RESEARCH ON DNA VACCINES FOR INFECTIOUS DISEASES

NIH GUIDE, Volume 22, Number 22, June 18, 1993



PA NUMBER:  PA-93-096



P.T. 34



Keywords:

  AIDS 

  Vaccine 

  Immunology 

  Pathogenesis 



National Institute of Allergy and Infectious Diseases



PURPOSE



The National Institute of Allergy and Infectious Diseases (NIAID)

plays a central role in the support of biomedical research on the

design and evaluation of candidate vaccines for the development of

high priority vaccines to prevent diseases.  To fulfill its mission,

it is crucial that the Division of AIDS and the Division of

Microbiology and Infectious Diseases, NIAID, support promising

additional basic preclinical research on novel vaccine strategies.

The purpose of this program announcement is to solicit applications

from institutions and industry on research that will investigate the

feasibility of the development of clinical-candidate DNA (genetic)

vaccines for the prevention and/or therapy of infectious diseases.

Prior to preparing an application, prospective applicants are

strongly encouraged to consult with NIAID staff.



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, Research on DNA for Infectious Diseases, is related to

the priority areas of HIV infection and Women's Health Research.

Potential applicants may obtain a copy of "Healthy People 2000" (Full

Report:  Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary

Report:  Stock No. 017-001-00473-1) through the Superintendent of

Documents, Government Printing Office, Washington, DC 20402-9325,

(telephone 202/783-3238).



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.

Foreign institutions are ineligible for the First Independent

Research Support and Transition (FIRST) (R29) award.  Applications

from minority individuals and women are encouraged.



MECHANISM OF SUPPORT



Applications considered appropriate responses to this announcement

are the traditional research project grants (R01) and the FIRST award

(R29).   Although no funds are specifically set aside for funding

grants submitted in response to this program announcement, the NIAID

regards research in this area as high priority.



Background



Currently, the NIAID is supporting research aimed at the development

of safe and effective vaccines for many infectious diseases,

including AIDS.  Research in this area focuses on live-attenuated

vaccines, liver-vector vaccines, whole-inactivated vaccines, and

novel adjuvant and delivery systems for subunit vaccines.  Results

from recent investigations indicate that DNA vaccines may be an

alternative to live-attenuated vaccines for the prevention of

infectious diseases.  DNA vaccines may offer a safety advantage in

that they need not contain an entire viral genome.  Preliminary

studies show no evidence of integration into host cell DNA.  In

addition, DNA vaccines appear to be superior to peptide vaccines in

eliciting a CTL response.  Funding of research in the area of genetic

vaccines will contribute to an integrated strategy to optimize

protective immune responses to HIV.



RESEARCH OBJECTIVES



The NIAID is committed to support research that will lead to the

development of safe and effective vaccines against HIV and other

infectious diseases.  The objective of this program announcement is

to promote basic research on DNA vaccines, specifically addressing

the special problems encountered in the development of effective

vaccines.  Research utilizing protection studies employing a live

challenge animal model, suitable in vitro virus neutralization

assays, or measurement of cell-mediated immune responses will be

given high priority.  An applicant institution should describe a

research plan in one or more of the following areas of research:



o  Basic research addressing the mechanisms of action of DNA

vaccines.  Research areas may include, for example, studies on the

ability of DNA vaccines to promote cell-mediated immunity including

proliferative and cytotoxic T cell (CTL) responses, or on the ability

of DNA vaccines to stimulate various helper T cell compartments

(e.g., Th1 and Th2 responses).



o  Studies on elicitation of antibody responses through DNA

immunization.  For example, research may focus on strategies to

enhance priming for appropriate antibody class and subclass responses

and for the production of neutralizing antibodies.



o  Research on mucosal immunization through the delivery of

appropriately formulated DNA vaccines to mucosal surfaces and

measurement of antibody and CMI responses generated via the mucosal

route.



o  Research addressing safety concerns for DNA vaccines including the

development of methods to detect persistence of, or integration of

vaccine DNA into host cells (including germ-line cells), and

potential mechanisms of immune pathogenesis resulting from genetic

immunization.



o  Studies addressing improvement of delivery of DNA vaccines to

cells such as investigations of novel delivery systems and routes of

administration.



o  Research on improving the design of DNA vaccines such as the

incorporation of tissue specific promoters or co-expression of

cytokines.



o  Studies addressing optimization of the persistence of an effective

immune response.



Review committees will look most favorably on applications that are

focused.



APPLICATION PROCEDURES



Applications are to be submitted on the grant application form PHS

398 (rev. 9/91).  Application kits are available from most

institutional offices of sponsored research and may be obtained from

the Office of Grants Inquiries, Division of Research Grants, National

Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD

20892, telephone (301) 710-0267.



The budget should include a request for travel funds in the

application each year for a scientific meeting of the applicants

choice.  The request for funds for travel should include an itemized

breakdown of costs, and may not exceed $1,500 per year.



The typed original application and five signed exact single-sided

photocopies must be mailed or delivered to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



REVIEW CONSIDERATIONS



Applications will be assigned on the basis of established PHS

referral guidelines.  Applications will be reviewed for scientific

and technical merit by study sections of the Division of Research

Grants, NIH, and in accordance with the standard NIH peer review

procedures.  Following scientific-technical review, the applications

will receive secondary review by the appropriate national advisory

council.



AWARD CRITERIA



Applications will compete for available funds with other approved

applications.  The following will be considered in making funding

decisions:



o  scientific and technical merit of the application as determined by

peer review

o  availability of funds

o  program balance among research areas of announcement and targeted

infectious diseases



INQUIRIES



Written and telephone inquiries concerning the objectives and scope

of this announcement are encouraged and may be directed to:



HIV RESEARCH

Frederick R. Vogel, Ph.D.

Division of AIDS

National Institute of Allergy and Infectious Diseases

Solar Building, Room 2B06

Bethesda, MD  20892

Telephone:  (301) 496-8200

FAX:  (301) 402-1506



NON-HIV RESEARCH

Regina Rabinovich, M.D.

Division of Microbiology and Infectious Diseases

National Institute of Allergy and Infectious Diseases

Solar Building, Room 3A09

Bethesda, MD  20892

Telephone: (301) 496-8285

FAX:  (301) 402-1506



Direct inquiries regarding fiscal matters to



HIV RESEARCH

Ms. Jane Unsworth

AIDS Grants Management Section

National Institute of Allergy and Infectious Diseases

Solar Building, Room 4B25

Bethesda, MD  20892

Telephone:  (301) 496-7075

FAX:  (301) 480-3780



NON-HIV RESEARCH

Mr. Todd Ball

Microbiology Grants Management Section

National Institute of Allergy and Infectious Diseases

Solar Building, Room 4B25

Bethesda, MD  20892

Telephone:  (301) 496-7075

FAX:  (301) 480-3780



AUTHORITY AND REGULATIONS



This program is supported under authorization of the Public Health

Service Act, Sec. 301 (c), Public Law, 78-410, as amended.  The

Catalogue of Federal Domestic Assistance Citations is Sec. 93.855,

Immunology, Allergy and Transplantation Research, and Sec. 93.856,

Microbiology and Infectious Diseases Research.  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 Agency review.



.

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