CFAR Administrative Supplements in "Outside-the-Box" AIDS Vaccine Discovery – FY2009 Awards

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PURPOSE

The purpose of this administrative supplement announcement is two fold:

• The first purpose is to support a broad range of highly innovative discovery research in the basic disciplines. This includes novel assay/technology development, immunology, virology, cellular and structural biology and host genetics that potentially can lead to expanded knowledge, and novel concepts and approaches applicable to the design of an effective prophylactic HIV vaccine
• The second purpose is to foster new investigators who have not yet received an NIH award in AIDS research as well as established investigators in non-HIV fields who have never received an NIH research award for HIV/AIDS studies. It is intended that this funding will provide support for development of preliminary data in support of an NIH application.

Applications must clearly demonstrate how the proposed research will directly contribute to the design of an effective prophylactic HIV vaccine that prevents infection and/or disease. This is especially important if the development of a new technology or assay is proposed.

BACKGROUND

The identification of a safe and effective prophylactic vaccine to prevent HIV infection and disease is among the highest priorities of NIAID. Major gaps exist in our basic understanding of how to develop a vaccine that prevents HIV infection and/or controls disease progression. In September 2007 the Merck STEP Trial was halted after the MRKAd5 trivalent vaccine was judged to be ineffective and potentially harmful. The NIAID convened a Vaccine Summit in March 2008 to solicit ideas from investigators/attendees about the status of the field and the research approaches that should be pursued to reinvigorate the effort. One of the strongest recommendations was to substantially invest in fostering new discoveries that improve understanding of the types of immune responses most relevant in preventing HIV infection, and novel approaches for generating those responses. Advancement toward these goals will require a broader base of discovery research in virology, immunology, cellular and structural biology, and host genetics. Furthermore, major advances in these fields are often preceded by advances in fields such as physics where new discoveries can inform design of more sophisticated measurement techniques. It is for these reasons that new, truly “outside-the-box” approaches to vaccine design including transfer of new information in the physical sciences to biological areas of investigation is encouraged.

Support is designed to promote studies in these areas to assist investigators in the development of preliminary data, or begin a program, that can enable long-term funding by standard research funding mechanisms, such as R21, R01, P01, etc. CFARs are strongly encouraged to identify projects appropriate for collaborative efforts with investigators and disciplines not usually involved in AIDS vaccine development that will utilize the strengths of each group. Mentoring of junior scientists is strongly encouraged as appropriate. Studies that are an expansion of previously funded CFAR supplements, or previously submitted or funded NIH applications are not eligible for funding under this announcement.

ELIGIBILITY REQUIREMENTS

The grantee institution must be a currently funded CFAR institution that will have at least one year remaining in its current project period at the time of the supplement award, assumed to be July 1, 2009.

Each CFAR is limited to submitting a maximum of two applications. CFARs are encouraged to collaborate with other CFARs. Core and program groups within the CFAR institution are encouraged to collaborate on their applications, and to collaborate with appropriate individuals not currently involved in AIDS research.

Project leaders are restricted to new investigators (please see NIH definition of new investigator) and to established investigators in non-HIV fields who have never received an NIH research award for HIV/AIDS studies. Mentorship and collaboration by the project director with established AIDS investigators is strongly encouraged.

FUNDING SUPPORT

Grants will be made as one year supplements. The maximum funding allowed per application is $100,000 Direct Costs. Awards are dependent upon the scientific merit of the applications and funding availability. Funding will be as a supplement to the Developmental Core with funds restricted for the proposed funded study(s).

RESEARCH OBJECTIVES

The primary goal of this program is to build research capacity at the CFAR institution in the area of vaccine discovery. This supplement is intended to complement ongoing domestic and International HIV/AIDS research efforts of the NIH and, in the case of international collaborations, to respond to the research priorities in the foreign country.

REQUIREMENTS

Applications will include: the background and rationale for the proposed study; a description of the activities to be undertaken, and roles of key staff; expected outcome of these activities; expected follow-up plan upon completion of the supplement; a description of how the supplement and follow-up plan are expected to achieve this outcome (“value-added”); and plans to monitor and evaluate the ability of the activities to achieve the outcome. Most importantly, applicants must clearly indicate how the proposed research activities are expected to lead to development of an HIV vaccine. Mentorship and collaborations must be explained as appropriate.

If the research plan involves clinical studies or work with clinical samples the applicant must:

• Show evidence of approval from domestic (including collaborating US institutions) IRBs, documentation of human subjects training for all key personnel.

Before any funds can be expended for a research plan involving clinical studies or work with clinical samples in a foreign country, the grantee institution must:

• Show evidence of approval from domestic (including collaborating US institutions), and foreign IRBs, documentation of human subjects training for all key personnel, evidence of OHRP required project assurance, and any required approval from the appropriate foreign government officials, per the standard in that country. Additional information can be found at the OHRP website.
• Further NIH-initiated administrative actions are required for ALL international studies (NOTE: this also includes the CFAR International Checklist requirement), especially for human subject research.

NOTE: Studies involving clinical trials are not allowed.

APPLICATION INSTRUCTIONS

Applicants are asked to submit, by March 2, 2009, supplement application(s) following the instructions for competing supplements in the PHS 398 with the following modifications:

Face Page:

• Item 1. Enter a descriptive title of the supplement application limited to 56 characters, including punctuation and spaces, just as for NIH grants
• Item 2. Enter CFAR Supplement for AIDS Vaccine Discovery.
• Item 3. Enter name of CFAR PI, and following this name, in parentheses the name of the project director. (Example: Dr. Bill Jones (CFAR PI); Dr. John Smith (Project Director).
• Include the NIH budget pages showing direct cost, indirect cost and total cost.
• NO other support. This information will be required for all applications that will be funded. NIH will request complete and up to date “other support” information at an appropriate time after review.
• NO resource page (unless there are new resources that will be used for this study)
• NO appendices (except for glossies that have reproduced in the research plan)

Checklist:

• TYPE OF APPLICATION. Check SUPPLEMENT box and enter your CFAR grant number.
• Applicants must state that all required federal citations for PHS grants wil be met (e.g., human subjects, animal welfare, data sharing, etc.)

SUBMITTING AN APPLICATION

For applications in response to this supplement announcement the page limitation is FIVE (5) pages for the research plan, excluding letters of collaboration, the PHS398 form pages, checklist, budget and biosketches, and human subjects or animal care and use information.

Submit a letter of collaboration endorsing the proposed study from each of the following participants: investigator performing the study and any collaborators, foreign investigator(s) (if applicable), foreign institution (if applicable).

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies, plus the application on a CD in one package to:

Ann Namkung Lee, M.P.H.
Program Officer
Basic Sciences Program
Division of AIDS
National Institute of Allergy and Infectious Diseases, NIH, DHHS
Room 4211
6700-B Rockledge Drive
Bethesda, MD 20892-7620
Telephone: (301) 496-9176
FAX: (301) 402-3211
E-mail: anamkung@niaid.nih.gov

Applications must be received (not postmarked) by March 2, 2009. If an application is received after that date, it will be returned to the applicant without review.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed by the CFAR program officer for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to this announcement, the application will be returned without review.

Applications that are complete and responsive to the announcement will be evaluated for scientific and technical merit by an internal NIH review group convened by the NIAID in accordance with standard NIH review procedures.

REVIEW CRITERIA

The following criteria apply to all applications. Each of these criteria will be addressed and considered by the reviewers, weighing them as appropriate for each request. The administrative supplement request does not need to be strong in all categories in order for it to receive a favorable evaluation. Factors to be considered in the evaluation of each application include:

Significance – The effect that a collaborative competitive supplement would have on the overall AIDS vaccine discovery effort at the institution(s).

1. Evidence that the proposed project(s) will enhance new, “outside the box” multidisciplinary collaborations, that may include international collaboration, collaboration with industry, collaboration with junior or minority investigators, or collaboration with other CFAR sites.
2. The extent to which the supplement will address AIDS vaccine development (“value-added” of the supplemental monies)

Approach – The quality of the CFAR scientific project proposed, including planning, management, and training (as appropriate) process

3. Project design and appropriate core selection
4. Utilization or development of unique and appropriate expertise, technology, and resources at the CFAR institution(s), and at the international site, as appropriate
5. The adequacy of the described plans to monitor the impact of the competitive supplemental award.
6. The quality and appropriateness of mentorship and collaboration that is planned.

Innovation - The identification of a unique, “outside-the-box” approach to solve a significant question or gap in AIDS vaccine research

7. The degree of variety/novelty in scientific disciplines that are included in proposed scientific projects, especially including areas not usually involved in HIV vaccine development.
8. The degree of innovation in project selection and experimental design.

Investigator - Choice of appropriate scientists to lead the identification and development of the collaborative competitive supplement project

9. Choice of appropriate competitive supplement project leader and participating investigators for individual collaborative projects proposed: scientific qualifications, commitment, and experience.
10. The choice of collaborators and mentors available within and outside of the CFAR, as appropriate.

Environment – The likelihood that the proposed project will lead to the development of an HIV vaccine

11. Availability of appropriate scientific expertise
12. The potential and intent to collaborate with other institutions and to coordinate program activities with related efforts of other CFARs, NIH programs, other federal agencies (e.g., CDC and USAID), international organizations (e.g., UNAIDS), and NGOs
13. Previous history of support for developmental projects and outcomes, and for training
14. Evidence that scientific collaborative areas and projects arise from the complementary scientific environment at the CFAR institution(s)

In addition, for applications involving international collaborations:

15. The demonstration of interest for international collaboration with scientists from developing countries, and emerging democracies, and institutions included in the proposed competitive supplement.
16. The demonstration of continued or of future support for the program from governments, and either institutions or other non-governmental organizations from collaborating countries.

Reviewers will also examine the appropriateness of the budget, in consideration of the research environment, for the scientific projects and cores.

ALLOWABLE COSTS

Funding may be requested for any category normally funded by a CFAR grant that is required to fulfill the goals of the proposed study, and must be fully justified.

SCHEDULE FOR APPLICATIONS

AWARD CRITERIA

The following will be considered in making awards:

• quality of the proposed project as determined by the NIH convened internal review panel, and relevance to the ability of the proposed project to lead to development of an AIDS vaccine
• funding availability;
• program and geographic balance among the scientific areas.

INQUIRIES

Prospective applicants are strongly encouraged to discuss their applications, including proposed collaborating countries and institutions, with the NIH contacts below.

For questions concerning eligibility of the CFAR to respond to this announcement, and any other administrative issues:

Ann Namkung Lee, M.P.H.
Program Officer
Basic Sciences Program
Division of AIDS
National Institute of Allergy and Infectious Diseases, NIH, DHHS
Room 4211
6700-B Rockledge Drive
Bethesda, MD 20892-7620
Telephone: (301) 496-9176
FAX: (301) 402-3211
E-mail: anamkung@niaid.nih.gov

For questions concerning the scientific research plan:

Janet M. Young, Ph.D.
Program Officer
Basic Sciences Program
Division of AIDS
National Institute of Allergy and Infectious Diseases, NIH, DHHS
Room 4152
6700-B Rockledge Drive
Bethesda, MD 20892-7620
Telephone: (301) 496-6714
FAX: (301) 402-3211
E-mail: jy6r@nih.gov

For questions concerning budget and fiscal matters:

Deanna L. Ingersoll
Grants Management Specialist, DEA, GMP
National Institute of Allergy and Infectious Diseases, NIH, DHHS
6700B Rockledge Drive, Room 2262
Bethesda, MD 20892-7614
Telephone: 301-451-2686
Fax: 301-493-0597
Email: ingersolld@niaid.nih.gov