NOT-99-097: INDO-US VACCINE ACTION PROGRAM STARR GRANTS

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INDO-US VACCINE ACTION PROGRAM STARR GRANTS Release Date: May 27, 1999 P.T. National Institute of Allergy and Infectious Diseases The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health and the Government of India seek to continue and expand the INDO-US Vaccine Action Program (VAP) using funds provided by the Starr Foundation. The overall goal of the VAP is to support research leading to the development of new or improved vaccines, vaccine delivery systems and immunodiagnostic reagents for the prevention and detection of infectious diseases of importance to India and the United States. The VAP was created in 1988 and was extended for a third five-year period in a Joint Statement signed by the US Secretary of Health and Human Services and the Minister of State for Power and Science and Technology, Republic of India on November 28, 1997. The VAP has supported collaborative research between US and Indian scientists through paired grants to their institutions exchange visits and limited training. This announcement is an invitation for applications for research support. Awards of US dollars under this program will be made to US scientists and institutions and will complement the counterpart rupee awards made by the Government of India to Indian researchers. BACKGROUND The VAP has supported collaborations in research on vaccines and immunodiagnostics for the last ten years. It makes paired awards from the US and Indian governments for research conducted by US and Indian scientists, respectively. The awards are based upon successful joint applications which are jointly prepared by the US and Indian scientists and are submitted simultaneously for review by the US and Indian VAP secretariats. The research addresses the immunology, pathogenesis or epidemiology of infectious disease pathogens of importance to the US and India that will lead to the development of vaccines or immunodiagnostic reagents. These studies require access to populations (humans, pathogens, vectors and/or reservoir hosts) and environmental conditions which are available only in India, so it is anticipated that the majority of the work will be carried out there. Current projects focus primarily on enteric, respiratory and vector-borne diseases. Specific objectives are to: o to identify and characterize pathogen antigens which interact with the human host’s immune system and/or play a role in the pathogenesis of the disease; o to characterize the human response to a pathogen which may confer or block susceptibility to infection or predisposition to one or more sequelae of infection; o to evaluate the potential as vaccine candidates or immunodiagnostic reagents of selected antigens; o to develop and maintain epidemiological data, including information about the animal reservoirs and arthropod vectors of infection, with which such candidates may be evaluated; and, o to conduct preliminary assessments of the safety, immunogenicity and efficacy of candidate vaccines and immunodiagnostic reagents in strict accordance with the relevant guidelines and regulations of the US and Indian governments. Additional objectives are to encourage the development of collaborative relationships that increase relevant research experience for both U.S. and Indian scientists, and to stimulate self-sufficiency of the collaborating foreign institution and thus strengthen the scientific infrastructure for further international collaborations. ELIGIBILITY Applications may be submitted by collaborating Indian and US scientists from eligible institutions. Eligible institutions include public and private, non-profit research and/or scientific organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government in both countries. MECHANISMS OF SUPPORT FOR THE US PARTNER Funds for this research are provided by the Starr Foundation. Extramural US scientists will be eligible for supplements to current grants or R03 grant awards of up to three years of $50,000 direct costs per year from the NIAID. US Federal scientists will be eligible for support of comparable duration and scope as the extramural scientists and will be funded by interagency agreements from the NIAID. Indian scientists and institutions are eligible for awards from the Indian Department of Biotechnology. Funds to be awarded through this announcement are grant funds. Responsibility for the planning, direction, and execution of the proposed research for all applicable mechanisms of support will be solely that of the applicant. SPECIAL REQUIREMENTS Recipients of awards under the INDO US Vaccine Action Program Announcement will be strongly encouraged to attend the annual meeting of the INDO US VAP Joint Working Group (JWG). This meeting is held in the US and India in alternate years, so it is expected that the Co- investigator in whose country the meeting is held will attend the JWG meeting and present an oral report of the progress made under the award. Requested budgets should include support for this participation. These studies require access to populations (humans, pathogens, vectors and/or reservoir hosts) and environmental conditions which are available only in India. The expectation is the majority of the research effort will be carried out in India but that the US laboratory will make a substantial and significant contribution to the overall research effort. Recipients of VAP awards must agree in advance to an equitable distribution of any intellectual property interest that is developed as a result of the research. The expectation is both Co-investigators will share in authorship of publications which derive from the work and any patents that are filed in either country will reflect the jointly held intellectual property interest of the two investigators and their institutions. STUDY POPULATIONS Clinical studies must meet the requirements for protection of human subjects of research and clinical trials are subject to additional requirements for conduct and monitoring of the intervention being studied. 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, compelling rationale, and justification are 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", 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 which is available via the WWW. at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and which is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators may obtain copies from these sources or from Dr. Aultman who may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES The application process involves two stages, a Letter of Intent and, if invited, a full application (VAP Proposal). Each of these documents must be prepared jointly by the two co-investigators (US and Indian) and submitted simultaneously to the secretariats in India and the United States for review. Applications are to be submitted on the grant application form that is available from the program offices in Bethesda, Maryland, USA and New Delhi, India. Applications will be accepted year round. The application should cite the title of this notice (INDO-US VACCINE ACTION PROGRAM STARR GRANTS) and identify the requested mechanism of funding [supplement to current NIAID grant or R03 grant]). The completed, signed original and the legible, single-sided copies (see below for number of copies needed) of the application must be sent or delivered to: For USA (5 copies), mail to: VAP Program Officer 6003 Executive Blvd Room 3A11 Rockville, MD 20852 USA For India (25 copies), mail to: Director Indian VAP Secretariat Department of Biotechnology Block 2, Seventh Floor Block 2, Seventh Floor CGO Complex, Lodhi Road New Delhi, 110003 India REVIEW CONSIDERATIONS Review Procedures Applications submitted by the two investigators will be reviewed simultaneously by NIAID and by the VAP APEX Committee of the Government of India. The VAP APEX committee meets on an as needed basis to consider the pool of available applications. Approval of both committees is required before an award can be made. For additional information about the Government of India review, contact: Principal Scientific Officer Department of Biotechnology CGO Complex New Delhi, India NIAID Review: A review will be conducted by the NIAID, to evaluate applications that are complete and responsive to this PA for scientific and technical merit. 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, and assigned a priority score. Review Criteria NIAID Review The five criteria to be used by the NIAID 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 strength of the proposed collaboration, the appropriateness of proposed project budget and duration; the adequacy of plans to include children and 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. INDIAN Review: Information about this review can be obtained from the Department of Biotechnology at the address given above. AWARD CRITERIA Only those applications which are approved by both the US and Indian secretariats will be eligible for funding. Funding decisions will be based on the quality of the proposed project as determined by application review, program balance among research areas of the announcement, the strength of the proposed collaboration and availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries may be directed to: Kathryn S. Aultman, Ph.D. VAP Program Officer Division of Microbiology & Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A11 6003 Executive Blvd. Bethesda, MD 20892-7640 Telephone: (301) 496-2544 Fax: (301) 402 0659 EMAIL: KA6Z@nih.gov

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