Award/Mechanisms in Immunomodulation Trials – Addendum to RFA-AI-04-001 - NOT-AI-04-036: The participating Institutes intend to commit approximately $1,100,000 in FY 2005 to fund 3 to 4 new grants for immune mechanistic, ancillary studies of immunomodulatory interventions for immune system mediated diseases clinical trials and of vaccine clinical trials for non-HIV/AIDS infectious diseases. NIAID does not have specified funds committed in FY 2005 as were available in FY 2004 for immune mechanistic ancillary studies of vaccine clinical trials for the prevention and treatment NIAID Category A, B and C agents of bioterrorism and non-HIV/AIDS emerging/re-emerging infectious diseases, however, these applications are responsive to this RFA.
Findings of Scientific Misconduct - NOT-OD-04-053: Tirunelveli S. Ramalingam, Ph.D., California Institute of Technology: Based on the report of an investigation conducted by the California Institute of Technology (CIT Report) and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Tirunelveli S. Ramalingam, Ph.D., former Postdoctoral Fellow, Division of Biology at CIT, engaged in scientific misconduct in research supported by National Institute for Allergy and Infectious Disease (NIAID), National Institutes of Health (NIH), grant 1 R01 AI41239-01, ``Neonatal Fc receptor/IgG interaction.''
Addendum to RFA-AI-04-001 - NOT-AI-04-048: The participating Institutes intend to commit approximately $1,500,000 in FY 2005 to fund 4 to 5 new grants for immune mechanistic, ancillary studies of immunomodulatory interventions for immune system mediated diseases clinical trials and of vaccine clinical trials for non-HIV/AIDS infectious diseases. NIAID does not have specified funds committed in FY 2005 as were available in FY 2004 for immune mechanistic ancillary studies of vaccine clinical trials for the prevention and treatment NIAID Category A, B and C agents of bioterrorism and non-HIV/AIDS emerging/re-emerging infectious diseases; however, these applications are responsive to this RFA.
Guidance for Sharing of Data and Resources Generated By The Molecular Libraries Screening Centers Network (MLSCN) – NOT-RM-04-014: This addendum to RFA-RM-04-017, "Molecular Libraries Screening Centers Network (MLSCN)" (http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-04-017.html), which was released in the NIH Guide for Grants and Contracts on April 21, 2004, provides further information about the NIH guidance relevant to sharing of data from, and the management of intellectual property (IP) related to resources generated by the pilot MLSCN centers. The MLSCN was described in detail in RFA-RM-04-017, including NIH's programmatic interest in having assay protocols, screening data, and optimization chemistry for probe development within the MLSCN centers publicly available as rapidly and freely as possible, e.g., minimizing restrictive enforcement of IP. Specifically, the RFA provided preliminary information on NIH's proposed plans for sharing data and research resources generated by the MLSCN centers as well as IP rights and accessibility of research resources. However, the RFA also indicated that the NIH would convene meetings to further discuss IP issues associated with the Molecular Libraries Roadmap, and would issue updated guidance in the NIH Guide prior to the receipt date for RFA-RM-04-017. Since the issuance of the RFA, the Molecular Libraries Roadmap Implementation Group has convened two meetings, received opinions, and discussed these issues with a broad range of chemists, technology transfer experts, and legal advisors from the academic, non-profit, government, biotechnology, pharmaceutical, and disease foundation sectors of the scientific community. Taking these discussions into consideration, NIH has developed this notice to provide the updated guidance for the subject RFA.
Change in Receipt Dates: RFA-RM-04-020 “Molecular Libraries Screening Instrumentation” - NOT-RM-04-015: This Notice is in reference to Roadmap initiative RFA-RM-04-020. All NIH Institutes and Centers participate in Roadmap initiatives. This RFA will be administered by the National Human Genome Research Institute on behalf of the NIH.
Announcement: Biodefense Countermeasure Development: Project Bioshield - NOT-AI-04-044: The Project BioShield Act of 2004, enacted on July 21, 2004, authorizes the Secretary, Department of Health and Human Services (DHHS), through the program carried out by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), to expedite peer review of grants, contracts, and cooperative agreements to perform, administer, or support research and development of countermeasures determined by the Secretary to be a priority to treat, identify, or prevent harm from any biological, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security, or adverse health consequences that may arise from using such a countermeasure. Consistent with this new authority, the NIAID is announcing two new grant initiatives.
Molecular Libraries Screening Instrumentation - RFA-RM-04-020: The National Institutes of Health invites research applications to develop innovative instrumentation to accelerate the pace and maximize the efficiency of molecular library high throughput screening. This RFA is one component of the Molecular Libraries and Imaging Initiative of the NIH Roadmap. Investigators are encouraged to collaborate, as appropriate, with investigators working on assay development and on establishment of screening centers for the Molecular Libraries and Imaging Initiative.
Innovation In Molecular Imaging Probes - RFA-RM-04-021: This Request for Applications (RFA) is part of the Molecular Libraries and Imaging (MLI) Initiative of the NIH Roadmap. Molecular imaging has the potential to monitor both normal and abnormal biochemical and physiological parameters in individual patients. A major road-block to clinical application of molecular imaging is the poor sensitivity, specificity and spatial localization of current imaging probes. The purpose of this RFA is to encourage the development of new probes that will achieve one or two orders of magnitude (i.e., a factor of 10 to 100) improvement in the ability to detect and image specific molecular events in vivo, and also have potential for clinical applications.
DIVISION ACTIVITIES
Immune System Development and the Genesis of Asthma. The NIAID, in collaboration with the National Heart, Lung, and Blood Institute, funded 12 R01 grants on basic and clinical research focused on the immune origins of asthma. Research topics include the effect of exposure to bacterial and viral components on asthma development in children, antigen-presenting cell function in early allergen sensitization, and analysis of the regulation of inflammatory immune responses.
Asthma and Allergic Diseases Research Centers Directors Meeting. Principal investigators from each of the 13 NIAID/NIEHS co-funded Asthma and Allergic Diseases Research Centers participated in their biannual meeting September 21-22, 2004 in Bethesda to present updates on current research and to discuss resources, clinical samples, and novel model systems. This biannual meeting facilitates collaborations and new project development in this basic and clinical research network.
Healthy People 2010 Progress Review: On June 29, 2004, NIAID along with NHLBI, NIEHS and CDC, participated in a mid-course Progress Review on Respiratory Diseases, chaired by Dr. Larry E. Fields, Senior Executive Advisor to the Assistant Secretary for Health, OPHS, DHHS. The Respiratory Diseases Chapter areas are asthma, chronic obstructive pulmonary diseases, and sleep apnea. NIAID focused on those asthma research programs which are intended to facilitate the goals of Healthy People 2010, including reducing asthma morbidity and disparities in asthma morbidity between Caucasians vs. other ethnic groups.
Workshop on Animal Model Models for Radiation Injury, Protection, and Therapy On May 25-26, 2004, the NIAID convened a workshop focused on the use of animal models to evaluate many aspects of radiation exposure. Presentations included topics related to host response to radiation exposure, mechanisms of radiation injury, methods to rapidly assess radiation dose, drugs and regimens of prophylaxis, mitigation, and treatment of radiation-induced injury.
Workshop on Nanobiology Strategies for Understanding the Immune System On June 21-22, 2004, the NIAID convened a workshop focused on the application of nanotechnology to immunological research related to category A-C organisms. The application of this promising technology to novel therapeutics, immunotherapies vaccine development and assay of immune function.
CONCEPT REVIEW
All concepts were presented and approved.
Collaborative Network for Clinical Research on Immune Tolerance: This initiative will renew NIAID’s successful Immune Tolerance Network (ITN), a consortium of basic and clinical scientists that: (1) develops a scientific agenda for clinical trials and mechanistic studies of various approaches to tolerance induction; (2) develops, tests and validates assays to measure the induction, maintenance and loss of immune tolerance in humans; (3) designs and conducts clinical trials at all phases to determine the feasibility, safety, toxicity and efficacy of tolerogenic intervention strategies for multiple immune system diseases; and (4) designs and conducts research to delineate the underlying mechanisms of immune tolerance in conjunction with clinical trials undertaken by the ITN as well as clinical trials sponsored by other Federal and private sector organizations and companies.
For this initiative, tolerance is broadly defined as specific lack of an immune response to targeted antigens (e.g. alloantigens, autoantigens, or allergens) by any of a variety of approaches including deletion, induction of anergy, immune deviation, sequestration, or suppression. Approaches may target antigen specific receptors, molecules of the co-stimulation pathways, homing molecules, or other relevant approaches; and may use any of a variety of agents including antigen, peptides, altered peptides, monoclonal antibody blockade, cytokines, molecularly engineered cells or tissues, DNA vectors, or other relevant molecules.
Asthma and Allergic Diseases Research Centers: The NIAID Asthma and Allergic Diseases Research Centers (AADRC) program was established nearly three decades ago to promote innovative, multidisciplinary basic and clinical research focused on new approaches for the diagnosis, treatment and prevention of asthma and allergic diseases. In order to achieve these goals, the AADRC program emphasizes clinical studies of patients with asthma or allergic diseases. Examples of research areas to be supported include, but are not limited to: (i) the natural history of asthma and allergic diseases, including the identification of genetic and environmental risk factors for the development of these diseases; (ii) studies of pre- and postnatal alterations in immune function that contribute to the onset or progression of asthma and allergic diseases; (iii) studies of cellular and molecular mechanisms that contribute to airway inflammation and their role in the pathophysiology of asthma; (iv) identification of asthma phenotypes and the characterization of asthma expression in relation to underlying mechanisms that distinguish distinct subsets of asthma patients; (v) role of the innate immune system in the pathogenesis of asthma and allergic diseases; (vi) characterization of the pulmonary and systemic immune response to aeroallergens, including mechanisms that result in immune tolerance; (vii) cellular and molecular mechanisms involved in food allergy and other severe allergic reactions, with an emphasis on novel therapeutic or prevention strategies such as DNA vaccines.
Genomics of Transplantation Cooperative Research Program: This initiative will expand the Genomics of Transplantation Cooperative Research Program and will support collaborative multidisciplinary teams with expertise in various disciplines, including transplantation medicine, genetics, immunology, molecular biology, pharmacogenomics, biostatistics, and bioinformatics. Research supported under this initiative will focus on: (1) the identification of unique immune response genes or gene expression patterns during acute and chronic graft rejection; (2) the identification of genetic variation in response to immunosuppressive therapeutics; and/or (3) the identification of SNPs, SNP haplotypes, or microsatellite polymorphisms that correlate with and/or predict differences in transplant outcomes in individuals due to race or gender. These studies will utilize recipient and donor samples, as well as clinical data, for large-scale, broad-scope, prospective and/or retrospective genomic studies in clinical transplantation Innovative Grants on Immune Tolerance: Projects funded under this program will have a high degree of innovation and have a clearly articulated potential to improve understanding of immune tolerance to self antigens. The tolerance mechanisms used at different stages of development, i.e., neonatal, infant, childhood, adult and elderly, will be addressed. Investigators new to immune tolerance research are especially encouraged to develop projects in this area. Research projects will be supported by the exploratory/developmental research grant mechanism, which provides the resources to carry out preliminary tests of feasibility for new research hypotheses.
Innovative Grants on Immune Tolerance: Projects funded under this program will have a high degree of innovation and have a clearly articulated potential to improve understanding of immune tolerance to self antigens. The tolerance mechanisms used at different stages of development, i.e., neonatal, infant, childhood, adult and elderly, will be addressed. Investigators new to immune tolerance research are especially encouraged to develop projects in this area. Research projects will be supported by the exploratory/developmental research grant mechanism, which provides the resources to carry out preliminary tests of feasibility for new research hypotheses.
Cooperative Study Group for Autoimmune Disease Prevention: This program will support a coordinated set of cooperative agreements (Autoimmunity Prevention Centers), collectively comprising the Cooperative Study Group, that will engage in collaborative and individual projects focused on prevention of clinical onset of autoimmune disease by mechanisms other than global immunosuppression. Specific areas of research include: understanding the immune mechanisms that underlie autoimmunity and autoimmune diseases; understanding the mechanisms and consequences of manipulation of the immune response in autoimmunity; and application of this information to the prevention of autoimmune disease in humans
Non-Human Primate Transplantation Cooperative Study Group (NHPCSG): Opportunities Pool: While the NHPCSG has many promising therapeutic strategies under study and in development, an opportunities pool of funds will allow newly identified tolerance-inducing therapeutics and strategies to be developed and evaluated in a timely manner, prior to the conduct of clinical trials. This initiative will also provide an opportunity for critical pre-clinical research to complement NIAID-supported transplantation clinical trials. Proposals for new projects undergo competitive review within the NHPCSG as determined by the NHPCSG Steering Committee. The emphasis will be on the funding of collaborative projects and newly emerging opportunities.
Expansion of the NIAID Specific Pathogen-Free Rhesus and Cynomolgus Macaque Breeding Colonies for the NIAID NHP: NIAID currently owns approximately 500 Rhesus macaque and 300 Cynomolgus macaques, the majority of which are breeders and young monkeys. The specific-pathogen free colonies were established and are currently maintained by LABS of Virginia, in South Carolina, under a cooperative agreement, which expires in 2005. The maintenance of the colony will continue under a contract award, which will be solicited and funded in FY 2005. At full production capacity in FY 2007, the colonies will yield approximately 140 Rhesus and 90 Cynomolgus macaques per year for research studies. The current NHPSG consists of pre-clinical research for islet and kidney transplantation. In FY 2005, it is anticipated that the program will be expanded through an RFA to include pre-clinical studies in heart, liver, and lung transplantation. This expansion of research studies will necessitate expansion of the colonies, particularly the Cynomolgus macaque colony. It is anticipated that the Cynomolgus colony will require expansion by 50%, while the Rhesus colony will require expansion by approximately 10%. The award will support purchase of breeders and maintenance of the expanded colony, including housing, care, breeding, maintenance of detailed pedigree and health records, derivation of SPF research animals, and testing for viruses and tuberculosis.
Hyperaccelerated Award/Mechanisms in Immunomodulation Trials: The renewal of this program will incorporate the same elements pioneered by NIAID in FY 1999 to facilitate submission, peer review, and award of successful applications within 13 weeks of receipt for highly meritorious applications, including: 1) monthly receipt of applications; 2) monthly internet- and teleconference-based peer review; 3) negotiated assignments among participating ICs; and 4) expedited council approval. This renewal will also incorporate all aspects of RFA AI-04-001, released November 2004. Studies focus on the inclusion of patients and utilization of patient samples for:
- evaluation of immunologic and other relevant parameters to facilitate the study and definition of immunological mechanisms underlying the intervention;
- definition and characterization of the mechanisms of disease pathogenesis;
- definition of surrogate/biomarkers of disease stage, activity, and therapeutic effect;
- definition and characterization of the human immune system; and
- evaluation of the underlying immune mechanisms of effective responses to candidate vaccines.
Proposed mechanistic studies associated with clinical trials supported by industry are particularly encouraged; however, clinical trials supported by any source, public or private, are eligible.
Stem Cell Transplantation for the Treatment of Autoimmune Disease: To continue support for the executing contracts to conduct clinical trials to determine the safety, toxicity, and efficacy of stem cell transplantation for the treatment of autoimmune disease and the mechanism underlying this intervention.
Innate Immunity to NIAID Category B Protozoan Pathogen-Associated Molecular Patterns (PAMPs): This program will support cooperative agreements to elucidate the immunostimulatory or immuno-inhibitory effects of eukaryotic pathogen-associated carbohydrates, lipids, nucleic acids and proteins, as well as determine the roles of host PAMP recognition molecules and effector pathways.
Specific areas of research will include: Identification of novel PAMP recognition molecules; Characterization of host cells involved in the innate immune response to protozoan PAMPs; Detection of soluble mediators of innate immunity that are released as a result of stimulation by protozoan PAMPs.
-Elucidation of the intracellular signaling pathways induced by PAMP recognition; Characterization of novel PAMPs that are common to a broad spectrum of protozoan species and genera; and Application of innate immune response mechanisms to develop novel biodefense approaches against NIAID Category B pathogens.
Centers for Medical Countermeasures Against Radiation: The Centers for Radiobiology Research (CRBR) will operate in a flexible, cooperative, and multidisciplinary manner to provide comprehensive research support to counter radiation damage. The program will support both basic and translational research. Funds will also be available for critical infrastructure needs, animal model development and utilization, pilot projects, phase I clinical trials, and web-based informatics and database support. The CRBR will support both laboratory training and formal coursework in radiobiology for medical and graduate students, postdoctoral fellows, and independent investigators to expand the number of radiobiologists for future countermeasure development and the treatment of casualties. Ongoing training programs may be expanded and new programs established. 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 the event and during the treatment and recovery phase;
- Radioprotectant drugs and therapeutic regimens with emphasis on broadly effective activity, ease of administration, and safety;
- Therapeutic antibiotic regimens using single or combinations of antimicrobial drugs to control post-exposure infection in the context of immunosuppression and trauma;
- Innate and adaptive immunological enhancement and reconstitution mediated by cytokines, growth factors, defensins, and hematopoietic stem cell transplantation;
- Mechanisms of radiation injury at the systemic, organ, cellular, and molecular levels with emphasis on hematopoietic, immunological, gastrointestinal, and pulmonary function;
- Mechanisms of host response to radiation injury in different tissues that either exacerbates or ameliorates damage and disease;
- Identification and characterization of injury and therapy in subpopulations that are at risk of radiation damage from even low doses that do not affect healthy adults; and
- Study of long term medical effects that compromise health in radiation survivors.
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