Daniel Rotrosen, M.D., Director
Dr. Rotrosen announced the following new staff members and scientific activities:
Petr Bocek, M.D., Ph.D. - Dr. Bocek joined the Asthma, Allergy, and Inflammation Branch in October 2003 as a medical officer. Dr. Bocek received his M.D. from the Masaryk University Medical School in Brno, Czech Republic and his Ph.D. in immunology from the Weizmann Institute of Science, Israel. He completed his Internal Medicine residency training at the State University of New York, Stony Brook, NY and Allergy/Immunology fellowship in the NIAID. After his fellowship he spent two years as a clinical associate in the lab of William E. Paul, M.D., Laboratory of Immunology, NIAID.
Charles J. Hackett, Ph.D. - Dr. Hackett was appointed chief of the Asthma, Allergy, and Inflammation Branch in January 2004. He had been chief of the Molecular and Structural Immunology Section in the Basic Immunology Branch, DAIT, since 1996. Dr. Hackett received his Ph.D. from Wayne State University and was a postdoctoral fellow at the National Institute of Medical Research, Mill Hill, London. He was on the staff of the Wistar Institute and then Director of Cellular Immunology at ImmuLogic Pharmaceutical Corporation before joining NIH.
Alicia Krupa - Ms. Krupa joined the Clinical Immunology Branch in December 2003 as a program analyst. Ms. Krupa earned her bachelor’s degree in biology and nutrition from the Pennsylvania State University. Prior to joining the division she was an associate scientist in the Clinical Pharmacogenetics Department at Novartis Pharmaceuticals.
Tomeka Templeton - Mrs. Templeton joined the Office of Clinical Applications in September 2003 as the quality assurance documentation specialist in the Regulatory Affairs Group. Mrs. Templeton received her bachelor’s degree in English from the University of Memphis in Tennessee. She obtained quality assurance and regulatory experience from Alpha Therapeutic Corporation (pharmaceutical company) and Hemagen Diagnostics, Inc. (manufacturer of in vitro diagnostic devices).
Amanda Trayer - Ms. Trayer joined the Transplantation Immunology Branch in November 2003 as a health specialist. Ms. Trayer earned her B.S. degree in biological sciences from the University of Maryland Baltimore County. Before joining the division, she conducted vaccine research as a research associate in the Carbohydrate Chemistry/ Immunochemistry Department at Baxter Biosciences.
Ashley Xia, M.D., Ph.D. - Dr. Xia joined the Basic Immunology Branch in December 2003 as a program officer for bioinformatics. Dr. Xia received her M.D. from Beijing University of Chinese Medicine in Beijing, P.R. China and her Ph. D. in biology from Wayne State University, post doctoral training in neuroscience and six years experience in systems and database design in private industry. Her most recent experience was at Celera Genomics where she was a database specialist, responsible for genomic database design and development.
SCIENTIFIC INITIATIVES
Clinical Trials in Organ Transplantation (CTOT) – RFA-AI-04-003: NIAID, in collaboration with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the National Heart, Lung and Blood Institute (NHLBI) invites applications from consortia of two or more institutions to participate in a clinical studies program of immune-mediated pathological processes in organ transplantation. The purpose of this program is to support a cooperative, multi-site consortium for interventional or observational clinical studies, accompanied by mechanistic studies, to enhance our understanding of and ultimately reduce the immune-mediated morbidity and mortality of organ transplantation. These studies will be carried out on pediatric and adult candidates for and recipients of organ transplants.
Genomics of Transplantation Cooperative Research Program – RFA-AI-04-002: NIAID issued a Request for Applications (RFA) entitled “Genomics of Transplantation Cooperative Research Program.” This initiative will support interdisciplinary, large scale, and broad scope genomic studies in clinical transplantation, including solid organ, tissue, and cell transplantation. The goal of the program is to understand the genetic basis of immune-mediated graft rejection and differences in transplant outcomes, and provide a rational basis for the development of more effective treatment and prevention strategies to improve long-term graft survival and provide better quality of life for transplant recipients.
Challenge Grants: Biodefense and SARS Product Development – RFA-AI-03-016: The NIAID Division of Microbiology and Infectious Diseases (DMID) and the Division of Allergy, Immunology and Transplantation (DAIT) support extramural research to control and prevent diseases caused by virtually all infectious agents. This includes basic biomedical research, such as studies of microbial physiology and antigenic structure; immunity; applied research, including the development of diagnostic tests; and clinical trials to evaluate experimental drugs and vaccines.
Hyperaccelerated Award/Mechanisms in Immunomodulation Trials – RFA-AI-04-001: The National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Dental and Craniofacial Research (NIDCR) of the National Institutes of Health (NIH) invite investigator-initiated research applications for mechanistic studies in clinical trials of (1) immunomudulatory interventions for immune system mediated diseases, including, but not limited to: asthma and allergic diseases; graft failure in solid organ, cell, tissue and stem cell transplantation; and chronic inflammatory, autoimmune, and immunodeficiency diseases; and (2) preventative and therapeutic, vaccines for non-HIV/AIDS infectious diseases, including NIAID category A,B, and C agents of bioterrorism and emerging/re-emerging infectious diseases.
Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) to Develop New Therapies For Type 1 Diabetes and Its Complications – RFA-DK-03-020: The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Eye Institute (NEI), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Nursing Research (NINR), National Institute of Child Health and Human Development (NICHD) invite the small business community to apply cutting edge technology to research to develop new approaches to prevent, treat, and cure type 1 diabetes and its complications.
Clinical Islet Transplantation: Clinical Centers – RFA-DK-04-005: NIAID and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invite applications for Clinical Centers to participate in a consortium of investigators and institutions that will perform studies of islet transplantation in patients with type 1 diabetes mellitus (T1D). This consortium will develop and implement a program of single- and/or multi-center clinical studies, accompanied by mechanistic studies, in islet transplantation with or without accompanying kidney transplantation, for the treatment of T1D. Successful applicants for Clinical Centers, together with a Data Coordinating Center (see below), will constitute a Clinical Islet Transplantation (CIT) consortium whose aim is to design and implement human islet transplantation studies that will result in improved treatment of T1D.
Clinical Islet Transplantation: Data Coordinating Center – RFA-DK-04-004: NIAID and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invite applications for a Data Coordinating Center (DCC) to participate in a consortium of investigators and institutions that will perform clinical studies of islet transplantation in patients with type 1 diabetes mellitus (T1D). This consortium will develop and implement a program of single- and/or multi-center clinical trials, accompanied by mechanistic studies, in islet transplantation with or without accompanying kidney transplantation, for the treatment of T1D. The DCC will provide a broad range of support services for the CIT, including statistical, monitoring, and operational support. It will also assist with the preparation of DSMB reports, scientific manuscripts, and other reports and documents as needed to support the work and goals of the clinical centers in the consortium and/or as required by the NIH.
NIH Support For Conferences and Scientific Meetings – PAR-03-176: This program announcement (PA) provides updated guidelines for National Institutes of Health (NIH) support of scientific meetings. It replaces the previous guidelines issued in the NIH Guide on October 30, 1998 and is effective with the December 15th receipt date for cycle III applications. An NIH conference grant Web site has been created to centralize information regarding grants for scientific meetings and conferences. This site includes contract information for the participating NIH institutes, centers, and offices and links to detailed information regarding specific interests and funding parameters.
Correction to RFA-DK-03-024: Proteomics and Metabolomics in Type 1 Diabetes and its Complications – NOT-DK-04-001: The purpose of this notice is to announce a correction to the RFA-DK-03-024. The correction applies to the section of the RFA titled RECEIPT AND REVIEW SCHEDULE, and changes the letter of intent receipt date to February 18, 2004 and application receipt date to March 18, 2004. All other aspects of the RFA remain unchanged.
BBA Announcement: Population Genetics Analysis Program- NOT-AI-03-057: NIAID is establishing a Broad Agency Announcement (BAA) to solicit proposals to address the Institute’s need for research programs focused on identifying associations between specific immune response gene polymorphisms and susceptibility to infection, or the quality of response to vaccination, with a focus on one or more of the high priority NIAID category A, B, or C pathogens. The correlation of genetic polymorphisms with response to phenotypes, such as severity of infection, or with vaccination outcome, will be further studied through the analysis of expression levels and/or functions of the proteins encoded by the variant immune response genes.
Development of Immune Monitoring Reagents and Major Histocompatibility (MHC) Typing Technologies for Non-Human Primates- RFP-NIH-NIAID-DAIT-04-24: NIAID invites contract proposals for the development of reagents for monitoring and modulating immunity, and development of rapid, high-throughput technologies for MHC typing in multiple NHP species. The purpose of this contract solicitation is to accelerate pre-clinical, NHP research in the fields of infectious disease vaccine development, transplantation, and autoimmune diseases.
Large Scale Antibody and T Cell Epitope Discovery Program-RFP-NIH-NIAID-DAIT-04-39: The primary purpose of this initiative is to establish and support several highly interactive, multi-disciplinary teams focused on large-scale discovery of novel antibody (B cell) or T cell epitopes associated with microorganisms responsible for emerging and re-emerging infectious diseases, including potential agents of bioterrorism and their toxins, listed as NIAID category A-C agents.
Immune Tolerance Network – Clinical Site Monitoring Group: RFP-NIH-NIAID-DAIT-04-06: The Division of Allergy, Immunology and Transplantation (DAIT), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is requesting proposals to establish a Clinical Site Monitoring Group (CSMG) to assess the quality and enhance performance of sites participating in clinical trials conducted by the Immune Tolerance Network (ITN). The ITN is an international consortium dedicated to the clinical evaluation of novel, tolerance-including therapies for autoimmune disease, asthma, and allergic diseases and to preventing the rejection of transplanted kidneys and pancreatic islets.
Clinical Products Distribution Center–DAIT: RFP-NIH-NIAID-DAIT-04-45: The purpose of this contract will be to obtain, store and deliver investigational agents used in clinical trials performed by the Immune Tolerance (ITN) at a central location for the receipt, storage, repackaging, labeling, and distribution of study products in accordance with Federal regulations governing investigational agents.
Regulatory Management Center–DAIT: RFP-NIH-NIAID-04-44: The objective of this contract is to provide regulatory support services to DAIT’s clinical research programs. DAIT and its clinical research networks interact in a complex research environment composed of, but not limited to: clinical investigators and their institutions; statistical and data analysis centers; clinical coordinating centers; the U.S. Food and Drug Administration (FDA); the DHHS Office for Human Research Protections (OHRP); non-U.S. regulatory agencies; pharmaceutical companies; local and national institutional review boards/ethics committees (IRBs/ECs); and NIH scientific and administrative personnel.
Administrative Support Contract for DAIT Clinical Research Programs- RFP-NIH-NIAID-DAIT-04-43: The purpose of this solicitation is to establish the Technical and Administrative Support Center for DAIT clinical research programs to provide technical and administrative support to multiple ongoing clinical research networks and associated NIAID data and safety monitoring boards (DSMBs). This support will enable DAIT to fulfill its responsibilities as sponsor of a large portfolio of clinical trials conducted at many sites throughout the U.S. and internationally.
DIVISION ACTIVITIES
Immune-Mediated Drug Hypersensitivity: NIAID participated in a workshop entitled Immune-mediated Drug Hypersensitivity Reactions (IDHR): “Mechanisms to Increase IDHR Research Opportunities” on November 17 – 18, 2003. Participants and speakers included scientists from industry, academia, the FDA and other program staff from NIH. The workshop was organized by the International Life Sciences Institute, Health and Environmental Science Institute. The meeting focused on identifying potential mechanisms to increase research opportunities in IDHR. The participants concluded that it would be highly desirable to form a national or international network to pursue research on IDHR. Some participants intend to form an organization to develop a plan to find funding mechanisms for such a network.
Annual U.S.-Japan Immunology Board Joint Meeting: The twenty-first annual joint meeting of the U.S. and Japanese Immunology Boards of the U.S.-Japan Cooperative Medical Sciences Program convened in Philadelphia, PA, on November 18 and 19, 2003. This meeting included scientific presentations by members of the U.S. and Japanese boards, as well as invited speakers from the University of Pennsylvania and the Wistar Institute.
Biodefense Projects: Research Supplements Report Meeting: On November 5, 2003, the NIAID convened a meeting of immunology investigators who had been awarded one-year supplementary funding to existing grants in order to pursue biodefense projects as soon as possible. The goal of the meeting was to discuss research findings and their implications for biodefense strategies. Presentations included research on the structure and immune recognition of bacterial toxins, cellular immune responses to influenza viruses, mechanisms of viral evasion of innate immunity, and identification of molecules important for anthrax spore entry into macrophages.
Workshop on CD1 Tetramers – Reagents for Glycolipid Antigen Specific T Cells: On January 20, 2004, the NIAID convened a workshop focused on the development of CD1 tetramer reagents and their use in biodefense research. Topics of discussion included the production of CD1 tetramers, the detection of glycolipid-reactive T cells by CD1 tetramers, and the role of CD1 tetramers in the development of vaccines and immunotherapeutics for biodefense. The feasibility of CD1 tetramer production by the NIH Tetramer Facility was also assessed.
Post-Transplant Lymphoproliferative Disease: On September 16, 2003, NIAID sponsored a conference on post-transplant lymphoproliferative disease (PTLD). The goals of this meeting were to: bring together experts in the field to enhance communication between transplant physicians, surgeons, oncologists, infectious disease specialists, pathologists and basic scientists interested in PTLD; identify the priority areas for clinical trials and mechanistic studies in PTLD following solid organ transplantation; discuss how to overcome the problems of performing studies in heterogeneous patient populations involving a wide range of ages and solid organ transplants; and develop strategies for moving forward with multi-center studies of the priority areas identified by the conference participants. The multi-disciplinary group of experts addressed a range of topics, including: prevention of PTLD, biological and pharmacological therapies, and strategies to monitor and predict outcomes of therapy. This conference was co-sponsored by the National Cancer Institute and the Office of Rare Diseases at the National Institutes of Health.
Clinical Studies in Pediatric Organ Transplantation: Defining Priorities and Feasibility: On September 14-15, 2003, NIAID co-sponsored a conference on pediatric organ transplantation. The goals of this conference were to: identify critical organ-specific areas of research facing the pediatric transplant population; identify obstacles to initiation of, participation in, and completion of clinical trials and develop strategies to overcome these obstacles; and develop concepts for organ-specific and all-organ research proposals that are feasible within the constraints of the study population. In the plenary sessions, participants discussed overviews of mechanistic studies in transplantation, existing registries, clinical study design, and the role of industry in clinical trials. Breakout sessions were devoted to establishing research priorities in thoracic, liver and small bowel, and kidney transplantation, as well as infectious diseases and mechanistic studies. Co-sponsors included the Office of Rare Diseases at the National Institutes of Health, the American Society of Transplant Surgeons, the American Society of Transplantation, the International Society of Heart and Lung Transplantation, the National Kidney Foundation, and the North American Pediatric Renal Transplant Cooperative Study.
Implications of Preserving Long-Term Renal Function after Renal Transplantation: On November 11, 2003, NIAID co-sponsored a program on the role of renal function in the development of cardiovascular disease (CVD), specifically in the renal transplant population. The goal of this meeting was to develop educational materials for transplant professionals. Participants discussed the epidemiology and potential mechanisms of CVD in the general population and among renal transplant recipients, the relationship between renal dysfunction and CVD after renal transplantation, and strategies to preserve renal function after transplantation. The program was co-sponsored by Wyeth, the University of Minnesota Office of Continuing Medical Education, and SynerMed Communications.
CONCEPT REVIEW
All concepts were presented and approved.
FY 2005 Research Concept Clearances
Non-Human Primate Immune Tolerance Cooperative Study Group Expansion to Include Heart, Liver, & Lung Transplantation Research: This initiative will expand the existing Non-Human Primate Cooperative Study Group (NHPCSG) to evaluate novel tolerance induction regimens in kidney and islet transplantation, including heart, lung, and liver transplantation. Research supported under this initiative will also investigate the immunological mechanisms of tolerance induction and develop surrogate markers for induction, maintenance, and loss of tolerance. This initiative will also provide an opportunity for critical non-human primate (NHP) research to complement the multi-center cooperative clinical trials in organ transplantation program that NIAID will establish in FY2004 to evaluate innovative therapeutic approaches in kidney, liver, and heart transplantation.
Maintenance of NIAID Specific Pathogen-Free Rhesus & Cynomolgus Macaque Breeding Colonies for the NIAID Non-Human Primate Cooperative Study Group: This contract will support maintenance of the colony, including housing, care, breeding, maintenance of detailed pedigree and health records, derivation of SPF research animals, and testing for viruses and tuberculosis. Furthermore, it will support maintenance of the NIAID-owned Indian Rhesus macaque and Cynomolgus macaque specific-pathogen-free (SPF) breeding colonies, established in August 2000 and 2002, respectively. The colonies provide macaques for pre-clinical research in solid organ and tissue transplantation conducted by the NIAID Non-Human Primate Cooperative Study Group (NHPCSG).
Immunobiology of Xenotransplantation: This program will address key immunologic and physiologic issues required to achieve safe and efficacious xenotransplantation. Research areas to be supported include: cellular and molecular mechanisms of xenograft graft rejection; regulation of innate, B, and T-cell immune responses to xenografts; mechanisms of accommodation and tolerance induction; pathogenic consequences of xenogeneic infectious agents, immune responses to these agents, and strategies to circumvent the impact of these agents on the host; and characterization of physiological function(s) of xenografts post-transplantation.
Human Leukocyte Antigen Genetics in Infectious & Immune-Mediated Diseases: This program will support basic and clinical research on the genetics of the HLA complex. Research projects will address the following areas: (1) evolution and diversity of HLA genes; (2) correlation of transplant outcome with the level of donor-recipient HLA matching at the allele level; (3) association of HLA alleles with immune mediated diseases; and (4) discovery of new genes in the HLA gene complex.
Statistical Coordinating Center for Clinical Trials in Organ Transplantation: The NIAID FY 2004 research initiative, “Clinical Trials in Organ Transplantation” (CTOT) will be a cooperative group conducting human studies and trials focusing on immunologic aspects of adult renal, adult and pediatric thoracic, and adult and pediatric liver transplantation. The role of the data coordinating center for the CTOT will be to support the conduct of these trials and studies, including: (1) statistical leadership for trial design, implementation, and monitoring; (2) analyses of interim and study results; (3) clinical site monitoring and training; (4) data collection, management, quality assurance, and reporting systems; (5) distribution and quality control of study products; (7) support for the technical and administrative functions of the steering committee; and (8) support for the activities of an independent data and safety monitoring board. In addition, the statistical coordinating center will work with the DAIT Office of Clinical Applications to support all regulatory functions and requirements of the CTOT studies, and will maintain appropriate lines of communication and responsibility with the steering committee and the DAIT program and project officers.
Living Organ Donor Registry: This initiative will create a consortium charged with defining, prioritizing, and implementing the scientific agenda for this research program, which will address survival and health outcomes of living donors, risk assessment for living donors, and medical care needs of living donors. The consortium will consist of centers with expertise in living donor transplantation that bring a substantial data set on living donors, and a data coordinating center. Specific performance goals are listed under “Benchmarks of Performance.”
Isolation and Expansion of Human Hematopoietic Stem Cells (HSC) for Immune System
Reconstitution: This program will support research to discover new methods for the isolation and expansion of HSC that will be stable to long-term storage conditions and that will retain their ability to fully reconstitute the immune system after radiation exposure.
FY 2004 DAIT Clinical Research Support Contracts Concept Clearance
Clinical Products Distribution Center for the Immune Tolerance Network: The Clinical Products Distribution Center contract will be responsible for carrying out the following activities: receive and store shipments of products from a variety of sources; purchase study products when necessary; label and package study products; ship and distribute study products; provide inventory control and quality assurance; provide pharmaceutical services; develop and implement security and safety measures for the storage of study products; process and dispose of returned products; and maintain a computerized tracking system for product inventory.
Administrative Support Contract for DAIT Clinical Research Programs: This contract will support day-to-day management activities associated with DAIT’s clinical research programs, logistical arrangements for small scientific meetings and workshops on critical scientific issues, and the development and maintenance of databases that contain information essential for program management. Specifically, the contract will provide support services in the following areas: administrative, technical, and logistical support for scientific meetings and conferences, and data and safety monitory boards; logistical and technical services for conference calls; management and administrative support for regulatory operations; and preparation of scientific and technical reports and documents. This contract will be managed by the DAIT Office of Clinical Applications, which is responsible for site monitoring and regulatory activities associated with clinical trials in solid organ and islet transplantation, autoimmune diseases, and asthma and allergic diseases.
Regulatory Management Center: This initiative will provide continued funding for essential services to support clinical trials sponsored by DAIT, including: prepare, distribute, track, and archive Investigational New Drug Applications (INDs) and Clinical Trials Agreements (CTAs) and all amendments for INDs sponsored by DAIT, ITN clinical investigators, and, when appropriate, pharmaceutical companies, for all ITN clinical trials; establish and maintain an electronic tracking system for the reporting and disposition of adverse events for all ITN clinical trials; develop and maintain an electronic clinical site registration system for all ITN clinical trials; provide administrative support for regulatory activities and good clinical practice (GCP) compliance activities for all ITN and DAIT sponsored clinical trials; and provide logistical support for all DAIT sponsored clinical trials.
Immune Tolerance Network Clinical Site Monitoring Group: The clinical site monitoring contractor will be responsible for the following activities: on-site good clinical practice (GCP) monitoring of ITN-supported clinical studies at clinical sites and pharmacies in the U.S. and international locations; monitoring laboratory facilities and procedures for obtaining, testing, and storing clinical research specimens; training site personnel in GCP and on the policies and procedures established by DAIT, the FDA, the DHHS Office of Human Research Protections (OHRP), the NIH, and the ITN; recruiting and training site monitors; providing reports on monitoring findings and training activities; and collaborating with DAIT and the ITN.
Periodic on-site monitoring visits will be conducted to examine source documents to assess the accuracy and completeness of trial data, to identify problems with protocol implementation, GCP, and all applicable regulatory requirements. Additionally, the monitors will verify the proper storage, dispensing, tracking, and disposal of investigational products. Monitors will perform audits of regulatory files including IRB documentation, informed consent documents, and all safety reports.
back to top