Full Text PAR-97-042 INNOVATION GRANT PROGRAM FOR APPROACHES IN HIV VACCINE RESEARCH NIH GUIDE, Volume 26, Number 7, March 7, 1997 PA NUMBER: PAR-97-042 P.T. 34 Keywords: AIDS Pathogenesis Disease Model 079000 National Institute of Allergy and Infectious Diseases Application Receipt Date: May 23, 1997 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) gives special consideration for funding to scientifically meritorious applications in response to our program announcements (PAs). PAs identify current areas of ongoing research emphasis for the NIAID. The NIAID, National Institutes of Health (NIH) on the recommendation of the AIDS Vaccine Research Committee (AVRC), seeks to implement a new program aimed at rapidly exploiting new scientific opportunities to broaden the base of scientific inquiry in areas related to vaccine discovery and development. This program announcement represents the first step in establishing the INNOVATION Grant Program. The NIAID invites applications, including those from researchers previously outside the field of AIDS research, for research projects that involve a high degree of innovation, risk and novelty-- as well as a clear promise of helping to improve vaccine design or evaluation-- in the following three general areas: 1) the structure/function of HIV envelope protein; 2) creation/improvement of animal models for vaccine evaluation and pathogenesis studies; and 3) mechanisms of directing antigen processing in vivo. This INNOVATION Grant Program utilizes a grant mechanism which provides the resources to carry out preliminary tests of feasibility for new research hypotheses, and a rapid and streamlined review and award process. This approach will be evaluated by the AVRC for suitability and responsiveness following this initial offering. If successful, other announcements may be made in the future. 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, Innovation Grant Program for Approaches in HIV Vaccine Research, is related to the priority areas of HIV infection, and 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 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, foreign for-profit and non-profit organizations, both public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Research projects will be supported with the exploratory/developmental research grant mechanism (R21). This mechanism provides short-duration support for preliminary studies of a highly speculative nature which are expected to yield, within this time frame, sufficient information upon which to base a well-planned and rigorous series of further investigations. Applicants may request up to two years of support and up to $150,000 per annum in direct costs, although with compelling justification exceptions can be made if specific costly reagents, animals, specimens or laboratory modifications are needed to perform these studies. Program staff may be able to advise prospective applicants concerning NIAID-sponsored resources which may be available to them. Please contact the program staff listed under INQUIRIES for further information. The award is non-renewable; however, applicants may elect to seek continuing support for this research through the R01 mechanism. RESEARCH OBJECTIVES After an initial examination of the state of the art of HIV vaccine discovery, the National Institute of Allergy and Infectious Diseases and the AIDS Vaccine Research Committee seek to broaden the base of scientific inquiry in three key scientific areas related to HIV vaccine discovery and development. o The structures of HIV envelope proteins as they relate to their function as immunogens. Examples of areas of interest include, but are not limited to: - Understanding the oligomeric structure of the envelope protein both free and on the virion; - Novel approaches to a detailed understanding of the structure of Env as it interacts with cellular receptors upon virus entry; - Development of methods to preserve native structure and evaluate different protein forms as immunogens; o Creation of new animal models for vaccine evaluation and pathogenesis studies, or innovations to improve existing animal models. Examples of areas of interest include, but are not limited to: - Methods to produce populations of primates that can accept grafts of hematopoietic cells (e.g., populations of macaques that are twins, or clonally-derived or otherwise rendered MHC-compatible); - Novel small animal models produced with transgene that render them sensitive to HIV infection. - Creation or study of SCID mice, or other animals, that would allow for analysis of protective cellular immune responses through passive transfer of cells from infected immunized, or exposed and uninfected humans or primates. o Mechanisms of directing in vivo antigen processing to maximize immune response. Examples of areas of interest include, but are not limited to: - Defining and comparing pathways of processing various HIV/SIV vaccine classes (e.g., subunit, recombinant, whole killed, live attenuated, DNA) by various antigen processing cells (e.g., APC subsets, macrophages, B cells); - Developing methods to expand, in vitro, each of the processing and/or presenting cells such that they can be charged with SIV/HIV vaccine candidates, ex vivo. - Developing assays to test the APC subsets for their ability to stimulate TH1, TH2, CTL and B cell responses; - Identifying cytokines and/or other molecules that improve APC functions; - Evaluating vaccine-charged APCs for their ability to induce relevant immunity, in vivo, (e.g., clearance of HIV infected cells, development of appropriate humoral/mucosal immunity). To help meet the research objectives defined by the AIDS Vaccine Research Committee, research applications intended to produce preliminary data or precedent for an idea or a concept are particularly 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 subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects of 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 the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 5/95), the standard application form for research grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: ASKNIH@odrockm1.od.nih.gov. Application kits may also be obtained electronically via the WWW at http://www.nih.gov/grants/phs398/phs398.html. Applicants must adhere to the format and requirements specified in the PHS 398 application kit, except as noted below. A modular budget application format will be pilot tested, in which budgets and justifications are simplified. Applicants may apply for up to two years of support at up to $150,000 per annum, and total direct costs may be requested in modular increments of $10,000. The form, ~Detailed Budget for Initial Budget Period (page 4 of the PHS 398 application kit, rev. 5/95),~ is not required and will not be accepted at the time of application. Applicants should use the form, ~Budget for Entire Proposed Period of Support (page 5 of the PHS 398 application kit, rev. 5/95),~ leaving blank the categorical budget table and providing only the requested total direct costs for each year and total direct costs for the entire proposed period of support. The budget justification should begin in the space provided, using continuation pages as necessary, and should justify the requested budget on the basis of overall requirements, scientific aims and scope of the proposed research. All project personnel (salaried or unsalaried) should be listed by name, role on project and per cent effort, and a narrative justification provided for each person based on his/her role on the project and proposed level of effort. All consultants should be identified by name and organizational affiliation and the services they will perform should be described. A narrative justification should be provided for any major budget items, other than personnel, which would be considered unusual for the scope of research; otherwise, no specific costs for items or categories should be shown. Applications exceeding $150,000 in requested total direct costs will also require a special justification, identifying the specific costly reagents, animals, specimens or laboratory modifications which are required. Key personnel and their level of effort must be specified, and biosketches provided. If consortium/contractual costs are requested, the percentage of the subcontract total costs (direct and indirect) relative to the total direct cost of the overall project should be specified. The subcontract budget justification should be prepared according to the instructions provided above. The research plan shall be limited to 10 pages, and any appendices to 10 pages. For purposes of identification and processing the application, mark ~YES~ in item 2 on the face page and enter the PA number PAR-97-042 and the title ~INNOVATION Grant Program for Approaches in HIV Vaccine Research.~ The completed, signed original and three (3) 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) At the same time, two complete copies of the application and all five copies of any appendices must be sent or delivered to: Dr. Dianne E. Tingley National Institute of Allergy and Infectious Diseases Solar Building, Room 4C07 6003 Executive Boulevard Rockville, MD 20852-7610 Telephone: (301) 496-2550 REVIEW CONSIDERATIONS Review Procedures Applications will be assigned on the basis of established PHS referral guidelines. Upon receipt, applications will be reviewed for completeness by the Division of Research Grants, NIH, and for responsiveness to the goals of the PA by NIAID staff. Incomplete applications will be returned to the applicant without further consideration. Applications will be evaluated for scientific and technical merit by appropriately constituted Scientific Peer Review Group(s) convened by the NIAID, in accordance with standard NIH review policies. As part of the initial merit review, all applications may undergo a process in which only those applications deemed to have the highest scientific merit will be assigned a priority score and receive a second level review by the National Advisory Council of the National Institutes of Allergy and Infectious Diseases. Review Criteria The Scientific Peer Review Group(s) will consider and score each application according to the following three dimensions of scientific merit, and will also assign an overall priority score for the application. Impact: The quality (e.g. innovativeness, significance, importance) of the idea/hypothesis and the relevance of the idea/concept to understanding host/pathogen interactions and vaccine development; Approach: The appropriateness of the methods, subjects, and materials chosen to produce data addressing the hypothesis; Feasibility: Prospects for accomplishing the objectives, given the requested budget and term of award, the qualifications and research experience of the Principal Investigator and staff, and the access to necessary resources. The Scientific Peer Review Group(s) also will examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to NIAID. The following will be considered in making funding decisions: the scientific and technical merit of the proposed project as determined by peer review, and the availability of funds. In the final selection of applications to be funded, consideration will be given to the ability to achieve balanced coverage of the scientific areas of emphasis recommended by the AIDS Vaccine Research Committee. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Carole A. Heilman., Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2A16 MSC 7620 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 496-0545 FAX: (301) 402-1505 Email: ch25v@nih.gov Direct inquiries regarding fiscal matters to: Jane Unsworth Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, 4B25 6003 Executive Blvd. Rockville, MD 20892-7610 Telephone: (301) 402-6824 Fax: (301) 480-3780 Email: ju3a@nih.gov Direct inquiries regarding review matters to: Dianne Tingley, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, 4C07 MSC 7610 6003 Executive Blvd. Rockville, MD 20892-7610 Telephone: (301) 496-2550 Fax: (301) 402-2638 Email: dt15g@nih.gov AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Sec. 301(c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assistance Citation is both (No. 93.855 - Immunology, Allergy, and Transplantation Research and No. 93.856 - Microbiology and Infectious Disease Research ). 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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