RESEARCH TO BETTER UNDERSTAND AND PREVENT MEASLES NIH GUIDE, Volume 21, Number 21, June 5, 1992 PA NUMBER: PA-92-84 P.T. 34 Keywords: Infectious Diseases/Agents Viral Studies (Virology) Vaccine Immunology Genetics Pathogenesis National Institute of Allergy and Infectious Diseases PURPOSE Since the introduction of the measles vaccine in 1963, basic research on the measles virus has been reduced in this country. Recently, there has been a resurgence of measles in the U.S., and measles continues to be a deadly disease in the developing world. The National Institute of Allergy and Infectious Diseases invites investigator-initiated research grant applications to explore the basic biology of the measles virus and the host's response to infection. The purpose is to expand the understanding of the biologic basis of measles with the goal of developing improved vaccines to prevent disease and measles-related infant deaths. State-of-the-art application of knowledge derived from this research should lead to new vaccines with reduced primary failure rates that induce long-lasting immunity and can be given safely to very young infants. Success in this endeavor will require basic research in measles virology, immunity, genetics, and pathogenesis. 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 Program Announcement (PA), Research to Better Understand and Prevent Measles, 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 "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Research grant 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. Applications from minority individuals and women are encouraged. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) Award. MECHANISMS OF SUPPORT Applications considered appropriate responses to this announcement are the traditional research project grants (R01) and the FIRST Award (R29). RESEARCH OBJECTIVES Background From 1981-1988, a steady average of 3,000 cases of measles occurred each year. This represents a reduction of over 99 percent from the 400,000 to 700,000 annual cases per year reported before the introduction of the measles vaccine in 1963. However, in 1989, there were 18,193 cases, and in 1990, the number rose to 27,672 cases. These cases were reported from all but one state. The 1990 outbreak year included the largest number of cases since 1977 and the largest number of deaths (89) since 1971. Of the reported cases, 22.7 percent included complications, and 21.1 percent (5844) required hospitalization. At one medical center, nine percent of the hospitalized cases eventually required intubation. The epidemiology of the disease in the U.S. is changing, and the distribution of cases is shifting from older, previously vaccinated, school-age children to younger, unvaccinated children. As more outbreaks occur in younger children, more infants less than 1 year old are exposed. The principal cause of the re-emergence of measles in the U.S. is the failure to vaccinate children at the appropriate age. Although very effective when used properly, the current vaccine has deficiencies as a public health tool. There is a primary failure rate of about five percent, and thus, susceptible individuals accumulate in the population. The failure rate is higher if the current vaccine is given at less than 15 months of age when maternal antibody interferes with vaccine efficacy. Measles is highly infectious and can spread even in communities where a high percentage of the population is vaccinated. In developing countries, measles continues to be a deadly disease claiming over one and a half million deaths each year. In those countries, infants are at greatest risk for serious complications during the interval between loss of maternal antibody and receipt of vaccine. In both U.S. inner cities and inner cities abroad, this window of exposure is too wide. In order to close this window and protect young infants, new vaccines are needed that can safely overcome the maternal antibody barrier. Development of improved vaccines will depend upon new insights gleaned from basic research. Research Objectives and Experimental Approaches This program announcement is intended to stimulate measles research on a broad front, with an emphasis on studies necessary for the development of improved vaccines. Research projects are sought that investigate topics including, but not limited to: the quantitative and qualitative differences between vaccine-induced and naturally induced measles immunity, the antigens required for protective humoral and cellular immunity, the development of efficient methods for delivery of immunogens, strategies to overcome maternal antibody as a block to immunization, characterization of measles immune response in young infants, the viral correlates of virulence, factors contributing to immunologically induced adverse events, and the changing epidemiology of measles. Also needed are improved laboratory methods for studying viral genetics and an animal model for measles. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions that disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups must be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the review will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on the research grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit (February 1, June 1 and October 1). Application kits are available at most institutional business offices and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. On the first (face) page, item 2a, of the application, the word "Yes" must be checked and the title and number of the announcement typed in the space provided: PA-92-84: Research to Better Understand and Prevent Measles. The original and five legible copies of the application must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW PROCEDURES Applications in response to this announcement will be assigned on the basis of established Public Health Service Referral Guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, and in accordance with the standard NIH peer review procedures. Following scientific-technical review of the applications considered to have significant and substantial merit, a secondary review will be by the appropriate national advisory council or board. AWARD CRITERIA Applications will compete for available funds with all other applications considered to have significant and substantial merit. The following will be considered when making funding decisions: relative scientific merit, program relevance, availability of funds. INQUIRIES Direct inquiries regarding programmatic issues to: James M. Meegan, Ph.D. Virology Branch Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A15 Bethesda, MD 20892 Telephone: (301) 496-7453 Fax: (301) 402-0804 Direct inquiries regarding fiscal matters to: Mr. Todd Ball Chief, Microbiology and Infectious Diseases GM Section Grants Management Branch Division of Extramural Affairs National Institute of Allergy and Infectious Diseases Solar Building, Room 4B35 Bethesda, MD 20892 Telephone: (301) 496-7075 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.856, Microbiology and Infectious Disease Research. Grants will be awarded under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grants policies and Federal Regulations at 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 Agency review. .
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