HIV VACCINE RESEARCH AND DESIGN - PROGRAM PROJECT GRANTS

Release Date:  July 9, 1998

PA NUMBER:  PAR-98-090

P.T.

National Institute of Allergy and Infectious Diseases

Application Receipt Dates:  November 24 (annually)

PURPOSE

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) -
Program 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.  Foreign institutions are eligible to apply for program
project (P01) grants in response to this PA.  Foreign applications must adhere
to NIH policies.  Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

Program project grant (P01) 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.

Program project grants (P01) support broadly based multi-disciplinary research
programs that have a well-defined central research focus or objective.  An
important feature of this research mechanism is that the contributing and
collaborative efforts of the associated projects can result in more valuable and
efficiently achieved research goals than those that might be achieved through
individually pursued projects.  NIH policy requires that there be a minimum of
three fundable interrelated research projects in the P01 application to qualify
a program project grant for award.  For this PA, although submission of
applications containing three interrelated projects is strongly encouraged, two
fundable projects will qualify the program project grant application for award. 
P01 applications may include two types of Cores, an Administrative Core and/or
Scientific Core(s).  Each core unit, regardless of type, must provide essential
facilities or services for two or more individual research projects.

Applicants for P01 grants must follow special application guidelines in the NIAID
brochure entitled Instructions for Applications for Multi-Project Awards
(September 1997); this brochure is available via the WWW at:
http://www.niaid.nih.gov/ncn/grants/multibron.htm

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.  As
summarized in PURPOSE above, HIVRAD is designed to accept projects too advanced
for the exploratory Innovation Grant Program but not yet sufficiently advanced
for the product-oriented IPCAVD Program.  Although supporting general research
toward an AIDS vaccine is the goal of this program, specific product development
is not a requirement.

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 three 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)

Two single-sided copies of the application and five copies of appendices must be
sent or delivered to Dr. Dianne Tingley at the address listed under INQUIRIES.

P01 APPLICANTS AND ALL APPLICANTS REQUESTING $500,000 OR MORE IN ANNUAL DIRECT
COSTS.  An applicant planning to submit an investigator-initiated new (type 1),
competing continuation (type 2), competing supplement or any amended/revised
version of the preceding grant application type requesting $500,000 or more in
direct costs for any year is advised that he or she must contact Institute
program staff (see INQUIRIES, below) before submitting the application, i.e, as
plans for the study are being developed.  Furthermore, the applicant must obtain
agreement from Institute staff that the Institute will accept the application for
consideration for award.  Finally, the applicant must identify, in the cover
letter that is sent with the application, the staff member and Institute who
agreed to accept assignment of the application.  This policy update was published
in the NIH Guide of March 20, 1998 and is available on the web at
http://www.nih.gov/grants/guide/notice-files/not98-030.html

CONCURRENT SUBMISSION OF AN R01 AND A COMPONENT PROJECT OF A P01 APPLICATION. 
Current NIH policy permits a component research project of a multi-project P01
grant application to be concurrently submitted as a traditional individual
research project (R01) application.  If, following review, both the multi-project
P01 application and the R01 application are found to be in the fundable range,
the investigator must relinquish the R01 and will not have the option to withdraw
from the multi-project P01 grant.  This is an NIH policy intended to preserve the
scientific integrity of a multi-project grant, which may be seriously compromised
if a strong component project(s) is removed from the program.  Investigators
wishing to participate in a multi-project grant must be aware of this policy
before making a commitment to the Principal Investigator and awarding
institution.

SPECIAL INSTRUCTIONS FOR COMPLETION OF P01 APPLICATIONS IN RESPONSE TO THIS PA

The NIAID brochure, "Instructions for Applications for Multi-Project Awards,"
(September 1997) presents specific instructions for sections of the PHS 398 (rev.
5/95) application form that must be completed differently than usual.  This
brochure is available via the WWW at:
http://www.niaid.nih.gov/ncn/grants/multibron.htm

P01 applications that are not received as a single package on the receipt date
or that do not conform to the instructions contained in PHS 398 (rev. 5/95)
Application Kit (as modified in, and superseded by, the NIAID BROCHURE ENTITLED
"Instructions for Applications for Multi-Project Awards," (September 1997) will
be judged non-responsive and will be returned to the applicant.

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 that are complete will
be evaluated for scientific and technical merit by an appropriate peer review
group convened by the NIAID.

As part of the initial merit review, a process will be used by the initial review
group in which applications will be determined to be competitive or non-
competitive based on their scientific merit relative to other applications
received in response to the PA.  Applications judged to be competitive will be
discussed and be assigned a priority score.  Applications determined to be non-
competitive will be withdrawn from further consideration and the Principal
Investigator and the official signing for the applicant organization will be
notified.

Review Criteria

Review criteria for P01 applications are listed in the NIAID brochure
"Instructions for Applications for Multi-Project Awards (September 1997)

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 review issues and mail two copies of the application
to:

Dr. Dianne Tingley
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 4C07
Bethesda, MD  20892-7610
Telephone:  (301) 496-2550
FAX:  (301) 402-2638
Email:  dt15g@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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