PAR-00-093: HIV VACCINE RESEARCH AND DESIGN

Department of Health
and Human Services (HHS)

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HIV VACCINE RESEARCH AND DESIGN Release Date: May 8, 2000 PA NUMBER: PAR-00-093 National Institute of Allergy and Infectious Diseases Application Receipt Dates: October 10, 2000, 2001, 2002 APPLICATIONS IN RESPONSE TO THIS PROGRAM ANNOUNCEMENT (PA) MUST BE PREPARED USING A MULTI-PROJECT GRANT APPLICATION FORMAT; SPECIFIC INSTRUCTIONS FOR COMPLETING THE APPLICATION ARE IN THE NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS. PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) invites applications for research aimed at obtaining a safe and efficacious vaccine against HIV or AIDS. NIAID supports the progressive stages of AIDS vaccine research and development including basic research, iterative product development, and clinical trials. NIAID supports AIDS prophylactic vaccine research and development via three grant programs. The Innovation Grant Program for AIDS Vaccine Research supports high risk/high impact early stage concept evaluation for projects with limited preliminary data. The HIV Vaccine Research and Design (HIVRAD) Program supports multi-project investigator-initiated HIV vaccine design and development research. The Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) Program supports iterative product development and optimization in the later stages of vaccine research and includes limited human studies. This Program Announcement (PA) replaces PAR-98-090 and is a continuation of the HIV Vaccine Research and Design (HIVRAD) Program. For an overview of these research programs and other information, visit the NIAID AIDS Vaccine Research Website at: http://www.niaid.nih.gov/daids/vaccine/default.htm HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS- led national activity for setting priority areas. This PA, HIV VACCINE RESEARCH AND DESIGN, is related to the focus areas of immunization and infectious diseases; HIV infection; and sexually transmitted diseases. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic 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. In accordance with NIH policy, foreign institutions are not eligible for Program Project Grant (P01) awards. However, for this initiative, NIAID has been granted an exception. Foreign institutions may apply for grants under this Program Announcement, however all other restrictions on foreign grant applications will apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT Program project grant (P01) applications may be submitted in response to this program announcement. Program project grants support broadly based, multidisciplinary research programs that have a well-defined, central research focus or objective. An important feature is that the interrelationships of the individual scientifically meritorious projects will result in a greater contribution to the overall program goals than if each project were pursued individually. Standard NIH policy requires P01 applications to consist of a minimum of three interrelated individual research projects that contribute to the program objective. This type of award also can provide support for certain common resources termed cores. Such resources should be utilized by two or more projects within the award. An exception to standard policy has been granted for this program announcement such that fundable applications must have at least two (2) projects and one core. The total project period for P01 grants may not exceed five (5) years. 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 for P01 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS (April 1999); this brochure is available via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm. RESEARCH OBJECTIVES Background Vaccine research requires contributions from multiple fields including immunology, virology, animal models, and molecular biology. The HIVRAD program supports multidisciplinary AIDS vaccine-related studies. As summarized in PURPOSE above, HIVRAD is designed to accept projects too advanced for the exploratory Innovation Grant Program but not yet sufficiently advanced for the product-oriented IPCAVD Program. Research Objectives and Scope The overall objective of the HIVRAD program and this program announcement is to advance concepts further toward development of an AIDS vaccine. To that end, applications may target any area of AIDS vaccine research. These areas include, but are not limited to, HIV antigen processing, correlates of immunity, animal model development, DNA vaccination, studies of the structure of HIV immunogens, development of virus and bacterial vaccine vectors, studies targeting initial infection (dendritic cells). This includes extensive modeling of vaccine concepts in non-human primates. Clinical studies involving humans would not be considered appropriate for this PA. In addition, vaccine research focused solely on therapeutic application is not responsive to this announcement. The safety evaluation of immunogens in infected animals may be included if these studies directly support the development of a prophylactic vaccine. For information on programs that support therapeutic vaccine development please contact program staff. SPECIAL REQUIREMENTS All awardees are strongly encouraged to attend an NIAID-sponsored annual meeting on AIDS vaccine research and development and may include a request for travel funds for this purpose. Patent Coverage Since applications may involve several institutions, including the private sector, complex patent situations may arise. To avoid delays in the implementation of new vaccines for HIV related to intellectual property issues, each multi-project group is required to provide a plan as part of the application, detailing 1) the approach, agreed to by all parties, to be used for obtaining patent coverage and for licensing, where appropriate, and, 2) the procedures to be followed for the resolution of legal problems that may potentially develop. Attention is drawn to the reporting requirements of 35 U.S.C. Parts 200-212 and 37 CFR Part 401 or FAR 55.227-11. Instructions were also published in the NIH GUIDE FOR GRANTS AND CONTRACTS, Vol. 19, No. 23, June 22, 1990. Note that non-profit organizations (including universities) and small business firms retain the rights to any patent resulting from Government grants or cooperative agreements. It is also noted that in a Presidential memorandum of February 18, 1983, extended to all business concerns, regardless of size, the first option is to the ownership of rights to inventions as provided in P.L. 96-517. As a result of this memorandum, the relationships among industrial organizations and other participants are simplified, since all Group members can now be full partners in the research and in any inventions resulting there from. The specific patenting arrangements among the institutions may vary and could include joint patent ownership, exclusive licensing arrangements, etc. Applicants are encouraged to develop an arrangement that is most suitable for the Group's particular circumstances. The agreement among the institutions comprising the Group, signed and dated by the organizational officials authorized to enter into patent arrangements for each Group member and member institution, must be delivered prior to submission of the application to Dr. Steve Bende, at the address listed under INQUIRIES. A copy of the patent agreement should also be submitted with the application. If the Group wishes to place all inventions and discoveries resulting from these studies within the public domain, a letter to that effect must be submitted to Dr. Bende in lieu of the patent agreement. The letter must be co-signed by the Principal Investigator, each of the Project Leaders, and each of the business officials representing the respective institutions. Federal regulation clause 37-CFR-401 and HHS Inventions regulations at 45 CFR Parts 6 and 8 require that NIH be informed of inventions and licensing occurring under NIH funded research. Invention and licensing reports must be submitted to the Extramural Invention Reports Office at 301 435 1986. APPLICATION PROCEDURES Applicants for P01 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS (April 1999); this brochure is available via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, email: GrantsInfo@nih.gov. Applications are also available on the World Wide Web at http://grants.nih.gov/grants/forms.htm. Applicants submitting amended applications may take up to three (3) pages each for the overall application, each project and each core to respond to previous reviewer criticisms, but are encouraged to be as brief as possible. Applications that are not received as a single package on the receipt date or that do not conform to the instructions contained in PHS 398 (rev. 4/98) Application Kit (as modified in, and superseded by, the NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS") will be judged non-responsive and will be returned to the applicant. For purposes of identification and processing, item 2a on the face page of the application must be marked "YES" and the PA number and the words "HIV VACCINE RESEARCH AND DESIGN" must be typed in. Submit a signed, typewritten original of the application, including the checklist and original appendix (if any), and three signed, exact, single- sided photocopies of the application (no copies of the appendix), in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express mail or courier service) At the time of submission, two additional exact copies of the grant application and all five copies of any appendix material must be sent to Dr. Dianne Tingley at the address listed under INQUIRIES. Concurrent submission of an R01 and a Component Project of a Multi-project Application: Current NIH policy permits a component research project of a multi-project grant application to be concurrently submitted as a traditional individual research project (R01) application. If, following review, both the multi-project application and the R01 application are found to be in the fundable range, the investigator must relinquish the R01 and will not have the option to withdraw from the multi-project grant. This is an NIH policy intended to preserve the scientific integrity of a multi-project grant, which may be seriously compromised if a strong component project(s) is removed from the program. Investigators wishing to participate in a multi-project grant must be aware of this policy before making a commitment to the Principal Investigator and awarding institution. 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 GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. REVIEW CONSIDERATIONS Review Procedures Applications will be assigned to NIAID. 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. P01 applications that are complete and responsive to this PA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID. Review Criteria Applicants should see the NIAID brochure "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS (April 1999) for review criteria for P01 applications. AWARD CRITERIA Applications will compete for available funds with all other 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. The NIAID gives special consideration for funding, including award of grants beyond the established NIAID percentile and priority score paylines, to scientifically meritorious applications in response to Program Announcements. 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 INSTRUCTIONS FOR APPLICATIONS FOR MULTI- PROJECT AWARDS as well as inquiries regarding programmatic (research scope, eligibility and responsiveness) issues may be directed to: Dr. Steve Bende Division of AIDS National Institute of Allergy and Infectious Diseases 6700-B Rockledge Drive, Rm. 4107, MSC 7628 Bethesda, MD 20892-7628 Telephone: (301) 435-3756 Fax: (301) 435-6511 Email: sb22k@nih.gov Direct inquiries regarding review issues to: Dr. Dianne Tingley Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6700-B Rockledge Dr. Room 2148, MSC 7616 Bethesda, MD 20892-7616 Bethesda, MD 20817 (for express/courier service) Telephone:(301) 496-0818 FAX: (301) 402-2638 Email: dt15g@nih.gov Direct inquiries regarding fiscal matters to: Jane Unsworth Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6700-B Rockledge Drive, Rm. 2128, MSC 7614 Bethesda, MD 20892-7614 Telephone: (301) 402-6824 Fax: (301) 480-3780 Email: ju3a@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance No. 93.856, Microbiology and Infectious Diseases Research, and No. 93.855 - Immunology, Allergy, and Transplantation Research. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service 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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