Full Text PA-97-106 FELINE IMMUNODEFICIENCY VIRUS: A POTENTIAL MODEL OF AIDS NIH GUIDE, Volume 26, Number 31, September 19, 1997 PA NUMBER: PA-97-106 P.T. Keywords: National Institute of Allergy and Infectious Diseases PURPOSE The NIAID, National Institutes of Health (NIH), invites applications on the molecular biology, immunology, and host factors involved in feline immunodeficiency virus (FIV) infection of cats. The overall goal of these studies is to advance the understanding of the virus/host infection process in this model to determine the potential use of, and to validate the application of, the FIV/cat model for testing potential therapeutics, topical microbicides, and novel mucosal-targeted vaccine designs against the human immunodeficiency virus (HIV). Applicants proposing studies focusing solely on FIV pathogenesis are encouraged to apply under PA-96-072 "Mechanisms of AIDS Pathogenesis". Applications submitted in response to PAs are assigned according to established PHS referral guidelines. 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, "FELINE IMMUNODEFICIENCY VIRUS: A POTENTIAL MODEL OF AIDS", is related to the priority area of human immunodeficiency virus (HIV) infection. 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 202-2512-1800). ELIGIBILITY Applications may be submitted by 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. Domestic and foreign institutions are eligible to apply for R01 and R03 grants. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) awards (R29). Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISMS OF SUPPORT Traditional research project grants (R01) as well as R03 and R29 applications may be submitted in response to this announcement. The duration of R01 grants under this PA is limited to five (5) years; applications for R29 grants must request five (5) years of support. NIAID uses R03 grants to support small, highly innovative or pilot projects. Applicants for R03 grants may request up to $50,000 annual direct costs for a period not to exceed three (3) years. Funds and time requested should be appropriate for the research proposed. Applicants for R03 grants must follow the special application guidelines and Terms and Conditions of Award in the NIAID SMALL RESEARCH GRANTS brochure (September 1996); this brochure is available via the WWW at: http://www.niaid.nih. gov/ncn/tools/broch.htm. Responsibility for the planning, direction, and execution of the proposed research for all applicable mechanisms of support will be solely that of the applicant. RESEARCH OBJECTIVES Background A major problem in evaluating the effectiveness and safety of therapeutic compounds and strategies against HIV disease is the lack of a reproducible, reliable, and inexpensive animal model. Currently, two models are used extensively for therapeutic evaluation: HIV-infected severe combined immunodeficient (SCID) mice transplanted with human tissue, and simian immunodeficiency virus (SIV)-infected monkeys. However, studies in these models have certain limitations, for example limited pathogenesis, disease, and biological scope of the model (SCID/HIV), or lack of specific pathogen-free animals and the expense of the model which precludes large, statistically significant studies (SIV/monkey). As the most recently identified lentivirus, FIV represents a valuable but understudied small animal model for HIV/AIDS research because: (i) analogous to HIV infection of human CD4 cells, FIV primarily infects and replicates to the highest levels in CD4 lymphocytes of cats and appears to bind to the CXC chemokine receptor; (ii) FIV produces an immunodeficiency disease in cats that closely mimics AIDS caused by HIV in humans; (iii) specific pathogen-free cats are readily available and are relatively inexpensive to purchase and maintain; and, (iv) vaginal and rectal challenge experiments have demonstrated the feasibility of using this model to investigate mucosal transmission of FIV. The FIV/cat model may thus fill an important niche and promote a more aggressive and wider use of animal models for identifying and optimizing promising therapeutic and preventative candidates. In addition to expanding the breadth of the model for testing therapeutic and topical microbicides, the FIV/cat model could stimulate the development of immunogens and immunization strategies for inducing genital and gastrointestinal mucosal T- and B-cell immunity to lentiviruses that are both critical for successful HIV vaccine development. Research Objectives and Scope This program announcement is designed to stimulate research on the molecular biology of FIV in order to develop and validate the animal model for application in HIV studies such as testing potential therapeutics, topical microbicides, and novel mucosal-targeted vaccine designs for humans and optimizing current therapeutic regimens. Relevant research objectives include, but are not limited to, the following: o Studying FIV genes and their encoded proteins; o Studying host factors that interact with FIV proteins or regulatory sequences; o Elucidating key aspects of the biology, immunology, and sanctuary sites of FIV infection of cats; and, o Advancing and optimizing the mucosal challenge model for testing potential topical microbicides and vaccines. These and related areas of investigation will be considered responsive to the objectives of the PA as they are vital for in-depth understanding of the model, its validation, and its subsequent use in evaluating therapeutics, preventative agents, and vaccines. 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 as subjects 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 new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. 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. Investigators may obtain copies from these sources or from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application for PHS 398 (rev. 5/95) and will be accepted on the standard application deadlines as indicated on the application kit. 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.nih.gov. For purposes of identification and processing, item 2 on the face page of the application must be marked "YES". The PA number and the PA title must also be typed in section 2. 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) FIRST (R29) awards applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants for small research (R03) grants are to follow the application guidelines in the NIAID SMALL RESEARCH GRANTS brochure (September 1996) which is available from the program staff listed under INQUIRIES and via the WWW at: http://www.niaid.nih.gov/ncn/tools/broch.htm. R03 applications that do not conform to the instructions in the brochure will be judged non-responsive and returned to the applicant. 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 NIH Division of Research Grants. Incomplete applications will be returned to the applicant without further consideration. When the subject of an application is of interest to more than one component of NIH, dual assignments are made. R01 and R29 applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, 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. R03 applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID. Review Criteria The five criteria to be used in the evaluation of grant applications are listed below. To put those criteria in context, the following information is contained in instructions to the peer reviewers. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? The initial review group will also examine: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. Review criteria for R03 applications are described in the guidelines cited above. 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 announcement, and availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Requests for the NIAID brochure "NIAID SMALL RESEARCH GRANTS" as well as inquiries regarding programmatic (research scope, eligibility and responsiveness) issues may be directed to: Dr. Roger H. Miller Targeted Interventions Branch Division of AIDS, NIAID Solar Building, Room 2C36A 6003 Executive Blvd. Bethesda, MD 20892-7640 Telephone: (301) 496-6430 Fax: (301) 402-3211 Email: rm42i@nih.gov Direct inquiries regarding fiscal matters to: Ms. Jane Unsworth Division of Extramural Activities, NIAID Solar Building, Room 4B25 6003 Executive Blvd. Bethesda, MD 20892-7610 Telephone: (301) 496-7075 Fax: (301) 480-3780 Email: ju3a@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 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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