Full Text PA-97-029 IMMUNOLOGIC INTERVENTION IN INFECTIOUS DISEASES NIH GUIDE, Volume 26, Number 3, January 31, 1997 PA NUMBER: PA-97-029 P.T. 34 Keywords: Infectious Diseases/Agents Immunotherapy National Institute of Allergy and Infectious Diseases PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), invites applications for innovative preclinical and clinical research, in relevant animal models and human subjects, to identify and accelerate development of novel, immunologically-based, therapeutic interventions for infectious diseases, such as interventions based on targeted disruption of the contribution of cytokines to pathology in such diseases. Multidisciplinary research and a focus on studies in human populations are particularly encouraged. Since other NIAID initiatives have recently been available to support research on other high priority areas such as HIV, opportunistic infections in AIDS patients, Lyme disease, and tuberculosis, projects on these topics will not be considered responsive to this PA. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, "IMMUNOLOGIC INTERVENTION IN INFECTIOUS DISEASES," is related to the priority area of immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-783-3238). ELIGIBILITY Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT Traditional research project grant (R01), FIRST award (R29), and Interactive Research Project Grant (IRPG) applications may be submitted in response to this program announcement. Applications for R01 grants may request up to five years of support; applications for R29 grants must request five years of support. The Small Business Innovation Research Program (SBIR) and the Small Business Technology Transfer Research Program (STTR) also solicit applications in this research area. SBIR and STTR solicitation packages may be requested from MTL, Inc., 13687 Baltimore Avenue, Laurel, MD 20707-5096, telephone (301) 206-9385, FAX (301) 206-9722, Email: a2y@cu.nih.gov. If an IRPG is proposed, it must consist of a minimum of two independent applications (see PA-96-001, NIH Guide for Grants and Contracts, Vol. 24, No. 35, October 6, 1995). An IRPG may consist of a combination of R01s and R29s or R01s only, but may not consist solely of R29 applications. An IRPG may also contain shared interactive resources (Cores), which must serve at least two of the research projects in order to facilitate achievement of the Group's common research goals. Collaborative arrangements involving more than one institution are especially encouraged, including participation of the pharmaceutical or biotechnology industry where appropriate. Responsibility for the planning, direction, and execution of the proposed research for all applicable mechanisms of support will be solely that of the applicant. Applicants are encouraged to coordinate, through the use of consortium arrangements or subcontracts, integrated approaches with individuals or institutions having relevant reagents and expertise in their use, demonstrated ability in a particular area of relevant research, or access to relevant patient populations so as to accelerate technical progress and clinical development of promising therapies. RESEARCH OBJECTIVES Background In a wide variety of infectious diseases inappropriate or excessive immune responses result in pathology rather than protection. For example, whether a deleterious or protective immune response is elicited may depend on which T lymphocyte subsets (i.e., Th1 or Th2) dominate the response to infection and elaborate characteristic cytokines. In the first four years of this initiative, during which it was restricted to research on protozoan and helminth diseases, investigators examined the role of cytokine-mediated pathology in leishmaniasis, schistosomiasis, toxoplasmosis, onchocerciasis, and malaria. Much of the importance of Interleukin-12 in inducing Th1 lymphocyte responses in parasitic diseases was developed in the models under investigation as a result of this initiative, and has contributed to current efforts to use Interleukin-12 either as an adjuvant or as therapy for a variety of infectious diseases, including viral, bacterial and fungal infections. These and similar observations on a variety of immunopathologic consequences of diverse infections indicate the need for a systematic and focused analysis of the relationship between cytokine effects and infectious disease, with the aim of developing new therapeutic strategies for intervention. Research Objectives and Scope The purpose of this Program Announcement is to stimulate innovative research to investigate novel therapeutic interventions based on targeted disruption of cytokine-induced pathology in infectious diseases, and to initiate or accelerate development of such therapies for clinical use. The specific goals of these studies may include, but are not limited to: (1) identification and definition at the molecular level of the immunopathogenic role played by individual cytokines in infectious diseases of humans; (2) production, characterization and/or improvement of specific inhibitors (e.g., monoclonal antibodies, counterregulatory cytokines, synthetic cytokine antagonists, or pharmacologic agents) of those cytokines found to have deleterious roles; and (3) testing the efficacy and safety of such inhibitors in ameliorating disease. While limited testing in animal models is permitted, studies involving human subjects (e.g., limited phase I/II trials in clinical settings) are particularly encouraged. It is likely that some potentially relevant inhibitors are already in existence or under development for other purposes in either private industry or public institutions. As noted above, in such cases collaborative research arrangements, including the use of consortia or subcontracts, are encouraged. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. APPLICATION PROCEDURES Applicants are strongly encouraged to contact the program staff listed under INQUIRIES early in project development with any questions regarding the proposed project(s). Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted on the standard application deadlines as indicated on the application kit and at the beginning of this PA. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, email: ASKNIH@odrockm1.nih.gov. For purposes of identification and processing, the number and title of this program announcement must be typed in item 2 and the "YES" box must be marked. The completed, signed original and five legible, single-sided copies of the application must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director must be included in the application material. REVIEW CONSIDERATIONS Review Procedures Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants (DRG) in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council. Review Criteria o scientific, technical, or medical significance and originality of the proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other favorably recommended applications. The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance among research areas of the program announcement, and availability of funds. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: B. Fenton Hall, M.D., Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3A09 - MSC 7630 Bethesda, MD 20892-7630 Telephone: (301) 496-2544 FAX: (301) 402-0659 Email: bh24q@nih.gov Direct inquiries regarding fiscal matters to: Todd C. Ball Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4B35 - MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 402-5512 FAX: (301) 480-3780 Email: TB22J@NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.855 and 93.856. This program is supported under authorization of the Public Health Service Act, Sec. 301(c), Public Law 78-410, as amended. Awards will be administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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