HIV VACCINE RESEARCH AND DESIGN - RESEARCH PROJECT GRANTS

Release Date:  July 9, 1998

PA NUMBER:  PA-98-089

P.T.

National Institute of Allergy and Infectious Diseases

PURPOSE

This Program Announcement replaces PA-96-078, "Novel HIV Vaccine Design," for
which the final receipt date was May 1, 1998.

The National Institute of Allergy and Infectious Diseases (NIAID) of the National
Institutes of Health (NIH) invites applications for research aimed at obtaining
an efficacious vaccine against HIV or AIDS.  NIAID supports all stages of AIDS
vaccine research and development: from basic research, to iterative product
development, through clinical trials.  Recently NIAID revamped its design for
funding AIDS vaccine research and development (excluding clinical trials) with
the creation of three grant programs: (1) the Innovation Grant Program for
Approaches in AIDS Vaccine Research that supports high risk/high impact early
stage concept evaluation for projects with limited preliminary data; (2) the HIV
Vaccine Research and Design (HIVRAD) Program that supports investigator-initiated
HIV vaccine research for which the investigator has already generated significant
preliminary data; and, (3) the Integrated Preclinical/Clinical AIDS Vaccine
Development (IPCAVD) Program that supports further product development and
optimization in the later stages of the research including limited human studies.

This program announcement (PA), HIV Vaccine Research and Design (HIVRAD) -
Research Project Grants, is for the second of the three grant programs identified
in the preceding paragraph.  For an overview of these funding programs and other
information, visit the Division of AIDS, NIAID AIDS Vaccine Research Website at:
http://www.niaid.nih.gov/daids/vaccine/default.htm

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, HIV Vaccine Research and Design,
is related to the priority areas of HIV infection, prevention, 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-
001-00473-1) through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone 202-512-1800).

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.  Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

Traditional research project grant (R01) applications may be submitted in
response to this program announcement.  Applicants may request up to five years
of support.  Responsibility for the planning, direction, and execution of the
proposed research for all applicable mechanisms of support will be solely that
of the applicant.

RESEARCH OBJECTIVES

Background

The NIAID supports research aimed at obtaining an efficacious vaccine against HIV
or AIDS.  NIAID supports all stages of AIDS vaccine research and development:
from basic research, to product development, through clinical trials.

Vaccine research requires contributions from multiple fields including
immunology, virology, animal models, and molecular biology.  The HIVRAD program
supports AIDS vaccine-related studies in all fields of investigation.

Research Objectives and Scope

The overall objective of the HIVRAD program and this program announcement is to
move science closer to an AIDS vaccine.  To that end, applications may target any
area of AIDS vaccine research.  These areas include, but are not limited to, HIV
antigen processing, correlates of immunity, animal model development, DNA
vaccination, studies of the structure of HIV immunogens, development of virus and
bacterial vaccine vectors, studies of existing vaccinee cohorts, studies
targeting initial infection (dendritic cells), and extensive modeling of vaccine
concepts in macaques or chimps, etc.  Clinical studies involving humans would not
be considered appropriate for this PA.

SPECIAL REQUIREMENTS

All awardees are strongly encouraged to attend the NIAID-sponsored annual meeting
on AIDS vaccine development normally held in the metropolitan Washington, DC
area, and may include a request for travel funds for this purpose.

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.

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://www.nih.gov/grants/guide/notice-files/not98-024.html

Investigators may obtain copies from these sources or from the program staff
listed under INQUIRIES.  Program staff may also provide additional relevant
information concerning the policy.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
5/95).  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 301/710-0267, email: Grantsinfo@nih.gov.
Application kits also may be obtained electronically via the WWW at
http://www.nih.gov/grants/funding/phs398/phs398.html

For purposes of identification and processing, item 2 on the face page of the
application must be marked "YES".  The PA number and the PA title must also be
typed in section 2.

The completed, signed original and five legible, single-sided copies of the
application must be sent or delivered to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

Applicants from institutions that have a General Clinical Research Centers (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.  Upon receipt, applications will be reviewed for completeness by the
NIH Center for Scientific Review.  Incomplete applications will be returned to
the applicant without further consideration.

Applications will be reviewed for scientific and technical merit by study
sections of the Center for Scientific Review, NIH, 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

The five criteria to be used 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 methods? 
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 appropriateness of proposed
project budget and duration; the adequacy of plans to include both genders,
minorities and their subgroups, and children 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.

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

Written and telephone inquiries are encouraged.  The opportunity to clarify any
issues or questions from potential applicants is welcome.

Additional information about NIAID funding programs and other AIDS vaccine-
related information is available at
http://www.niaid.nih.gov/daids/vaccine/default.htm

Inquiries regarding programmatic issues may be directed to:

Dr. Steve Bende
Division of AIDS
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 2A29
Bethesda, MD  20892-7620
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 435-3756
FAX:  (301) 402-3684
Email:  sb22k@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Laura Eisenman
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 4C26
Bethesda, MD  20892-7610
Telephone:  (301) 402-5541
FAX:  (301) 480-3780
Email:  le55d@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos.
93.855 and 93.856.  Awards are made 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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