INNOVATION GRANT PROGRAM FOR AIDS VACCINE RESEARCH

Release Date:  January 10, 2000

PA NUMBER:  PA-00-044 

National Institute of Allergy and Infectious Diseases

Application Receipt Date:

THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES 
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED 
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA.

PURPOSE

This program announcement (PA) is a continuation of the Innovation Grant 
Program for Approaches in HIV Vaccine Research, implemented by the National 
Institute of Allergy and Infectious Diseases (NIAID), National Institutes of 
Health (NIH), on the recommendation of the AIDS Vaccine Research Committee 
(AVRC).  This program encourages the entrance of novel and innovative vaccine 
discovery and development concepts into the research pipeline.  As such, the 
emphasis of this program is on supporting prophylactic vaccine research 
projects that are particularly innovative, novel, may be high risk/high 
impact, and that exhibit the potential to advance AIDS prophylactic vaccine 
design or evaluation.  Applications are especially welcome from young 
investigators and those not currently active in the field of AIDS research.  
The Innovation Grant Program utilizes a grant mechanism that provides funding 
for projects of an exploratory nature to generate preliminary data for 
further studies.

Applications targeting any scientific area(s) related to AIDS prophylactic 
vaccine research are encouraged.  Before each application receipt date, 
scientific areas of particular importance will be posted on the NIAID website 
http://www.niaid.nih.gov/daids/vaccine/innovation.htm.  These areas are 
chosen based on advice received from the AIDS Vaccine Research Committee 
(AVRC) as a result of its meetings and workshops.  Applicants are strongly 
encouraged to contact program staff and visit the website before submitting 
an application.  Applications for research aimed at these targeted areas are 
especially encouraged, but as explained above, will not be required to focus 
on those areas.

NIH SUPPORT OF RESEARCH ON THIS TOPIC

Although this PA is being issued by NIAID, other components of NIH mentioned 
below also have an interest in, and support research on, the topics covered.  
Applicants may wish to contact each of the NIH components listed in INQUIRIES 
to find out about other funding opportunities.

The National Institute for Dental and Craniofacial Research (NIDCR) has no 
set-aside funds for this PA but will consider supporting highly meritorious 
applications meeting the mission of the Institute.

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 Program Announcement 
(PA),  Innovation Grant Program for AIDS Vaccine Research , is related to the 
priority areas of immunization and infectious diseases, HIV infection, and 
sexually transmitted diseases. Potential applicants may obtain a copy of 
"Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000.

ELIGIBILITY REQUIREMENTS

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

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. 
Complete and detailed instructions and information on Modular Grant 
applications can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm

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.

Applications will request direct costs in $25,000 modules, up to a total 
direct cost of $150,000 per year.  Current policy limits support under the 
R21 grant to two years with no extensions or supplements.  However, awardees 
may request no-cost extensions if they so desire.  A typical modular grant 
application requests the same number of modules in each year.

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 that 
may be available to them. Contact the program staff listed under INQUIRIES 
for further information.

This award is non-renewable.  However, it is hoped that successful grantees 
funded through this exploratory phase program will elect to seek continuing 
support for research further along the development pipeline through the R01 
or P01 grant mechanisms.

The applicant will have full responsibility for the planning, direction, and 
execution of the proposed research.

RESEARCH OBJECTIVES

All pertinent areas of investigation that will contribute toward development 
of an efficacious HIV/AIDS vaccine are welcome.  These might include but are 
not limited to: methods to enhance antigen presentation/processing, 
structural studies of HIV proteins as related to their antigenicity, nucleic 
acid vaccination, non-HIV live virus vaccine vectors, pseudovirion 
approaches, analysis of correlates of immunity, approaches to enhance HIV 
vaccine-induced immunologic memory, and, development of improved assays for 
antibody neutralization, CTL or other immune responses.

To help meet the research objectives defined by NIAID and the AIDS Vaccine 
Research Committee, research applications intended to produce preliminary 
data or precedent for an idea or a concept are particularly encouraged.

Vaccine research solely focused on therapeutic applications is not within the 
scope of this program announcement. The safety evaluation of immunogens in 
infected animals or people can 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

Awardees will be expected to attend a meeting convened by NIAID to showcase 
the progress of the work funded under this program.  Details of this meeting 
will be provided post-award.  Thus, applicants should include in their budget 
request funds for the PI to attend one two-day meeting in the Washington, DC 
area.

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 is provided that inclusion is 
inappropriate with respect to the health of the subjects or 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 in the NIH Guide for Grants and Contracts, Vol. 
23, No. 11, March 18, 1994 available on the web at the following URL address: 
http://grants.nih.gov/grants/guide/notice-files/not94-100.html

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 is available at the following URL 
address:
http://grants.nih.gov/grants/guide/notice-files/not98-024.html

Investigators also may obtain copies of these policies 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 for PHS 398 (rev. 
4/98) and will be accepted on the standard AIDS-related application receipt 
dates as indicated in the application kit.  These forms are available at most 
institutional offices of sponsored research, 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, and on the internet at 
http://grants.nih.gov/grants/funding/phs398/phs398.html

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets. Only 
limited budgetary information is required under this approach. The just-in-
time concept allows applicants to submit certain information only when there 
is a possibility for an award. It is anticipated that these changes will 
reduce the administrative burden for the applicants, reviewers and Institute 
staff.

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 modules, up 
to a total direct cost request of $150,000 per year. The total direct costs 
must be requested in accordance with the program guidelines and the 
modifications made to the standard PHS 398 application instructions described 
below:
 
PHS 398

o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in 
$25,000 increments up to a maximum of $150,000) and Total Costs [Modular 
Total Direct plus Facilities and Administrative (F&A) costs] for the initial 
budget period.  Items 8a and 8b should be completed indicating the Direct and 
Total Costs for the entire proposed period of support.

o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 
of the PHS 398.

o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the 
categorical budget table on Form Page 5 of the PHS 398.  It is not required 
and will not be accepted with the application.

o NARRATIVE BUDGET JUSTIFICATION - Use a Modular Grant Budget Narrative page. 
(See http://grants.nih.gov/grants/funding/modular/modular.htm for sample 
pages.)  At the top of the page, enter the total direct costs requested for 
each year.

o Under Personnel, list key project personnel, including their names, percent 
of effort, and roles on the project.  No individual salary information should 
be provided.

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus facilities and administrative) for each year, each rounded to the 
nearest $1,000.  List the individuals/organizations with whom consortium or 
contractual arrangements have been made, the percent effort of key personnel, 
and the role on the project.  Indicate whether the collaborating institution 
is foreign or domestic.  The total cost for a consortium/contractual 
arrangement is included in the overall requested modular direct cost amount.

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by 
reviewers in the assessment of each individual"s qualifications for a 
specific role in the proposed project, as well as to evaluate the overall 
qualifications of the research team.  A biographical sketch is required for 
all key personnel, following the instructions below.  No more than three 
pages may be used for each person.  A sample biographical sketch may be 
viewed at:
http://grants.nih.gov/grants/funding/modular/modular.htm
- Complete the educational block at the top of the form page,
- List current position(s) and any honors,
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years,
- List selected peer-reviewed publications, with full citations,

o CHECKLIST - This page should be completed and submitted with the 
application.  If the F&A rate agreement has been established, indicate the 
type of agreement and the date. It is important to identify all exclusions 
that were used in the calculation of the F&A costs for the initial budget 
period and all future budget years.

o The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information 
is necessary following the initial review. 

APPLICATIONS NOT CONFORMING TO THESE GUIDELINES WILL BE CONSIDERED 
UNRESPONSIVE TO THIS PA AND WILL BE RETURNED WITHOUT FURTHER REVIEW.

For purposes of identification and processing the application, mark "YES" in 
item 2 on the face page and enter the PA number and the title "Innovation 
Grant Program for AIDS Vaccine Research".

The research plan will be strictly limited to 10 pages total.  Applications 
that exceed the page limit will be returned without review.  An appendix may 
be included in the application, however, the appendix is not to be used to 
circumvent the page limit of the research plan.  Explicit instructions 
concerning what may be included in an appendix can be found in Section 1B 
"General Instructions" for the PHS 398 Grant Application.  Late or incomplete 
applications will not be accepted.

Submit a signed, typewritten original of the application and five signed, 
photocopies, 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/courier service)

The Center for Scientific Review (CSR) will not accept any application in 
response to this PA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already 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.

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral 
guidelines.  Applications will be evaluated for scientific and technical 
merit by an appropriate scientific review group convened in accordance with 
the standard NIH peer review procedures.  As part of the initial merit 
review, all applications will receive a written critique. Only those 
applications deemed to have the highest scientific merit, generally the top 
half of applications under review, will be discussed, assigned a priority 
score, and receive a second level review by the appropriate national advisory 
council or board.

Review Procedures

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments reviewers will be asked to discuss the following aspects 
of the application 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 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 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.

Review Criteria

(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?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research. Plans for the recruitment and retention of subjects will also be 
evaluated.
o The reasonableness of the proposed budget and duration in relation to the 
proposed research
o The adequacy of the proposed protection for humans, animals or the 
environment, to the extent they may be adversely affected by the project 
proposed in the application.

AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications.  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 achieving balanced 
coverage of all AIDS vaccine areas of investigation.

INQUIRIES

Inquiries are strongly encouraged.  The opportunity to clarify any issues or 
questions from potential applicants is welcome.

The Division of AIDS now has a website: 
http://www.niaid.nih.gov/daids/vaccine/default.htm for AIDS vaccine research 
with an emphasis on facilitating participation in applying for AIDS vaccine 
research funds and accessing other resources available to AIDS vaccine 
investigators through the Division.  The website has information describing 
the various programs targeting AIDS vaccine research and listings of 
currently active AIDS vaccine-related program announcements and contracts and 
their associated deadlines.  Updates concerning the continuing Innovation 
Grant Program will also be posted there.

Applicants new to the field of AIDS research are encouraged to explore the 
NIH AIDS Research and Reference Reagent Program and availability of human 
specimens at http://www.niaid.nih.gov/reposit/default.htm.  These programs 
make available small quantities of viruses, antibodies, HIV proteins, 
plasmids, and other reagents to researchers. 

Direct inquiries regarding programmatic issues to:

Dr. Steve Bende
Division of AIDS
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Dr, Room 4107, MSC 7628
Bethesda, MD  20892-7628
Rockville, MD 20817 (for express/courier service)
Telephone:  (301) 435-3756
FAX:  (301) 435-6511
Email:  sb22k@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Jeanette Gordon
Grants Management Branch
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Drive, Room 2234 - MSC 7614
Bethesda, MD 20892-7614
Telephone:  (301) 402-6580
FAX:  (301) 480-3780
Email:  pf49e@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.855 and 93.856. Awards are made under authorization of the Public Health 
Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 
99-158, 42 USC 241 and 285) and administered under NIH grants policies and 
Federal Regulations 42 CFR 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 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, and 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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