INDO-US VACCINE ACTION PROGRAM STARR GRANTS

Release Date:  May 27, 1999

P.T.

National Institute of Allergy and Infectious Diseases


The National Institute of Allergy and Infectious Diseases (NIAID), 
National Institutes of Health and the Government of India seek to 
continue and expand the INDO-US Vaccine Action Program (VAP) using funds 
provided by the Starr Foundation.  The overall goal of the VAP is to 
support research leading to the development of new or improved vaccines, 
vaccine delivery systems and immunodiagnostic reagents for the 
prevention and detection of infectious diseases of importance to India 
and the United States.  The VAP was created in 1988 and was extended for 
a third five-year period in a Joint Statement signed by the US Secretary 
of Health and Human Services and the Minister of State for Power and 
Science and Technology, Republic of India on November 28, 1997.  The VAP 
has supported collaborative research between US and Indian scientists 
through paired grants to their institutions exchange visits and limited 
training.  This announcement is an invitation for applications for 
research support.  Awards of US dollars under this program will be made 
to US scientists and institutions and will complement the counterpart 
rupee awards made by the Government of India to Indian researchers.

BACKGROUND

The VAP has supported collaborations in research on vaccines and 
immunodiagnostics for the last ten years.  It makes paired awards from 
the US and Indian governments for research conducted by US and Indian 
scientists, respectively.  The awards are based upon successful joint 
applications which are jointly prepared by the US and Indian scientists 
and are submitted simultaneously for review by the US and Indian VAP 
secretariats.  The research addresses the immunology, pathogenesis or 
epidemiology of infectious disease pathogens of importance to the US and 
India that will lead to the development of vaccines or immunodiagnostic 
reagents.  These studies require access to populations (humans, 
pathogens, vectors and/or reservoir hosts) and environmental conditions 
which are available only in India, so it is anticipated that the 
majority of the work will be carried out there.  Current projects focus 
primarily on enteric, respiratory and vector-borne diseases. 

Specific objectives are to: 

o  to identify and characterize pathogen antigens which interact with 
the human host�s immune system and/or play a role in the pathogenesis of 
the disease; 
o  to characterize the human response to a pathogen which may confer or 
block susceptibility to infection or predisposition to one or more 
sequelae of infection; 
o  to evaluate the potential as vaccine candidates or immunodiagnostic 
reagents of selected antigens; 
o  to develop and maintain epidemiological data, including information 
about the animal reservoirs and arthropod vectors of infection, with 
which such candidates may be evaluated; and,
o  to conduct preliminary assessments of the safety, immunogenicity and 
efficacy of candidate vaccines and immunodiagnostic reagents in strict 
accordance with the relevant guidelines and regulations of the US and 
Indian governments.

Additional objectives are to encourage the development of collaborative 
relationships that increase relevant research experience for both U.S. 
and Indian scientists, and to stimulate self-sufficiency of the 
collaborating foreign institution and thus strengthen the scientific 
infrastructure for further international collaborations.  

ELIGIBILITY

Applications may be submitted by collaborating Indian and US scientists 
from eligible institutions.  Eligible institutions include public and 
private, non-profit research and/or scientific organizations, such as 
universities, colleges, hospitals, laboratories, units of State and 
local governments, and eligible agencies of the Federal government in 
both countries.

MECHANISMS OF SUPPORT FOR THE US PARTNER

Funds for this research are provided by the Starr Foundation.

Extramural US scientists will be eligible for supplements to current 
grants or R03 grant awards of up to three years of $50,000 direct costs 
per year from the NIAID.  US Federal scientists will be eligible for 
support of comparable duration and scope as the extramural scientists 
and will be funded by interagency agreements from the NIAID.  Indian 
scientists and institutions are eligible for awards from the Indian 
Department of Biotechnology.

Funds to be awarded through this announcement are grant funds.  
Responsibility for the planning, direction, and execution of the 
proposed research for all applicable mechanisms of support will be 
solely that of the applicant.

SPECIAL REQUIREMENTS

Recipients of awards under the INDO US Vaccine Action Program 
Announcement will be strongly encouraged to attend the annual meeting of 
the INDO US VAP Joint Working Group (JWG).  This meeting is held in the 
US and India in alternate years, so it is expected that the Co-
investigator in whose country the meeting is held will attend the JWG 
meeting and present an oral report of the progress made under the award.  
Requested budgets should include support for this participation.

These studies require access to populations (humans, pathogens, vectors 
and/or reservoir hosts) and environmental conditions which are available 
only in India.  The expectation is the majority of the research effort 
will be carried out in India but that the US laboratory will make a 
substantial and significant contribution to the overall research effort.  
Recipients of VAP awards must agree in advance to an equitable 
distribution of any intellectual property interest that is developed as 
a result of the research.  The expectation is both Co-investigators will 
share in authorship of publications which derive from the work and any 
patents that are filed in either country will reflect the jointly held 
intellectual property interest of the two investigators and their 
institutions.

STUDY POPULATIONS

Clinical studies must meet the requirements for protection of human 
subjects of research and clinical trials are subject to additional 
requirements for conduct and monitoring of the intervention being 
studied.

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 sub-populations must be included in all NIH supported 
biomedical and behavioral research projects involving human subjects, 
unless a clear, compelling rationale, and justification are 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", 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 which is available via the 
WWW. at: 
https://grants.nih.gov/grants/guide/notice-files/not94-100.html

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

Investigators may obtain copies from these sources or from Dr. Aultman 
who may also provide additional relevant information concerning the 
policy.

APPLICATION PROCEDURES

The application process involves two stages, a Letter of Intent and, if 
invited, a full application (VAP Proposal).  Each of these documents 
must be prepared jointly by the two co-investigators (US and Indian) and 
submitted simultaneously to the secretariats in India and the United 
States for review.

Applications are to be submitted on the grant application form that is 
available from the program offices in Bethesda, Maryland, USA and New 
Delhi, India.  Applications will be accepted year round.  The 
application should cite the title of this notice (INDO-US VACCINE ACTION 
PROGRAM STARR GRANTS) and identify the requested mechanism of funding 
[supplement to current NIAID grant or R03 grant]).

The completed, signed original and the legible, single-sided copies (see 
below for number of copies needed) of the application must be sent or 
delivered to:

For USA (5 copies), mail to:
VAP Program Officer
6003 Executive Blvd
Room 3A11             
Rockville, MD 20852
USA

For India (25 copies), mail to:
Director
Indian VAP Secretariat
Department of Biotechnology 
Block 2, Seventh Floor Block 2, Seventh Floor
CGO Complex, Lodhi Road
New Delhi, 110003
India

REVIEW CONSIDERATIONS

Review Procedures

Applications submitted by the two investigators will be reviewed 
simultaneously by NIAID and by the VAP APEX Committee of the Government 
of India.  The VAP APEX committee meets on an as needed basis to 
consider the pool of available applications.  Approval of both 
committees is required before an award can be made.  For additional 
information about the Government of India review, contact:

Principal Scientific Officer
Department of Biotechnology
CGO Complex
New Delhi, India

NIAID Review: A review will be conducted by the NIAID, to evaluate 
applications that are complete and responsive to this PA for scientific 
and technical merit.  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, and assigned a priority score.

Review Criteria

NIAID Review

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

INDIAN Review: Information about this review can be obtained from the 
Department of Biotechnology at the address given above.

AWARD CRITERIA

Only those applications which are approved by both the US and Indian 
secretariats will be eligible for funding.  Funding decisions will be 
based on the quality of the proposed project as determined by 
application review, program balance among research areas of the 
announcement, the strength of the proposed collaboration and 
availability of funds.
 
INQUIRIES

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

Inquiries may be directed to:

Kathryn S. Aultman, Ph.D.
VAP Program Officer
Division of Microbiology & Infectious Diseases
National Institute of Allergy and Infectious Diseases
Solar Building, Room 3A11
6003 Executive Blvd.
Bethesda, MD 20892-7640
Telephone: (301) 496-2544
Fax:       (301) 402 0659
EMAIL:     KA6Z@nih.gov

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