NB: Concepts represent early planning stages for PAs, RFAs, or RFPs 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
Maintenance of Macaque Specific Pathogen-Free Breeding Colonies
Request for Proposals
Contact: Wanda Neal
Phone: 301-451-3685
Email: wneal@niaid.nih.gov
Objective: This initiative will continue the maintenance and directed breeding of the NIAID-owned Indian Rhesus macaque (Macaca mulatta) and Cynomolgus macaque (Macaca fascicularis) specific pathogen-free (SPF) breeding colonies. These colonies provide SPF macaques of known pedigree to the NIAID and NIDDK co-sponsored Non-human Primate Transplantation Tolerance Cooperative Study Group (NHPCSG), which conducts pre-clinical immune tolerance research in solid organ and cell transplantation.
Description: The contract will produce 150 to 250 research-aged animals a year. Approximately 1,000 to 1,500 animals are required to achieve this goal. The contract will support high-quality maintenance of the colonies including housing, medical care, breeding, detailed pedigree and health records, and derivation of SPF research animals. In addition, the contractor will meet the special requirements of the investigators and NIAID by facilitating MHC typing; establishing directed breeding groups; culling non-SPF, aged, and unsuitable animals; analyzing and maintaining genetic diversity; and providing enhanced colony database capabilities.
No changes in the scope are anticipated. In FY 2005, this initiative was funded with a JOFOC because of concerns related to the potential impact of relocation on newly established colonies, as well as concerns about the costs of relocation. However, in FY 2010 the RFP will be a full and open competition; the colony will be well-established, and the benefits of full and open competition will outweigh the concerns related to relocation.
Data Coordinating Center for Transplantation Clinical Trials
Request for Applications
Contact: Nancy Bridges
Phone: 301-451-4406
Email: NBridges@niaid.nih.gov
Objective: The Data Coordinating Center (DCC) for Transplantation Clinical Trials will provide support for and collaborate with the investigators of the Transplantation Immunobiology Branch’s two U01-funded clinical trial consortia, the Clinical Trials in Organ Transplantation (CTOT) and the Clinical Trials in Organ Transplantation in Children (CTOT-C). The DCC will provide statistical and clinical trial design expertise, data management, site monitoring, regulatory support, adverse event reporting, specimen tracking, drug distribution, support for the NIAID Transplant DSMB, and medical writing.
Description: The DCC for Transplantation Clinical Trials will continue to support those clinical trials already underway at the time of award as well as any new clinical trials developed by CTOT or CTOT-C investigators. The scope of the award will increase as a result of adding new areas of research in CTOT-C (pediatric heart, lung, and liver transplantation). Costs will increase as a result of the need to support a larger number of investigators and sites. The cost of supporting transplant trials was underestimated in the first funding period, resulting in the need for supplemental funding.
Primary Immunodeficiency Diseases Registry/Repository
For the published initiative, see the January 12, 2009, Guide announcement, Resources to Assist Investigations in Primary Immunodeficiency Diseases.
Request for Applications
Contact: Josiah Wedgwood
Phone: 301-496-7104
Email: JWedgwood@niaid.nih.gov
Objective: To provide resources to encourage research in primary immunodeficiency disease (PID). These resources will include the PID registry and repository and educational activities currently being supported under contract to USIDnet.
Description: This project will develop resources to encourage and promote research in primary immunodeficiency diseases. The project will renew a portion of the work currently being conducted by the NIAID-funded Primary Immunodeficiency Disease Consortium.
Consortium of Food Allergy Research and Statistical Coordinating Center
Request for Applications
Contact: Marshall Plaut
Phone: 301-435-4425
Email: mplaut@niaid.nih.gov
Objective: To support basic and clinical research to develop new approaches to prevent and treat food allergy, including studies of food allergy-associated anaphylaxis.
This initiative will also fund a Statistical and Clinical Coordinating Center (SCCC) for the CoFAR. The SCCC will provide support for the clinical research studies performed in CoFAR.
Description: The CoFAR will support basic, pre-clinical, and clinical research on food allergy, to provide critical information concerning the pathophysiology and natural history of food allergy, including life-threatening food allergy. It will develop effective interventions to prevent and treat this disease. It will also carry out educational activities. These activities are identical to those in the previous (FY 2005) solicitation except that the Consortium may include larger, phase II clinical trials, and may extend the scope of the natural history studies to evaluation of food allergy-associated anaphylaxis.
This initiative will also support the SCCC for the Consortium. The SCCC will assist in the development of protocols (design and statistical approaches), manuals of operation, standard operating procedures, and case report forms. It will monitor good clinical practice at the CoFAR clinical sites, provide regulatory support for investigational new drug (IND) applications and required FDA reporting, conduct clinical site training and monitoring, and serve as the site for centralized data collection. It will perform quality assurance and data analysis and aid in publishing CoFAR study findings. These activities are identical to those in the previous (FY 2005) solicitation.
Exploratory Mechanisms in Food Allergy
Request for Applications
Contact: Richard Sawyer
Phone: 301-402-8179
Email: sawyerr@niaid.nih.gov
Objective: To support high impact, innovative exploratory/developmental investigations to determine the mechanisms of IgE-mediated food allergy and related co-morbid conditions, focusing on ex vivo studies with human specimens and on studies with current or new animal models of food allergy; and to bring new investigators into food allergy research.
Description: This initiative will support ex vivo studies with human specimens and studies with current or new animal models of food allergy. Areas for research focus may include: pathogenesis, biomarkers, and genetic components of food allergy and severe food allergy; food allergens and their epitopes including molecular characteristics; and pathogenesis, biomarkers, genetics, mechanistic studies, and risk assessment in animal models. These activities are identical to those in the previous (FY 2008) solicitation. (The FY 2008 solicitation also includes some research areas of interest to EPA but of lesser interest to NIAID.)
Atopic Dermatitis Network: Clinical and Animal Studies
Broad Agency Announcement
Contact: Tom Bahrami
Phone: 301-451-2654
Email: bahramit@niaid.nih.gov
Objective: (1) To determine why individuals with atopic dermatitis (AD) are highly susceptibility to cutaneous infections, including eczema vaccinatum (EV) as a potentially lethal consequence of vaccination against smallpox, eczema herpeticum (EH), and methicillin-resistant Staphylococcus aureus (MRSA); (2) to discover biomarkers that can be used to identify AD patients, including subsets of patients with AD who are especially susceptible to EV and to other infections; and (3) to develop short- and long-term approaches to reduce the incidence and severity of EV.
Description: This initiative will continue to support the development of diagnostic tools and biomarkers/surrogate markers to identify subjects with AD who are at risk for EV and other disseminated cutaneous viral infections. It will also develop tools and markers which characterize subsets of subjects with AD. The initiative will focus on studies of innate and adaptive immune responses, skin barrier function, and genetic markers and gene expression studies. These studies will continue to evaluate immune function in AD skin and will continue to develop safe protocols for cutaneous viral challenge of AD subjects. The initiative will also test the response of subsets of AD patients to vaccines utilizing the modified vaccinia virus Ankara (MVA). Subsets of AD patients, including those with both AD and eczema herpeticum (ADEH), subjects with more severe AD, and subjects with genetic deficiency of filaggrin, may have a more severe cutaneous immune defect than typical subjects with AD. Such individuals might also have reduced immune response to MVA, thus potentially reducing the effectiveness of MVA-based vaccines. These AD subjects with more severe cutaneous immune defects will also be evaluated for susceptibility to staphylococcal infections, including MRSA. This initiative also supports animal models of AD in projects that will be closely integrated with human studies.
Changes from the previous initiative include (a) increased emphasis on the role of skin barrier function in increased susceptibility to infection, (b) integration of the clinical and animal studies, (c) studies of vaccination with MVA in subsets of AD subjects, and (d) evaluation of susceptibility not only to viral infections, but also to staphylococcal infections.
Atopic Dermatitis Network: Statistical and Data Coordinating Center
Request for Proposals
Contact: Mylinh Pham
Phone: 301-496-0993
Email: phamm@niaid.nih.gov
Objective: (1) To understand why atopic dermatitis (AD) subjects are highly susceptibility to certain cutaneous infections, including eczema vaccinatum (EV) as a potentially lethal consequence of vaccination against smallpox, eczema herpeticum (EH), and colonization with and infection with methicillin-resistant Staphylococcus Aureus (MRSA); (2) to find biomarkers which identify those individual patients and subsets of patients with AD who are especially susceptible to EV and to the other infections; and (3) to develop short- and long-term approaches to reduce the incidence and severity of EV.
Description: This initiative will continue to develop diagnostic tools and biomarkers/surrogate markers to identify subjects with AD who are at risk for EV and other disseminated cutaneous viral infections. It will also develop tools and markers which characterize subsets of subjects with AD. The initiative will focus on studies of innate and adaptive immune responses, skin barrier function, and genetic markers and gene expression studies. Evaluation of immune function will include in vitro studies and also will continue to develop safe protocols for cutaneous viral challenge of AD subjects. The initiative will also test the response of subsets of AD patients to the viral vaccine modified vaccinia virus Ankara (MVA). Subsets of AD patients, including those with both AD and eczema herpeticum (ADEH), subjects with more severe AD, and subjects with genetic deficiency of filaggrin, may have a more severe cutaneous immune defect than typical subjects with AD. Such individuals might also have reduced immune response to MVA. These AD subjects with more severe cutaneous immune defects will also be evaluated for susceptibility to staphylococcal infections. This initiative also supports animal models of AD, in projects which will be closely integrated with human studies.
Changes from the previous initiative include (a) increased emphasis on the role of skin barrier function in increased susceptibility to infection, (b) integration of the clinical and animal studies (c) studies of vaccination with MVA in subsets of AD subjects, and (d) evaluation of susceptibility not only to viral infections, but also to staphylococcal infections.
The Statistical and Data Coordinating Center (SDCC) provides statistical leadership, Web site management, and logistics management for the entire Network and is focused on assistance with the clinical activities. The SDCC activities include: statistical and clinical leadership needed for study design and protocol development, data collection and quality assurance, clinical site training and monitoring, and regulatory and other support for applications for investigational new drugs.
Modeling Immunity for Biodefense
Broad Agency Announcement
Contact: Donald Collie
Phone: 301-496-0992
Email: dcollie@niaid.nih.gov
Objective: To support multi-disciplinary centers to develop novel or improved highly predictive mathematical models that simulate immune function. These model systems will be developed for analysis of host immune responses to NIAID category A-C priority pathogens and may apply to other infectious and immune-mediated diseases. Knowledge gained from these studies will: advance our understanding of the delicate balance required to induce protective immunity; guide laboratory experiments of host immune responses; and lay the foundation for development of models that can extrapolate human immune responses to infection or immune-mediated diseases based on results from relevant in vitro and in vivo studies. Results obtained from these programs will sharpen our assessments of vaccine efficacy and responses to other prophylactic and therapeutic treatments, and will advance development of novel or improved vaccines, prophylactics, and immunotherapeutics against emerging and re-emerging infectious diseases.
Description: This program will support multi-disciplinary centers focused on developing a mathematical modeling package that provides tools for high (whole organism or system), intermediate (tissue or organ), or fine (single cell) resolution modeling of host immune responses to infection and vaccines, with an emphasis on NIAID Category A-C pathogens. The research team will consist of immunologists, physicists, mathematicians, computer scientists, and infectious disease experts. Centers may be “virtual;” however, frequent interactions and communication are key elements to the program’s success. Investigators may choose to focus on various aspects of innate or adaptive immunity, as well as the interface between innate and adaptive immune responses. Each center will have strong bioinformatics and training components: (i) the bioinformatics component will develop methods to foster data sharing and communication among the centers, and facilitate the development and distribution of “user-friendly” immune modeling tools to the broader research community; and (ii) the training component is directed at graduate students, post-doctoral fellows, and senior scientists working in the fields of immunology, mathematics, physics, and engineering. Each training component will be required to host at least one summer school and one symposium, open to the broader research community, during the life of the contract. The training component can also support internal programs that provide trainees with an understanding of the power of applying mathematical principles to biological phenomena in immunology; drawing from other fields, such as population genetics, ecology, and epidemiology; and may develop teaching tools based on simulations of immune function.
Population Genetics Analysis Program
Broad Agency Announcement
Contact: Phil Hastings-Tickerhoff
Phone: 301-496-0194
Email: phastings@niaid.nih.gov
Objective: To characterize polymorphisms in human immune response genes, including the expression patterns of innate and adaptive immune response genes after natural infections with, or vaccination against, pathogens, and to examine the functional significance of these polymorphisms. These studies will provide a better understanding of immune responses to infection and vaccination, which may lead to identification of novel immunotherapeutic targets for vaccines and drugs to prevent and treat infections.
Description: This program will support studies on the association of genetic polymorphisms with host immune responsiveness to infections and vaccination. The focus will be on NIAID Category A-C agents of bioterrorism and emerging/reemerging infectious diseases. Human specimens for these studies will be obtained from patients with a history of natural infections; individuals currently enrolled in vaccine trials; and/or previously vaccinated high-risk groups, such as military, laboratory, and health care personnel. Genomic information from mouse model systems will be used to facilitate identification of relevant human immune response genes. Particular emphasis will be placed on studies identifying host immune factors that play a role in controlling, protecting, or predisposing to an infection; exacerbating disease; determining resistance to treatments; or that might serve as targets for passive immunotherapy. Interdisciplinary teams that combine diverse scientific expertise (e.g., microbiology, immunology, genetics, mathematics, computer science) will be encouraged.
NIAID Radiological/Nuclear Medical Countermeasure Product Development Program
Program Announcement
Contact: Bert Maidment
Phone: 301-594-0641
Email: maidmentb@niaid.nih.gov
Objective: To provide funds to continue and expand non-clinical efforts for product development of radiological/nuclear medical countermeasures effective for the mitigation or treatment of acute radiation syndromes, radionuclide decorporation agents to treat internal contamination, and radiation biodosimetry products for inclusion in the Strategic National Stockpile for potential use during a radiological emergency.
Description: This program will fund small business R41/42 or R43/44 grants (Phase I, Phase II, and Phase II competing continuations) to support specific IND/IDE-enabling product development activities leading to an IND or IDE submission packages to be submitted to FDA. The IND/IDE-enabling activities will include efficacy studies to optimize formulation, dose, and dose schedule; and to conduct drug product stability studies, drug product GMP manufacturing scale-up, GLP toxicology and pharmacology safety studies, pharmacokinetic and metabolism studies, development of GLP analytical methods for efficacy studies and product characterization, and completion of IND or IDE package for FDA submission. The product development efforts will advance the new medical countermeasures towards phase I clinical safety studies, GLP animal pivotal efficacy studies, and licensure.
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