Subject: NIH GUIDE - RFA AI-92-02 - V20(42) 11/08/91
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Mon, 11 Nov 91 16:01 EST

Dear Paul,
Another RFA to post to the NIH Listserver.  Post as:
RFAAI9202.911108
The fourth of four RFAs.  Thanks for your help!
 ---------------------------- Text of forwarded message -----------------------
$$XID RFA AI9202 AI-92-02 P1O1 *****************************************
 
ENHANCING VACCINE IMMUNOGENICITY
 
RFA:  AI-92-02
 
P.T. 34; K.W. 0740075, 0710065
 
National Institute of Allergy and Infectious Diseases
 
Letter of Intent Receipt Date:  December 30, 1991
Application Receipt Date:  February 24, 1992
 
PURPOSE
 
The National Institute of Allergy and Infectious Diseases (NIAID)
invites applications for innovative preclinical research on efficient
methods to increase the immunogenicity of vaccines for eventual human
use.
 
BACKGROUND INFORMATION
 
Developing and testing vaccines is a major component of research
supported by the NIAID.  This effort supports a wide spectrum of
research from basic molecular, biologic, and immunologic studies
through efficacy trials of candidate vaccines and includes research on
vaccines for pertussis, influenza, Haemophilus influenzae, Neisseria
meningitidis, rotavirus, Escherichia coli, Salmonella, malaria, herpes
viruses, papilloma viruses, and other microorganisms.  The interest of
the NIAID in these areas has been given additional impetus because of
the recently launched international effort termed the Children's
Vaccine Initiative.  The focus of this effort is on developing improved
vaccines that can be used to ultimately decrease the number of clinic
visits that a child requires before he/she is adequately immunized
against a variety of infectious diseases.  In some cases, this will
require that new vaccines be developed, but in other cases, it is
possible that existing vaccines could be either reformulated or
modified to make them more immunogenic.
 
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 Request
for Applications (RFA), Enhancing Vaccine Immunogenicity, 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 20402-9325 (telephone
202-783-3238).
 
RESEARCH OBJECTIVES
 
The purpose of this RFA is to stimulate innovative preclinical research
on methods to increase the immunogenicity of existing and candidate
vaccines for human use.  The major emphasis will be on safe and
efficient methods to enhance protective immune responses against a wide
variety of infectious diseases of interest to the NIAID.  These
include, but are not limited to, pertussis, bacteria meningitis,
bacterial and viral diarrheas, acute respiratory infections, sexually
transmitted diseases, and malaria.  (Research on vaccines against the
Human Immunodeficiency Virus (HIV) and related viruses will not be
considered under this initiative.)
 
Because of the emphasis on inducing high-quality protective immune
responses, research using experimental challenge in relevant animal
models will be encouraged.  Alternatively, new immunization strategies
for diseases for which established correlates of immunity exist (e.g.,
serum antibodies to Haemophilus influenzae capsule after immunization
with conjugate vaccines) can also be proposed.  The most important
consideration will be the relevance of these studies for protection
against human disease.
 
Applications to test innovative immunization strategies, such as the
use of yeast Ty elements or hepatitis B virus core-antigen fusion
proteins, are strongly encouraged, as are projects to test other types
of novel conjugate vaccines that offer an improvement over existing or
candidate vaccines.  Applications to test vaccine vectors (e.g.,
Salmonella, adenovirus, or BCG expressing heterologous antigens) in the
context of enhancing immune responses to target antigens will also be
considered; however, applications to construct such vectors will not be
considered.  Again, the long-term goal is to develop vaccine candidates
that warrant eventual study in humans.
 
MECHANISM OF SUPPORT
 
The support mechanism for this program will be the traditional
individual research grant (R01).  Responsibility for planning,
direction, and execution of the proposed project will be solely that of
the applicant.
 
NIAID anticipates making five to seven awards, totaling $1,000,000, as
a result of this request.  However, the number of awards to be made is
dependent upon receipt of a sufficient number of applications with high
scientific merit and programmatic relevance and upon the availability
of funds.  If appropriate, collaboration with other investigators or
institutions is encouraged.  It is expected that the initial year award
for successful applications will be in the range of $125,000 to
$200,000 in total (direct plus indirect) costs for each award, although
individual awards may be slightly higher or lower.  Awards will be made
for a project period of up to four years.  (Awards to applicant
institutions outside the United States will be limited to three years
and will not include indirect costs).  The earliest possible award date
is September 30, 1992.
 
ELIGIBILITY REQUIREMENTS
 
Universities, medical colleges, hospitals, public and private
institutions, including State and local government units, and for
profit companies are eligible.  Awards to foreign institutions under
this request will be made only for research of unusually high merit,
need, and promise, and in accordance with Public Health Service policy
governing such awards.  Applications from minority investigators and
women are encouraged.
 
REVIEW PROCEDURES
 
Applications will be received by the NIH Division of Research Grants
(DRG).  Applications will be reviewed by NIAID staff to determine
administrative and programmatic responsiveness to this RFA; those
judged to be non-responsive will be returned to the applicant without
review.  By mutual agreement between the applicant and NIAID staff, a
non-responsive application may also be retained at NIH and processed as
an unsolicited R01 application during the next review cycle.
 
Those applications considered responsive to the RFA may be subjected to
a triage review by an NIAID peer review group, before or during the
initial review committee meeting, to determine competitiveness relative
to the other applications received in response to the RFA.  The NIAID
will withdraw from further competition those applications judged by the
triage peer review group to be noncompetitive for award and will notify
the applicant Principal Investigator and the institutional business
official.
 
Those applications judged to be competitive will be reviewed for
scientific and technical merit by a review committee convened by the
Division of Extramural Activities, NIAID, during June 1992.  The second
level of review will be provided by the National Advisory Allergy and
Infectious Diseases Council in September 1992.
 
REVIEW CRITERIA
 
The factors to be considered in scientific evaluation of the
applications are:
 
o  Originality and scientific merit of research approach, design, and
methodology and the potential medical significance of the proposed
research.
 
o  Relevance of the proposed research to the stated objectives of this
RFA.
 
o  Research experience and competence of the Principal Investigator and
staff to conduct the proposed studies.  The Principal Investigator and
key personnel must document appropriate experience and competencies
(with respect to their specific roles in the research proposed) to
conduct research studies on vaccines.
 
o  Adequacy of time (effort) that the Principal Investigator and staff
would devote to the proposed studies.
 
o  Reasonableness of requested budget.
 
While scientific merit is of prime consideration, programmatic
relevance will also be an important factor in selecting applications
for funding.
 
METHOD OF APPLICATION
 
Letter of Intent:  Prospective applicants are asked to submit, by
December 30, 1991, a letter of intent that includes a descriptive title
of the proposed research, and the names and affiliation(s) of the
Principal Investigator and other key investigators.  The letter of
intent is requested solely to provide review staff with an indication
of the number and scope of applications to be reviewed.  The letter of
intent does not commit the sender to submit an application, nor is it
a requirement for submission of an application, and does not enter into
the review of an application subsequently submitted.
 
The letter of intent is to be sent to:
 
Dr. Olivia T. Preble
Chief, Microbiology and Immunology Review Section
Scientific Review Branch
National Institute of Allergy and Infectious Diseases
Control Data Building, Room 4C-20
6003 Executive Blvd
Rockville, MD  20852
Telephone: (301) 496-8208
 
Format of Applications:  Applications must be submitted on form PHS 398
(Rev. 10/88), the application form for research grants.  Application
kits are available at most institutional business offices and may be
obtained from the Office of Grants Inquiries, Room 449, Westwood
Building, Division of Research Grants, NIH, Bethesda, MD 20892,
telephone 301/496-7441.  The instructions for format and other
requirements for research grant applications must be followed, and the
requirements specified under the above section entitled REVIEW CRITERIA
must be fulfilled.
 
For purposes of identification and processing, mark "yes" in item 2 on
the face page of the application, and type in the RFA title "ENHANCING
VACCINE IMMUNOGENICITY" and the RFA number, AI-92-02.
 
The RFA label available in the form PHS 398 kit (rev. 10/88) must be
affixed to the bottom of the face page of the original signed
application.  Failure to use this label could result in delayed
processing of the application such that it may not reach the committee
in time for review.
 
Application Procedure:  The completed original application and four
exact copies must be sent or delivered to:
 
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
(Applications sent by overnight mail should be addressed to the
Division of Research Grants at 5333 Westbard Avenue, Bethesda, MD
20816)
 
**  TWO ADDITIONAL COPIES MUST BE SENT TO DR. PREBLE AT THE ADDRESS
GIVEN ABOVE.
 
CONSEQUENCES OF LATE APPLICATIONS AND DUPLICATE SUBMISSIONS
 
To ensure their review, applications must be received by DRG by
February 24, 1992.  Applications received after that date will be
returned without review.  If the application submitted in response to
this RFA is substantially similar to a research grant application
already submitted to the NIH but not yet reviewed, the applicant will
be asked to withdraw either the pending application or the new one.
Simultaneous submission of identical applications will not be allowed,
nor will essentially identical applications be reviewed by different
review committees.  Therefore, an application cannot be submitted in
response to this RFA that is essentially identical to one that has
already been reviewed.  This does not preclude the submission of
substantial revisions of applications already reviewed, but such
applications must include an introduction addressing the previous
critique.
 
FUTURE FUNDING
 
This is a one-time RFA.  The NIAID has no plans to reissue this
announcement at any future date.  Continuation of research projects
funded through this RFA, beyond the time period awarded, can be applied
for through the customary competitive renewal process for R01 research
grants.
 
INQUIRIES
 
Investigators seeking information about this RFA may contact the
following:
 
For questions regarding the scientific/programmatic issues:
 
Dr. Dale R. Spriggs
Enteric Disease Branch
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Control Data Building, Room 3A-05
6003 Executive Blvd.
Rockville, MD  20852
Telephone:  (301) 496-7051
 
For questions regarding fiscal and administrative matters:
 
Mrs. Barbara Huffman
Microbiology and Infectious Diseases Grants Management Section
Grants Management Branch, DEA
National Institute of Allergy and Infectious Diseases
Control Data Building, Room 4B-35
6003 Executive Blvd.
Rockville, MD  20852
Telephone:  (301) 496-7075
 
For questions regarding the review of applications:
 
Dr. Olivia Preble at the address given under "Method of Application"
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic Assistance
No. 93.856 - Microbiology and Infectious Disease Research.  Grants are
awarded under the authority of the Public Health Service Act, Title IV,
Section 301 as amended, Public Law 78-410; Public Law 97-219; Public
Law 99-158; Public Law 99-500; and Report 99-711 to accompany HR 5233
and administered under PHS grants policies and Federal Regulations 42
CFR 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.