HIV VACCINE RESEARCH AND DESIGN

Release Date:  May 8, 2000

PA NUMBER:  PAR-00-093

National Institute of Allergy and Infectious Diseases

Application Receipt Dates:  October 10, 2000, 2001, 2002

APPLICATIONS IN RESPONSE TO THIS PROGRAM ANNOUNCEMENT (PA) MUST BE PREPARED 
USING A MULTI-PROJECT GRANT APPLICATION FORMAT; SPECIFIC INSTRUCTIONS FOR 
COMPLETING THE APPLICATION ARE IN THE NIAID BROCHURE ENTITLED "INSTRUCTIONS 
FOR APPLICATIONS FOR MULTI-PROJECT AWARDS. 

PURPOSE

The National Institute of Allergy and Infectious Diseases (NIAID) of the 
National Institutes of Health (NIH) invites applications for research aimed 
at obtaining a safe and efficacious vaccine against HIV or AIDS.  NIAID 
supports the progressive stages of AIDS vaccine research and development 
including basic research, iterative product development, and clinical trials.  
NIAID supports AIDS prophylactic vaccine research and development via three 
grant programs.  The Innovation Grant Program for AIDS Vaccine Research 
supports high risk/high impact early stage concept evaluation for projects 
with limited preliminary data.  The HIV Vaccine Research and Design (HIVRAD) 
Program supports multi-project investigator-initiated HIV vaccine design and 
development research.  The Integrated Preclinical/Clinical AIDS Vaccine 
Development (IPCAVD) Program supports iterative product development and 
optimization in the later stages of vaccine research and includes limited 
human studies.

This Program Announcement (PA) replaces PAR-98-090 and is a continuation of 
the HIV Vaccine Research and Design (HIVRAD) Program.  For an overview of 
these research programs and other information, visit the NIAID AIDS Vaccine 
Research Website at:  http://www.niaid.nih.gov/daids/vaccine/default.htm

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a PHS-
led national activity for setting priority areas.  This PA,  HIV VACCINE 
RESEARCH AND DESIGN,  is related to the focus areas of immunization and 
infectious diseases; HIV infection; and sexually transmitted diseases.  
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople. 

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic 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.  In accordance with NIH policy, foreign institutions 
are not eligible for Program Project Grant (P01) awards.  However, for this 
initiative, NIAID has been granted an exception. Foreign institutions may 
apply for grants under this Program Announcement, however all other 
restrictions on foreign grant applications will apply.  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.  Program project grants support broadly based, 
multidisciplinary research programs that have a well-defined, central 
research focus or objective.  An important feature is that the 
interrelationships of the individual scientifically meritorious projects will 
result in a greater contribution to the overall program goals than if each 
project were pursued individually.  Standard NIH policy requires P01 
applications to consist of a minimum of three interrelated individual 
research projects that contribute to the program objective.  This type of 
award also can provide support for certain common resources termed cores.  
Such resources should be utilized by two or more projects within the award.  
An exception to standard policy has been granted for this program 
announcement such that fundable applications must have at least two (2) 
projects and one core.  The total project period for P01 grants may not 
exceed five (5) years.

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 for P01 grants must follow special application guidelines in the 
NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT 
AWARDS (April 1999); this brochure is available via the WWW at:
http://www.niaid.nih.gov/ncn/grants/multibron.htm.

RESEARCH OBJECTIVES

Background

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

Research Objectives and Scope

The overall objective of the HIVRAD program and this program announcement is 
to advance concepts further toward development of 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 targeting initial infection (dendritic cells). This includes 
extensive modeling of vaccine concepts in non-human primates.  Clinical 
studies involving humans would not be considered appropriate for this PA.  In 
addition, vaccine research focused solely on therapeutic application is not 
responsive to this announcement.  The safety evaluation of immunogens in 
infected animals may be included if these studies directly support the 
development of a prophylactic vaccine.  For information on programs that 
support therapeutic vaccine development please contact program staff.

SPECIAL REQUIREMENTS 

All awardees are strongly encouraged to attend an NIAID-sponsored annual 
meeting on AIDS vaccine research and development and may include a request 
for travel funds for this purpose.

Patent Coverage
 
Since applications may involve several institutions, including the private 
sector, complex patent situations may arise.  To avoid delays in the 
implementation of new vaccines for HIV related to intellectual property 
issues, each multi-project group is required to provide a plan as part of the 
application, detailing 1) the approach, agreed to by all parties, to be used 
for obtaining patent coverage and for licensing, where appropriate, and, 2) 
the procedures to be followed for the resolution of legal problems that may 
potentially develop.

Attention is drawn to the reporting requirements of 35 U.S.C. Parts 200-212 
and 37 CFR Part 401 or FAR 55.227-11. Instructions were also published in the 
NIH GUIDE FOR GRANTS AND CONTRACTS, Vol. 19, No. 23, June 22, 1990.  Note 
that non-profit organizations (including universities) and small business 
firms retain the rights to any patent resulting from Government grants or 
cooperative agreements.

It is also noted that in a Presidential memorandum of February 18, 1983, 
extended to all business concerns, regardless of size, the first option is to 
the ownership of rights to inventions as provided in P.L. 96-517.  As a 
result of this memorandum, the relationships among industrial organizations 
and other participants are simplified, since all Group members can now be 
full partners in the research and in any inventions resulting there from.  
The specific patenting arrangements among the institutions may vary and could 
include joint patent ownership, exclusive licensing arrangements, etc.  
Applicants are encouraged to develop an arrangement that is most suitable for 
the Group's particular circumstances.

The agreement among the institutions comprising the Group, signed and dated 
by the organizational officials authorized to enter into patent arrangements 
for each Group member and member institution, must be delivered prior to 
submission of the application to Dr. Steve Bende, at the address listed under 
INQUIRIES.  A copy of the patent agreement should also be submitted with the 
application.  If the Group wishes to place all inventions and discoveries 
resulting from these studies within the public domain, a letter to that 
effect must be submitted to Dr. Bende in lieu of the patent agreement.  The 
letter must be co-signed by the Principal Investigator, each of the Project 
Leaders, and each of the business officials representing the respective 
institutions.
 
Federal regulation clause 37-CFR-401 and HHS Inventions regulations at 45 CFR 
Parts 6 and 8 require that NIH be informed of inventions and licensing 
occurring under NIH funded research.  Invention and licensing reports must be 
submitted to the Extramural Invention Reports Office at 301 435 1986.

APPLICATION PROCEDURES

Applicants for P01 grants must follow special application guidelines in the 
NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT 
AWARDS (April 1999); this brochure is available via the WWW at: 
http://www.niaid.nih.gov/ncn/grants/multibron.htm

Applications are to be submitted on the grant application form PHS 398 (rev. 
4/98) and will be accepted at the standard application deadlines as indicated 
in the application kit.  Application kits are available at most institutional 
offices of sponsored research and 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: 
GrantsInfo@nih.gov.  Applications are also available on the World Wide Web at 
http://grants.nih.gov/grants/forms.htm. 

Applicants submitting amended applications may take up to three (3) pages 
each for the overall application, each project and each core to respond to 
previous reviewer criticisms, but are encouraged to be as brief as possible.

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. 4/98) 
Application Kit (as modified in, and superseded by, the NIAID BROCHURE 
ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS") will be 
judged non-responsive and will be returned to the applicant.

For purposes of identification and processing, item 2a on the face page of 
the application must be marked "YES" and the PA number and the words "HIV 
VACCINE RESEARCH AND DESIGN" must be typed in.

Submit a signed, typewritten original of the application, including the 
checklist and original appendix (if any), and three signed, exact, single-
sided photocopies of the application (no copies of the appendix), in one 
package 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 mail or courier service)

At the time of submission, two additional exact copies of the grant 
application and all five copies of any appendix material must be sent to Dr. 
Dianne Tingley at the address listed under INQUIRIES.
  
Concurrent submission of an R01 and a Component Project of a Multi-project 
Application:  Current NIH policy permits a component research project of a 
multi-project grant application to be concurrently submitted as a traditional 
individual research project (R01) application.  If, following review, both 
the multi-project 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 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.

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 GCRC as a resource for conducting the proposed research.  If so, 
a letter of agreement from either the GCRC program director or principal 
investigator could be included with the application.

REVIEW CONSIDERATIONS

Review Procedures

Applications will be assigned to NIAID. Upon receipt, applications will be 
reviewed for completeness by the NIH Division of Research Grants.  Incomplete 
applications will be returned to the applicant without further consideration.

P01 applications that are complete and responsive to this PA will be 
evaluated for scientific and technical merit by an appropriate peer review 
group convened by the NIAID.

Review Criteria

Applicants should see the NIAID brochure "INSTRUCTIONS FOR APPLICATIONS FOR 
MULTI-PROJECT AWARDS (April 1999) for review criteria for P01 applications.

AWARD CRITERIA

Applications will compete for available funds with all other 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 announcement, and availability of 
funds.  The NIAID gives special consideration for funding, including award of 
grants beyond the established NIAID percentile and priority score paylines, 
to scientifically meritorious applications in response to Program 
Announcements.

INQUIRIES

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

Requests for the NIAID brochure  INSTRUCTIONS FOR APPLICATIONS FOR MULTI-
PROJECT AWARDS  as well as inquiries regarding programmatic (research scope, 
eligibility and responsiveness) issues may be directed to:

Dr. Steve Bende
Division of AIDS
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Drive, Rm. 4107, MSC 7628
Bethesda, MD 20892-7628
Telephone: (301) 435-3756
Fax: (301) 435-6511
Email: sb22k@nih.gov

Direct inquiries regarding review issues to:
 
Dr. Dianne Tingley
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Dr. Room 2148, MSC 7616
Bethesda, MD  20892-7616
Bethesda, MD  20817 (for express/courier service)
Telephone:(301) 496-0818
FAX: (301) 402-2638
Email: dt15g@nih.gov

Direct inquiries regarding fiscal matters to:

Jane Unsworth
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Drive, Rm. 2128, MSC 7614
Bethesda, MD 20892-7614
Telephone: (301) 402-6824
Fax: (301) 480-3780
Email: ju3a@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalogue of Federal Domestic Assistance No. 
93.856, Microbiology and Infectious Diseases Research, and No. 93.855 - 
Immunology, Allergy, and Transplantation Research. Awards are made under 
authorization of Sections 301 and 405 of the Public Health Service Act as 
amended (42 USC 241 and 284) and administered under NIH grants policies and 
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.  This program 
is not subject to the intergovernmental review requirements of Executive 
Order 12372 or Health Systems Agency review.

The Public Health Service 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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