Full Text PAR-97-042
 
INNOVATION GRANT PROGRAM FOR APPROACHES IN HIV VACCINE RESEARCH
 
NIH GUIDE, Volume 26, Number 7, March 7, 1997
 
PA NUMBER:  PAR-97-042
 
P.T. 34

Keywords: 
  AIDS 
  Pathogenesis 
  Disease Model 
  079000 

 
National Institute of Allergy and Infectious Diseases
 
Application Receipt Date:  May 23, 1997
 
PURPOSE
 
The National Institute of Allergy and Infectious Diseases (NIAID)
gives special consideration for funding to scientifically meritorious
applications in response to our program announcements (PAs).  PAs
identify current areas of ongoing research emphasis for the NIAID.
 
The NIAID, National Institutes of Health (NIH) on the recommendation
of the AIDS Vaccine Research Committee (AVRC), seeks to implement a
new program aimed at rapidly exploiting new scientific opportunities
to broaden the base of scientific inquiry in areas related to vaccine
discovery and development.
 
This program announcement represents the first step in establishing
the INNOVATION Grant Program. The NIAID invites applications,
including those from researchers previously outside the field of AIDS
research, for research projects that involve a high degree of
innovation, risk and novelty-- as well as a clear promise of helping
to improve vaccine design or evaluation-- in the following three
general areas:  1) the structure/function of HIV envelope protein; 2)
creation/improvement of animal models for vaccine evaluation and
pathogenesis studies; and 3) mechanisms of directing antigen
processing in vivo.  This INNOVATION Grant Program utilizes a grant
mechanism which provides the resources to carry out preliminary tests
of feasibility for new research hypotheses, and a rapid and
streamlined review and award process.  This approach will be
evaluated by the AVRC for suitability and responsiveness following
this initial offering.  If successful, other announcements may be
made in the future.
 
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,
Innovation Grant Program for Approaches in HIV Vaccine Research, is
related to the priority areas of HIV infection, and 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 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic, foreign for-profit and
non-profit organizations, both public and private, such as
universities, colleges, hospitals, laboratories, units of state and
local governments, and eligible agencies of the federal government.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as principal investigators.
 
MECHANISM OF SUPPORT
 
Research projects will be supported with the
exploratory/developmental research grant mechanism (R21).  This
mechanism provides short-duration support for preliminary studies of
a highly speculative nature which are expected to yield, within this
time frame, sufficient information upon which to base a well-planned
and rigorous series of further investigations.  Applicants may
request up to two years of support and up to $150,000 per annum in
direct costs, although with compelling justification exceptions can
be made if specific costly reagents, animals, specimens or laboratory
modifications are needed to perform these studies.  Program staff may
be able to advise prospective applicants concerning NIAID-sponsored
resources which may be available to them.  Please contact the program
staff listed under INQUIRIES for further information.  The award is
non-renewable; however, applicants may elect to seek continuing
support for this research through the R01 mechanism.
 
RESEARCH OBJECTIVES
 
After an initial examination of the state of the art of HIV vaccine
discovery, the National Institute of Allergy and Infectious Diseases
and the AIDS Vaccine Research Committee seek to broaden the base of
scientific inquiry in three key scientific areas related to HIV
vaccine discovery and development.
 
o  The structures of HIV envelope proteins as they relate to their
function as immunogens.  Examples of  areas of interest include, but
are not limited to:
-  Understanding the oligomeric structure of the envelope protein
both free and on the virion;
-  Novel approaches to a detailed understanding of  the structure of
Env as it interacts with cellular receptors upon virus entry;
-  Development of methods to preserve native structure and evaluate
different protein forms as immunogens;
 
o  Creation of new animal models for vaccine evaluation and
pathogenesis studies, or innovations to improve existing animal
models.  Examples of areas of interest include, but are not limited
to:
-   Methods to produce populations of primates that can accept grafts
of hematopoietic cells (e.g., populations of macaques that are twins,
or clonally-derived  or otherwise rendered MHC-compatible);
-   Novel small animal models produced with transgene that render
them sensitive to HIV infection.
-   Creation or study of SCID mice, or other animals, that would
allow for analysis of protective cellular immune responses through
passive transfer of cells from infected immunized, or exposed and
uninfected humans or primates.
 
o  Mechanisms of directing in vivo antigen processing to maximize immune response.
Examples of areas of interest include, but are not limited to:
-   Defining and comparing pathways of processing various HIV/SIV vaccine classes (e.g.,
subunit, recombinant, whole killed, live attenuated, DNA) by various antigen processing cells
(e.g., APC subsets, macrophages, B cells);
-   Developing methods to expand, in vitro, each of the processing and/or presenting cells
such that they can be charged with SIV/HIV vaccine candidates, ex vivo.
-   Developing assays to test the APC subsets for their ability to stimulate TH1, TH2, CTL
and B cell responses;
-   Identifying cytokines and/or other molecules that improve APC functions;
-   Evaluating vaccine-charged APCs for their ability to induce relevant immunity, in vivo,
(e.g., clearance of HIV infected cells, development of appropriate humoral/mucosal
immunity).
 
To help meet the research objectives defined by the AIDS Vaccine
Research Committee, research applications intended to produce
preliminary data or precedent for an idea or a concept are
particularly 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 subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification are
provided that inclusion is inappropriate with respect to the health
of the subjects of 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 the NIH Guide for Grants and Contracts, Vol. 23, No. 11,
March 18, 1994.
 
APPLICATION PROCEDURES
 
Applications are to be submitted on form PHS 398 (rev. 5/95), the
standard application form for research grants.  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 301/435-0714, email:
ASKNIH@odrockm1.od.nih.gov.  Application kits may also be obtained
electronically via the WWW at
http://www.nih.gov/grants/phs398/phs398.html.  Applicants must adhere
to the format and requirements specified in the PHS 398 application
kit, except as noted below.
 
A modular budget application format will be pilot tested, in which
budgets and  justifications are simplified.  Applicants may apply for
up to two years of support at up to $150,000 per annum, and total
direct costs may be requested in modular increments of  $10,000.
The form, ~Detailed Budget for Initial Budget Period (page 4 of the
PHS 398 application kit, rev. 5/95),~ is not required and will not be
accepted at the time of application.  Applicants should use the form,
~Budget for Entire Proposed Period of Support (page 5 of the PHS 398
application kit, rev. 5/95),~ leaving blank the categorical budget
table and providing only the requested total direct costs for each
year and total direct costs for the entire proposed period of
support.  The budget justification should begin in the space
provided, using continuation pages as necessary, and should justify
the requested budget on the basis of overall requirements, scientific
aims and scope of the proposed research.  All project personnel
(salaried or unsalaried) should be listed by name, role on project
and per cent effort, and a narrative justification provided for each
person based on his/her role on the project and proposed level of
effort.  All consultants should be identified by name and
organizational affiliation and the services they will perform should
be described.  A narrative justification should be provided for any
major budget items, other than personnel, which would be considered
unusual for the scope of research; otherwise, no specific costs for
items or categories should be shown.  Applications exceeding $150,000
in requested total direct costs will also require a special
justification, identifying the specific costly reagents, animals,
specimens or laboratory modifications which are required.
 
Key personnel and their level of effort must be specified, and
biosketches provided.  If consortium/contractual costs are requested,
the percentage of the subcontract total costs (direct and indirect)
relative to the total direct cost of the overall project should be
specified.  The subcontract budget justification should be prepared
according to the instructions provided above.
 
The research plan shall be limited to 10 pages, and any appendices to
10 pages.
 
For purposes of identification and processing the application, mark
~YES~ in item 2 on the face page and enter the PA number PAR-97-042
and the title ~INNOVATION Grant Program for Approaches in HIV Vaccine
Research.~
 
The completed, signed original and three (3) 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)
 
At the same time, two complete copies of the application and all five
copies of any appendices must be sent or delivered to:
 
Dr. Dianne E. Tingley
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4C07
6003 Executive Boulevard
Rockville, MD  20852-7610
Telephone:  (301) 496-2550
 
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 Division of Research Grants, NIH, and for
responsiveness to the goals of the PA by NIAID staff.  Incomplete
applications will be returned to the applicant without further
consideration.   Applications will be evaluated for scientific and
technical merit by appropriately constituted Scientific Peer Review
Group(s) convened by the NIAID, in accordance with standard NIH
review policies.   As part of the initial merit review, all
applications may undergo a process in which only those applications
deemed to have the highest scientific merit will be assigned a
priority score and receive a second level review by the National
Advisory Council of the National Institutes of Allergy and Infectious
Diseases.
 
Review Criteria
 
The Scientific Peer Review Group(s) will consider and score each
application according to the following three dimensions of scientific
merit, and will also assign an overall priority score for the
application.
 
Impact:  The quality (e.g. innovativeness, significance, importance)
of the idea/hypothesis and the relevance of the idea/concept to
understanding host/pathogen interactions and vaccine development;
 
Approach:  The appropriateness of the methods, subjects, and
materials chosen to produce data addressing the hypothesis;
 
Feasibility:  Prospects for accomplishing the objectives, given the
requested budget and term of award,  the qualifications and research
experience of the Principal Investigator and staff, and the access to
necessary resources.
 
The Scientific Peer Review Group(s) also will examine the provisions
for the protection of human and animal subjects, the safety of the
research environment, and conformance with the NIH Guidelines for the
Inclusion of Women and Minorities as Subjects in Clinical Research.
 
AWARD CRITERIA
 
Applications will compete for available funds with all other approved
applications assigned to NIAID.  The following will be considered in
making funding decisions: the scientific and technical merit of the
proposed project as determined by peer review, and the availability
of funds. In the final selection of applications to be funded,
consideration will be given to the ability to achieve balanced
coverage of the scientific areas of emphasis recommended by the AIDS
Vaccine Research Committee.
 
INQUIRIES
 
Inquiries are encouraged.  The opportunity to clarify any issues or
questions from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues to:
 
Carole A. Heilman., Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Solar Building, Room 2A16 MSC 7620
6003 Executive Boulevard
Bethesda, MD  20892-7610
Telephone:  (301) 496-0545
FAX:  (301) 402-1505
Email:  ch25v@nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Jane Unsworth
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, 4B25
6003 Executive Blvd.
Rockville, MD 20892-7610
Telephone:  (301) 402-6824
Fax:  (301) 480-3780
Email:  ju3a@nih.gov
 
Direct inquiries regarding review matters to:
 
Dianne Tingley, Ph.D.
Division of Extramural Activities
National Institute of Allergy and  Infectious Diseases
Solar Building, 4C07 MSC 7610
6003 Executive Blvd.
Rockville, MD 20892-7610
Telephone:  (301) 496-2550
Fax:  (301) 402-2638
Email: dt15g@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  both (No.
93.855 - Immunology, Allergy, and Transplantation Research and 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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