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Protective Immunity in Special Populations

Solicitation Number: BAA-NIAID-DAIT-NIHAI2010085
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute of Allergy and Infectious Diseases
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BAA-NIAID-DAIT-NIHAI2010085
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Presolicitation
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Added: Jan 15, 2010 4:25 pm
Introduction
Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS) strives to understand, treat and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten billions of human lives. The NIAID Division of Allergy, Immunology, and Transplantation (DAIT) promotes and supports research to enhance the understanding of basic immunology, and the etiology, treatment and prevention of immune-mediated diseases. As part of its biodefense research program, NIAID is issuing a Broad Agency Announcement (BAA) to encourage research to understand the immune status of special populations. The solicitation title is "PROTECTIVE IMMUNITY IN SPECIAL POPULATIONS". The solicitation number is BAA-NIAID-DAIT-NIHAI2010085.

Description
As part of its biodefense research program, NIAID is issuing a Broad Agency Announcement (BAA) to encourage research to understand the immune status of special populations. This research program seeks to identify the factors and mechanisms that contribute to susceptibility to infection from or limit vaccine efficacy against potential bioterrorism agents and emerging/re-emerging infectious diseases in immunocompromised populations, including neonates, children under 5 years of age, pregnant women, the elderly, and individuals receiving immunosuppressive drug therapies to treat a defective immune response or to suppress the rejection of transplanted organs. The continued threat of bioterrorism and greater worldwide spread of emerging/re-emerging infectious diseases underscore the need for vaccines and immune-based therapeutics that can protect the entire population. For example, the number of the most vulnerable individuals, in terms of immune status, is increasing. More effective and better tolerated vaccines and immunotherapies are required for these immunocompromised populations. Research is needed to understand the mechanisms of immune compromise, and to provide the foundation for the development of novel interventions.

For this initiative, special populations are defined as neonates, children under 5 years of age, pregnant women the elderly, and individuals who are receiving immunosuppressive drug therapies to treat a defective immune response or to suppress the rejection of transplanted organs. All of these populations are referred to as ‘immunocompromised' throughout the solicitation. This research program seeks to identify the factors and mechanisms that contribute to increased susceptibility to infection from or limit vaccine efficacy against potential bioterrorism agents and emerging/re-emerging infectious diseases in these immunocompromised populations. The continued threat of bioterrorism and greater worldwide spread of emerging/re-emerging infectious diseases underscore the need for vaccines and immune-based therapeutics that can protect the entire population. More effective and better tolerated vaccines and immunotherapies are required for these immunocompromised populations.

This solicitation is a recompetition of the Immune Function and Biodefense in Children, Elderly and Immunocompromised Populations program, with a focus on the mechanisms of immunosuppression. Although progress has been made towards the original goals of the prior solicitation, further examination of immunocompromised populations is needed. This BAA is soliciting proposals that identify and characterize the mechanistic cause(s) of immune dysfunction as a result of infection, vaccination, or therapeutic interventions against emerging/re-emerging infectious diseases and potential agents of bioterrorism and their toxins (listed as NIAID Emerging and Re-emerging Infectious Diseases and NIAID Category A, B, and C Priority Pathogens). Therefore this solicitation will seek proposals that investigate the mechanisms of immunosuppression in immunocompromised populations. As stated above, immunocompromised populations are defined as the following for this solicitation: neonates and/or young children under 5 years of age, pregnant women, elderly populations, transplant patients receiving immunosuppressive therapy, and patients with autoimmune disorders receiving immunosuppressive therapy. The immunocompromised populations no longer include cancer patients receiving chemotherapy or radiation, and individuals receiving bone marrow transplant with primary immunodeficiency disease or cancer. In addition, this current solicitation no longer supports the development of treatments to enhance immune responses in immunocompromised populations. Funding under the prior solicitation is NOT required for submission to this current solicitation.

Areas of interest for examination under the Protective Immunity in Special Populations Program involve the characterization of immune defects to infection, vaccination, or therapeutic interventions in immunocompromised populations with respect to emerging/re-emerging infectious agents and potential agents of bioterrorism and their toxins. Examples of potential research focus are:

• defects in signaling pathways and regulatory networks of Toll-Like Receptors (TLRs), Nod-Like Receptors (NLRs), and other pathogen recognition molecules;
• altered expression or activation of anti-microbial peptides and other host anti-microbial molecules;
• defects in T cell activation, effector function, and memory;
• deficits in innate immune orchestration of adaptive immune responses;
• changes in T cell repertoire;
• changes in antigen receptor signaling capabilities;
• defects in B cell activation, including plasma cell differentiation, antibody production and class switching, and generation of memory; and
• alterations in antigen processing and presentation events, such as antigen presenting cell maturation, differentiation, and function during infection or following vaccination or immunotherapeutic interventions.


Research teams from all contracts supported by the Protective Immunity in Special Populations program are expected to exchange ideas; share information on technical objectives, progress, and impediments through, for example, annual program progress meetings; and where appropriate, establish collaborations.


Statement of Work: Offeror(s) are required to develop their own Statement of Work. Offerors are advised to limit the amount of proprietary data or markings in their Statement of Work. The final negotiated Statement of Work will be incorporated into the contract upon an award and may be subject to release to the public. If the Statement of Work does include proprietary data or markings, offeror(s) are advised to clearly mark these portions and provide an explanation why these data/markings are proprietary.


All proposals will be evaluated using the following criteria: scientific and technical approaches to address the mandatory components described above; expertise and qualification of the scientific and technical personnel including the principal investigator and the project manager; the project management plan; and facilities, equipment, and other resources.


The NIAID anticipates that one or more cost reimbursement completion-type awards will be made beginning on or about March 1, 2011 utilizing special contracting methods, FAR Subpart 17.1 - Multi-year Contracting. The NIAID estimates that the average annual total cost (direct and indirect costs combined) will be $1.5 million per contract. However, it is anticipated that the total cost for the award(s) may vary depending upon the scope of the project and the technical objectives of the award(s). The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research. In no event shall the period of performance proposed by an offeror exceed five 5 years.


All responsible sources may submit a proposal which shall be considered by the Agency. This BAA will be available electronically on/about January 29, 2010, and may be accessed through FedBizOpps (http://www.fedbizopps.gov). This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.

:
Office of Acquisitions
6700 B Rockledge Room 3214 MSC7612
Bethesda, Maryland 20892-7612
:
George Ralis,
Contract Specialist
Phone: 301-496-0194
:
Donald E Collie,
Contracting Officer
Phone: 301-496-0992
Fax: 301-480-4675