Full Text PA-97-029
 
IMMUNOLOGIC INTERVENTION IN INFECTIOUS DISEASES
 
NIH GUIDE, Volume 26, Number 3, January 31, 1997
 
PA NUMBER:  PA-97-029
 
P.T. 34

Keywords: 
  Infectious Diseases/Agents 
  Immunotherapy 

 
National Institute of Allergy and Infectious Diseases
 
PURPOSE
 
The National Institute of Allergy and Infectious Diseases (NIAID),
National Institutes of Health (NIH), invites applications for
innovative preclinical and clinical research, in relevant animal
models and human subjects, to identify and accelerate development of
novel, immunologically-based, therapeutic interventions for
infectious diseases, such as  interventions based on targeted
disruption of the contribution of cytokines to pathology in such
diseases.  Multidisciplinary research and a focus on studies in human
populations are particularly encouraged. Since other NIAID
initiatives have recently been available to support research on other
high priority areas such as HIV, opportunistic infections in AIDS
patients, Lyme disease, and tuberculosis, projects on these topics
will not be considered responsive to this PA.
 
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,
"IMMUNOLOGIC INTERVENTION IN INFECTIOUS DISEASES," 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 Summary Report: Stock No. 017-001-00473)
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-0325 (telephone 202-783-3238).
 
ELIGIBILITY
 
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.
Foreign institutions are not eligible for First Independent Research
Support and Transition (FIRST) (R29) awards.  Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to
apply as Principal Investigators.
 
MECHANISM OF SUPPORT
 
Traditional research project grant (R01), FIRST award (R29), and
Interactive Research Project Grant (IRPG) applications may be
submitted in response to this program announcement.  Applications for
R01 grants may request up to five years of support; applications for
R29 grants must request five years of support.
 
The Small Business Innovation Research Program (SBIR) and the Small
Business Technology Transfer Research Program (STTR) also solicit
applications in this research area.  SBIR and STTR solicitation
packages may be requested from MTL, Inc., 13687 Baltimore Avenue,
Laurel, MD 20707-5096, telephone (301) 206-9385, FAX (301) 206-9722,
Email: a2y@cu.nih.gov.
 
If an IRPG is proposed, it must consist of a minimum of two
independent applications (see PA-96-001, NIH Guide for Grants and
Contracts, Vol. 24, No. 35, October 6, 1995).  An IRPG may consist of
a combination of R01s and R29s or R01s only, but may not consist
solely of R29 applications.  An IRPG may also contain shared
interactive resources (Cores), which must serve at least two of the
research projects in order to facilitate achievement of the Group's
common research goals. Collaborative arrangements involving more than
one institution are especially encouraged, including participation of
the pharmaceutical or biotechnology industry where appropriate.
 
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 are encouraged to coordinate, through the use of
consortium arrangements or subcontracts, integrated approaches with
individuals or institutions having relevant reagents and expertise in
their use, demonstrated ability in a particular area of relevant
research, or access to relevant patient populations so as to
accelerate technical progress and clinical development of promising
therapies.
 
RESEARCH OBJECTIVES
 
Background
 
In a wide variety of infectious diseases inappropriate or excessive
immune responses result in pathology rather than protection. For
example, whether a deleterious or protective immune response is
elicited may depend on which T lymphocyte subsets (i.e., Th1 or Th2)
dominate the response to infection and elaborate characteristic
cytokines.  In the first four years of this initiative, during which
it was restricted to research on protozoan and helminth diseases,
investigators examined the role of cytokine-mediated pathology in
leishmaniasis, schistosomiasis, toxoplasmosis, onchocerciasis, and
malaria.  Much of the importance of Interleukin-12 in inducing Th1
lymphocyte responses in parasitic diseases was developed in the
models under investigation as a result of this initiative, and has
contributed to current efforts to use Interleukin-12 either as an
adjuvant or as therapy for a variety of infectious diseases,
including viral, bacterial and fungal infections.  These and similar
observations on a variety of immunopathologic consequences of diverse
infections indicate the need for a systematic and focused analysis of
the relationship between cytokine effects and infectious disease,
with the aim of developing new therapeutic strategies for
intervention.
 
Research Objectives and Scope
 
The purpose of this Program Announcement is to stimulate innovative
research to investigate novel therapeutic interventions based on
targeted disruption of cytokine-induced pathology in infectious
diseases, and to initiate or accelerate development of such therapies
for clinical use.  The specific goals of these studies may include,
but are not limited to: (1) identification and definition at the
molecular level of the immunopathogenic role played by individual
cytokines in infectious diseases of humans; (2) production,
characterization and/or improvement of specific inhibitors (e.g.,
monoclonal antibodies, counterregulatory cytokines, synthetic
cytokine antagonists, or pharmacologic agents) of those cytokines
found to have deleterious roles; and (3) testing the efficacy and
safety of such inhibitors in ameliorating disease.  While limited
testing in animal models is permitted, studies involving human
subjects (e.g., limited phase I/II trials in clinical settings) are
particularly encouraged.  It is likely that some potentially relevant
inhibitors are already in existence or under development for other
purposes in either private industry or public institutions.  As noted
above, in such cases collaborative research arrangements, including
the use of consortia or subcontracts, are 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 sub-populations must be included 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 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 reprinted
in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume
23, Number 11.
 
APPLICATION PROCEDURES
 
Applicants are strongly encouraged to contact the program staff
listed under INQUIRIES early in project development with any
questions regarding the proposed project(s).
 
Applications are to be submitted on the grant application form PHS
398 (rev. 5/95) and will be accepted on the standard application
deadlines as indicated on the application kit and at the beginning of
this PA.  Application kits are available at most institutional
offices of sponsored research and may be obtained from the Division
of Extramural Outreach and Information, National Institutes of
Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910,
telephone (301) 435-0714, email: ASKNIH@odrockm1.nih.gov.
 
For purposes of identification and processing, the number and title
of this program announcement must be typed in item 2 and the "YES"
box must be marked.
 
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)
 
Applications for the FIRST Award (R29) must include at least three
sealed letters of reference attached to the face page of the original
application.  FIRST Award (R29) applications submitted without the
required number of reference letters will be considered incomplete
and will be returned without review.
 
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 Center as a resource for
conducting the proposed research.  If so, a letter of agreement from
the GCRC Program Director must be included in the application
material.
 
REVIEW CONSIDERATIONS
 
Review Procedures
 
Applications will be assigned on the basis of established PHS
referral guidelines.  Applications will be reviewed for scientific
and technical merit by study sections of the Division of Research
Grants (DRG) 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.
 
Review Criteria
 
o  scientific, technical, or medical significance and originality of
the proposed research;
 
o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;
 
o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;
 
o  availability of the resources necessary to perform the research;
 
o  appropriateness of the proposed budget and duration in relation to
the proposed research;
 
o  adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be
evaluated.
 
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 program announcement, and availability of funds.
 
INQUIRIES
 
Inquiries are encouraged.  The opportunity to clarify any issues or
questions from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues to:
 
B. Fenton Hall, M.D., Ph.D.
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 3A09 - MSC 7630
Bethesda, MD  20892-7630
Telephone:  (301) 496-2544
FAX:  (301) 402-0659
Email:  bh24q@nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Todd C. Ball
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 4B35 - MSC 7610
Bethesda, MD  20892-7610
Telephone:  (301) 402-5512
FAX:  (301) 480-3780
Email:  TB22J@NIH.GOV
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance Nos. 93.855 and 93.856.  This program is supported under
authorization of the Public Health Service Act, Sec. 301(c), Public
Law 78-410, as amended.  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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